40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for...

340
1554 Emanera esomeprazole (esomeprazole magnesium) capsules gastro- resistant 40mg, in blister (7/1x7/, 14/2x7/, 15/3x5/, 28/4x7/, 30/3x10/, 56/8x7/, 60/6x10/) KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Slovenia A02BC05 14185 06.02.2015 06.02.2020 PoM KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto, Slovenia 1555 Emend fosaprepitant (fosaprepitant dimeglumine) powder lyophilized for solution for infusion 150mg, 10ml glass vial Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem - secondary packager, batch releaser (bulk manufacturer, primary packager - Patheon Manufacturing Services LLC, 5900 Martin Luther King Jr. Higway, Greenville, North Carolina 27834, USA) the Netherlands A04AD12 12302/3 19.08.2016 22.03.2018 PoM Schering-Plough Central East AG, Weystrasse 20, P.O. Box CH-6000 Lucerne 6, Switzerland 1556 Emend fosaprepitant (fosaprepitant dimeglumine) powder lyophilized for solution for infusion 150mg, 10ml glass vial (1) Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem - secondary packager, batch releaser (bulk manufacturer, primary packager - Patheon Manufacturing Services LLC, 5900 Martin Luther King Jr. Higway, Greenville, North Carolina 27834, USA) the Netherlands A04AD12 16883 08.08.2017 08.08.2022 PoM Schering-Plough Central East AG, Weystrasse 20, P.O. Box CH-6000 Lucerne 6, Switzerland 341

Transcript of 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for...

Page 1: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1554 Emanera

esomeprazole

(esomeprazole

magnesium)

capsules gastro-

resistant

40mg,

in blister (7/1x7/, 14/2x7/,

15/3x5/, 28/4x7/,

30/3x10/, 56/8x7/,

60/6x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BC05 1418506.02.2015

06.02.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1555 Emend

fosaprepitant

(fosaprepitant

dimeglumine)

powder lyophilized

for solution for

infusion

150mg,

10ml glass vial

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

secondary packager,

batch releaser (bulk

manufacturer,

primary packager -

Patheon

Manufacturing

Services LLC, 5900

Martin Luther King

Jr. Higway,

Greenville, North

Carolina 27834, USA)

the Netherlands A04AD12 12302/319.08.2016

22.03.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1556 Emend

fosaprepitant

(fosaprepitant

dimeglumine)

powder lyophilized

for solution for

infusion

150mg,

10ml glass vial (1)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

secondary packager,

batch releaser (bulk

manufacturer,

primary packager -

Patheon

Manufacturing

Services LLC, 5900

Martin Luther King

Jr. Higway,

Greenville, North

Carolina 27834, USA)

the Netherlands A04AD12 1688308.08.2017

08.08.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

341

Page 2: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1557 Emoxypine emoxipine drops eye (solution)10mg/ml,

5ml glass vial

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus S01XA 1289507.10.2013

07.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

1558 Emoxypine emoxipine drops eye (solution)10mg/ml,

5ml vial-dropper

Belmedpreparaty

RUE, 220007, Minsk,

Mayakovskogo St., 1 ,

No 5

Belarus S01XA 1728926.12.2017

26.12.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1559Emoxypine-

Belmedemoxypine solution for injection

10mg/ml,

1ml ampoules,

in blister (10/1x10/,

5/1x5/, 10/2x5/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus N07XX 1423620.02.2015

20.02.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1560Emoxypine-

Belmedemoxypine

solution for i/v and

i/m injection

30mg/ml,

5ml ampoules (5/1x5/,

10/2x5/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus N07XX 1681522.06.2017

22.06.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1561Ena+HCT-Denk

20/12,5

enalapril (enalapril

maleate),

hydrochloro-

thiazide

tablets20mg+12,5mg,

in blister (30/3x10/)

Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luchow

Germany C09BA02 1252801.06.2013

01.06.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

1562 Ena-Denk 10enalapril (enalapril

maleate)tablets

10mg,

in blister (30/3x10/)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C09AA02 1264604.07.2013

04.07.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

1563 Ena-Denk 20enalapril (enalapril

maleate)tablets

20mg,

in blister (30/3x10/)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C09AA02 1264704.07.2013

04.07.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

342

Page 3: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1564 Enalaprilenalapril (enalapril

maleate)tablets

5mg,

blisters (30/3x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09AA02 13529/111.07.2016

30.05.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

1565 Enalaprilenalapril (enalapril

maleate)tablets

10mg,

blisters (30/3x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09AA02 13530/111.07.2016

30.05.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

1566 Enalaprilenalapril (enalapril

maleate)tablets

20mg,

blisters (30/3x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09AA02 13531/111.07.2016

30.05.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

1567 Enalaprilenalapril (enalapril

maleate)tablets

5mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus C09AA02 1367708.07.2014

08.07.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1568 Enalaprilenalapril (enalapril

maleate)tablets

10mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus C09AA02 1367808.07.2014

08.07.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1569 Enalaprilenalapril (enalapril

maleate)tablets

20mg,

in blister (20/2x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C09AA02 1682110.07.2017

10.07.2022PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

343

Page 4: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1570 Enalaprilenalapril (enalapril

maleate)tablets

10mg,

in blister (20/2x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C09AA02 1682210.07.2017

10.07.2022PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1571 Enalaprilenalapril (enalapril

maleate)tablets

5mg,

in blister (20/2x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C09AA02 1682310.07.2017

10.07.2022PoM

for Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1572 Enalapril-H

enalapril (enalapril

maleate),

hydrochloro-

thiazide

tablets10mg+25mg,

in blister (20/2x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC09BA02 13966

04.11.2014

04.11.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1573Enalapril-H-

Zdorovye

enalapril (enalapril

maleate),

hydrochlorothia-

zide

tablets

10mg+25mg,

in blister (20/1x20/,

30/1x30/, 40/2x20/,

60/2x30/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine C09BA02 1636730.12.2016

30.12.2021PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

1574 Enapenalapril (enalapril

maleate)tablets

2,5mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA02 1303525.11.2013

25.11.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1575 Enapenalapril (enalapril

maleate)tablets

5mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA02 1639210.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1576 Enapenalapril (enalapril

maleate)tablets

20mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA02 1639310.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

344

Page 5: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1577 Enapenalapril (enalapril

maleate)tablets

10mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA02 1639410.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1578 Enap enalaprilat solution for injection

1,25mg/ml,

1ml ampoules, in blister

(5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia 1694905.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1579 Enap-H

enalapril (enalapril

maleate),

hydrochlorothiazid

e

tablets10mg+25mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA02 1639610.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1580 Enap-HL

enalapril (enalapril

maleate),

hydrochlorothiazid

e

tablets10mg+12,5mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA02 1639510.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1581 Enap-HL 20

enalapril (enalapril

maleate),

hydrochloro-

thiazide

tablets20mg+12,5mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA02 1567008.06.2016

08.06.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1582 Enbrel etanerceptsolution for s/c

injection

50mg/ml,

1ml glass pre-filled

syringes (4),

alcohol swabs (4)

Wyeth

Pharmaceuticals, New

Lane, Havant,

Hampshire PO9 2NG

- secondaryt packager,

batch releaser (dosage

form manufacturer -

Pfizer Ireland

Pharmaceuticals,

Grange Castle

Business Park,

Clondalkin, Dublin

22, Ireland)

UK L04AB01 1257306.06.2013

06.06.2018PoM

Pfizer LTD, Ramsgate

Road, Sandwich,

CT13 9NJ, Kent, UK

345

Page 6: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1583 Enbrel etanerceptsolution for s/c

injection

50mg/ml,

1ml pre-filled glass pen-

syringes (4) and (4)

alcohol swabs

Wyeth

Pharmaceuticals, New

Lane, Havant, PO9

2NG - batch releaser,

secondary packager,

Pfizer Ireland

Pharmaceuticals,

Grange Castle

Business Park,

Clondalkin, Dublin

22, Ireland-bulk

manufacturer, Vetter

Pharma-Fertigung,

Eisenbahnstr. 2-4,

Langenargen, Baden-

Wuerttemberg,

88085, Germany-

primary packager

UK L04AB01 1702826.09.2017

26.09.2022PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York 10017, USA

1584 EnciferIron sucrose

complex

solution for i/v

injection

20mg/ml,

5ml ampoules (5)

Emcure

Pharmaceuticals Ltd.,

Plot NO. J-174, J-168,

J-168/1, MIDC,

Tarapur, Boisar,

Thane 401506,

Maharashtra State

India B03AC 1509715.12.2015

15.12.2020PoM

Emcure

Pharmaceuticals Ltd.,

T-184, M.I.D.C.,

Bhosari, Pune-

411026, Maharashtra,

India

1585 Eneas

enalapril (enalapril

maleate),

nitrendipine

tablets10mg+20mg,

in blister (30/3x10/)

Ferrer International,

S.A., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain C09BB06 1625619.12.2016

19.12.2021PoM

Ferrer International,

S.A., Gran Via Carlos

III, 94, 08028,

Barcelona, Spain

1586 Enerion sulbutiamine tablets coated200mg,

in blister (20/2x10/)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France A11DA02 1683610.07.2017

10.07.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

346

Page 7: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1587 Engerix B Adult

hepatitis B surface

antigene

(recombinant DNA)

suspension for

injection

20mcg/ml,

pre-filled syringe/(1 dose)

and needle

GlaxoSmithKline

Biologicals s.a., Rue

de l' Institut, 89 B-

1330 Rixensart-batch

releaser, bulk

manufacturer, Glaxo

SmithKline

Biologicals NL der

SmithKline Beecham

Pharma GmbH & Co.

K.G., Zirkusstrasse 40,

01069 Dresden

Germany- packager

BelgiumJ07BC01;

vaccine16312

30.12.2016

30.12.2021PoM

GlaxoSmithKline

Biologicals s.a., Rue

de l` Institut, 89 B-

1330 Rixensart,

Belgium

1588 Engerix B Junior

hepatitis B surface

antigene

(recombinant DNA)

suspension for

injection

10mcg/0,5ml,

pre-filled syringe/(1 dose)

and needle

GlaxoSmithKline

Biologicals s.a., Rue

de l' Institut, 89 B-

1330 Rixensart-batch

releaser, bulk

manufacturer, Glaxo

SmithKline

Biologicals NL der

SmithKline Beecham

Pharma GmbH & Co.

K.G., Zirkusstrasse 40,

01069 Dresden

Germany- packager

BelgiumJ07BC01;

vaccine16313

30.12.2016

30.12.2021PoM

GlaxoSmithKline

Biologicals s.a., Rue

de l` Institut, 89 B-

1330 Rixensart,

Belgium

1589 Enroflox enrofloxacin solution for injection50mg/ml,

100ml glass vial

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

Spain

QJ01MA90;

veterinary

drug

1507907.12.2015

07.12.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

347

Page 8: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1590

ENROVETo-20

oral solution

A.U.V.

enrofloxacin solution oral200mg/ml,

1000mll plastic bottle

Laboratories Biove, 3

Rue Lorraine, BP45, F-

62510 Arques-

packager, batch

releaser, Pernix

Pharma

Gyogyszergyarto Kft,

H-8900 Zalaegerszeg,

Eszaki Iparterulet,

Kamilla u.3, Hungary-

bulk manufacturer

France

QJ01MA90;

veterinary

drug

1526822.01.2016

22.01.2021PoM

V.M.D. NV, Hoge

Mauw 900, 2370

Arendonk, Belgium

1591 Enterofuryl nifuroxazide suspension oral

200mg/5ml,

90ml suspension in 125ml

glass bottle and plastic

measuring spoon

(2.5ml/5ml)

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaA07AX03 16380

30.12.2016

30.12.2021PoM

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo, Bosnia And

Herzegovina

1592 Enterofuryl nifuroxazide capsules100mg,

in blister (30/3x10/)

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaA07AX03 16943

05.09.2017

05.09.2022PoM

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo, Bosnia And

Herzegovina

1593 Enterofuryl nifuroxazide capsules200mg,

in blister (16/2x8/)

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaA07AX03 16944

05.09.2017

05.09.2022PoM

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo, Bosnia And

Herzegovina

1594 Enterogermina

spores of

polyantibiotic-

resistant Bacillus

clausii

suspension oral2x10^9/5ml,

5ml plastic vials (10)

Sanofi-Aventis S.p.a.,

Viale Europa 11,

21040 Origgio (VA)

Italy A07FA 1475303.08.2015

03.08.2020OTC

Sanofi-Aventis S.p.a.,

Viale Europa 11,

21040 Origgio (VA),

Italy

348

Page 9: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1595 Enterokind

chamomilla D6,

cina D6, colocynthis

D6, lac defloratum

D6, magnesium

chloratum D6

drops oral (solution)

100mg/g+ 100mg/g+

100mg/g+ 100mg/g+

100mg/g,

20ml glass container

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe

Germany

A03A;

homeopathic

drug

1678922.06.2017

22.06.2022OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

1596 Enterol 250

lyophilized cells of

saccharomyces

boulardii

powder for oral

suspension

250mg,

sachets (10)

Biocodex,1 avenue

Blaise Pascal, 60000

Beauvais

France A07FA02 1230422.03.2013

22.03.2018OTC

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

1597 Enterol 250

lyophilized cells of

saccharomyces

boulardii

capsules250mg,

in glass bottle (10)

Biocodex,1 avenue

Blaise Pascal, 60000

Beauvais

France A07FA02 1230522.03.2013

22.03.2018OTC

Biocodex, 7 avenue

Gallieni 94250

Gentilly, France

1598 Entoban

holarrhena

antidysenterica,

myrtus communis,

berberis aristata,

aegle marmelos,

quercus infectoria,

butea frondosa

capsules

400mg+400mg+

100mg+100mg+

100mg+100mg,

in plastic container (20,

60)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900

PakistanA07XA;

herbal drug15241

25.12.2015

25.12.2020OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900,

Pakistan

1599 Entrop phenylpiracetam tablets

100mg,

in blister (10/1x10/,

20/2x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX 1690108.08.2017

08.08.2022PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1600 Enzix

I-enalapril

(enalapril maleate),

II-indapamide

tablets and film-

coated tablets

I-10mg, II-2,5mg,

(30/3x10//5-I tablets +5-II

film-coated tablets/) in

blister

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse

Russia C09BA02 1602917.10.2016

17.10.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1601 Enzix Duo

I-enalapril

(enalapril maleate),

II -indapamide

tablets and film-

coated tablets

I-10mg, II-2,5mg,

(45/3x15//10 I tablets + 5

II film-coated tablets/) in

blister

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse

Russia C09BA02 1602817.10.2016

17.10.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

349

Page 10: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1602 Enzix Duo Forte

I-enalapril

(enalapril maleate),

II-indapamide

tablets and film-

coated tablets

I-20mg, II-2,5mg,

(45/3x15/10-I tablets +5 II-

film coated tablets/) in

blister

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse

Russia C09BA02 1603017.10.2016

17.10.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1603 Epiduoadapalene, benzoyl

peroxidegel

1mg/g+25mg/g,

5g, 15g and 30g plastic

tube, 15g and 30g plastic

multidose container with

airless pump

Laboratoires

Galderma Z.I.

Montdesir, 74540

Alby-sur-Cheran

France D10AD53 1665611.05.2017

11.05.2022PoM

Galderma SA,

Zugerstrasse 8, CH-

6330 Cham,

Switzerland

1604 Equoral ciclosporin capsules soft25mg,

in blister (50/5x10/)

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic L04AD01 1378705.09.2014

05.09.2019PoM

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

1605 Equoral ciclosporin capsules soft50mg,

in blister (50/5x10/)

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic L04AD01 1378805.09.2014

05.09.2019PoM

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

1606 Equoral ciclosporin capsules soft100mg,

in blister (50/5x10/)

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic L04AD01 1378905.09.2014

05.09.2019PoM

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

1607 Equoral ciclosporin solution oral

100mg/ml,

a syringe and a dropper in

a plastic container and

50ml glass bottle

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic L04AD01 1379005.09.2014

05.09.2019PoM

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

350

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1608 Ercefuryl nifuroxazide capsules200mg,

in blister (28/2x14/)

Sanofi Winthrop

Industrie, 6,

Boulevard de l Europe

21800 Quetigny

France A07AX03 1524730.12.2015

30.12.2020PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014 Paris,

France

1609 Erexesilsildenafil (sildenafil

citrate)tablets coated

25mg,

in blister (1/1x1/, 4/1x4/,

8/2x4/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser

(Atlantic Pharma -

Producoes

Farmaceuticas S.A.,

Rua da Tapada

Grande,No 2,

Abrunheira 2710-089

Sintra, Portugal - bulk

manufacturer,

packager)

Hungary G04BE03 1379105.09.2014

05.09.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1610 Erexesilsildenafil (sildenafil

citrate)tablets coated

50mg,

in blister (1/1x1/, 4/1x4/,

8/2x4/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser

(Atlantic Pharma -

Producoes

Farmaceuticas S.A.,

Rua da Tapada

Grande,No 2,

Abrunheira 2710-089

Sintra, Portugal - bulk

manufacturer,

packager)

Hungary G04BE03 1379205.09.2014

05.09.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

351

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1611 Erexesilsildenafil (sildenafil

citrate)tablets coated

100mg,

in blister (1/1x1/, 4/1x4/,

8/2x4/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser

(Atlantic Pharma -

Producoes

Farmaceuticas S.A.,

Rua da Tapada

Grande,No 2,

Abrunheira 2710-089

Sintra, Portugal - bulk

manufacturer,

packager)

Hungary G04BE03 1379305.09.2014

05.09.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1612 Erfamectin ivermectin solution for injection10mg/ml,

50ml glass vial

Erfan Darou

Pharmaceutical

Company, 19th street,

Second phase,

Hashtgerd industrial

city, Tehran

Iran

QP54AA01;

veterinary

drug

1686611.07.2017

11.07.2022PoM

Erfan Darou

Pharmaceutical

Company, 19th

street, Second phase,

Hashtgerd industrial

city, Tehran, Iran

1613 Erfamycin LA

oxytetracycline

(oxytetracycline

dihydrate)

solution for injection200mg/ml,

50ml glass vial

Erfan Darou

Pharmaceutical

Company 19th street,

Second phase,

Hashtgerd industrial

city, Tehran

Iran

QS01AA04;

veterinary

drug

13446/107.07.2017

06.05.2019PoM

Erfan Darou

Pharmaceutical

Company 19th street,

Second phase,

Hashtgerd industrial

city, Tehran, Iran

1614Ergocalciferol

(Vitamin D2)ergocalciferol solution oil

1,25mg/ml (50000IU),

10ml glass bottle

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region

Ukraine A11CC01 1236919.04.2013

19.04.2018PoM

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region,

UKRAINE

352

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1615 Ergoferon

affinity purified

antibodies to

human interferon

gamma, affinity

purified antibodies

to histamine,

affinity purified

antibodies to CD4

tablets to be sucked

6mg+6mg+6mg,

in blister (20/1x20/,

40/2x20/, 100/5x20/)

NPF Materia Medica

Holding Ltd., 54,

Buguruslanskaya st.,

Chelyabinsk 454139

Russia

J05AX; R06A;

homeopathic

drug

12511/121.01.2014

01.06.2018OTC

NPF Materia Medica

Holding Ltd., 9 bld.,

3rd Samotyochny

per., Moscow 127473,

Russia

1616 Ermucin erdosteine capsules

300mg,

in blisters (10/1x10/,

20/2x10/)

Angelini Pharma

Ceska republika s.r.o.,

Paterni 1216/7, 635

00 Brno - packager,

batch releaser,

(Edmond Pharma

S.r.l., Strada Statale

dei Giovi no.131,

20037 Paderno

Dugnano (MI), Italy -

bulk manufacturer)

Czech Republic R05CB15 14476/224.07.2017

30.04.2020PoM

"UAB" MRA Totoriu

st. 20-9, LT-01121

Vilnius, Republic of

Lithuania

1617 Ermucin erdosteinegranules for oral

solution

225mg,

4,425g sachets (20)

Angelini Pharma

Ceska republika s.r.o.,

Paterni 1216/7, 635

00 Brno - packager,

batch releaser,

(Edmond Pharma

S.r.l., Strada Statale

dei Giovi no.131,

20037 Paderno

Dugnano (MI), Italy -

bulk manufacturer)

Czech Republic R05CB15 14477/224.07.2017

30.04.2020PoM

"UAB" MRA Totoriu

st. 20-9, LT-01121

Vilnius, Republic of

Lithuania

353

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1618 Ermucin erdosteinegranules for oral

suspension

175mg/5ml,

100ml glass bottle

Angelini Pharma

Ceska republika s.r.o.,

Paterni 1216/7, 635

00 Brno - packager,

batch releaser,

(Edmond Pharma

S.r.l., Strada Statale

dei Giovi no.131,

20037 Paderno

Dugnano (MI), Italy -

bulk manufacturer)

Czech Republic R05CB15 14478/224.07.2017

30.04.2020PoM

"UAB" MRA Totoriu

st. 20-9, LT-01121

Vilnius, Republic of

Lithuania

1619 Erolin loratadine tablets

10mg,

in blister (10/1x10/,

30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary R06AX13 1669323.05.2017

23.05.2022OTC

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1620 Erynit Tatpharmpentaerithrityl

tetranitratetablets

10mg,

blisters (50/5x10/)

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C01DA05 14334/130.12.2016

25.03.2020PoM

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

1621 Erythromycin

erythromycin

(erythromycin

ethylsuccinate)

tablets200mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01FA01 12203

07.03.2013

07.03.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1622 Erythromycin erythromycintablets enteric-

coated

100mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk region

Belarus J01FA01 12374/116.05.2016

19.04.2018PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk

region, Belarus

354

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1623 Erythromycin erythromycintablets enteric-

coated

250mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk region

Belarus J01FA01 12375/116.05.2016

19.04.2018PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1624 Erythromycin

erythromycin

(erythromycin

ethylsuccinate)

tablets400mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01FA01 12639

25.06.2013

25.06.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

1625 Erythromycin

erythromycin

(erythromycin

ethylsuccinate)

solution for topical

use

20mg/ml,

30ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD10AF02 12879

19.09.2013

19.09.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1626 Erythromycin erythromycingranules for oral

suspension

40mg/ml,

40g glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

Armenia

D10AF02,

J01FA01,

S01AA17

1397221.11.2014

21.11.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1627 Erythromycin erythromycin ointment eye10mg/g,

10g aluminium tube

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia S01AA17 1463703.07.2015

03.07.2020PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

1628 Erythromycin erythromycintablets gastro-

resistant coated

200mg,

in blister (16/1x16/)

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw

Poland J01FA01 1555812.05.2016

12.05.2021PoM

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw, Poland

355

Page 16: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1629Erythromycin

ointmenterythromycin ointment

10mg/g,

20g, 25g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD10AF02 14083/1

14.04.2015

16.12.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1630 Escapelle levonorgestrel tablets1,5mg,

in blister (1)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AC03 1446522.04.2015

22.04.2020OTC

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

1631 Escitalopram

escitalopram

(escitalopram

oxalate)

tablets coated10mg,

in blisters (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN06AB10 16873

31.07.2017

31.07.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1632 Esfolenessential

phospholipids

solution for i/v

injection

50mg/ml,

5ml glass vials (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaA05C 14407

16.04.2015

16.04.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1633 Esita

escitalopram

(escitalopram

oxalate)

tablets film-coated5mg,

in blister (20/2x10/)

Healthcare

Pharmaceuticals

Limited, Gazaria Para,

Rajendrapur, Gazipur

Bangladesh N06AB10 1576104.07.2016

04.07.2021PoM

Healthcare

Pharmaceuticals

Limited, Probashi

Kallyan Bhabon 71-

72, Old Elephant

Road, Eskaton

Garden, Dhaka-1000,

Bangladesh

356

Page 17: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1634 Esita

escitalopram

(escitalopram

oxalate)

tablets film-coated10mg,

in blister (20/2x10/)

Healthcare

Pharmaceuticals

Limited, Gazaria Para,

Rajendrapur, Gazipur

Bangladesh N06AB10 1576204.07.2016

04.07.2021PoM

Healthcare

Pharmaceuticals

Limited, Probashi

Kallyan Bhabon 71-

72, Old Elephant

Road, Eskaton

Garden, Dhaka-1000,

Bangladesh

1635 Eslidin

lipoid PPL-400

(phospholipids),

methionine

capsules300mg+100mg,

in blister (30/3x10/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A05C 15876/115.09.2017

23.08.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1636 Eslidin

lipoid PPL-400

(phospholipids),

methionine

capsules300mg+100mg,

in blister (30/3x10/)

Makiz-Pharma LLC, 6

Avtomobilny proezd,

buildings 4, 6, 8,

109029, Moscow

Russia A05C 15877/115.09.2017

23.08.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1637 Eslidin

lipoid PPL-400

(phospholipids),

methionine

capsules300mg+100mg,

in blister (30/3x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia A05C 1713907.11.2017

07.11.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1638 Esmeron

rocuronium

(rocuronium

bromide)

solution for injection10mg/ml,

5ml glass vial (10)

N.V. Organon,

Molenstraat 110, 5342

CC OSS - secondary

packager, batch

releaser (Hameln

Pharmaceutical

GmbH, Langes Feld

13, 31789 Hameln,

Germany - bulk

manufacturer,

primary packager)

the Netherlands M03AC09 1349830.05.2014

30.05.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

357

Page 18: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1639 Esmeron

rocuronium

(rocuronium

bromide)

solution for injection10mg/ml,

5ml glass vial (10)

N.V. Organon,

Molenstraat 110, 5342

CC OSS

the Netherlands M03AC09 1678322.06.2017

22.06.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

1640 Esmyaulipristal (ulipristal

acetate)tablets

5mg,

in blister (28/2x14/,

84/6x14/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary

G03AD02;

new

indication

13211/124.02.2014

24.02.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1641 EsoMed-40

esomeprazole

(esomeprazole

magnesium

trihydrate)

tablets gastro-

resistant

40mg,

in strip (100/10x10/)

Perdaman

Pharmaceuticals Pvt.

Ltd., G/5 & G/6

Gorwa B.I.D.C., City

Vadodara-390 016,

dist. Vadodara

India A02BC05 1387806.10.2014

06.10.2019PoM

Perdaman

Pharmaceuticals Pvt.

Ltd., Level-11, A-111,

Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

1642Esomeprazol

Sandoz

esomeprazole

(esomeprazole

sodium)

powder for solution

for injection and

infusion

40mg,

glass vial (1, 5, 10)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia A02BC05 1578920.07.2016

20.07.2021PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1643Esomeprazol

SANDOZ 20mg

esomeprazole

(esomeprazole

magnesium

dihydrate)

tablets gastro-

resistant

20mg,

in blister (14/2x7/,

28/4x7/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany A02BC05 1619116.11.2016

16.11.2021PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1644Esomeprazol

SANDOZ 40mg

esomeprazole

(esomeprazole

magnesium

dihydrate)

tablets gastro-

resistant

40mg,

in blister (14/2x7/,

28/4x7/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany A02BC05 1619016.11.2016

16.11.2021PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

358

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1645 Espolcapsicum spissum

extract

ointment for

external use

100mg/g,

30g aluminium tube

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

RussiaM02AB;

herbal drug13640/1

21.12.2016

27.06.2019OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1646 Espumisan simethicone capsules soft40mg,

in blister (25/1x25/)

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125,

12489 Berlin-

packager, batch

releaser, Catalent

Germany Eberbach

GmbH,

Gammelsbacherstrass

e 2, D-69412

Eberbach, Germany-

bulk manufacturer

Germany A03AX13 1422120.02.2015

20.02.2020OTC

Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin,

Germany

1647 Espumisan simethicone capsules soft40mg,

in blister (25/1x25/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, Catalent

Germany Eberbach

GmbH,

Gammelsbacherstrass

e 2, D-69412

Eberbach, Germany-

bulk manufacturer,

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany- packager

Germany A03AX13 1551419.04.2016

19.04.2021OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

1648 Espumisan L simethicone emulsion oral40mg/ml,

30ml glass vial-dropper

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125,

12489 Berlin

Germany A03AX13 1422220.02.2015

20.02.2020OTC

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125,

12489 Berlin,

Germany

359

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1649 Essentiale forte Nphospholipids

(essential)-EPLcapsules

300mg,

in blister (30/3x10/)

A. Nattermann & Cie.

GmbH,

Nattermannallee 1, D-

50829 Cologne

Germany A05C 1713007.11.2017

07.11.2022OTC

Casella-med GmbH &

Co. KG,

Gereonsmuhlengasse

1, 50670 Cologne,

Germany

1650 Essliver Forte

essential

phospholipids,

thiamine (thiamine

mononitrate),

riboflavin,

pyridoxine

(pyridoxine

hydrochloride),

nicotinamide, alpha-

tocopherol acetate,

cyanocobalamin

capsules

300mg+6mg+6mg+6mg+6

mg+30mg+ 6mcg,

in blister (30/3x10/,

50/5x10/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7-

batch releaser,

secondary packager,

Nabros Pharma Pvt.

Ltd., Survey

No110/A/2 Amit

Farm, Jain Upasrya,

N.H. No. 8 Kajipura,

Kheda, 387411,

Gujarat, India- bulk

manufacturer,

primary packager

Russia A05C 1650117.03.2017

17.03.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1651 Estrinorm estriol suppositories vaginal0,5mg

(15/3x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G03CA04 1325424.02.2014

24.02.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

1652 Etacizin ethacizine tablets coated50mg,

in blister (50/5x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia C01BC09 1598815.09.2016

15.09.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1653Ethambutol

Hydrochloride

ethambutol

(ethambutol

hydrochloride)

tablets film-coated400mg,

in blister (672/24x28/)

Macleods

Pharmaceuticals Ltd.,

Plot No 25-27, Sr. No

366, Premier Ind.

Estate, Kachigam,

Daman-396210 (UT)

India J04AK02 1601706.10.2016

06.10.2021PoM

Macleods

Pharmaceuticals Ltd.,

304, Atlanta Arcade,

Marol Church

Road,Andheri (East),

Mumbai-400 059,

India

360

Page 21: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1654Ethambutol

Hydrochloride

ethambutol

(ethambutol

hydrochloride)

tablets film-coated100mg,

in blister (100/10x10/)

Macleods

Pharmaceuticals Ltd.,

Plot No 25-27, Sr. No

366, Premier Ind.

Estate, Kachigam,

Daman-396210 (UT)

India J04AK02 1601806.10.2016

06.10.2021PoM

Macleods

Pharmaceuticals Ltd.,

304, Atlanta Arcade,

Marol Church

Road,Andheri (East),

Mumbai-400 059,

India

1655 Etoposid-Ebewe etoposideconcentrate for

solution for infusion

20mg/ml,

5ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01CB01 1451615.05.2015

15.05.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

1656 Etruzil letrozole tablets coated

2,5mg,

in blister (30/3x10/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120-batch releaser,

Synthon Hispaina,

S.L., Castello,

1,Poligono Las

Salines, 08830 Sant

Boi De Llobregat,

Spain-bulk

manufacturer,

primary and

secondary packager

Hungary L02BG04 1506102.12.2015

02.12.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

361

Page 22: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1657 Etruzil letrozole tablets coated

2,5mg,

in blister (30/3x10/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Synthon Hispaina,

S.L., Castello,

1,Poligono Las

Salines, 08830 Sant

Boi De Llobregat,

Spain - bulk

manufacturer,

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh, Germany-

primary and

secondary packager

Hungary L02BG04 1506202.12.2015

02.12.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1658 Euphyllin aminophylline tablets150mg,

in blister (30/3x10/)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia D10AF02 1281117.09.2013

17.09.2018PoM

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

1659 Euphyllin aminophyllinesolution for i/v

injection

24mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaR03DA05 15636

24.05.2016

24.05.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1660 Euphylline aminophylline tablets

150mg,

in blister (30/3x10/,

30/2x15/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia R03DA05 1390330.09.2014

30.09.2019PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

362

Page 23: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1661 Euphylline aminophylline tablets

150mg,

in blister (10/1x10/,

30/3x10/, 10)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus R03DA05 1562224.05.2016

24.05.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1662 Euphyllinum aminophylline solution for injection

24mg/ml,

5ml ampoules label

banderol (10), 5ml

ampoules, dividella

(10/2x5/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus R03DA05 1394329.10.2014

29.10.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1663 Eurespal

fenspiride

(fenspiride

hydrochloride)

tablets film-coated80mg,

in blister (30/2x15/)

Les Laboratoires

Servier Industrie, 905,

route de Saran, 45520

Gidy

France R03DX03 1604017.10.2016

17.10.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot 92284

Suresnes cedex,

France

1664 Eurespal syrup

fenspiride

(fenspiride

hydrochloride)

syrup2mg/ml,

150ml plastic bottle

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy- batch releaser,

Les Laboratoires

Servier Industrie-

Fleury les Aubrais,

326 rue Marcellin

Berthelot, Fleury les

Aubrais, 45407,

France-bulk

manufacturer,

packager

France R03DX03 1603917.10.2016

17.10.2021PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

363

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1665 Eurobiol 25000lipase, amylase,

proteasecapsules hard

25000U+22500U+1250U,

glass bottle (20, 50, 100)

Laboratoires Mayoly

Spindler, 6 avenue de

l`Europe B.P.

5178401 Chatou

Cedex -batch releaser,

Nordmark

Arzneimittel GmbH

& Co. KG,

Pinnauallee 4, 25436

Uetersen, Germany-

bulk manufacturer,

packager

France A09AA02 1465603.07.2015

03.07.2020OTC

Laboratoires Mayoly

Spindler, 6 avenue de

l`Europe B.P.

5178401 Chatou

Cedex, France

1666 Eurofer

iron (III) hydroxide

polymaltose

complex

syrup

10mg/ml,

30ml, 60ml, 120ml glass

bottle

Osoth Inter

Laboratories Co., Ltd.,

600/9 Moo 11,

Sukhaphiban 8 Road,

Nong Kham, Si Racha,

Chonburi 20230

Thailand B03AB05 1469716.07.2015

16.07.2020PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

1667 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets25mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1356010.06.2014

10.06.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1668 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets50mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1356110.06.2014

10.06.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1669 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets75mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1356210.06.2014

10.06.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

364

Page 25: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1670 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets125mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1356310.06.2014

10.06.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1671 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets150mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1356410.06.2014

10.06.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1672 Euthyrox

levothyroxine

(levothyroxine

sodium)

tablets100mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03AA01 1390030.09.2014

30.09.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1673 Evica

saraca indica,

symplocos

racemosa, valeriana

wallichi, matricaria

chamomilla, vitex

agnus castus, areca

catechu

capsules

150mg+50mg+

50mg+50mg+

50mg+50mg,

in plastic container (20,

60)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900

PakistanG02C

herbal drug 13849

18.09.2014

18.09.2019PoM

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900,

Pakistan

1674 Excedrin

paracetamol,

acetylsalicylic acid,

caffeine

tablets film-coated250mg+250mg+ 65mg,

in blister (10/1x10/)

Novartis Consumer

Health Inc., 10401

Highway 6, Lincoln,

NE 68517

USA N02BE71 1629630.12.2016

30.12.2021OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, Case postale

269, 1260 Nyon,

Switzerland

1675 Exforge

amlodipine

(amlodipine

besilate), valsartan

tablets film-coated

5mg+160mg,

in blister (14/1x14/,

28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain C09DB01 1559313.05.2016

13.05.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

365

Page 26: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1676 Exforge

amlodipine

(amlodipine

besilate), valsartan

tablets film-coated

10mg+160mg,

in blister (14/1x14/,

28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain C09DB01 1559413.05.2016

13.05.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1677 Exforge

amlodipine

(amlodipine

besilate), valsartan

tablets film-coated

5mg+80mg,

in blister (14/1x14/,

28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain C09DB01 1559513.05.2016

13.05.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1678 Exforge H

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

5mg+160mg+ 12,5mg,

in blister (14/1x14/,

28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria, 158, 08210

Barbera del Valles,

Barcelona

Spain C09DX01 1317310.01.2014

10.01.2019PoM

Novartis Pharma AG,

56, Lichtstrasse, 4056

Basel, Switzerland

1679 Exforge H

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

10mg+160mg+ 12,5mg,

in blister (14/1x14/,

28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria, 158, 08210

Barbera del Valles,

Barcelona

Spain C09DX01 1317410.01.2014

10.01.2019PoM

Novartis Pharma AG,

56, Lichtstrasse, 4056

Basel, Switzerland

1680

Exforge HCT

10mg/160mg/

25mg

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

10mg+160mg+ 25mg,

in blister (14/1x14,

28/2x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland C09DX01 1569206.06.2016

06.06.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

1681

Exforge HCT

10mg/160mg/12.5

mg

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

10mg+160mg+ 12,5mg,

in blister (14/1x14/,

28/2x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland C09DX01 1569006.06.2016

06.06.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

366

Page 27: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1682

Exforge HCT

5mg/160mg/

12.5mg

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

5mg+160mg+ 12,5mg,

(14/1x14/), in blister,

(28/2x14/), in blister

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland C09DX01 1568906.06.2016

06.06.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

1683Exforge HCT

5mg/160mg/25mg

amlodipine

(amlodipine

besilate), valsartan,

hydrochloro-

thiazide

tablets film-coated

5mg+160mg+25mg;

(14/1x14/), in blister,

(28/2x14/), in blister

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland C09DX01 1569106.06.2016

06.06.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

1684 Exjade deferasirox tablets dispersible250mg,

in blister (28/4x7/)

Novartis Pharma

Stein AG

(Schaffhauserstrasse,

4332 Stein)

Switzerland V03AC03 1291107.10.2013

07.10.2018PoM

Novartis Pharma AG

(Switzerland 35,

Lichtstrasse, 4056

Basel, Switzerland)

1685 Exjade deferasirox tablets dispersible500mg,

in blister (28/4x7/)

Novartis Pharma

Stein AG

(Schaffhauserstrasse,

4332 Stein)

Switzerland V03AC03 1291207.10.2013

07.10.2018PoM

Novartis Pharma AG

(Switzerland 35,

Lichtstrasse, 4056

Basel, Switzerland)

1686 Exoderilnaftifine (naftifine

hydrochloride)

solution for external

use

10mg/ml,

10ml, 20ml glass vial

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl - batch

releaser (dosage form

manufacturer,

packager -

Globopharm

Pharmazeutische

Produktions-und

Handels GmbH.,

Breitenfurter Strasse

251, 1231 Wien,

Austria)

Austria D01AE22 12673/125.12.2015

04.07.2018OTC

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

367

Page 28: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1687 Exoderilnaftifine (naftifine

hydrochloride)

cream for external

use

10mg/g,

15g aluminium tube

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl - batch

releaser (dosage form

manufacturer,

packager -

Globopharm

Pharmazeutische

Produktions-und

Handels GmbH.,

Breitenfurter Strasse

251, 1231 Wien,

Austria)

Austria D01AE22 1267404.07.2013

04.07.2018OTC

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

1688 Exoderilnaftifine (naftifine

hydrochloride)

cream for external

use

10mg/g,

15g aluminium tube

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl - batch

releaser, Merck KGaA

& Co., Werk Spittal,

Hosslgasse 20, 9800

Spittal an der Drau,

Austria- bulk

manufacturer,

packager

Austria D01AE22 1718628.11.2017

28.11.2022OTC

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

1689 Exoderilnaftifine (naftifine

hydrochloride)

solution for external

use

10mg/ml,

10ml and 20ml glass vial

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl - batch

releaser, Globopharm

Pharmazeutische

Produktions-und

Handels GmbH.,

Breitenfurter Strasse

251, 1230 Wien,

Austria- bulk

manufacturer,

packager

Austria D01AE22 1718728.11.2017

28.11.2022OTC

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

368

Page 29: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1690 Expectorant

guaifenesin,

chlorpheniramine

(chlorpheniramine

maleate),

phenylpropanolami

ne

(phenylpropanolam

ine hydrochloride)

syrup with cherry

flavour

100mg/5ml+

2mg/5ml+5mg/5ml, 60ml

glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR05FB01 16292

21.12.2016

21.12.2021OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1691Extract

Belladonnae extract belladonnae suppositories rectal

15mg,

in blister (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A03BA04;

herbal drug 16875

08.08.2017

08.08.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1692Extractum Aloes

fluidumaloe liquid extract solution for injection

360mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

Armenia

A16AX10

herbal drug 13861

18.09.2014

18.09.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1693 Eylea aflibercept solution for injection

40mg/ml,

0.278ml glass vial (1) and

needle

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin- batch

releaser, secondary

packager, Regeneron

Pharmaceuticals, Inc.,

81 Columbia

Turnpike, Rensselaer,

New York 12144,

USA- bulk

manufacturer, Vetter

Pharma-Fertigung

GmbH & Co. KG,

Eisenbahnstr. 2-4,

88085 Langenargen,

Germany- primary

packager

Germany S01LA05 1702326.09.2017

26.09.2022PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

369

Page 30: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

16945-Fluorouracil

Ebewefluorouracil

concentrate for

solution for infusion

50mg/ml,

5ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BC02 1474903.08.2015

03.08.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

16955-Fluorouracil

Ebewefluorouracil

concentrate for

solution for infusion

50mg/ml,

10ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BC02 1475003.08.2015

03.08.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

1696 9 months Folic acid folic acid tablets film-coated0.4mg,

in blister (30/3x10/)

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia B03BB01 15723/108.11.2017

22.06.2021PoM

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2,

Russia

1697 Falimintacetylaminonitropr

opoxybenzenetablets coated

25mg,

in blister (20)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, packager

(dosage form

manufacturer - Berlin-

Chemie AG,

Tempelhofer Weg 83,

12347 Berlin,

Germany)

Germany R02A 1326510.03.2014

10.03.2019OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

1698 Famotidine famotidine tablets film-coated40mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A02BA03 1591123.08.2016

23.08.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

370

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1699 Famotidine famotidine tablets film-coated20mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A02BA03 1591223.08.2016

23.08.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1700 Famvir famciclovir tablets film-coated125mg,

in blister (10/1x10/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain J05AB09 1548331.03.2016

31.03.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1701 Famvir famciclovir tablets film-coated250mg,

in blisters (21/3x7/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain J05AB09 1548431.03.2016

31.03.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1702 Famvir famciclovir tablets film-coated

500mg,

in blisters (14/2x7/,

30/3x10/, 56/8x7)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain J05AB09 1548531.03.2016

31.03.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1703Farmorubicin

Rapid Dissolution

epirubicin

(epirubicin

hydrochloride)

powder lyophilized

for solution for

infusion

10mg,

glass vial, 5ml solvent in

ampoules (1)

Actavis Italy S.p.A.,

Nerviano Plant, Viale

Pasteur 10, 20014

Nerviano (Milan)

Italy L01DB03 1318710.01.2014

10.01.2019PoM

Pfizer Italia S.r.l., via

Isonzo 71-04100

Latina, Italy

371

Page 32: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1704Farmorubicin

Rapid Dissolution

epirubicin

(epirubicin

hydrochloride)

powder lyophilized

for solution for

infusion

50mg,

glass vial (1)

Actavis Italy S.p.A.,

Nerviano Plant, Viale

Pasteur 10, 20014

Nerviano (Milan) for

Pfizer Italia S.r.l., via

Isonzo 71-04100

Latina, Italy

Italy L01DB03 1318810.01.2014

10.01.2019PoM

Pfizer Italia S.r.l., via

Isonzo 71-04100

Latina, Italy

1705 Fasigyn tinidazole tablets film-coated500mg,

in blister (4/1x4/)

Fareva Amboise, Zone

Industrielle, 29 route

des Industries, 37530

Poce-sur-Cisse

France P01AB02 1544202.04.2016

02.04.2021PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

1706 Faspic ibuprofen tablets film- coated

400mg,

in blister (6/1x6, 12/2x6/,

24/4x6/, 30/5x6/)

Zambon S.P.A., Via

della Chimica, 9,

Vicenza, 36100

Italy M01AE01 1726413.12.2017

13.12.2022OTC

Zambon S.P.A., Via

Lillo del Duca, 10,

Bresso, 20091, Italy

1707 Fastum gel ketoprofen gel

25mg/g,

30g, 50g and 100g

aluminium tube

A. Menarini

Manufacturing

Logistics and Services

S.r.l., Via Sette Santi,

3 50131 Firenze

Italy M02AA10 1462503.07.2015

03.07.2020PoM

A. Menarini Industrie

Farmaceutiche

Riunite S.r.l., Via

Sette Santi, 3 50131

Firenze, Italy

1708 Fastum gel ketoprofen gel

25mg/g,

100g plastic tube and

pump dispenser

A. Menarini

Manufacturing

Logistics and Services

S.r.l., Via Sette Santi,

3 50131 Firenze

Italy M02AA10 1462603.07.2015

03.07.2020PoM

A. Menarini Industrie

Farmaceutiche

Riunite S.r.l., Via

Sette Santi, 3 50131

Firenze, Italy

372

Page 33: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1709 Febrofid ketoprofen gel for external use25mg/g,

30g, 50g aluminium tube

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Medana

Pharma JSC, str.

Polskiej Organizacji

Wojskowej 57, 98-200

Sieradz, Poland-bulk

manufacturer,

packager

Poland M02AA10 1589123.08.2016

23.08.2021PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

1710 Feiba 25U/mlfactor VIII inhibitor

bypassing activity

powder and solvent

for solution for

infusion

500U (25U/ml), glass vial

with powder (1), glass

vial with 20ml solvent (1),

BaxJect ii Hi-Flow (1),

disposable syringe (1),

disposable needle (1),

butterfly needle with

clamp (1)

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna

Austria B02BD02 16611/102.06.2017

10.04.2022PoM

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna, Austria

1711 Feiba 50U/mlfactor VIII inhibitor

bypassing activity

powder and solvent

for solution for

infusion

1000U (50U/ml), glass

vial with powder (1),

glass vial with 20ml

solvent (1), BaxJect ii Hi-

Flow (1), disposable

syringe (1), disposable

needle (1), butterfly

needle with clamp (1)

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna

Austria B02BD02 16612/102.06.2017

10.04.2022PoM

Baxalta Innovations

GmbH,

Industriestrasse 67, A-

1221 Vienna, Austria

1712 Femaplex letrozole tablets film-coated 2,5mg

Genepharm S.A., 18th

km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L02BG04 1384518.09.2014

18.09.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51

Pallini Attiki, Greece

1713 Femara letrozole tablets film-coated2,5mg,

in bliser (30/3x10/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L02BG04 1220407.03.2013

07.03.2018PoM

Novartis Pharma AG,

Switzerland 56,

Lichtstrasse, 4056

Basel, Switzerland

373

Page 34: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1714 Femara letrozole tablets film-coated2,5mg,

in blister (30/3x10/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L02BG04 1661412.04.2017

12.04.2022PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

1715 Femilex lactic acid suppositories vaginal100mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia G01AD01 13224/215.09.2017

24.02.2019OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1716 Feminon Ccimicifuga racemosa

rhizomecapsules hard

6,5mg,

in blister (60/6x10/)

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532-

batch releaser,

packager,

intermediate product

manufacturer,

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Germany-capsules

filler

GermanyG02C;

herbal drug16464

06.03.2017

06.03.2022OTC

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532

1717 Femoston 1/10

white tablet -

estradiol, gray

tablet - estradiol,

dydrogesterone

tablets film-coated

1mg+1mg+10mg, (28/ 14

white tablets + 14 gray

tablets) in blister

ABBOTT Biologicals

B.V., Veerweg 12,

8121 AA Olst

the Netherlands G03FB08 1271823.07.2013

23.07.2018PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

1718 Femoston 1/5 conti

estradiol (estradiol

hemihydrate),

dydrogesterone

tablets film-coated1mg+5mg,

in blister (28)

ABBOTT Biologicals

B.V., Veerweg 12,

8121 AA Olst

the Netherlands G03FA14 1227322.03.2013

22.03.2018PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

374

Page 35: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1719 Femoston 2/10

pink tablet-

estradiol, yellow

tablet- estradiol +

dydrogesterone

tablets film-coated

2mg+2mg+10mg, (28/14

pink tablets + 14 yellow

tablets/) in blister

ABBOTT Biologicals

B.V., Veerweg 12,

8121 AA Olst

the Netherlands G03FB08 1405019.12.2014

19.12.2019PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

1720 Fenistil gel

dimetindene

(dimetindene

maleate)

gel1mg/g,

30g aluminium tube

Novartis Consumer

Health S.A. (Route de

I`Etraz, 1260 Nyon)

Switzerland D04AA13 1299728.10.2013

28.10.2018OTC

Novartis Consumer

Health S.A. (Route de

I`Etraz, 1260 Nyon,

Switzerland)

1721 Fenistil New

dimetindene

(dimetindene

maleate)

drops oral (solution)1mg/ml,

20ml glass bottle

Novartis Consumer

Health S.A., Route de

I`Etraz, Case postale

269, 1260 Nyon

Switzerland R06AB03 1344316.04.2014

16.04.2019OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, Case postale

269, 1260 Nyon,

Switzerland

1722 Fenistil Pencivir penciclovir cream10mg/g,

2g aluminium tube

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr/Baden

Germany D06BB06 1218301.02.2013

01.02.2018OTC

Novartis Consumer

Health S.A., Route de

l Etraz, 1260 Nyon,

Switzerland

1723 Fenkarol

quifenadine

(quifenadine

hydrochloride)

tablets10mg,

in blister (20/2x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia R06AX31 1571522.06.2016

22.06.2021OTC

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1724 Fenkarol

quifenadine

(quifenadine

hydrochloride)

tablets25mg,

in blister (20/2x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia R06AX31 1571622.06.2016

22.06.2021OTC

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1725 Fenkarol

quifenadine

(quifenadine

hydrochloride)

tablets

50mg,

in blister (15/1x15/,

30/2x15/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia R06AX31 1571722.06.2016

22.06.2021OTC

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1726 Fentanyl fentanyl solution for injection

0,05mg/ml,

2ml ampoules, in blister

(100/20x5)

"KPE" Zdorovje

narodu" LLC, 61002,

Kharkov, Melnikova

str. 41

Ukraine N02AB03 1620708.12.2016

08.12.2021PoM/UC

"KPE" Zdorovje

narodu" LLC, 61013,

Kharkov, Sevchenko

str. 22, Ukraine

375

Page 36: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1727 Fentanyl Kalceks fentanylsolution for i/v and

i/m injection

0,05mg/ml,

2ml ampoules, in blister

(10/2x5/)

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057 - batch

releaser (Sanitas JSC,

134B Veiveriu

street,Kaunas, LT-

46352, Lithuania -

bulk manufacturer,

packager)

Latvia N01AH01 1375425.07.2014

25.07.2019PoM/UC

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057, Latvia

1728 Fentanyl Kalceksfentanyl (fentanyl

citrate)

solution for i/v and

i/m injection

0,05mg/ml,

2ml ampoules, in blister

(10/2x5/, 100/20x5/)

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057- batch

releaser, HBM

Pharma s.r.o.,

Sklabinska 30, 03680

Martin, Slovakia-bulk

manufacturer,

packager

Latvia N01AH01 1536626.02.2016

26.02.2021PoM/UC

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057, Latvia

1729Fentavera 50mcg/h

transdermal patchfentanyl patch transdermal

50mcg/h,

patches (5)

Acino AG, Am

Windfeld 35, 83714

Miesbach

Germany N02AB03 1383418.09.2014

18.09.2019PoM/UC

Acino AG, Am

Windfeld 35, 83714

Miesbach, Germany

1730Fentavera 75mcg/h

transdermal patchfentanyl patch transdermal

75mcg/h,

patches (5)

Acino AG, Am

Windfeld 35, 83714

Miesbach

Germany N02AB03 1383518.09.2014

18.09.2019PoM/UC

Acino AG, Am

Windfeld 35, 83714

Miesbach, Germany

1731 Ferracin IVIron sucrose

complexsolution for injection

20mg/ml,

5ml ampoules (5)

Rafarm S.A., Thesi

Pousi- Hatzi, Agiou

Louka, str. Painania,

Attiki 19002 P.O. Box

37

Greece B03AC02 1357310.06.2014

10.06.2019PoM

Acino AG, Am

Windfeld 35, 83714

Miesbach, Germany

376

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1732 Ferro-Folgamma

iron sulfate, folic

acid,

cyanocobalamin

capsules

112,6mg+5mg+ 0,01mg,

in blister (20/2x10/,

50/5x10/)

C.P.M. Contract

Pharma GmbH & Co.

KG, Fruhling str. 7,

83678 Feldkirchen-

Westerham -

packager, batch

releaser (bulk

manufacturer -

Catalent Germany

Eberbach GmbH,

Gammelsbacher str. 2,

69412 Eberbach,

Germany)

Germany B03AE01 12333/106.08.2014

09.04.2018PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

1733 Ferro-Folgamma

iron sulfate, folic

acid,

cyanocobalamin

capsules

112,6mg+5mg+ 0,01mg;

(20/2x10/) and (50/5x10/)

in blister

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723- batch releaser,

packager, Catalent

Germany Eberbach

GmbH,

Gammelsbacher Str.

2, 69412 Eberbach,

Germany-bulk

manufacturer

Czech Republic B03AE01 1725813.12.2017

13.12.2022PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

1734 Ferropoliron (III) hydroxide

with polymaltosedrops oral

50mg/ml,

30ml glass bottle

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Medana

Pharma JSC, str.

Polskiej Organizacji

Wojskowej 57, 98-200

Sieradz, Poland-bulk

manufacturer,

packager

Poland B03AB05 1678522.06.2017

22.06.2022PoM

for Medana Pharma

JSC, 98-200 Sieradz,

W. Lokietka 10,

Poland

1735 Ferrum Lekiron (III)-hydroxide

dextran complex

solution for i/m

injection

50mg/ml,

2ml ampoules (5, 50)

Lek d.d., Verovskova

Str. 57, 1526 LjubljanaSlovenia B03AC 14412

08.04.2015

08.04.2020PoM

Lek d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

377

Page 38: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1736 Ferrum LEK

iron (III) hydroxide

with polymaltose

complex

tablets chewable100mg,

in blister (30/3x10/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia B03AB05 1677027.06.2017

27.06.2022PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

1737 Ferrum LEK

iron (III) hydroxide

with polymaltose

complex

syrup

50mg/5ml,

100ml glass bottle and

measuring spoon

Sandoz Ilac Sanayi ve

Ticaret A.S., Inoenue

Mahallesi, Gebze

Plastikciler Organize

Sanayi Boelgesi

Atatturk Bulvari 9,

Cadde No.2, 41400,

Kocaeli

Turkey B03AB05 1683710.07.2017

10.07.2022PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

1738 Fervex

paracetamol,

ascorbic acid,

pheniramine

(pheniramine

maleate)

powder for oral

solution with lemon

flavour and sugar

500mg+200mg+ 25mg,

13,1g sachets (8)

UPSA SAS, 979,

avenue des Pyrenees,

47520 Le Passage

France N02BE51 12428/1 24.08.2017

07.05.2018OTC

UPSA SAS, 3, rue

Joseph Monier- 92500

Rueil- Malmaison,

France

1739 Fervex

paracetamol,

ascorbic acid,

pheniramine

(pheniramine

maleate)

powder for oral

solution with

raspberry flavour

and sugar

500mg+200mg+ 25mg,

12,75g sachets (8)

UPSA SAS, 979,

avenue des Pyrenees,

47520 Le Passage

France N02BE51 12429/1 24.08.2017

07.05.2018OTC

UPSA SAS, 3, rue

Joseph Monier- 92500

Rueil- Malmaison,

France

1740 Fervex

paracetamol,

ascorbic acid,

pheniramine

(pheniramine

maleate)

powder for oral

solution with lemon,

sugar free

500mg+200mg+ 25mg,

4,95g sachets (8)

UPSA SAS, 979,

avenue des Pyrenees,

47520 Le Passage

France N02BE51 12989/1 17.08.2017

28.10.2018OTC

UPSA SAS, 3, rue

Joseph Monier- 92500

Rueil- Malmaison,

France

1741 Fevarin

fluvoxamine

(fluvoxamine

maleate)

tablets film-coated50mg,

in blister (15/1x15/)

Abbott Healthcare

SAS, Route de

Belleville, Lieu-dit

Maillard, 01400

Chatillon sur

Chalaronne

France N06AB08 1350330.05.2014

30.05.2019PoM

Abbott Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

378

Page 39: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1742 Fevarin

fluvoxamine

(fluvoxamine

maleate)

tablets film-coated100mg,

in blister (15/1x15/)

Abbott Healthcare

SAS, Route de

Belleville, Lieu-dit

Maillard, 01400

Chatillon sur

Chalaronne

France N06AB08 1350430.05.2014

30.05.2019PoM

Abbott Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

1743 Fexodine

fexofenadine

(fexofenadine

hydrochloride)

tablets film-coated120mg,

in blister (10/1x10/)

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,

Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of

ArmeniaR06AX26 16608

10.04.2017

10.04.2022OTC

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan, Republic of

Armenia

1744 Finalgonnonivamide,

nicoboxilointment

4mg/g+25mg/g, 20g

aluminium tube and

applicator

Boehringer Ingelheim

Pharma GmbH & Co.

KG, Binger Strasse

173, D-55216

Ingelheim am Rhein -

batch releaser (dosage

form manufacturer,

packager -

Globopharm

Pharmazeutische

Produktions-und

Handels GmbH.,

Breitenfurter Strasse

251, 1230 Wien,

Austria)

Germany M02AX10 1313610.01.2014

10.01.2019OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

379

Page 40: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1745

Finasteride 5mg

Film-coated

Tablets

finasteride tablets film-coated5mg,

in blister (28/2x14/)

Accord Healthcare

Limited, Sage House,

319 Pinner Road, North

Harrow, Middlesex,

HA1 4HF - batch

releaser, Intas

Pharmaceuticals

Limited, Plot No 457 &

458 & 191/218 P,

Sarkhej-Bavla Highway,

Matoda Village, Sanand,

District-Ahmedabad,

382 210, Gujarat, India-

bulk manufacturer,

Accord Healthcare

Limited, Unit C & D,

Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK G04CB01 1599519.09.2016

19.09.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1746

Finasteride 5mg

Film-coated

Tablets

finasteride tablets film-coated5mg,

in blister (28/2x14/)

Laboratorios Normon

S.A., Ronda de

Valdecarrizo 6, 28760

Tres Cantos, Madrid -

batch releaser, Intas

Pharmaceuticals

Limited, Plot No 457 &

458 & 191/218 P,

Sarkhej-Bavla Highway,

Matoda Village, Sanand,

District-Ahmedabad,

382 210, Gujarat, India-

bulk manufacturer,

Accord Healthcare

Limited, Unit C & D,

Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

Spain G04CB01 1599619.09.2016

19.09.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

380

Page 41: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1747 Finlepsin carbamazepine tablets200mg,

in blister (50/5x10/)

TEVA Operations

Poland Sp. z o.o,

Mogilska str. 80, 31-

546 Krakow

Poland N03AF01 1221007.03.2013

07.03.2018PoM

TEVA

Pharmaceutical

Industries LTD, 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

1748Finlepsin 200

retardcarbamazepine

tablets prolonged-

release

200mg,

in blister (50/5x10/,

100/10x10/, 200/20x10/)

TEVA Operations

Poland Sp. z o.o,

Mogilska str. 80, 31-

546 Krakow

Poland N03AF01 1221107.03.2013

07.03.2018PoM

TEVA

Pharmaceutical

Industries LTD, 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

1749Finlepsin 400

retardcarbamazepine

tablets prolonged-

release

400mg,

in blister (50/5x10/,

100/10x10/, 200/20x10/)

TEVA Operations

Poland Sp. z o.o,

Mogilska str. 80, 31-

546 Krakow

Poland N03AF01 1221207.03.2013

07.03.2018PoM

TEVA

Pharmaceutical

Industries LTD, 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

1750 Finoptin

verapamil

(verapamil

hydrochloride)

tablets film-coated

40mg,

in plastic container (30,

100)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland C08DA01 1474303.08.2015

03.08.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

1751 Finzepine carbamazepine tablets film-coated

200mg,

in blister (10/1x10/,

50/5x10/, 100/10x10/)

Protech Biosystems

Pvt. Ltd., Plot No 145-

146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001

India N03AF01 13077/121.01.2014

09.12.2018PoM

Protech Biosystems

Pvt. Ltd., Plot No 145-

146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001,

India

1752Fish oil

vitaminizedfish oil capsules

500mg,

in blister (50/5x10/)

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112

Belarus A11CB 1380005.09.2014

05.09.2019OTC

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112, Belarus

381

Page 42: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1753 Fitolizyn

extractum

compositum ex:

solidaginis virgaureae

herba, equiseti herba,

polygoni avicularis

herba, agropyri

rhizomate, allii cepae

squama, betulae folio,

foenugraeci semine,

petroselini radice,

levistici radice , salvia

sclarea aetheroleum,

menthae piperitae

aetheroleum, pini

sylvestris

aetheroleum, aurantii

dulcis aetheroleum

paste for oral use

67,2g+1g+0,5g+

0,2g+0,15g,

100g aluminium tube

Herbapol Warszawa

Sp. z o.o., 05-800

Pruszkow, ul.

Olowkowa 54

Poland G04BX 12578/130.08.2013

06.06.2018OTC

Herbapol Warszawa

Sp. z o.o., 05-800

Pruszkow, ul.

Olowkowa 54, Poland

1754 Fitolizyn

solidaginis

virgaureae herba,

equiseti herba,

polygoni avicularis

herba, agropyri

rhizomate, allii

cepae squama,

betulae folio,

foenugraeci semine,

petroselini radice,

levistici radice thick

extract, salvia

sclarea

aetheroleum,

menthae piperitae

aetheroleum, pini

sylvestris

aetheroleum,

aurantii dulcis

aetheroleum

paste oral

67,2g/100g+ 1g/100g+

0,5g/100g+ 0,2g/100g+

0,15g/100g,

100g aluminium tube

Herbapol Warszawa

Sp. z o.o., 05-800

Pruszkow, ul.

Olowkowa 54

PolandG04BX;

herbal drug17233

08.12.2017

08.12.2022OTC

Herbapol Warszawa

Sp. z o.o., 05-800

Pruszkow, ul.

Olowkowa 54, Poland

382

Page 43: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1755 Flammegis infliximab

powder lyophilized

for concentrate for

solution for infusion

100mg,

in glass vial (1)

Celltrion Inc., 20,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840, the

Republic of Korea

Korea Sourth L04AB02 13353/107.04.2015

04.04.2019PoM

Celltrion Healthcare

Co., Ltd., 19,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840, the

Republic of Korea

1756 Flammegis infliximab

powder lyophilized

for concentrate for

solution for infusion

100mg,

in glass vial (1)

Celltrion Inc., 20,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840, the

Republic of Korea-

batch releaser;

(Mustafa Nevzat Ilac

Sanayii A.S., Sanayi

Caddesi 13,

Yenibosna, Istanbul,

Turkey-bulk

manufacturer,

primary packager);

(Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120, Hungary-

secondary packager)

Korea Sourth L04AB02 13354/107.04.2015

04.04.2019PoM

Celltrion Healthcare

Co., Ltd., 19,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840, the

Republic of Korea

1757Flavamed cough

solution

ambroxol

(ambroxol

hydrochloride)

solution oral

15mg/5ml,

60ml, 100ml glass bottle

and measuring spoon

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin

Germany R05CB06 1442208.04.2015

08.04.2020OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

383

Page 44: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1758Flavamed cough

tablets

ambroxol

(ambroxol

hydrochloride)

tablets

30mg,

in blister (10/1x10/,

20/2x10/, 50/5x10/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

packager,batch

releaser Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347 Berlin,

Germany-bulk

manufacturer

Germany R05CB06 1449715.05.2015

15.05.2020OTC

Berlin-Chemie A.G.,

Glienicker Weg 125,

D-12489 Berlin,

Germany

1759Flavamed cough

tablets

ambroxol

(ambroxol

hydrochloride)

tablets

30mg,

in blister (10/1x10/,

20/2x10/, 50/5x10/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser (bulk

manufacturer -

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany)

Germany R05CB06 1485718.09.2015

18.09.2020OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

1760Flavamed

effervescent tablets

ambroxol

(ambroxol

hydrochloride)

tablets effervescent

60mg,

aluminium or plastic

container (10)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin-batch

releaser (bulk

manufacturer,

primary and

secondary packager-

Hermes Arzneimittel

GmbH, Hans-Urmiler

Ring 52, 82515

Wolfratshausen,

Germany)

Germany R05CB06 1478514.08.2015

14.08.2020OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

1761 Flavamed forte

ambroxol

(ambroxol

hydrochloride)

solution oral (with

raspberry flavor)

30mg/5ml,

100ml glass bottle and

measuring spoon

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin

Germany R05CB06 1442308.04.2015

08.04.2020OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

384

Page 45: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1762 Flazon

metronidazole

(metronidazole

benzoate)

suspension oral

25mg/ml,

100ml glass bottle and

measuring cup

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaP01AB01 13862

18.09.2014

18.09.2019PoM

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

1763 Flazon metronidazole suppositories vaginal500mg,

(10/2x5/)

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaG01AF01 16689

23.05.2017

23.05.2022PoM

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

1764 Flebaven diosmin, hesperidin tablets film-coated

450mg+50mg,

in blister (32/2x16/,

64/4x16/, 96/6x16/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C05CA53 1714107.11.2017

07.11.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1765 Flemoclav Solutab

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets dispersible875mg+125mg,

in blister (14/2x7/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands

J01CR02;

new

indication

14479/130.04.2015

30.04.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1766 Flemoclav Solutab

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets dispersible125mg+31,25mg, in

blister (20/5x4/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CR02 1593529.08.2016

29.08.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1767 Flemoclav Solutab

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets dispersible250mg+62,5mg,

in blister (20/5x4/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CR02 1593629.08.2016

29.08.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

385

Page 46: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1768 Flemoclav Solutab

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets dispersible500mg+125mg,

in blister (20/5x4/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CR02 1593729.08.2016

29.08.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1769 Flemoxin Solutab

amoxicillin

(amoxicillin

trihydrate)

tablets dispersible1000mg,

in blister (20/4x5/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CA04 13611/112.05.2015

27.06.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1770 Flemoxin Solutab

amoxicillin

(amoxicillin

trihydrate)

tablets dispersible125mg,

in blister (20/4x5/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CA04 1593229.08.2016

29.08.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1771 Flemoxin Solutab

amoxicillin

(amoxicillin

trihydrate)

tablets dispersible250mg,

in blister (20/4x5/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CA04 1593329.08.2016

29.08.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1772 Flemoxin Solutab

amoxicillin

(amoxicillin

trihydrate)

tablets dispersible500mg,

in blister (20/4x5/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands J01CA04 1593429.08.2016

29.08.2021PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1773 Flexid

levofloxacin

(levofloxacin

hemihydrate)

tablets film-coated

500mg,

in blister (5/1x5/, 7/1x7/,

10/1x10/, 10/2x5/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia J01MA12 15543/107.06.2016

19.04.2021PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

386

Page 47: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1774 Flixonase

fluticasone

(fluticasone

propionate)

spray nasal

(suspension)

50mcg/dose, glass bottle

fitted with a metering,

atomising pump, nasal

adaptor and a dust cover

(120dose)

Glaxo Wellcome

S.A.Avenida de

Extremadura 3 09400

Aranda de Duero

Burgos

Spain R01AD08 1334117.03.2014

17.03.2019PoM

GlaxoSmithKline,

S.A., Severo Ochoa, 2

28760- Tres Cantos

(Madrid), Spain

1775

Flixotide 125

micrograms

Evohaler

fluticasone

(fluticasone

propionate)

suspension,

pressurised

inhalation

125mcg/dose,

120 doses in aluminium

inhaller container

Glaxo Wellcome,

S.A., Avda. de

Extremadura, no 3,

09400- Aranda de

Duero, Burgos, Spain

Spain R01AD08 12407/119.08.2015

23.04.2018PoM

Glaxo Wellcome UK

Limited, Stockley

Park West, Uxbridge,

Middlesex, UB11

1BT, UK

1776

Flixotide 250

micrograms

Evohaler

fluticasone

(fluticasone

propionate)

suspension,

pressurised

inhalation

250mcg/dose,

120 doses in aluminium

inhaller container

Glaxo Wellcome,

S.A., Avda. de

Extremadura, no 3,

09400- Aranda de

Duero, Burgos, Spain

Spain R01AD08 12408/119.08.2015

23.04.2018PoM

Glaxo Wellcome UK

Limited, Stockley

Park West, Uxbridge,

Middlesex, UB11

1BT, UK

1777

Flixotide 50

micrograms

Evohaler

fluticasone

(fluticasone

propionate)

suspension,

pressurised

inhalation

50mcg/dose,

120 doses in aluminium

inhaller container

Glaxo Wellcome,

S.A., Avda. de

Extremadura, no 3,

09400- Aranda de

Duero, Burgos, Spain

Spain R01AD08 12406/119.08.2015

23.04.2018PoM

Glaxo Wellcome UK

Limited, Stockley

Park West, Uxbridge,

Middlesex, UB11

1BT, UK

1778 Flosteron

betamethasone

(betamethasone

dipropionate),

betamethasone

(betamethasone

sodium phosphate)

suspension for

injection

5mg/ml+2mg/ml, 1ml

ampoules (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia H02AB01 1652317.03.2017

17.03.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1779 Flotac

diclofenac

cholestyramine

(diclofenac sodium)

capsules145,6mg (75mg), in

blister (20/2x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr/Baden

Germany M01AB05 1237019.04.2013

19.04.2018PoM

Novartis Pharma AG,

56, Lichtstrasse, 4056

Basel, Switzerland

387

Page 48: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1780 Floxadex

ciprofloxacin

(ciprofloxacin

hydrochloride),

dexamethasone

suspension eye/ear3mg/ml+1mg/ml, 10ml

plastic vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS03CA01 14560

09.06.2015

09.06.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1781Floxaval 500mg

film-coated tablets

levofloxacin

(levofloxacin

hemihydrate)

tablets film-coated500mg,

in blister (10/1x10/)

Delorbis

Pharmaceuticals Ltd,

17 Athinon

str.,Ergates Industrial

Area,2643 Ergates,

P.O. Box 28629,2081

Lefkosia

Cyprus J01MA12 1405519.12.2014

19.12.2019PoM

Delorbis

Pharmaceuticals Ltd,

17 Athinon

str.,Ergates Industrial

Area,2643 Ergates,

P.O. Box 28629,2081

Lefkosia, Cyprus

1782 Flucinarfluocinolone

acetonide

ointment for topical

use

0,25mg/g,

15g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AC04 1497618.11.2015

18.11.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1783 Flucinarfluocinolone

acetonidegel for topical use

0,25mg/g,

15g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AC04 1497718.11.2015

18.11.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1784 Flucinar N

fluocinolone

acetonide,

neomycin

(neomycin

sulphate)

ointment for topical

use

0,25mg/g+5mg/g,

15g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07CC02 1501902.12.2015

02.12.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

388

Page 49: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1785 Fluco fluconazole capsules150mg,

in blister (10/1x10/)

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,

Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of

ArmeniaJ02AC01 16953

05.09.2017

05.09.2022PoM

Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan, Republic of

Armenia

1786 Flucona-Denk 100 fluconazole capsules100mg,

in blister (10)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany J02AC01 1322824.02.2014

24.02.2019PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

1787 Flucona-Denk 150 fluconazole capsules150mg,

in blister (1)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany J02AC01 1322924.02.2014

24.02.2019PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

1788 Fluconazole fluconazole tablets50mg,

in blister (12)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ02AC01 12471

09.12.2013

09.12.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

389

Page 50: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1789 Fluconazole fluconazole capsules150mg,

in blister (1)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus J02AC01 1266704.07.2013

04.07.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

1790 Fluconazole fluconazole capsules50mg,

in blister (7)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus J02AC01 1266804.07.2013

04.07.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

1791 Fluconazole fluconazole tablets coated150mg,

in blister (2)

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine J02AC01 1327504.03.2014

04.03.2019PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

1792 Fluconazole fluconazole capsules150mg,

in blister (10/1x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ02AC01 14319

09.03.2015

09.03.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1793Fluconazole-

Asteria Cap. 50mgfluconazole capsules hard

50mg,

in blister (2/2x1/,

10/1x10/, 100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

Si, Chungcheongbuk-

do

Korea Sourth J02AC01 1535526.02.2016

26.02.2021PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

390

Page 51: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1794Fluconazole-

Asteria Cap.150mgfluconazole capsules hard

150mg,

in blister (2/2x1/,

10/1x10/, 100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

Si, Chungcheongbuk-

do

Korea Sourth J02AC01 1535426.02.2016

26.02.2021PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

1795Fluconazole-

Biocomfluconazole capsules

150mg,

blister (1, 2/2x1/, 4/4x1/,

8/2x4/, 16/4x4/, 7,

14/2x7/, 28/4x7/, 10,

20/2x10/, 40/4x10/)

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016

Russia J02AC01 12986/128.06.2016

28.10.2018PoM

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016,

Russia

1796 Fluconazole-Inta fluconazole capsules50mg,

in blister (30/3x10/)

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka

Bangladesh J02AC01 1447022.04.2015

22.04.2020PoM

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka, Bangladesh

1797 Fluconazole-Inta fluconazole capsules150mg,

in blister (10/1x10/)

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka

Bangladesh J02AC01 1447122.04.2015

22.04.2020PoM

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka, Bangladesh

1798Fluconazole-

Zdorovyefluconazole capsules hard

50mg,

in blister (7/1x7/,

10/1x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine J02AC01 1655303.04.2017

03.04.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

1799Fluconazole-

Zdorovyefluconazole capsules hard

100mg,

in blister (7/1x7/,

10/1x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine J02AC01 1655403.04.2017

03.04.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

391

Page 52: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1800Fluconazole-

Zdorovyefluconazole capsules hard

150mg,

in blister (1, 2, 3/1x3/,

3/3x1/, 7)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine J02AC01 1667911.05.2017

11.05.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

1801 Flucopt fluconazole drops eye3mg/ml,

5ml vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01X 14618

03.07.2015

03.07.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1802 Flucostat fluconazole capsules50mg,

in blister (7)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia J02AC01 13096/126.12.2017

09.12.2018PoM

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

1803 Flucostat fluconazole capsules

150mg,

in blister (2/1x2/, 3/1x3/,

24/4x6/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia J02AC01 13097/226.12.2017

09.12.2018PoM

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

1804 Flugarda

fludarabine

(fludarabine

phosphate)

powder lyophilized

for solution for

injection

50mg,

glass vials (5)

Biocad CJSC, Petrovo-

Dalnee, Krasnogorsky

district, Moscow

Region, 143422

Russia L01BB05 1373824.07.2014

24.07.2019PoM

Biocad CJSC, 34 bld.,

lit. A, Svyazi

st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

1805 Fluifort

carbocisteine

lysinate

(carbocisteine

lysinate

monohydrate)

syrup

90mg/ml,

40ml, 120ml glass bottle

and measuring spoon

M & H

Manufacturing Co.

Ltd., 41 Sukhumvit

Road, Paknam,

Muang, Samutprakarn

10270

Thailand R05CB03 1230122.03.2013

22.03.2018OTC

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat ,

Belgium

392

Page 53: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1806 Fluifort

carbocisteine

lysinate

(carbocisteine

lysinate

monohydrate)

powder for solution

for oral use

2700mg,

2,7g sachets

(5, 30, 50)

Polipharm Co., Ltd.,

109 Bangna-Trad

Road, Bang Phli

District, Samut

Prakan 10540

Thailand R05CB03 1255906.06.2013

06.06.2018OTC

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

1807 Fluimucil acetylcysteine tablets effervescent600mg,

in blister (10/5x2/)

Zambon Switzerland

Ltd., Via Industria 13,

CH-6814, Cadempino

Switzerland R05CB01 1459918.06.2015

18.06.2020OTC

Zambon S.P.A., Via

Lillo Del Duca, 10,

Bresso, 20091, Italy

1808 Fluimucil acetylcysteine

solution for i/m and

i/v injection and

inhalation

100mg/ml,

3ml ampoules (5)

Zambon S.P.A., Via

della Chimica, 9,

Vicenza, 36100

Italy R05CB01 1579420.07.2016

20.07.2021PoM

Zambon S.P.A., Via

Lillo del Duca, 10,

Bresso, 20091, Italy

1809 Fluimucil acetylcysteinegranules for oral

solution

200mg,

1g sachet (20, 60)

Zambon Switzerland

Ltd., Via Industria 13,

CH-6814, Cadempino

Switzerland R05CB01 1621608.12.2016

08.12.2021OTC

Zambon S.P.A., Via

Lillo Del Duca, 10,

Bresso, 20091, Italy

1810Fluimucil-

antibiotic IT

thiamphenicol

(thiamphenicol

glycinate

acetylcysteinate)

powder lyophilized

for solution for i/m

injection and

inhalation

500mg,

glass vial (3) and 4ml

solvent in ampoules (3)

Zambon S.P.A., Via

della Chimica, 9,

Vicenza, 36100

Italy J01BA02 1592223.08.2016

23.08.2021PoM

Zambon S.P.A., Via

Lillo del Duca, 10,

Bresso, 20091, Italy

1811 Flumex fluconazole capsules hard150mg,

in blister (2)

ABC Farmaceutici

S.p.A, Via Cantone

Moretti, 29, 10090,

Ivrea

Italy J02AC01 1608610.11.2016

10.11.2021PoM

ABC Farmaceutici

S.p.A, Corso Vittorio

Emanuele II, 72,

Torino, Italy

1812 Fluocinolonefluocinolone

acetonide

ointment for

external use

0,25mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD07AC04 16378

30.12.2016

30.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

393

Page 54: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1813 Fluracedyl fluorouracil solution for injection50mg/ml,

100ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands Լ01BC02 1412529.12.2014

29.12.2019PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552, 2003 RN

Haarlem, the

Netherlands

1814 Fluracedyl fluorouracil solution for injection50mg/ml,

10ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands L01BC02 1412629.12.2014

29.12.2019PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552, 2003 RN

Haarlem, the

Netherlands

1815 Fluracedyl fluorouracil solution for injection50mg/ml,

20ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands L01BC02 1412729.12.2014

29.12.2019PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552, 2003 RN

Haarlem, the

Netherlands

1816 Fluracedyl fluorouracil solution for injection50mg/ml,

5ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands L01BC02 1412829.12.2014

29.12.2019PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552, 2003 RN

Haarlem, the

Netherlands

1817 Flutamide flutamide tablets250mg,

in blister (84/4x21/)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland L02BB01 1349523.05.2014

23.05.2019PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

394

Page 55: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1818 FlyuremAnvi

capsule A- ascorbic

acid. acetylsalicylic

acid. rutoside

(rutoside

trihydrate), capsule

B- metamizole

(metamizole

sodium

monohydrate),

calcium gluconate

(calcium gluconate

monohydrate),

diphenhydramine

(diphenhydramine

hydrochloride)

capsules

300mg+250mg+

20mg+250mg+

100mg+20mg,

in blister (20/2x10//10

capsules A+10 capsules

B/)

Pharmproject JSC,

bld. 14, lit. A,

Sofiyskaya str., Saint

Petersburg, 192236

Russia R05X 1650517.03.2017

17.03.2022OTC

"AnviLab" LLC,

141302 Sergiev Posad,

Festival street, 10,

Sergiev Posad

municipal district,

urban settlement

Sergiev Posad,

Moscow region,

Russia

1819 Fokusin

tamsulosin

(tamsulosin

hydrochloride)

capsules modified-

release

0,4mg,

in blister (30/3x10/)

Zentiva a.s.

(Nitrianska 100, 920

27 Hlohovec)

Slovakia G04CA02 1290407.10.2013

07.10.2018PoM

Zentiva, k.s. (U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic)

1820 Folacin folic acid tablets5mg,

in blister (30/3x10/)

JADRAN- GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka

Croatia B03BB01 1571422.06.2016

22.06.2021PoM

JADRAN- GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka, Croatia

1821 Folic Acid folic acid tablets1mg,

in blister (48/2x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaB03BB01 13866

18.09.2014

18.09.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

395

Page 56: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1822 Folic Acid folic acid tablets1mg,

in blister (50/5x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus B03BB01 1428319.03.2015

19.03.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1823 Folic Acid folic acid tablets

5mg,

in blisters (48/2x24/,

50/5x10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaB03BB01 14728/1

25.12.2017

30.07.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1824 Folic Acid folic acid tablets5mg,

in blister (20/2x10/)

Replek Farm Ltd,

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia B03BB01 1500602.12.2015

02.12.2020PoM

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

1825 Folic Acid folic acid tablets5mg,

in plastic container (50)

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine B03BB01 1505202.12.2015

02.12.2020PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

1826 Folic Acid folic acid tablets1mg,

in plastic container (50)

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine B03BB01 1505302.12.2015

02.12.2020PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

1827 Forlaxmacrogol (macrogol

4000)

powder for oral

solution

10g,

sachets (20)

Beaufour Ipsen

Industrie , Ethe

Virton, 28100 Dreux

France A06AD65 1419506.02.2015

06.02.2020OTC

Ipsen Pharma, 65

quai Georges Gorse,

92100 Boulogne-

Billancourt, France

396

Page 57: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1828 Formetin

metformin

(metformin

hydrochloride)

tablets

1000mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Tomskchimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211

Russia A10BA02 1419006.02.2015

06.02.2020PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

1829 Formetin

metformin

(metformin

hydrochloride)

tablets

850mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Tomskchimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211

Russia A10BA02 1419106.02.2015

06.02.2020PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

1830 Formetin

metformin

(metformin

hydrochloride)

tablets

500mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Tomskchimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 212

Russia A10BA02 1419206.02.2015

06.02.2020PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

1831 Formetin

metformin

(metformin

hydrochloride)

tablets

500mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608310.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

1832 Formetin

metformin

(metformin

hydrochloride)

tablets

850mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608410.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

1833 Formetin

metformin

(metformin

hydrochloride)

tablets

1000mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BA02 1608510.11.2016

10.11.2021PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

397

Page 58: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1834 Formidron formaldehydesolution for external

use

37mg/ml,

30ml glass bottle

ESCO-PHARM LLC

(Nor-Norq V block,

Mikoyan 13, Yerevan

0079)

Republic of

ArmeniaD08AX 12992

28.10.2013

28.10.2018OTC

ESCO-PHARM LLC

(Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia)

1835 Fortransmacrogol (macrogol

4000)

powder for oral

solution

64g,

73,69g sachets (4)

Beaufour Ipsen

Industrie, rue Ethe

Virton, 28100 Dreux

France A06AD15 1630730.12.2016

30.12.2021OTC

Ipsen Pharma, 65

quai Georges

Gorse,92100

Boulogne-Billancourt,

France

1836 ForTRONN

ceftazidime

(ceftazidime

sodium)

powder for solution

for injection

1000mg,

glass vial

Protech Biosystems

Pvt Ltd.,Plot No 145-

146, Pace City-1,

Sector-37 Gurgaon,

Haryana

India J01DD02 1234009.04.2013

09.04.2018PoM

Protech Biosystems

Pvt Ltd.,Plot No 145-

146, Pace City-1,

Sector-37 Gurgaon,

Haryana, India

1837 Fortum

ceftazidime

(ceftazidime

pentahydrate)

powder for solution

for injection/infusion

500mg,

glass vial

GlaxoSmithKline

Manufacturing S.p.A.,

Via A. Fleming 2,

37135, Verona

Italy J01DD02 1310810.12.2013

10.12.2018PoM

GlaxoSmithKline

Manufacturing S.p.A.,

Via A. Fleming 2,

37135, Verona, Italy

1838 Fortum

ceftazidime

(ceftazidime

pentahydrate)

powder for solution

for injection/infusion

1000mg,

glass vial

GlaxoSmithKline

Manufacturing S.p.A.,

Via A. Fleming 2,

37135, Verona

Italy J01DD02 1310910.12.2013

10.12.2018PoM

GlaxoSmithKline

Manufacturing S.p.A.,

Via A. Fleming 2,

37135, Verona, Italy

1839 Fotil

pilocarpine

(pilocarpine

hydrochloride),

timolol (timolol

maleate)

drops eye20mg/ml+5mg/ml, 5ml

plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01ED51 1245207.05.2013

07.05.2018PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

398

Page 59: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1840 Fotil forte

pilocarpine

(pilocarpine

hydrochloride),

timolol (timolol

maleate)

drops eye40mg/ml+5mg/ml, 5ml

plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01ED51 1245307.05.2013

07.05.2018PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

1841 Frangulax

aloe capensis,

frangulae corticis

extractum siccum

tablets coated35mg+42mg,

in blister (20/2x10/)

Poznan Plant of

Medicinal herbs

"Herbapol" S.A. 47/51,

Towarowa str., 61-896

Poznan

PolandA06AB

herbal drug 12169

01.02.2013

01.02.2018OTC

Poznan Plant of

Medicinal herbs

"Herbapol" S.A.

47/51, Towarowa str.,

61-896 Poznan,

POLAND

1842Fraxiparine 2850IU

AXa/0,3mlnadroparin calcium solution for injection

2850IU AXa/0,3ml,

0,3ml pre-filled syringes

(10)

Aspen Notre Dame de

Bondeville, 1 rue de

l’Abbaye, 76960

Notre Dame de

Bondeville, France

France B01AB06 14076/131.07.2015

16.12.2019PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

1843Fraxiparine 5700IU

AXa/0,6mlnadroparin calcium solution for injection

5700IU AXa/0,6ml,

0,6ml pre-filled syringes

(2, 10)

Aspen Notre Dame de

Bondeville, 1 rue de

l’Abbaye, 76960

Notre Dame de

Bondeville, France

France B01AB06 14077/131.07.2015

16.12.2019PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

1844 Fromilid clarithromycin tablets film-coated250mg,

in blister (14/2x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01FA09 1303325.11.2013

25.11.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1845 Fromilid clarithromycin tablets film-coated500mg,

in blister (14/2x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01FA09 1303425.11.2013

25.11.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

399

Page 60: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1846 Fromilid uno clarithromycintablets prolonged-

release

500mg,

in blister (7/1x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01FA09 1628819.12.2016

19.12.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1847 Ftorafur tegafur capsules400mg,

in plastic container (100)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia L01BC03 1626619.12.2016

19.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

1848 Ftorocort

triamcinolone

(triamcinolone

acetonide)

ointment1mg/g,

15g aluminium tube

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary D07AB09 1445204.05.2015

04.05.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1849 Fungazolemiconazole

(miconazole nitrate)

cream for external

use

20mg/g,

15g aluminium tube

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine D01AC02 1718828.11.2017

28.11.2022OTC

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

1850Fungicide-acaricide

ointment Yam

birch liquid tar,

turpentine oil,

sulfur, salicylic acid,

zinc oxide, lysol

ointment

100mg/g+70mg/g+100mg/

g+20mg/g+100mg/g+60mg

/g, 20g, 50g, 90g, 250g, in

plastic container or 20g,

50g, 90g, 250g, in tube

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kiev

region, 07400

Ukraine

QD10AB;

veterinary

drug

14380/120.05.2015

16.04.2020PoM

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kiev

region, 07400,

Ukraine

1851 Fungolon fluconazole capsules hard50mg,

in blister (4/1x4/, 8/1x8/)

Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad

Bulgaria J02AC01 1410329.12.2014

29.12.2019PoM

Balkanpharma-

Razgrad

AD(ACTAVIS

GROUP), 68 Aprilsko

Vastanie Blvd, 7200

Razgrad, Bulgaria

400

Page 61: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1852 Fungoterbin

terbinafine

(terbinafine

hydrochloride)

cream for external

use

10mg/g,

15g aluminium or plastic

laminated tube

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D01AE15 1446404.05.2015

04.05.2020OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1853 Fungoterbin NEO

terbinafine

(terbinafine

hydrochloride),

urea

gel for external use

10mg+100mg,

15g aluminium or plastic

tube

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D01AE 12813/130.06.2016

17.09.2018OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1854 Fungoterbine

terbinafine

(terbinafine

hydrochloride)

spray10mg/g,

30g plastic container

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D01AE15 1354330.05.2014

30.05.2019OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1855Furacilin ointment

0,2%nitrofural ointment

2mg/g,

25g aluminium tube

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaD08AF01 12523

01.06.2013

01.06.2018OTC

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan, Armenia

1856 Furacilin Tatpharm nitrofuraltablets for solution

for local use

20mg,

strip (10),

blister (10)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia D08AF01 12779/213.03.2017

14.08.2018OTC

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

1857 Furadonin

nitrofurantoin

(nitrofurantoin

monohydrate)

tablets50mg,

in blister (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia J01XE01 1283717.09.2013

17.09.2018PoM

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

401

Page 62: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1858 Furadonin nitrofurantoin tablets50mg,

in strip (10)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus J01XE01 1552419.04.2016

19.04.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1859 Furagin furazidin tablets50mg,

in blister (30/3x10/)

Kievmedpreparat

OJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01XE03 1380405.09.2014

05.09.2019PoM

Kievmedpreparat

OJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

1860 Furagin furazidin tablets50mg,

in blister (30/3x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia J01XE03 1649217.03.2017

17.03.2022PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1861Furaginum

Adamedfurazidin tablets

50mg,

in blister (30/1x30/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland J01XE03 1727713.12.2017

13.12.2022PoM

Adamed Sp. z o.o.,

Pienkow 149, 05-152

Czosnow, Poland

1862 Furalgin

phenazone,

tetracaine

(tetracaine

hydrochloride),

nitrofural

drops ear70mg/g+25mg/g+ 2mg/g,

5g plastic vial

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaS02DA30 12524

01.06.2013

01.06.2018OTC

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan, Armenia

1863 Furamagfurazidin (furazidin

potassium)capsules hard

25mg,

in blister (30/3x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia J01XE03 1623219.12.2016

19.12.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

402

Page 63: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1864 Furamagfurazidin (furazidin

potassium)capsules hard

50mg,

in blister (30/3x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia J01XE03 1623319.12.2016

19.12.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1865 Furasolfurazidin (furazidin

potassium)

powder for solution

for external use

100mg,

1g sachets (15)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia D06BX 1600106.10.2016

06.10.2021OTC

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

1866 Furazolidon furazolidone tablets50mg,

in blister (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia G01AX06 1319810.01.2014

10.01.2019PoM

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

1867 Furazolidone furazolidone tablets50mg,

in strip (10)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus G01AX06 1568308.06.2016

08.06.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1868 Furosemide furosemide solution for injection10mg/ml,

2ml ampoules (10)

Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8

Ukraine C03CA01 1309809.12.2013

09.12.2018PoM

Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8, Ukraine

1869 Furosemide furosemide tablets

40mg,

in blister (50/5x10/,

50/2x25/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus C03CA01 1410829.12.2014

29.12.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

403

Page 64: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1870 Furosemide furosemide tablets40mg,

in blister (40/1x40/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC03CA01 14882

24.09.2015

24.09.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1871 Furosemide furosemide solution for injection

10mg/ml,

2ml ampoules (10), 2ml

ampoules label banderol

(10), 2ml ampoules

dividella (10)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus C03CA01 1568508.06.2016

08.06.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1872 Furosemide furosemide solution for injection

10mg/ml,

2ml ampoules (10,

10/1x10/) and 2ml

ampoules, in blister

(10/2x5/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine C03CA01 1643106.03.2017

06.03.2022PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

1873 Furosemide furosemide tablets

40mg,

in blister (50/5x10,

100/4x25/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben-

batch releaser,

packager, Sandoz

Private Limited,

MIDC Plot No. 8-A/2

,8-B, T.T.C. Industrial

Area, Kalwe Block,

Village-Digha, Opp.

Thane-Belapur Road,

Mumbai, 400 708,

India-bulk

manufacturer

Germany C03CA01 1656503.04.2017

03.04.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

404

Page 65: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1874 Furosemide furosemide tablets40mg,

in blister (50/5x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine C03CA01 1662625.04.2017

25.04.2022PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

1875

Furotalgin

2.5mg/31.25mg/87.

5mg/ml ear drops,

solution

nitrofural,

tetracaine

(tetracaine

hydrochloride),

phenazone

drops ear (solution)

2,5mg/ml+ 31,25mg/ml+

87,5mg/ml,

glass (1) or 5ml plastic

vial with dropper

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria S02DA30 1545902.04.2016

02.04.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

1876 Furoxitonus

cefuroxime

(cefuroxime

sodium)

powder for solution

for injection

750mg,

glass vials (25)

Panpharma Z.I., du

Clairay-Luitre 35133,

Fougeres

France J01DC02 1275914.08.2013

14.08.2018PoM

Panpharma Z.I., du

Clairay-Luitre 35133,

Fougeres, France

1877 Fusarpi sodium fusidateointment for topical

use

20mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD06AX01 14078

16.12.2014

16.12.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1878

5% Glucose

solution for

injection

glucose anhydrous solution for infusion

50mg/ml,

100ml, 200ml, 250ml,

400ml, 500ml, 1000ml,

2000ml and 3000ml

plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaB05CX01 14865

24.09.2015

24.09.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

1879

10% Glucose

solution for

injection

glucose anhydrous solution for infusion

100mg/ml,

100ml, 200ml, 250ml,

500ml, 1000ml, 2000ml

and 3000ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaB05CX01 14866

24.09.2015

24.09.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

405

Page 66: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1880 Gabagamma gabapentin capsules hard

400mg,

in blister (20/2x10/,

50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723- batch releaser,

packager,

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Germany-bulk

manufacturer

Czech Republic N03AX12 1542602.04.2016

02.04.2021PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

1881 Gabagamma gabapentin capsules hard

300mg,

in blister (20/2x10/,

50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723- batch releaser,

packager,

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Germany-bulk

manufacturer

Czech Republic N03AX12 1542702.04.2016

02.04.2021PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

1882 Gabagamma gabapentin capsules hard100mg,

(20/2x10/, 50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723- batch releaser,

packager,

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Germany-bulk

manufacturer

Czech Republic N03AX12 1542802.04.2016

02.04.2021PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

406

Page 67: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1883Gabagamma

100mggabapentin capsules hard

100mg,

in blister (20/2x10/,

50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723 - packager,

batch releaser

(Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf,

Germany - bulk

manufacturer)

Czech Republic N03AX12 1345706.05.2014

06.05.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

1884Gabagamma

300mggabapentin capsules hard

300mg,

in blister (20/2x10/,

50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723 - packager,

batch releaser

(Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf,

Germany - bulk

manufacturer)

Czech Republic N03AX12 1345806.05.2014

06.05.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

1885Gabagamma

400mggabapentin capsules hard

400mg,

in blister (20/2x10/,

50/5x10/)

Medis International

a.s., Prumyslova

961/16, Bolatice,

74723 - packager,

batch releaser

(Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf,

Germany - bulk

manufacturer)

Czech Republic N03AX12 1345906.05.2014

06.05.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

407

Page 68: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1886 Gabapentin gabapentin capsules300mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AX12 16293

21.12.2016

21.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1887

Galantamine

Pharmathen 16mg

prolonged-release

capsules hard

galantamine

(galantamine

hydrobromide)

capsules prolonged-

release, hard

16mg,

in blister (28/2x14/)

Pharmaten

International S.A.

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5, Rodopi

69300

Greece N06DA04 1333317.03.2014

17.03.2019PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini Attiki, Greece

1888

Galantamine

Pharmathen 8mg

prolonged-release

capsules hard

galantamine

(galantamine

hydrobromide)

capsules prolonged-

release, hard

8mg,

in blister (28/2x14/)

Pharmaten

International S.A.

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5, Rodopi

69300

Greece N06DA04 1333217.03.2014

17.03.2019PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini Attiki, Greece

1889Galazolin Polfa

0,05%

xylometazoline

(xylometazoline

hydrochloride)

drops nasal (solution)0,5mg/ml,

10ml plastic vial

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland R01AA07 13046/102.02.2017

25.11.2018OTC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

1890Galazolin Polfa

0,05%

xylometazoline

(xylometazoline

hydrochloride)

drops nasal, solution0,5mg/ml,

10ml plastic vial-dropper

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland R01AA07 1727313.12.2017

13.12.2022OTC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

408

Page 69: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1891Galazolin Polfa

0,1%

xylometazoline

(xylometazoline

hydrochloride)

drops nasal (solution)1mg/ml,

10ml plastic vial

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland R01AA07 13047/102.02.2017

25.11.2018OTC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

1892Galazolin Polfa

0,1%

xylometazoline

(xylometazoline

hydrochloride)

drops nasal, solution1mg/ml,

10ml plastic vial-dropper

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland R01AA07 1727413.12.2017

13.12.2022OTC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

1893 Galoziloc

xylometazoline

(xylometazoline

hydrochloride)

drops nasal0.5mg/ml,

5ml, 10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch

releaser,packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaR01AA07 15181

30.12.2015

30.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

1894 Galoziloc

xylometazoline

(xylometazoline

hydrochloride)

drops nasal1mg/ml,

5ml, 10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch

releaser,packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaR01AA07 15182

30.12.2015

30.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

409

Page 70: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1895 Galoziloc

xylometazoline

(xylometazoline

hydrochloride)

spray nasal0.5mg/ml,

10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch

releaser,packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaR01AA07 15183

30.12.2015

30.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

1896 Galoziloc

xylometazoline

(xylometazoline

hydrochloride)

spray nasal1mg/ml,

10ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch

releaser,packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaR01AA07 15184

30.12.2015

30.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

1897 Galvus vildagliptin tablets

50mg,

in blister (7/1x7/,

28/2x14/, 56/4x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland A10BH02 1543001.04.2016

01.04.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

1898 Galvus vildagliptin tablets

50mg,

in blister (28/2x14/,

56/4x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain A10BH02 1618723.11.2016

23.11.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1899 GalvusMET

vildagliptin,

metformin

(metformin

hydrochloride)

tablets film-coated

50mg+500mg,

in blister (30/3x10/,

60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr (Baden

Wurttemberg)

Germany A10BD08 1314410.01.2014

10.01.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

410

Page 71: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1900 GalvusMET

vildagliptin,

metformin

(metformin

hydrochloride)

tablets film-coated

50mg+850mg

in blister (30/3x10/,

60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr (Baden

Wurttemberg)

Germany A10BD08 1314510.01.2014

10.01.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1901 GalvusMET

vildagliptin,

metformin

(metformin

hydrochloride)

tablets film-coated

50mg+1000mg,

in blister (30/3x10/,

60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr (Baden

Wurttemberg)

Germany A10BD08 1314610.01.2014

10.01.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1902 GalvusMet

vildagliptin,

metformin

(metformin

hydrochloride)

tablets film-coated

50mg+850mg,

in blister (30/3x10/,

60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr (Baden

Wurttemberg) -batch

releaser, packager,

Novartis Singapore

Pharmaceutical

Manufacturing Pte.

Ltd., 10 Tuas Bay

Lane, 637461

Singapore-bulk

manufacturer

Germany A10BD08 1633630.12.2016

30.12.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1903 GalvusMet

vildagliptin,

metformin

(metformin

hydrochloride)

tablets film-coated50mg+1000mg,

in blister (60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr (Baden

Wurttemberg) -batch

releaser, packager,

Novartis Singapore

Pharmaceutical

Manufacturing Pte.

Ltd., 10 Tuas Bay

Lane, 637461

Singapore-bulk

manufacturer

Germany A10BD08 1633730.12.2016

30.12.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

411

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1904 Gamalate B6

magnesium

glutamate

hydrobromide,

gamma-

aminobutyric acid,

gamma-amino-beta-

hydroxybutyric

acid, vitamin B6

tablets coated

75mg+75mg+

37mg+37mg,

in blister (20/2x10/)

Ferrer International,

S.A., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain N06BX 1477903.08.2015

03.08.2020PoM

Laboratorios Novag,

S.A., Gran Via Carlos

III, 94 08028,

Barcelona, Spain

1905 Gamalate B6

magnesium

glutamate

hydrobromide,

gamma-

aminobutyric acid,

gamma-amino-beta-

hydroxybutyric

acid, vitamin B6

solution oral

20mg/ml+ 20mg/ml+

10mg/ml+10mg/ml, 80ml

glass bottle

Ferrer International,

S.A., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain N05BX 1494920.10.2015

20.10.2020PoM

Ferrer International,

S.A., Joan Gran Via

Carlos III, 94 08028,

Barcelona, Spain

1906 Gangleron ganglefene capsules

40mg,

in blister (60/5x12/), in

plastic container (30)

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry,A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26 - batch

releaser (Arpimed

LLC, Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia -

bulk manufacturer,

packager)

Republic of

ArmeniaA03AB, C02B 13683

08.07.2014

08.07.2019PoM

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry,A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26, Republic

of Armenia

412

Page 73: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1907 Gangleron ganglefene solution for injection15mg/ml,

2ml ampoules (10)

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry,A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26 - batch

releaser (Arpimed

LLC, Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia -

bulk manufacturer,

packager)

Republic of

ArmeniaA03AB, C02B 13684

08.07.2014

08.07.2019PoM

the Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry,A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Yerevan, Azatutyun

avenue 26, Republic

of Armenia

1908 Gardasil

human

papillomavirus type

6 L1 protein,

human

papillomavirus type

11 L1 protein,

human

papillomavirus type

16 L1 protein,

human

papillomavirus type

18 L1 protein

suspension for i/m

injection

20mcg/dose+

40mcg/dose+

40mcg/dose+ 20mcg/dose,

0,5ml/dose glass vial

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, secondary

packager, Merck

Sharp & Dohme

Corp., 770

Sumneytown

Pike,West Point,

19486, USA- bulk

manufacturer,

primary packager

the NetherlandsJ07BM01;

vaccine15703

22.06.2016

22.06.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

413

Page 74: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1909 Gardasil

human

papillomavirus type

6 L1 protein,

human

papillomavirus type

11 L1 protein,

human

papillomavirus type

16 L1 protein,

human

papillomavirus type

18 L1 protein

suspension for i/m

injection

20mcg/dose+

40mcg/dose+

40mcg/dose+ 20mcg/dose,

0,5ml/dose pre-filled

syringe, (1) or (2) needles

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, secondary

packager, Merck

Sharp & Dohme

Corp., 770

Sumneytown

Pike,West Point,

19486, USA- bulk

manufacturer,

primary packager

the NetherlandsJ07BM01;

vaccine15704

22.06.2016

22.06.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

1910 Gastritol

anserinae herba,

matricariae flos,

liquiritiae radix,

angelicae radix,

cnici benedicti

herba, absinthii

herba

drops oral

0.35ml/ml+ 0.2ml/ml+

0.15ml/ml+ 0.05ml/ml+

0.05ml/ml+ 0.05ml/ml,

20ml, 50ml, 100ml glass

vial

Dr. Gustav Klein

GmbH & Co. KG,

Steinenfeld 3, 77736

Zell am Harmersbach

GermanyA03AX

herbal drug13511

30.05.2014

30.05.2019OTC

Dr. Gustav Klein

GmbH & Co. KG,

Steinenfeld 3, 77736

Zell am Harmersbach,

Germany

1911 Gaviscon

sodium alginate,

sodium bicarbonate,

calcium carbonate

suspension oral with

peppermint flavour

50mg/ml+ 26,7mg/ml+

16mg/ml,

100ml, 150ml, 300ml

glass bottle

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS

UK A02BX 1369124.07.2014

24.07.2019OTC

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS,

UK

414

Page 75: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1912 Gaviscon

sodium alginate,

sodium bicarbonate,

calcium carbonate

tablets chewable

with peppermint

flavor

250mg+133.5mg+ 80mg,

in blister (12/2x6/,

16/2x8/, 24/3x8, 32/4x8/,

48/6x8)

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS-

bulk manufacturer,

primary packager,

batch releaser,

Pharmapac Limited,

Unit 20, Valley Road

Business Park,

Bidston, Wirral,

Merseyside, CH41

7EL,UK-secondary

packager

UK A02BX 14761/126.12.2017

03.08.2020OTC

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS,

UK

1913 Gaviscon Forte

sodium alginate,

potassium hydrogen

carbonate

suspension oral with

peppermint flavour

100mg/ml+ 20mg/ml,

80ml, 150ml, 200ml,

250ml, 300ml glass bottle

and 10ml sachets (4, 8,

12, 16, 20)

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS

UK A02BX 1369224.07.2014

24.07.2019OTC

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS,

UK

1914 Gazyva obinutuzumabconcentrate for

solution for infusion

1000mg/40ml,

40ml glass vial (1)

F. Hoffmann-La

Roche Ltd. 4303

Kaiseraugst- batch

releaser, secondary

packager, Roche

Diagnostics GmbH,

Sandhofer Strasse 116,

68305 Mannheim,

Germany- bulk

manufacturer,

primary packager

Switzerland L01XC15 1702626.09.2017

26.09.2022PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

415

Page 76: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1915 Gelmicidoxyclozanide,

albendazoletablets

175mg+360mg,

in blister (100/4x25/)

NVT

Agrovetzashchita S-P

Ltd. ('AVZ S-P'),

Moscow Region,

Sergiyev Posad, 1,

Tsentralnaya Str.,

141300

Russia

QP52AC11

veterinary

drug

1387323.09.2014

23.09.2019PoM

LLC 'Scientific and

Implamentation

Center

Agrovetzaschita',

Kolskaya str. 1, bldg.

1, Moscow, 129329,

Russia

1916 Gelofusine

gelatin

succinylated,

sodium chloride

solution for infusion40mg/ml+ 7,01mg/ml,

500ml plastic bottle (10)

B.Braun Medical AG,

Route de Sorge, 9 CH-

1023 Crissier

Switzerland B05AA06 1636830.12.2016

30.12.2021PoM

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen, Germany

1917 Gembio

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

injection

200mg,

glass vial

Bioprofarma S.A.,

Terrada 1270, Ciudad

Autonoma de Buenos

Aires - packager,

batch releaser (dosage

form manufacturer -

Quality Pharma

S.A.Gral. Villegas

1320/1510, San Justo,

Provinicia de Buenos

Aires, Argentina)

Argentina L01BC05 1270223.07.2013

23.07.2018PoM

Bioprofarma S.A.,

Terrada 1270, Ciudad

Autonoma de Buenos

Aires, Argentina

1918 Gembio

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

injection

1000mg,

glass vial

Bioprofarma S.A.,

Terrada 1270, Ciudad

Autonoma de Buenos

Aires - packager,

batch releaser (dosage

form manufacturer -

Quality Pharma

S.A.Gral. Villegas

1320/1510, San Justo,

Provinicia de Buenos

Aires, Argentina)

Argentina L01BC05 1270323.07.2013

23.07.2018PoM

Bioprofarma S.A.,

Terrada 1270, Ciudad

Autonoma de Buenos

Aires, Argentina

416

Page 77: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1919 Gemcitabin Ebewe

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

10mg/ml,

20ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BC05 1605417.10.2016

17.10.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

1920 Gemcitabin Ebewe

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

10mg/ml,

100ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BC05 1605517.10.2016

17.10.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

1921 Gemcitabine

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

infusion

200mg,

10ml glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BC05 1510915.12.2015

15.12.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1922 Gemcitabine

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

infusion

1000mg,

50ml glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BC05 1511015.12.2015

15.12.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

417

Page 78: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1923

Gemcitabine

100mg/ml

concentrate for

solution for

infusion

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

100mg/ml,

2ml glass vial (1)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF-batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk

manufacturer, primary

packager, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

secondary packager

UK L01BC05 1490702.10.2015

02.10.2020PoM

Accord Healthcare

Limited, Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

1924

Gemcitabine

100mg/ml

concentrate for

solution for

infusion

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

100mg/ml,

10ml glass vial (1)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF-batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk

manufacturer, primary

packager, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

secondary packager

UK L01BC05 1490802.10.2015

02.10.2020PoM

Accord Healthcare

Limited, Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

418

Page 79: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1925

Gemcitabine

100mg/ml

concentrate for

solution for

infusion

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

100mg/ml,

20ml glass vial (1)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF-batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk

manufacturer, primary

packager, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

secondary packager

UK L01BC05 1490902.10.2015

02.10.2020PoM

Accord Healthcare

Limited, Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

1926

Gemcitabine

100mg/ml

concentrate for

solution for

infusion

gemcitabine

(gemcitabine

hydrochloride)

concentrate for

solution for i/v

infusion

100mg/ml,

15ml glass vial (1)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF-batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk

manufacturer, primary

packager, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

secondary packager

UK L01BC05 1491002.10.2015

02.10.2020PoM

Accord Healthcare

Limited, Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

1927Gemcitabine for

injection

gemcitabine

(gemcitabine

hydrochloride)

powder for solution

for infusion

1000mg,

glass vial (1)

Atlanta Bioligical

PVT Ltd, Vill. Kotla,

Barotiwala, Distt.

Solan, Himachal

Pradesh

India L01BC05 1394129.10.2014

29.10.2019PoM

Atlanta Biological

PVT Ltd, Poddar

Court 9th floor, Gate

No.1, 18 Rabindra

Sarani, Kolkata- 700

001, India

419

Page 80: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1928 Gemcitabine PCH

gemcitabine

(gemcitabine

hydrochloride)

powder for solution

for infusion

200mg,

10ml glass vials

Pharmachemie B.V.,

Swensweg 5, P.O. Box

552 2003 RN Haarlem

the Netherlands L01BC05 1227422.03.2013

22.03.2018PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552 2003 RN

Haarlem, the

Netherlands

1929 Gemcitabine PCH

gemcitabine

(gemcitabine

hydrochloride)

powder for solution

for infusion

1000mg,

50ml glass vial

Pharmachemie B.V.,

Swensweg 5, P.O. Box

552 2003 RN Haarlem

the Netherlands L01BC05 1227522.03.2013

22.03.2018PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552 2003 RN

Haarlem, the

Netherlands

1930 Gemcitabine PCH

gemcitabine

(gemcitabine

hydrochloride)

powder for solution

for infusion

2000mg,

100ml glass vial

Pharmachemie B.V.,

Swensweg 5, P.O. Box

552 2003 RN Haarlem

the Netherlands L01BC05 1227622.03.2013

22.03.2018PoM

Pharmachemie B.V.,

Swensweg 5, P.O.

Box 552 2003 RN

Haarlem, the

Netherlands

1931Gemozol corn

ointmentsalicylic acid

ointment for

external use

500mg/g,

10g plastic container

Pharmaceutical

Manufacturing

Enterprise "GEMI", 05-

480 Karczew,

Mickiewicza 36 str.

Poland D02AF 1708005.10.2017

05.10.2022OTC

Pharmaceutical

Manufacturing

Enterprise "GEMI",

05-480 Karczew,

Mickiewicza 36 str.,

Poland

1932 Gemzar

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for i/v

injection

1000mg,

glass vial (1)

Eli Lilly and

Company,

Indianapolis, IN

46285

USA L01BC05 1649517.03.2017

17.03.2022PoM

Eli Lilly and

Company,

Indianapolis, IN

46285, USA

1933 Gemzar

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for i/v

injection

200mg,

glass vial (1)

Eli Lilly and

Company,

Indianapolis, IN

46285

USA L01BC05 1649617.03.2017

17.03.2022PoM

Eli Lilly and

Company,

Indianapolis, IN

46285, USA

420

Page 81: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1934 Genferon lightinterferon alfa-2b,

taurine

suppositories vaginal

and rectal

250000IU+5mg,

in blister (5, 10/2x5/)

BIOCAD CJSC,

Petrovo-Dalnee,

Krasnogorsky district,

Moscow Region,

143422

Russia L03AB05 1532704.02.2016

04.02.2021PoM

BIOCAD CJSC, 34

bld., lit. A, Svyazi

st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

1935 Genferon lightinterferon alfa-2b,

taurine

suppositories vaginal

and rectal

125000IU+5mg,

in blister (5, 10/2x5/)

BIOCAD CJSC,

Petrovo-Dalnee,

Krasnogorsky district,

Moscow Region,

143422

Russia L03AB05 1532904.02.2016

04.02.2021PoM

BIOCAD CJSC, 34

bld., lit. A, Svyazi

st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

1936 Gentamicingentamicin

(gentamicin sulfate)

ointment for

external use

1mg/g,

15g aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus D06AX07 1385118.09.2014

18.09.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1937 Gentamicingentamicin

(gentamicin sulfate)drops eye

3mg/ml,

5ml plastic bottle

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland S01AA11 1437325.03.2015

25.03.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

1938 Gentamicin-Kgentamicin

(gentamicin sulfate)solution for injection

80mg/2ml,

2ml ampoules (10/2x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01GB03 1665811.05.2017

11.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

421

Page 82: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1939 Gentamicin-Kgentamicin

(gentamicin sulfate)solution for injection

40mg/ml,

1ml ampoules (10/2x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01GB03 1665911.05.2017

11.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1940Gentamicin-

Zdorovye

gentamicin

(gentamicin sulfate)solution for injection

40mg/ml,

2ml ampoules (10), 2ml

ampoules, in blister

(10/2x5/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine J01GB03 1642906.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

1941 Gentos oral drops

populus D1, sabal

D6, conium D6,

potassium iodide

D12, ferrum

picrinicum D12

drops oral

7ml/100ml+ 10ml/100ml+

10ml/100ml+

10ml/100ml+

10ml/100ml,

20ml and 50ml glass

bottle

Richard Bittner AG,

Ossiacherstrasse 7, A-

9560 Feldkirchen

Austria

G04;

homeopathic

drug

1669623.05.2017

23.05.2022OTC

Richard Bittner AG,

Reisnerstrasse 55-57,

A-1030 Wien, Austria

1942Gentos sublingual

tablets

populus D1, sabal

D6, conium D6,

potassium iodide

D12, ferrum

picrinicum D12

tablets sublingual

25mg+37,2mg+

37,2mg+37,2mg+ 37,2mg,

in blister (20/1x20/)

Richard Bittner AG,

Ossiacherstrasse 7, A-

9560 Feldkirchen

Austria

G04;

homeopathic

drug

1669523.05.2017

23.05.2022OTC

Richard Bittner AG,

Reisnerstrasse 55-57,

A-1030 Wien, Austria

1943 Geral ornidazole tablets coated500mg,

in blister (10)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia P01AB03 1249401.06.2013

01.06.2018PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

422

Page 83: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1944 Geucamen

levomenthol,

racemic camphor,

eucalyptus oil,

clove oil

ointment for

external use

180mg/g+ 100mg/g+

100mg/g+10mg/g, 25g

aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

BelarusM02AX10;

herbal drug 14339

25.03.2015

25.03.2020OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1945 Gexosept-Rn chlorhexidine suppositories vaginal 16mg,

(10/2x5/)

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk

Belarus G01AX 1571322.06.2016

22.06.2021OTC

"Rubicon" LLC, 62B,

M. Gorky street,

210002, Vitebsk,

Belarus

1946Ginkgo Biloba-

Astrapharm

ginkgo biloba dry

extractcapsules

40mg,

in blister (30/3x10/)

'ASTRAFARM' LLC,

6 Kyivska St,

Vyshneve, Kyivo-

Sviatoshynskyi

district, Kyiv region,

08132

UkraineN06DX02

herbal drug13536

30.05.2014

30.05.2019OTC

ASTRAFARM' LLC, 6

Kyivska St, Vyshneve,

Kyivo-Sviatoshynskyi

district, Kyiv region,

08132, Ukraine

1947 Ginkofar Forteginkgo biloba

extracttablets coated

80mg,

in blister (20/2x10/,

60/6x10/)

Biofarm Sp. z.o.o., 13,

Walbrzyska Str., 60-

198, Poznan

PolandN06DX02;

herbal drug14998

02.12.2015

02.12.2020OTC

Biofarm Sp. z.o.o., 13,

Walbrzyska Str., 60-

198, Poznan, Poland

1948 Ginkor Fort

ginkgo biloba

extract, troxerutin,

heptaminol

hydrochloride

capsules14mg+300mg+ 300mg,

in blister (30/3x10/)

Beaufour Ipsen

Industrie, rue Ethe

Virton, 28100 Dreux

France C05CA54 1545802.04.2016

02.04.2021OTC

Ipsen Pharma, 65

quai Georges

Gorse,92100

Boulogne-Billancourt,

France

1949 Glaoxbetaxolol (betaxolol

hydrochloride)drops eye

5mg/ml,

5ml plastic vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01ED02 12384

19.04.2013

19.04.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

423

Page 84: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1950 Glaveral omeprazolecapsules gastro-

resistant hard

20mg,

in plastic container (14,

28)

Help S.A., Pedini

Ioanninon, Ioannina,

45500 for Help S.A.,

10 Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

Greece A02BC01 1710823.10.2017

23.10.2022PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

1951 Glempid glimepiride tablets6mg,

in blister (30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

packager, Specifar SA,

1, 28 Octovriou str.,

Agia Varvara, 12351,

Greece- bulk

manufacturer

Hungary A10BB12 1710223.10.2017

23.10.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1952 Glempid glimepiride tablets4mg,

in blister (30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

packager, Specifar SA,

1, 28 Octovriou str.,

Agia Varvara, 12351,

Greece- bulk

manufacturer

Hungary A10BB12 1710323.10.2017

23.10.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1953 Glempid glimepiride tablets3mg,

in blister (30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

packager, Specifar SA,

1, 28 Octovriou str.,

Agia Varvara, 12351,

Greece- bulk

manufacturer

Hungary A10BB12 1710423.10.2017

23.10.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

424

Page 85: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1954 Glempid glimepiride tablets2mg,

in blister (30/3x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

packager, Specifar SA,

1, 28 Octovriou str.,

Agia Varvara, 12351,

Greece- bulk

manufacturer

Hungary A10BB12 1710523.10.2017

23.10.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

1955 Gliatilin choline alfosceratesolution for i/v & i/m

injection

250mg/ml,

4ml ampoules (3)

Italfarmaco S.p.A.,

Viale Fulvio Testi,

330-20126 Milan

Italy N07AX02 1321724.02.2014

24.02.2019PoM

Italfarmaco S.p.A.,

Viale Fulvio Testi,

330-20126 Milan,

Italy

1956 Gliatilin choline alfoscerate capsules400mg,

in blister (14)

Italfarmaco S.p.A.,

Viale Fulvio Testi,

330-20126 Milan -

batch releaser,

packager (bulk

manufacturer -

Catalent Italy S.p.A.,

Via Nettunense Km.

20, 100-Aprilia (LT),

Italy)

Italy N07AX02 1321824.02.2014

24.02.2019PoM

Italfarmaco S.p.A.,

Viale Fulvio Testi,

330-20126 Milan,

Italy

1957 Glibenclamide glibenclamide tablets5mg,

in blister (48/2x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BB01 13348

13.03.2014

13.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1958Glibenclamid-

Zdorovyeglibenclamide tablets

5mg,

in blister (50/5x10/,

120/6x20/),

in plastic container (50,

50/1x50/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine A10BB01 1631430.12.2016

30.12.2021PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

425

Page 86: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

1959 Glicised glycine tablets100mg,

in blister (50/5x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine N07XX 1715607.11.2017

07.11.2022OTC

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

1960 Gliclazide gliclazidetablets modified-

release

30mg,

in blister (60/6x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus A10BB09 1363527.06.2014

27.06.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

1961 Gliclazide Canon gliclazidetablets prolonged-

release

60mg,

in blister (30/3x10/,

30/2x15/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia A10BB09 1728513.12.2017

13.12.2022PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

1962 Glimepiride glimepiride tablets4mg,

in blister (30/3x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A10BB12 1411829.12.2014

29.12.2019PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

1963Glimepiride 1mg

tabletsglimepiride tablets

1mg,

in blister (30/3x10/)

Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser,

packager, Lek S.A.,16

Podlipie Str., 95-010

Strykow, Poland-bulk

manufacturer

Poland A10BB12 1669723.05.2017

23.05.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

426

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1964Glimepiride 2mg

tabletsglimepiride tablets

2mg,

in blister (90/9x10/)

Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser,

packager, Lek S.A.,16

Podlipie Str., 95-010

Strykow, Poland-bulk

manufacturer

Poland A10BB12 1669823.05.2017

23.05.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1965Glimepiride 4mg

tabletsglimepiride tablets

4mg,

in blister (90/9x10/)

Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser,

packager, Lek S.A.,16

Podlipie Str., 95-010

Strykow, Poland-bulk

manufacturer

Poland A10BB12 1669923.05.2017

23.05.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1966 Glivecimatinib (imatinib

mesylate)tablets film-coated

100mg,

in blister (60/6x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr/Baden

Germany

L01XE01,

new

indication

13072/109.12.2013

09.12.2018PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1967 Glivecimatinib (imatinib

mesylate)tablets film-coated

400mg,

in blister (30/3x10/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L01XE01 1523323.12.2015

23.12.2020PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1968 Glivecimatinib (imatinib

mesylate)tablets film-coated

400mg,

in blister (30/3x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr

Germany L01XE01 1697605.09.2017

05.09.2022PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

1969Glucantime

1,5g/5ml

meglumine

antimoniatesolution for injection

300mg/ml,

5ml ampouls (5)

Famar Health Care

Services Madrid,

S.A.U., Avenida de

Leganes, 62, 28923

Alcorcon(Madrid)

Spain P01CB01 12793/107.03.2014

14.08.2018PoM

Sanofi-Aventis

France, 1-13

boulevard Romain

Rolland 75014 Paris,

France

427

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1970 Glucophage

metformin

(metformin

hydrochloride)

tablets film-coated

1000mg,

in blister (30/2x15/,

30/3x10/, 60/6x10/,

60/4x15/)

Merck Sante s.a.s., 2

rue du Pressoir Vert,

45400 Semoy

France A10BA02 1507407.12.2015

07.12.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

1971 Glucophage

metformin

(metformin

hydrochloride)

tablets film-coated

500mg,

in blister (30/2x15/,

30/3x10/, 60/3x20/)

Merck Sante s.a.s., 2

rue du Pressoir Vert,

45400 Semoy

France A10BA02 1507507.12.2015

07.12.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

1972 Glucophage

metformin

(metformin

hydrochloride)

tablets film-coated

850mg,

in blister (30/2x15/,

60/3x20/)

Merck Sante s.a.s., 2

rue du Pressoir Vert,

45400 Semoy

France A10BA02 1507607.12.2015

07.12.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

1973 Glucosamine Plus

glucosamine

(glucosamine

hydrochloride),

chondroitin sulfate

(chondroitin sulfate

sodium)

tablets film-coated

500mg+400mg,

in plastic container (30,

60, 100)

IBN AL-Haytham

Pharma Industries

Co., P.O.Box 16232,

Al Mansoura-Aleppo

SyriaM01AX05,

M01AX2513731

24.07.2014

24.07.2019OTC

IBN AL-Haytham

Pharma Industries

Co., P.O.Box 16232,

Al Mansoura-Aleppo,

Syria

1974 Glucose dextrosesolution for i/v

injection

400mg/ml,

5ml ampoules label

banderol (10),

5ml ampoules,

in blister (10/2x5/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus V06DC01 1625419.12.2016

19.12.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

1975 Glucose glucose anhydrous solution for infusion

50mg/ml,

100ml, 200ml, 250ml,

400ml and 500ml plastic

vial

Kelun-Kazpharm

LLP, Almaty region,

Karasai area, Eltay

rural district, the

village of Kokozek

Kazakhstan B05CX01 1651817.03.2017

17.03.2022PoM

Kelun-Kazpharm

LLP, Almaty region,

Karasai area, Eltay

rural district, the

village of Kokozek,

Kazakhstan

428

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1976 Glucose glucose anhydrous solution for infusion

100mg/ml,

100ml, 200ml, 250ml,

400ml and 500ml plastic

vial

Kelun-Kazpharm

LLP, Almaty region,

Karasai area, Eltay

rural district, the

village of Kokozek

Kazakhstan B05CX01 1651917.03.2017

17.03.2022PoM

Kelun-Kazpharm

LLP, Almaty region,

Karasai area, Eltay

rural district, the

village of Kokozek,

Kazakhstan

1977 Glucosedextrose (dextrose

monohydrate)solution for infusion

50mg/ml,

50ml,100ml, 200ml,

250ml, 500ml and 3000ml

plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05CX01 17112

23.10.2017

23.10.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1978 Glucoton MR gliclazidetablets modified-

release

30mg,

in blister (30/3x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia A10BB09 1638216.01.2017

16.12.2021PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

1979 Glucovance

glibenclamide,

metformin

(metformin

hydrochloride)

tablets film-coated5mg+500mg,

in blister (30/2x15/)

Merck Sante s.a.s., 2

rue du Pressoir Vert,

45400 Semoy

France A10BD02 1507207.12.2015

07.12.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

1980 Glucovance

glibenclamide,

metformin

(metformin

hydrochloride)

tablets film-coated2,5mg+500mg,

in blister (30/2x15/)

Merck Sante s.a.s., 2

rue du Pressoir Vert,

45400 Semoy

France A10BD02 1507307.12.2015

07.12.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

1981 Glurenorm gliquidone tablets30mg,

in blister (60/6x10/)

Boehringer Ingelheim

Ellas A.E. (5th km,

Paiania-Markopoulo,

194 00 Koropi, Attiki)

Greece A10BB08 1293307.10.2013

07.10.2018PoM

Boehringer Ingelheim

International GmbH

(Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany)

429

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1982 Glycelax glycerol suppositories rectal750mg

(10/2x5/)

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow

Russia A06AX01 1329704.03.2014

04.03.2019OTC

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow,

Russia

1983 Glycelax glycerol suppositories rectal1500mg

(10/2x5/)

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow

Russia A06AX01 1329804.03.2014

04.03.2019OTC

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow,

Russia

1984 Glycerin glycerolsolution for external

use

900mg/g,

30ml, 100ml glass or

plastic vial, 10ml plastic

container

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaD11AX 13439

14.04.2014

14.04.2019OTC

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan, Republic of

Armenia

1985 Glycerin glycerol suppositories rectal1000mg

(10/2x5/)

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaA06AX01 13475

06.05.2014

06.05.2019OTC

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

1986 Glycerin glycerol suppositories rectal2110mg

(10/2x5/)

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaA06AX01 13476

06.05.2014

06.05.2019OTC

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

1987 Glycerin glycerol suppositories rectal1,24g,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A06AG04 15475/103.03.2017

02.04.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

430

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1988 Glycerin glycerol suppositories rectal2.11g,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A06AG04 16356/122.03.2017

30.12.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1989 Glycerin glycerol suppositories rectal1,24g,

in blister (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A06AG04 1703526.09.2017

26.09.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1990 Glycerin glycerol suppositories rectal2.11g,

in blister (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia A06AG04 1703626.09.2017

26.09.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

1991

Glycerin

Suppositories BP 4g

Adult Size

glycerol suppositories rectal2,8g

(12)

LCM Ltd.,

Linthwaite,

Huddersfield, West

Yorkshire, HD7 5QH

UK A06AX01 1280527.08.2013

27.08.2018OTC

Thornton & Ross Ltd.,

Huddersfield, HD7

5QH, UK

1992 Glycine glycine tablets sublingual100mg,

in blister (50/1x50/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaB05CX03 13641

27.06.2014

27.06.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

1993 Glycine glycine tablets sublingual100mg,

in blister (50/1x50/)

"Limited Liability

Company "Medical

Scientific and

Production Complex"

BIOTIKI", 6-ya

Radialnaya str. 24, b.

14, 115404, Moscow

Russia N06BX 1701326.09.2017

26.09.2022OTC

"Limited Liability

Company "Medical

Scientific and

Production Complex"

BIOTIKI", 6-ya

Radialnaya str. 24, b.

14, 115404, Moscow,

Russia

431

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1994 Glycine glycinesolution for

irrigation

15mg/ml,

3000ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05CX03 17083

05.10.2017

05.10.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1995 Glycofor 850mg

metformin

(metformin

hydrochloride)

tablets film-coated850mg,

in blister (30/3x10/)

Medopharm Private

Limited (34-B,

Industrial Area,

Malur-563 130,

Karnataka)

India A10BA02 1294828.10.2013

28.10.2018PoM

Troge Medical GmbH

(Milchstrasse 19, D-

20148 Hamburg,

Germany)

1996 Glycyron Tablets

monoammonium

glycyrrhizinate

(glycyrrhizic acid),

glycine, DL-

methionine

tablets coated35mg+25mg+ 25mg,

in blister (100/10x10/)

Minophagen

Pharmaceutical Co.,

Ltd,. 2-3,

Komatsubara 2-

chome, Zama-shi,

Kanagawa-batch

releaser, secondary

packager, Akiyama

Jozai Co. Ltd., 2-4-21

Hiratsuka, Shinagawa-

ku,Tokyo, Japan-bulk

manufacturer,

primary packager

Japan A05B 1566408.06.2016

08.06.2021PoM

Minophagen

Pharmaceutical Co.,

Ltd., Shinjuku Mitsui

Building #2, 3-2-11,

Nishi-Shinjuku,

Shinjuku-ku,

Tokyo,160-0023,

Japan

1997 Golden Star Balsam

crystallic menthol,

camphor, menthae

oil, eucalypt oil,

cloves oil, cassia oil

pencil inhalation

658mg+124mg+

258mg+65mg+ 5mg+6mg,

1,3g plastic container

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city

Vietnam R05X 1245807.05.2013

07.05.2018OTC

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city,

Vietnam

1998 Golden Star Balsam

crystallic menthol,

camphor, menthae

oil, eucalypt oil,

cloves oil, cassia oil

liquid balsam

280mg/ml+ 88,8mg/ml+

229mg/ml+

1mg/ml+4,6mg/ml+3,8mg

/ml,

5ml glass bottle

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city

Vietnam R05X 1245907.05.2013

07.05.2018OTC

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city,

Vietnam

432

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1999 Golden Star Balsam

crystallic menthol,

camphor, oil

menthae piperitae,

eucalyptus leaf oil,

cloves flowers oil,

chinese cassia oil

balsam

113,75mg/g+ 227,5mg/g+

174,5mg/g+

35mg/g+57mg/g+

13,25mg/g,

4g metallic container

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city

Vietnam R05X 1246007.05.2013

07.05.2018OTC

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Danang city,

Vietnam

2000Gonadotropin

chorionic

gonadotropin

chorionic

powder lyophilized

for solution for i/m

injection

500U,

glass vial (5) and 1ml

solvent in ampoule (5)

"Moscow Endocrine

Plant FSUE", 25,

Novokhokhlovskaya

st., Moscow 109052

Russia G03GA01 1473130.07.2015

30.07.2020PoM

"Moscow Endocrine

Plant FSUE", 25,

Novokhokhlovskaya

st., Moscow 109052,

Russia

2001Gonadotropin

chorionic

gonadotropin

chorionic

powder lyophilized

for solution for i/m

injection

1000IU,

glass vial (5) and 1ml

solvent in ampoule (5)

"Moscow Endocrine

Plant FSUE", 25,

Novokhokhlovskaya

st., Moscow 109052

Russia G03GA01 1473230.07.2015

30.07.2020PoM

"Moscow Endocrine

Plant FSUE", 25,

Novokhokhlovskaya

st., Moscow 109052,

Russia

2002 Gonal-F follitropin alfapowder for solution

for injection

5,5mcg (75IU),

3ml glass vial, 1ml solvent

in pre-filled syringe,

sterill needles (2)

Merck Serono S.A.

(Succursale d

Aubonne, Zone

Industrielle de l

Ouriettaz, 1170

Aubonne)

Switzerland G03GA05 1298828.10.2013

28.10.2018PoM

Merck Serono Europe

Limited (56 Marsh

Wall, E14 9TP

London, UK)

2003 GONAL-f follitropin alfasolution for s/c

injection

450IU(33mcg)/ 0,75ml,

0.75ml pre-filled pen-

syringe (1) and needles

(12)

Merck Serono S.p.A.,

Via delle Magnolie

15, 70026 Modugno

(BA)

Italy G03GA05 1630230.12.2016

30.12.2021PoM

Merck Serono Europe

Ltd., Marsh Wall 56,

London E14 9TP, UK

2004 GONAL-f follitropin alfasolution for s/c

injection

300IU(22mcg)/ 0,5ml,

0.5ml glass pre-filled

syringe (1) and needles (8)

Merck Serono S.p.A.,

Via delle Magnolie

15, 70026 Modugno

(BA)

Italy G03GA05 1630330.12.2016

30.12.2021PoM

Merck Serono Europe

Ltd., Marsh Wall 56,

London E14 9TP, UK

433

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2005 GONAL-f follitropin alfasolution for s/c

injection

900IU(66mcg)/ 1,5ml,

1.5ml glass pre-filled pen-

syringe (1) and needles

(20)

Merck Serono S.p.A.,

Via delle Magnolie

15, 70026 Modugno

(BA)

Italy G03GA05 1630430.12.2016

30.12.2021PoM

Merck Serono Europe

Ltd., Marsh Wall 56,

London E14 9TP, UK

2006 Grammidin neo

gramicidin S

(gramicidin S

dihydrochloride),

cetylpyridinium

chloride

(cetylpyridinium

chloride

monohydrate)

tablets to be sucked3mg+1mg,

in blister (18/2x9/)

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia R02A 15770/108.12.2017

04.07.2021OTC

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2,

Russia

2007Grammidin with

anesthetic neo

gramicidin S

(gramicidin S

dihydrochloride),

oxybuprocaine

(oxybuprocaine

hydrochloride),

cetylpyridinium

chloride

(cetylpyridinium

chloride

monohydrate)

tablets to be sucked3mg+0.2mg+1mg, in

blister (18/2x9/)

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia R02A 15769/108.12.2017

04.07.2021OTC

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2,

Russia

2008 Grandaxin tofisopam tablets

50mg,

in blister (20/2x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65 -

batch releaser,

packager, Egis

Pharmaceuticals PLC,

1165 Budapest,

Bokenyfoldi st. 118-

120, Hungary-bulk

manufacturer

Hungary N05BA23 1644206.03.2017

06.03.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2009 Grandaxin tofisopam tablets

50mg,

in blister (20/2x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05BA23 1644306.03.2017

06.03.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

434

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2010Grani-Denk

1mg/ml

granisetron

(granisetron

hydrochloride)

concentrate for

solution for

injection/infusion

1mg/ml,

3ml ampoules (5)

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,

Niedersachsen, 31789

Germany A04AA02 1383818.09.2014

18.09.2019PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2011Grani-Denk

1mg/ml

granisetron

(granisetron

hydrochloride)

concentrate for

solution for

injection/infusion

1mg/ml,

1ml ampoules (5)

Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,

Niedersachsen, 31789

Germany A04AA02 1399126.11.2014

26.11.2019PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2012 Graphites Cream graphites cream6x9%,

30g aluminum tube

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

D11AX

homeopathic

drug

1352230.05.2014

30.05.2019PoM

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH,

UK

2013Grinterol capsules

250mg

ursodeoxycholic

acidcapsules

250mg,

in blister (50/5x10/,

100/10x10/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia A05AA02 1652017.03.2017

17.03.2022PoM

Grindeks Rus LLC,

5th floor, corpus 3,

74, Varshavskoe

shosse, Moscow,

117556, Russia

2014 Grippferon interferon alfa-2b drops nasal

10000IU/ml,

5ml,10ml plastic vial with

dropper

FIRN M CJSC, 4,

Dzerzhinskogo str.,

Kokoshkino

Settlement, Naro-

Fominsky district,

Moskow region,

143390

Russia L03AB01 1589823.08.2016

23.08.2021OTC

"FIRN M" CJSC, 15/1,

entrance "B", Borby

square, Moscow,

127055, Russia

435

Page 96: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2015GrippoFlu cold and

flu

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid

powder for oral

solution with

raspberry flavour

325mg+10mg+

20mg+50mg,

13g sachets (10)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia N02BE51 1451015.05.2015

15.05.2020OTC

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

2016GrippoFlu cold and

flu

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid

powder for oral

solution with

cranberry flavour

325mg+10mg+

20mg+50mg,

13g sachet (10)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia N02BE51 1712324.10.2017

24.10.2022OTC

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

2017GrippoFlu Extra

cold and flu

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid

powder for oral

solution with black-

currant flavour

0,65g+0,01g+ 0,02g+0,05g,

13g sachets (3, 8)

Marbiopharm JSC,

424006,Republic Mari

El,Yoshkar-Ola, st.

Karl Marx 121

Russia N02BE51 1389506.10.2014

06.10.2019OTC

Marbiopharm JSC,

424006,Republic Mari

El,Yoshkar-Ola, st.

Karl Marx 121, Russia

2018GrippoFlu Extra

cold and flu

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid

powder for oral

solution with lemon

flavour

0,65g+0,01g+ 0,02g+0,05g,

13g sachets (3, 8)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia N02BE51 1440616.04.2015

16.04.2020OTC

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

436

Page 97: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2019 Grippostadparacetamol,

ascorbic acid

powder for oral

solution

600mg+50mg,

5g sachets (5)

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel-

batch releaser,

allphamed PHARBIL

Arzneimittel GmbH,

Hildebrandstr. 10-12,

37081 Gottingen,

Niedersachsen,

Germany-bulk

manufacturer,

packager

Germany N02BE51 1697305.09.2017

05.09.2022OTC

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel,

Germany

2020 Grippostad C

paracetamol,

ascorbic acid,

caffeine,

chlorphenamine

(chlorphenamine

maleate)

capsules

200mg+150mg+

25mg+2,5mg,

in blister (10/1x10/)

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel

Germany N02BA71 1697205.09.2017

05.09.2022OTC

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel,

Germany

2021Grippostad Rhino

0,1% nasal drops

xylometazoline

(xylometazoline

hydrochloride)

drops nasal1mg/ml,

10ml glass bottle (1)

STADA Arzneimittel

AG, Stadastrasse 2-18

D-61118 Bad Vilbel

Germany R01AA07 1214001.02.2013

01.02.2018OTC

STADA Arzneimittel

AG, Stadastrasse 2-18

D-61118 Bad Vilbel,

Germany

2022 Grippoton

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,

10ml plastic bottle with

pump dispenser

Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus R01AA07 1672605.06.2017

05.06.2022OTC

Giga Farm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

2023 Grippoton

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

0.5mg/ml,

10ml plastic bottle with

pump dispenser

Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus R01AA07 1672705.06.2017

05.06.2022OTC

Giga Farm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

2024 Grippoton Sashe

paracetamol,

pheniramine

(pheniramine

maleate), ascorbic

acid

powder for oral

solution

325mg+25mg+ 220mg,

sachet (10)

Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus N02BE51 1680522.06.2017

22.06.2022OTC

Giga Farm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

437

Page 98: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2025 Groprinosin inosine pranobex syrup

50mg/ml,

120ml glass bottle and

measuring cup

Gedeon Richter

Polska Sp. z o.o. 5, ks.

J. Poniatowskiego Str.,

05-825 Grodzisk

Mazowiecki - batch

releaser (S.C. Gedeon

Richter Romania S.A.,

99-105 Guza Voda

street, 540306, Targu-

Mures, Romania -

bulk manufacturer,

packager)

Poland J05AX05 1342114.04.2014

14.04.2019PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2026 Groprinosin inosine pranobex tablets

500mg,

in blister (20/2x10/,

50/5x10/)

Gedeon Richter

Polska Sp. z o.o. 5, ks.

J. Poniatowskiego Str.,

05-825 Grodzisk

Mazowiecki

Poland J05AX05 1494320.10.2015

20.10.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2027Groprinosin-

Richterinosine pranobex syrup

50mg/ml,

150ml glass bottle and

plastic syringe 0.5ml-5ml

Gedeon Richter

Polska Sp. z o.o., ul.

Ks. J. Poniatowskiego

5, Grodzisk

Mazowiecki, 05-825-

batch releaser,

Gedeon Richter

Romania S.A., 99-105

Guza Voda str.,

540306, Targu-Mures,

Romania-bulk

manufacturer,

packager

Poland J05AX05 1570922.06.2016

22.06.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2028 Guttalax sodium picosulfate drops oral

7,5mg/ml,

15ml and 30ml plastic

bottle

Istituto de Angeli

S.R.L. Loc. Prulli,

103/C 50066 Reggello,

Firenze

Italy A06AB08 1673405.06.2017

05.06.2022OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

438

Page 99: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2029 Gynepriston mifepristone tablets10mg,

in blister (1)

Obninsk Chemical

Pharmaceutical

Company CJSC,

249036, 4 Koroleva

str., Obninsk, Kaluga

region

Russia G03XB01 1625119.12.2016

19.12.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2030 Gynocaps

miconazole

(miconazole

nitrate),

metronidazole

capsules vaginal 100mg+100mg, (10/2x5/)

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112

Belarus G01AF20 1306225.11.2013

25.11.2018PoM

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112, Belarus

2031 Gynofort

butoconazole

(butoconazole

nitrate)

cream vaginal20mg/g,

5g plastic applicator

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G01AF15 1483204.09.2015

04.09.2020PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2032 Gyno-Tardyferoniron sulfate, folic

acid

tablets prolonged-

release

80mg+0.35mg,

in blister (30/3x10/)

Pierre Fabre

Medicament

Production,

Etablissement

Progipharm, Rue du

Lycee, 45500 Gien

France B03AD 1425020.02.2015

20.02.2020PoM

Pierre Fabre

Medicament

Production, 45, place

Abel Gance, 92100

Boulogne, France

2033 Gynotril letrozole tablets film-coated2,5mg,

in blister (30/3x10/)

Douglas

Manufacturing Ltd,

Corner Te Pai Place

and Central Park

Drive, Lincoln

Auckland

New Zealand L02BG04 1498518.11.2015

18.11.2020PoM

Eris Pharmaceuticals

(Australia) Pty Ltd, 6

Eastern Road, South

Melbourne, Victoria,

3205, Australia

2034 H+care

aesculus

hippocastanum

tincture, calendula

officinalis tincture,

hamamelis virginica

tincture, paeonia

officinalis tincture

cream

1/10 2.4%+ 1/10 2.4%+

1/10 2.4%+ 1/10 2.4%,

30g aluminum tube

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

C05AX

homeopathic

drug

1352130.05.2014

30.05.2019PoM

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH,

UK

439

Page 100: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2035 Haemate P 1000

human blood

coagulation factor

VIII, human Von

Willebrand Factor

(VWF:RCo)

powder and solvent

for solution for

injection/ infusion

1000IU+2400IU, glass vial

(1), 15ml glass vial with

solvent, transfer/filter

device 20/20 (1), alcohol

swabs (2)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany B02BD06 1480604.09.2015

04.09.2020PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

2036 Haemate P 250

human blood

coagulation factor

VIII, human Von

Willebrand Factor

(VWF:RCo)

powder and solvent

for solution for

injection/ infusion

250IU+600IU, glass vial

(1), 5ml glass vial with

solvent, transfer/filter

device 20/20 (1), alcohol

swabs (2)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany B02BD06 1480404.09.2015

04.09.2020PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

2037 Haemate P 500

human blood

coagulation factor

VIII, human Von

Willebrand Factor

(VWF:RCo)

powder and solvent

for solution for

injection/ infusion

500IU+1200IU, glass vial

(1), 10ml glass vial with

solvent, transfer/filter

device 20/20 (1), alcohol

swabs (2)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany B02BD06 1480504.09.2015

04.09.2020PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

2038Haemodesum-

PharmaTech

polyvinylpyrrolidon

e, sodium chloride,

potassium chloride,

calcium chloride

(calcium chloride

dihydrate),

magnesium

chloride

(magnesium

chloride

hexahydrate),

sodium

hydrocarbonate

solution for infusion

60mg/ml+ 5,5mg/ml+

0,42mg/ml+ 0,375mg/ml+

0,005mg/ml+ 0,23mg/ml,

100ml, 200ml, 250ml,

400ml, 500ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaB05AA 15718

22.06.2016

22.06.2021PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

440

Page 101: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2039 Hairgaine for Men minoxidil solution50mg/g,

60ml plastic bottle

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD11AX01 13666

08.07.2014

08.07.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

2040Hairgaine for

Womenminoxidil solution

20mg/g,

60ml plastic bottle

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD11AX01 13665

08.07.2014

08.07.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

2041 Hairgaine Gel minoxidil gel20mg/g,

30g aluminium tube

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD11AX01 13667

08.07.2014

08.07.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

2042 H-AL therapeutic

I-.pollen - 1, 10, 100, 1000, 10000

JSK / 1, 10, 100, 1000, 10000 PNU

(1-grass pollen mixture I (1-

10000JSK/ml) - Arrhenatherum

elatius, Dactylis glomerata, Festuca

sp., Lolium sp., Phleum pratense,

Secale cereale, 2-Spring trees (1-

10000 JSK/ml) - Alnus glutinosa,

Betula pendula, Carpinus betulus,

Corylus avellana, 3-Autumn pollen

mixture (1-10000 PNU/ml) -

Artemisia absinthium, Artemisia

vulgaris, Solidago canadensis, 4-

ambrosia (1-10000JSK/ml) -

Ambrosia artemisiifolia, 5-ambrosia

(1-10000PNU/ml) - Ambrosia

artemisiifolia), II-mites - 1, 10, 100,

1000, 10000 PNU (mixture of mites

(1-10000PNU/ml) - Acarus siro,

Dermatophagoides farinae,

Dermatophagoides pteronyssinus),

III-moulds - 0.1, 1, 10, 100, 1000

PNU (1-outdoor mould mixture (0.1-

1000PNU/ml) - Alternaria sp..

Botrytis cinerea, Cladosporium sp.,

Fusarium sp., Chrysonilia sitophila, 2-

indoor mould mixture (0.1-

1000PNU/ml) - Aspergillus

fumigatus, Aspergillus niger,

Penicillium sp., Mucor sp., Rhizopus

sp.)

drops oral

I-pollen (1 JSK/ml, 10 JSK/ml, 100

JSK/ml, 1000 JSK/ml, 10000 JSK/ml

/ 1 PNU/ml, 10 PNU/ml, 100

PNU/ml, 1000 PNU/ml, 10000

PNU/ml)+ II-mites (1 PNU/ml, 10

PNU/ml, 100 PNU/ml, 1000

PNU/ml, 10000 PNU/ml) + III-

moulds (0.1 PNU/ml, 1 PNU/ml, 10

PNU/ml, 100 PNU/ml, 1000

PNU/ml); (1) glass vial 9ml:

1000PNU/ml or 10000PNU/ml or

10000JSK/ml and (1) sterile dosator;

(6) glass vial 9ml: 0,1PNU/ml,

1PNU/ml, 10PNU/ml, 100PNU/ml,

1000PNU/ml (N2) or 1PNU/ml,

10PNU/ml, 100PNU/ml,

1000PNU/ml, 10000PNU/ml (N2)

or 1JSK/ml, 10JSK/ml, 100JSK/ml,

1000JSK/ml, 10000JSK/ml (N2) and

(6) sterile dosator

Sevapharma a.s.,

Vitavska 53, 252 63

Roztoky, building 101

and 102 for

Czech Republic V01AA 1398426.11.2014

26.11.2019PoM

Sevapharma a.s.,

Prumyslova 1472/11,

102 19 Praha 10,

Czech Republic

441

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2043 Halidor

bencyclane

(bencyclane

fumarate)

solution for injection

25mg/ml,

2ml ampoules, in blister

(10/2x5/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C04AX11 1555912.05.2016

12.05.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2044 Halidor

bencyclane

(bencyclane

fumarate)

tablets100mg,

in glass container (50)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary C04AX11 1556012.05.2016

12.05.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2045 Halixol

ambroxol

(ambroxol

hydrochloride)

tablets30mg,

blisters (20/2x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary R05CB06 1595515.09.2016

15.09.2021OTC

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2046 Halixol

ambroxol

(ambroxol

hydrochloride)

syrup

3mg/ml,

100ml glass bottle and

measuring cup

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary R05CB06 1595615.09.2016

15.09.2021OTC

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2047 Haloperidol haloperidol tablets5mg,

in blister (48/2x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AD01 12470

04.12.2013

04.12.2018PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2048 Haloperidol haloperidol tablets1,5mg,

in blister (48/2x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AD01 14318

09.03.2015

09.03.2020PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2049Haloperidol-

Richterhaloperidol tablets

5mg,

in blister (50/2x25/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N05AD01 1478003.08.2015

03.08.2020PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

442

Page 103: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2050Haloperidol-

Richterhaloperidol

solution for i/m

injection

5mg/ml,

1ml ampoules (5)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N05AD01 1488924.09.2015

24.09.2020PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2051 Halopril haloperidol solution for injection

5mg/ml,

1ml ampoules,

in blister (10, 10/2x5/)

KPE Zdorovye

narodu" LLC,

Melnikova str., 41,

Kharkov, 61002

Ukraine N05AD01 1237319.04.2013

19.04.2018PoM/UC

"KPE" Zdorovye

narodu" LLC, 61013,

Kharkov,Sevchenko

str. 22, Ukraine

2052 Halothane halothane liquid for inhalation100%,

250ml glass bottle

Piramal Enterprises

Limited, Sy.No.7-70,

70/1 & 70/2, Digwal

Village, Kohir

Mandal, Sangareddy

District - 502 321,

Telangana

India N01AB01 1677522.06.2017

22.06.2022PoM

Piramal Enterprises

Limited, Piramal

Towers, Ganpatrao

Kadam Marg, Lower

Parel, Mumbai-

400013, India

2053 Hamamelis hamamelis D1 suppositories rectal57mg,

in blister (10/2x5/)

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow

Russiahomeopathic

drug12199

07.03.2013

07.03.2018OTC

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow,

RUSSIA

2054 Hamamelis hamamelis D1 ointment100mg/g,

30g aluminium tube

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow

Russiahomeopathic

drug12200

07.03.2013

07.03.2018OTC

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow,

RUSSIA

2055 Hartil ramipril tablets

5mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09AA05 1361927.06.2014

27.06.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

443

Page 104: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2056 Hartil ramipril tablets

10mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

121

Hungary C09AA05 1362027.06.2014

27.06.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2057 Hartil ramipril tablets

5mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120- batch releaser,

Actavis Ltd., BLB 015,

BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000,

Malta-bulk

manufacturer,

packager

Hungary C09AA05 1506802.12.2015

02.12.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2058 Hartil ramipril tablets

10mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120- batch releaser,

Actavis Ltd., BLB 015,

BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000,

Malta-bulk

manufacturer,

packager

Hungary C09AA05 1506902.12.2015

02.12.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2059 Hartil ramipril tablets

2,5mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120- batch releaser,

Actavis Ltd., BLB 015,

BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000,

Malta-bulk

manufacturer,

packager

Hungary C09AA05 1507002.12.2015

02.12.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

444

Page 105: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2060 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

5mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary C09BB07 1558212.05.2016

12.05.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2061 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

10mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary C09BB07 1558312.05.2016

12.05.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2062 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

10mg+10mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary C09BB07 1558412.05.2016

12.05.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2063 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

10mg+10mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659110.04.2017

10.04.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2064 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

5mg+10mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659210.04.2017

10.04.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2065 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

10mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659310.04.2017

10.04.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

445

Page 106: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2066 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

5mg+5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659410.04.2017

10.04.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2067 Hartil Amlo

ramipril,

amlodipine

(amlodipine

besilate)

capsules

2,5mg+2,5mg,

in blister (28/4x7/,

30/3x10/, 56/8x7/,

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C09BB07 1659510.04.2017

10.04.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2068 Hartil-D

ramipril,

hydrochlorothiazid

e

tablets2,5mg+12,5mg,

in blister (28/2x14/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120-batch releaser,

Allphamed Pharbil

Arzneimittel GmbH,

Hildebrandstr. 12,

37081 Gottingen,

Germany-bulk

manufacturer,

packager

Hungary C09BA05 1644706.03.2017

06.03.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

2069 Hartil-D

ramipril,

hydrochlorothiazid

e

tablets5mg+25mg,

in blister (28/2x14/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120-batch releaser,

Allphamed Pharbil

Arzneimittel GmbH,

Hildebrandstr. 12,

37081 Gottingen,

Germany-bulk

manufacturer,

packager

Hungary C09BA05 1644806.03.2017

06.03.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

446

Page 107: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2070 Havrix 1440hepatitis A vaccine

inactivated

suspension for

injection

1440 ELISA U/ml, 1ml

glass vial

GlaxoSmithKline

Biologicals s.a., Rue

de l' Institut, 89 B-

1330 Rixensart-batch

releaser,

GlaxoSmithkline

Biologicals SA, Parc

de la Noire Epine -

Rue Fleming 20,

Wavre, 1300, Belgium-

bulk manufacturer,

packager

BelgiumJ07BC02;

vaccine16311

30.12.2016

30.12.2021PoM

GlaxoSmithKline

Biologicals s.a., Rue

de l` Institut, 89 B-

1330 Rixensart,

Belgium

2071 Hedelix ivy leaves extract drops oral40mg/ml,

50ml glass bottle

Krewel Meuselbach

GmbH, Krewel str. 2,

53783 Eitorf -batch

releaser (dosage fom

manufacturer,

packager - Krewel

Meuselbach GmbH,

Xavier-Vorbruggen

str. 6, 98708 Gehren,

Germany)

GermanyR05CP;

herbal drug12824

17.09.2013

17.09.2018OTC

Krewel Meuselbach

GmbH, Krewel str. 2,

53783 Eitorf,

Germany

2072 Hedelix ivy leaves extract syrup

8mg/ml,

100ml glass bottle and

measuring spoon

Krewel Meuselbach

GmbH, Krewel str. 2,

53783 Eitorf

GermanyR05CA;

herbal drug15759

04.07.2016

04.07.2021OTC

Krewel Meuselbach

GmbH, Krewel str. 2,

53783 Eitorf,

Germany

2073 Helmintox 125mgpyrantel (pyrantel

embonate)tablets film-coated

125mg,

in blister (6)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France P02CC01 1410018.12.2014

18.12.2019PoM

Laboratoire Innotech

International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

2074Helmintox

125mg/2,5ml

pyrantel (pyrantel

embonate)suspension oral

125mg/2,5ml,

15ml glass bottle

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France P02CC01 1409918.12.2014

18.12.2019PoM

Laboratoire Innotech

International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

447

Page 108: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2075 Helmintox 250mgpyrantel (pyrantel

embonate)tablets film-coated

250mg,

in blister (3)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France P02CC01 1409818.12.2014

18.12.2019PoM

Laboratoire Innotech

International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

2076 Hemomycin

azithromycin

(azithromycin

dihydrate)

tablets film-coated500mg,

in blister (3)

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb

Serbia J01FA10 1512511.12.2015

11.12.2020PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

2077 Hemomycin

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

200mg/ml,

60ml glass bottle with 10g

powder and measuring

spoon 5ml

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia J01FA10 1628919.12.2016

19.12.2021PoM

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

2078 Hemomycin

azithromycin

(azithromycin

dihydrate)

capsules250mg,

in blister (6/1x6/)

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia J01FA10 1629019.12.2016

19.12.2021PoM

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

448

Page 109: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2079 HemoSol

sodium chloride,

potassium chloride,

magnesium

chloride, sodium

acetate, sodium

gluconate

solution for infusion

5,26mg/ml+ 0,37mg/ml+

0,3mg/ml+ 2,22mg/ml+

5,02mg/ml,

250ml, 500ml, 1000ml

plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05BB 12856

17.09.2013

17.09.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2080 Hepabel cynarae dry extract tablets film-coated200mg,

in plastic container (60)

Brupharmexport

SPRL (Rue de la

Grotte, 14, Brussels,

1020)

Belgium A05AX 1299028.10.2013

28.10.2018OTC

Brupharmexport

SPRL (Rue de la

Grotte, 14, Brussels,

1020, Belgium)

2081 Hepabene

extractum fumaria

officinalis,

extractum silybum

marianum

capsules275,10mg+ 83,10mg,

in blister (30/3x10/)

Merckle GmbH,

89143, Blaubeuren-

Weiler, Ludwig-

Merckle-Str.3

Germany A05B 1218401.02.2013

01.02.2018PoM

Ratiopharm GmbH,

89079, Ulm, Graf-

Arco-Str. 3, Germany

2082 Heparinheparin (heparin

sodium)gel for external use

1000IU/g,

30g aluminium tube

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C05BA03 1575304.07.2016

04.07.2021OTC

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

2083 Heparin ointment

heparin (heparin

sodium),

benzocaine, benzyl

nicotinate

ointment for

external use

100IU/g+40mg/g+0,8mg/g

; 25g aluminium or plastic

tube

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia C05BA53 1665111.05.2017

11.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

2084 Heparin-Belmedheparin (heparin

sodium)

solution for i/v and

s/c injection

5000UU/ml,

5ml vials (1, 5)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus B01AB01 1402526.11.2014

26.11.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

449

Page 110: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2085 Heparin-Indar heparin sodium solution for injection5000 IU/ml,

5ml glass vial (5)

PrJSC "On the

production of insulin

"INDAR", 02099,

Kyiv, 5 Zroshuvalna st

Ukraine B01AB01 1685510.07.2017

10.07.2022PoM

PrJSC "On the

production of insulin

"INDAR", 02099,

Kyiv, 5 Zroshuvalna

st, Ukraine

2086 Heparin-Liqvoheparin (heparin

sodium)

solution for i/v and

s/c injection

5000IU/ml,

5ml glass vial (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB01AB01 17208

08.12.2017

08.12.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2087 Hepasol-Neo

L-valine, L-

isoleucine, L-

leucine, L-lysine (L-

lysine

monoacetate), L-

methionine, L-

threonine, L-

phenylalanine, L-

tryptophan, L-

alanine, L-arginine,

glicine, L-histidine,

L-proline, L-serine,

L-cysteine (L-

cysteine

acetylcysteine)

solution for infusion

10,08mg/ml+ 10,4mg/ml+

13,09mg/ml+ 6,88mg/ml+

1.1mg/ml+ 4.4mg/ml+

0.88mg/ml+ 0.7mg/ml+

4.64mg/ml+ 10.72mg/ml+

5.82mg/ml+ 2.8mg/ml+

5.73mg/ml+ 2.24mg/ml+

0.52mg/ml,

500ml glass vial

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemomont d.o.o.,

81000,Podgorica, Ilije

Plamenca str. bb,

Montenegro-bulk

manufacturere,

packager

Serbia B05BA01 1626019.12.2016

19.12.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

2088 Hepathrombin

heparin sodium,

allantoin,

dexpanthenol

gel for external use

300IU/g+2,5mg/g+2,5mg/

g,

40g aluminium tube

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia C05BA53 1631630.12.2016

30.12.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

450

Page 111: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2089 Hepathrombin

heparin sodium,

allantoin,

dexpanthenol

cream for external

use

300IU/g+3mg/g+ 4mg/g,

40g aluminium tube

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia C05BA53 16437/110.10.2017

06.03.2022OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

2090 Hepathrombin H

heparin sodium,

prednisolone

(prednisolone

acetate),

polidocanol

ointment for rectal

and external use

65IU/g+ 2,233mg/g+

30mg/g,

20g aluminium tube

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia C05BA53 1637130.12.2016

30.12.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

2091 Hepathrombin H

heparin sodium,

prednisolone

(prednisolone

acetate),

polidocanol

suppositories rectal120IU+1,675mg+ 30mg,

(10/2x5/)

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb, Serbia-bulk

manufacturer,

packager

Serbia C05BA53 1637230.12.2016

30.12.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

2092

Hepatitis B

Vaccine (rDNA)

(Adult)

hepatitis B surface

antigene

suspension for

injection

20mcg/dose,

1ml glass vial

(1 dose) (50)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15208/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

451

Page 112: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2093

Hepatitis B

Vaccine (rDNA)

(Adult)

hepatitis B surface

antigene

suspension for

injection

20mcg/dose,

1ml ampoules

(1 dose) (50)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15209/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

2094

Hepatitis B

Vaccine (rDNA)

(Adult)

hepatitis B surface

antigene

suspension for

injection

20mcg/dose,

10ml glass vial

(10 doses) (25)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15210/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

2095

Hepatitis B

Vaccine (rDNA)

(Paediatric)

hepatitis B surface

antigene

suspension for

injection

10mcg/dose,

5ml glass vial,

(10 doses) (50)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15206/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

2096

Hepatitis B

Vaccine (rDNA)

(Paediatric)

hepatitis B surface

antigene

suspension for

injection

10mcg/dose; (50)

ampoules 0.5ml (1 dose)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15207/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

2097

Hepatitis B

Vaccine (rDNA)

(Paediatric)

hepatitis B surface

antigene

suspension for

injection

10mcg/dose,

0.5ml glass vial

(1 dose) (50)

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028

India J07BC01;

vaccine 15211/1

30.08.2017

30.12.2020PoM

Serum Institute of

India Pvt Ltd., 212/2,

Hadapsar, Pune

411028, India

2098 Hepatoprimornithine (ornithine

aspartate)

concentrate for

solution for injection

500mg/ml,

20ml glass vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaA05BA 12484

15.05.2013

15.05.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2099 Heptral ademetioninetablets gastro-

resistant

400mg,

in blister (20/2x10/)

AbbVie S.r.l., S.R. 148

Pontina KM 52, SNC -

Campoverde di

Aprilia (loc. Aprilia)-

04011 Aprilia (LT)

Italy A16AA02 1587011.08.2016

11.08.2021PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

452

Page 113: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2100 Heptral ademetionine

powder lyophilized

for solution for

injection

400mg,

glass vials (5) and 5ml

solvent in ampoules (5)

Famar L'Aigle, Usine

de Saint Remy, rue de

l'Isle, 28380, Saint

Remy Sur Avre

(Famar A.V.E. Alimos

Plant 63, Ag.

Dimitriou Str., Agiou

Dimitriou 63, Alimos

Attiki, 17456, Greece-

solvent manufacturer

and primary

packager)

France A16AA02 15871/102.06.2017

11.08.2021PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2101Herbion cowslip

syrup

liquid aqueous

cowslip root

extract, liquid

aqueous garden

thyme herb extract

syrup

1030mg/5ml+

2060mg/5ml,

150ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

KRKA, tovarna

zdravil, d.d., Novo

mesto, Povhova ulica

5, 8501 Novo Mesto,

Slovenia-bulk

manufacturer,

packager

SloveniaR05C;

herbal drug16498

17.03.2017

17.03.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2102Herbion Iceland

moss syrup

iceland moss thick

extractsyrup

6mg/ml,

150ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

SloveniaR05D;

herbal drug15784

20.07.2016

20.07.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2103 Herbion ivy syrup ivy leaf dry extract syrup

7mg/ml,

150ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

SloveniaR05C

herbal drug 13372

04.04.2014

04.04.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

453

Page 114: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2104Herbion plantain

syrup

liquid aqueous

extract of the

narrowleaf plantain

leaves, liquid

aqueous extract of

the common

mallow flower,

ascorbic acid

syrup

1250mg/5ml+

1250mg/5ml+ 65mg/5ml,

150ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

KRKA, tovarna

zdravil, d.d., Novo

mesto, Povhova ulica

5, 8501 Novo Mesto,

Slovenia-bulk

manufacturer,

packager

SloveniaR05D;

herbal drug16497

17.03.2017

17.03.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2105 Herbion Zen Sen

panax ginseng

radicis extractum

siccum

capsules350mg,

in glass container (24)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

SloveniaHN06WA;

herbal drug 12857

17.09.2013

17.09.2018OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2106 Herceptin trastuzumab

powder for

concentrate for

solution for infusion

440mg,

glass vial (1) and 20ml

solvent in vial

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel-

batch releaser, F.

Hoffmann-La Roche

Ltd., Wurmisweg, CH-

4303, Kaiseraugst,

Switzerland -primary

and secondary

packager, Genentech

Inc., DNA Way 1,

South San Francisco,

CA 94080, USA-bulk

manufacturer

Switzerland

L01XC03;

new

indication

14693/102.07.2015

02.07.2020PoM

Hoffmann-La Roche

Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

454

Page 115: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2107 Herceptin trastuzumab

powder for

concentrate for

solution for infusion

440mg,

glass vial (1) and 20ml

solvent in vial

F. Hoffmann-La

Roche Ltd.,

Wurmisweg, CH-

4303, Kaiseraugst-

packager, batch

releaser (Genentech

Inc., 4625 NW

Brookwood Parkway,

Hillsboro, Oregon,

OR 97124-9332, USA-

bulk manufacturer)

Switzerland L01XC03 1586528.07.2016

28.07.2021PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070,

Switzerland

2108 Herpevir aciclovir tablets200mg,

in blister (20/2x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J05AB01 1589423.08.2016

23.08.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2109 Herpevir aciclovir tablets400mg,

in blister (10/1x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J05AB01 1589523.08.2016

23.08.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2110 Herpevir aciclovir ointment

25mg/g,

5g and 15g aluminium

tube

Kievmedpreparat

PJSC, 03115, Kyiv,

Peremogy avenue,

120

Ukraine D06BB03 1638610.02.2017

10.02.2022OTC

Kievmedpreparat

PJSC, 01032, Kyiv,

Saksaganskogo street,

139, Ukraine

2111 Herpferon

interferon alfa-2b,

aciclovir, lidocaine

(lidocaine

hydrochloride)

ointment for

external use

20000IU/g+

30mg/g+10mg/g, 5g, 10g

and 30g aluminium tube

FIRN M CJSC, 4,

Dzerzhinskogo str.,

Kokoshkino

Settlement, Naro-

Fominsky district,

Moskow region,

143390

Russia D06BB53 1589923.08.2016

23.08.2021OTC

"FIRN M" CJSC, 15/1,

entrance "B", Borby

square, Moscow,

127055, Russia

455

Page 116: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2112 Hexalyse

biclotymol,

lysozyme (lysozyme

hydrochloride),

enoxolone

tablets orodispersible5mg+5mg+5mg, blisters

(30/3x10/)

Laboratoires Bouchara-

Recordati, Parc

Mecatronic 03410

Saint Victor

France R02AX 14591/107.06.2016

08.06.2020OTC

Laboratoires

Bouchara-Recordati,

Immeuble le Wilson,

70 avenue du General

de Gaulle, 92800

Puteaux, France

2113 Hexaspray biclotymol aerosol for local use

750mg/30g,

30g glass bottle with

pump dispenser

Laboratoires Bouchara-

Recordati, Parc

Mecatronic 03410

Saint Victor

France R02AA20 1486724.09.2015

24.09.2020OTC

Laboratoires

Bouchara-Recordati,

Immeuble le Wilson,

70 avenue du General

de Gaulle 92800

Puteaux

2114 Hexaxim

diphtheria toxoid,

tetanus toxoid,

pertussis

toxoid/filamentous

haemagglutinin,

poliovirus types

1/2/3, hepatitis B

surface antigen,

haemophilus

infuenzae type b

polysaccharide,

haemophilus

infuenzae type b

polysaccharide

conjugated to

tetanus protein

suspension for

injection

20IU/0.5ml+ 40IU/0.5ml+

25/25mcg/0.5ml+

40/8/32DU/0.5ml+10mcg/

0.5ml+ 12mcg/0.5ml+22-

36mcg/0.5ml, 0.5ml glass

vial (10)

Sanofi Pasteur SA,

Parc Industriel

d'Incarville, 27100

Val de Reuil

France

J07CA09;

vaccine, new

indication

15225/130.12.2015

30.12.2020PoM

Sanofi Pasteur SA, 2

avenue Pont Pasteur,

69007 Lyon, France

456

Page 117: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2115 Hexaxim

diphtheria toxoid,

tetanus toxoid,

pertussis

toxoid/filamentous

haemagglutinin,

poliovirus types

1/2/3, hepatitis B

surface antigen,

haemophilus

infuenzae type b

polysaccharide,

haemophilus

infuenzae type b

polysaccharide

conjugated to

tetanus protein

suspension for

injection

20IU/0.5ml+ 40IU/0.5ml+

25/25mcg/0.5ml+

40/8/32DU/0.5ml+

10mcg/0.5ml+

12mcg/0.5ml+22-

36mcg/0.5ml, 0.5ml pre-

filled syringe (1) and

needles (2)

Sanofi Pasteur SA,

Parc Industriel

d'Incarville, 27100

Val de Reuil

France

J07CA09;

vaccine, new

indication

15350/126.02.2016

26.02.2021PoM

Sanofi Pasteur SA, 2

avenue Pont Pasteur,

69007 Lyon, France

2116 Hexicon

chlorhexidine

(chlorhexidine

bigluconate)

suppositories vaginal 16mg, (1, 10)

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia G01AX 1257202.10.2013

02.10.2018OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2117 Hexicon

chlorhexidine

(chlorhexidine

bigluconate)

solution for topical

use

0,5mg/ml,

100ml plastic bottle

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D08AC02 1287619.09.2013

19.09.2018OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2118 Hexiloc

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

0.5mg/ml,

100ml and 250ml glass or

plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14872

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

457

Page 118: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2119 Hexiloc

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

2mg/ml,

50ml, 100ml, 250ml

plastic or glass vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14873

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2120 Hexiloc

chlorhexidine

(chlorhexidine

digluconate)

spray

2mg/ml,

15ml, 25ml and 60ml

glass or plastic vial with

pump dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14875

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2121 Hexiloc

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

10mg/ml,

100ml, 250ml, 1000ml

and 5000ml glass or

plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch

releaser,packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaD08AC02 15402

09.03.2016

09.03.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

458

Page 119: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2122 Hexiloc

chlorhexidine

(chlorhexidine

digluconate)

gel for external use

2mg/ml,

10ml, 15ml, 25ml and

30ml plastic vial with

pump dispenser or glass

vial with applicator

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 16360

30.12.2016

30.12.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2123 Hexiloc Denta

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

1.2mg/ml,

50ml, 100ml, 250ml glass

or plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14874

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2124 Hexiloc Denta

chlorhexidine

(chlorhexidine

digluconate)

spray

1.2mg/ml,

15ml, 25ml and 60ml

glass or plastic vial with

pump dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14880

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

459

Page 120: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2125 Hexiloc Denta

chlorhexidine

(chlorhexidine

digluconate)

gel for external use

1.2mg/ml,

10ml, 15ml, 25ml and

30ml plastic vial with

pump dispenser and

plastic or glass vial with

applicator

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 15890

23.08.2016

23.08.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2126Hexiloc Denta

Menthol

chlorhexidine

(chlorhexidine

digluconate)

spray

1.2mg/ml,

15ml, 25ml, 60ml glass or

plastic vial with pump

disnenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14877

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2127Hexiloc Denta

Menthol

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

1.2mg/ml,

50ml, 100ml and 250ml

glass or plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14879

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

460

Page 121: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2128Hexiloc Denta

Menthol

chlorhexidine

(chlorhexidine

digluconate)

gel for external use

1.2mg/ml,

10ml, 15ml, 25ml and

30ml plastic vial with

pump dispenser and

plastic or glass vial with

applicator

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 16359

30.12.2016

30.12.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2129 Hexiloc Menthol

chlorhexidine

(chlorhexidine

digluconate)

solution for external

use

2mg/ml,

50ml, 100ml, 250ml glass

or plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14876

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2130 Hexiloc Menthol

chlorhexidine

(chlorhexidine

digluconate)

spray

2mg/ml,

15ml, 25ml and 60ml

glass or plastic vial with

pump dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 14878

24.09.2015

24.09.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2131 Hexiloc Menthol

chlorhexidine

(chlorhexidine

digluconate)

gel for external use

2mg/ml,

10ml, 15ml, 25ml and

30ml plastic vial with

pump dispenser and

plastic or glass vial with

applicator

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaD08AC02 16361

30.12.2016

30.12.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

461

Page 122: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2132 Hexoral hexetidinepressurised

inhalation solution

2mg/ml,

40ml aluminium

container with pump

dispenser

Famar Orleans, 5

avenue de Concyr,

45071 Orleans, Cedex

2

France A01AB12 1720908.12.2017

08.12.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

2133 Hialurom Tendon

hyaluronic acid

(sodium

hyaluronate)

solution for injection20mg/ml,

2ml pre-filled syringe (1)

S.C. Rompharm

Company S.R.L.,

075100, Str. Drumul

Garii Nr.52,Otopeni

Romania M09AX01 1480304.09.2015

04.09.2020PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2134 Hiconcil

amoxicillin

(amoxicillin

trihydrate)

powder for oral

suspension

250mg/5ml,

100ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

packager, Sandoz

GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria- bulk

manufacturer

Slovenia J01CA04 12705/115.03.2016

23.07.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2135 Hiconcil

amoxicillin

(amoxicillin

trihydrate)

capsules hard500mg,

in blister (16/2x8/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01CA04 1595815.09.2016

15.09.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2136 Hiconcil

amoxicillin

(amoxicillin

trihydrate)

capsules hard250mg,

in blister (16/2x8/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01CA04 1595915.09.2016

15.09.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2137 Hidrasec racecadotrilgranules for oral

suspension

10mg,

1g sachets (16)

Sophartex, 28500,

Vernouillet, 21 rue du

Pressoir

France A07XA04 1383118.09.2014

18.09.2019PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

462

Page 123: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2138 Hidrasec racecadotrilgranules for oral

suspension

30mg,

3g sachets (16)

Sophartex, 28500,

Vernouillet, 21 rue du

Pressoir

France A07XA04 1383218.09.2014

18.09.2019PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2139 Hidrasec racecadotril capsules hard100mg,

in blister (10/1x10/)

Sophartex, 28500,

Vernouillet, 21 rue du

Pressoir

France A07XA04 1383318.09.2014

18.09.2019PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2140 Hierrodexina

iron polysaccharide,

cobalt chloride,

vitamin B12

solution for injection

100mg/ml+ 4mcg/ml+

25mcg/ml, 50ml, 100ml

glass vial

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

Spain

QB03AC;

veterinary

drug

1431310.03.2015

10.03.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19, Spain

2141 Hi-Flex Inj.

hyaluronic acid

(sodium

hyaluronate)

solution for injection20mg/2ml,

2ml pre-filled syringe (3)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South M09AX01 1652117.03.2017

17.03.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

2142 Hippopheae oil hippopheae oil suppositories rectal500mg,

(10/2x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova C05AX 1282217.09.2013

17.09.2018OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

2143 Hippopheae oil hippopheae oil suppositories rectal500mg

(10/2x5/)

Nizhpharm OJSC

(603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7)

Russia C05AX 1289907.10.2013

07.10.2018OTC

Nizhpharm OJSC

(603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia)

463

Page 124: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2144 Hippopheae oil hippopheae oil suppositories350mg,

in blister (10/2x5/)

Lekhim-Kharkiv JSC,

36,Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv

UkraineA16AX;

herbal drug17099

23.10.2017

23.10.2022OTC

Lekhim-Kharkiv JSC,

36,Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv,

Ukraine

2145 Holosas rose extract syrup

400mg/g,

140g glass vial or glass

bottle,

300g glass vial

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

RussiaA05AX;

herbal drug13059

25.11.2013

25.11.2018OTC

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.,

Russia

2146 Hondroxid

chondroitin sulfate

(chondroitin sulfate

sodium)

ointment50mg/g,

30g aluminium tube

Nizhpharm JSC,

Salganskaya str., 7,

GSP-459, Nizhniy

Novgorod 603950

Russia M01AX25 1337504.04.2014

04.04.2019OTC

Nizhpharm JSC,

Salganskaya str., 7,

GSP-459, Nizhniy

Novgorod 603950,

Russia

2147 Hotgra 100sildenafil (sildenafil

citrate)tablets film-coated

100mg,

in blister (4)

Akriti

Pharmaceuticals Pvt.

Ltd., Plot No. D-10, D-

11, M.I.D.C. Indl.

Estate, Nira Road,

Jejuri, Tal. Purandhar

(Saswad), Dist. Pune-

412 303, Maharashtra

India G04BE03 1353330.05.2014

30.05.2019PoM

Akriti

Pharmaceuticals Pvt.

Ltd., 117, Block No. 2,

Emerald Plaza,

Hiranandai Meadows,

Barrister Nath Pai

Road, Thane (West)

400 610, India

2148 Hotgra 50sildenafil (sildenafil

citrate)tablets film-coated

50mg,

in blister (4)

Akriti

Pharmaceuticals Pvt.

Ltd., Plot No. D-10, D-

11, M.I.D.C. Indl.

Estate, Nira Road,

Jejuri, Tal. Purandhar

(Saswad), Dist. Pune-

412 303, Maharashtra

India G04BE03 1353230.05.2014

30.05.2019PoM

Akriti

Pharmaceuticals Pvt.

Ltd., 117, Block No. 2,

Emerald Plaza,

Hiranandai Meadows,

Barrister Nath Pai

Road, Thane (West)

400 610, India

464

Page 125: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2149 Humalog insulin lispro solution for injection100IU/ml (3,5mg/ml),

3ml cartridges (5)

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim

France A10AB04 1592923.08.2016

23.08.2021PoM

Eli Lilly Nederland

B.V.,

Papendorpseweg 83,

3528 BJ Utrecht, the

Netherlands

2150 Humalog Mix 25

insulin lispro

solution and insulin

lispro protamine

suspension

suspension for

injection

100IU/ml (3,5mg/ml),

3ml cartridges (5)

Lilly France S.A.S., 2,

rue du Colonel Lilly,

67640 Fegersheim

France A10AB04 1235409.04.2013

09.04.2018PoM

Eli Lilly Nederland

B.V., Grootslag 1-5,

NL-3991, RA Houten,

the Netherlands

2151 Humalog Mix 50

50% insulin lispro

solution and 50%

insulin lispro

protamine

suspension

(recombinant DNA)

suspension for s/c

injection

100IU/ml (3.5mg/ml),

3ml glass cartridges (5)

Lilly France S.A.S., 2,

rue du Colonel Lilly,

67640 Fegersheim

France A10AB04 1407219.12.2014

19.12.2019PoM

Eli Lilly Nederland

B.V., Grootslag 1-5,

NL-3991, RA Houten,

the Netherlands

2152 Humulin 70/30insulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Eli Lilly and

Company,

Indianapolis, IN

46285

USA A10AD01 1591823.08.2016

23.08.2021PoM

Eli Lilly and

Company,

Indianapolis, IN

46285, USA

2153 Humulin 70/30insulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

3ml cartridges (5)

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim

France A10AD01 1592723.08.2016

23.08.2021PoM

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim,

France

2154 Humulin N

insulin human

isophane

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Eli Lilly and

Company,

Indianapolis, IN

46285

USA A10AC01 1591923.08.2016

23.08.2021PoM

Eli Lilly and

Company,

Indianapolis, IN

46285, USA

465

Page 126: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2155 Humulin N

insulin human

isophane

(recombinant DNA)

suspension for

injection

100IU/ml,

3ml cartridges (5)

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim

France A10AC01 1592823.08.2016

23.08.2021PoM

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim,

France

2156 Humulin R

insulin human

regular

(recombinant DNA)

solution for injection100IU/ml,

10ml glass vial (1)

Eli Lilly and

Company,

Indianapolis, IN

46285

USA A10AB01 1592023.08.2016

23.08.2021PoM

Eli Lilly and

Company,

Indianapolis, IN

46285, USA

2157 Humulin R

insulin human

regular

(recombinant DNA)

solution for injection100IU/ml,

3ml cartridges (5)

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim

France A10AB01 1592623.08.2016

23.08.2021PoM

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim,

France

2158 Hyalurom

hyaluronic acid

(sodium

hyaluronate)

solution for injection15mg/ml,

2ml pre-filled syring (1,3)

S.C. Rompharm

Company S.R.L.,

Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A

Romania M09AX01 1320510.01.2014

10.01.2019PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A,

Romania

2159Hydrochloro-

thiazide

hydrochloro-

thiazidetablets

25mg,

in blister (100/4x25/)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany C03AA03 1650017.03.2017

17.03.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

2160Hydrochloro-

thiazide

hydrochloro-

thiazidetablets

25mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64, No3,

ul. Chapaeva, Borisov,

Minsk region

Belarus C03AA03 1718130.11.2017

30.11.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

466

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2161Hydrochlorthia-

zide

hydrochlorothia-

zidetablets

25mg,

in blister (20/2x10/)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus C03AA03 1243811.08.2013

11.08.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

2162 Hydrocortisone

hydrocortisone

(hydrocortisone

acetate)

ointment for topical

use

10mg/g,

10g, 15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD07AA02 12467/1

16.01.2017

02.10.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2163 Hydrocortisone

hydrocortisone

(hydrocortisone

acetate)

ointment eye5mg/g,

3g, 5g aluminium tube

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia S01BA02 1466303.07.2015

03.07.2020PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

2164 Hydrocortisone

hydrocortisone

(hydrocortisone

acetate)

ointment eye5mg/g,

3g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland S01BA02 1533726.02.2016

26.02.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2165Hydrocortisone

eye ointment

hydrocortisone

(hydrocortisone

acetate)

ointment eye5mg/g,

3g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaS01BA02 15866

28.07.2016

28.07.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2166Hydrocortison-

Richter

hydrocortisone

(hydrocortisone

acetate), lidocaine

(lidocaine

hydrochloride)

suspension for

injection

25mg/ml+5mg/ml, 5ml

glass vial (1)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary H02AB09 1506302.12.2015

02.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

467

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2167Hydroxycarba-

mide medachydroxycarbamide capsules

500mg,

blisters

(50/5x10/)(100/10x10/)

blisters

Medac GmbH,

Theaterstrasse 6,

22880 Wedel - batch

releaser, (Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany

- bulk manufacturer,

packager)

Germany L01XX05 13414/106.12.2016

14.04.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

2168Hymecromone

Sopharmahymecromone tablets

400mg,

in blister (20/2x10/)

Unipharm JSC, 3

Traiko Stanoev Str.,

Sofia 1797

Bulgaria A05AX02 1482104.09.2015

04.09.2020PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2169 Hyoxyson

hydrocortisone

(hydrocortisone

acetate),

oxytetracycline

(oxytetracycline

hydrochloride)

ointment for

external use

10mg/g+30mg/g, 10g

aluminium tube

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia D07CA01 1523223.12.2015

23.12.2020PoM

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

2170 Hypomed

amlodipine

(amlodipine

besilate), lisinopril

(lisinopril

dihydrate)

tablets5mg+10mg,

in blister (40/1x40/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC09BB 13642

27.06.2014

27.06.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2171 Hypothiazidhydrochlorothia-

zidetablets

25mg,

in blister (20/1x20/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary C03AA03 1489324.09.2015

24.09.2020PoM

Sanofi-Aventis

Private Co. Ltd.,1045

Budapest, To u. 1-5,

Hungary

468

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2172 Hypothiazidhydrochlorothia-

zidetablets

100mg,

in blister (20/1x20/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary C03AA03 1489424.09.2015

24.09.2020PoM

Sanofi-Aventis

Private Co. Ltd.,1045

Budapest, To u. 1-5,

Hungary

2173

Iasibon 6mg

concetrate for

solution for

infusion

ibandronic acid

(ibandronic acid

sodium

monohydrate)

concentrate for

solution for infusion

6mg/6ml,

6ml glass vial

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki

Greece M05BA06 1274824.07.2013

24.07.2018PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

2174 Ibufene ibuprofen suspension oral

20mg/ml,

100ml glass bottle and

measuring cup

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaM01AE01 13545

30.05.2014

30.05.2019OTC

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

2175 Ibunok ibuprofen cream50mg/g,

50g aluminium tube

NOKI JV LTD Co.,

Nor-Kharberd, Ararat

region

Republic of

ArmeniaM02AA13 15314

04.02.2016

04.02.2021OTC

NOKI JV LTD Co.,

Nor-Kharberd, Ararat

region, Republic of

Armenia

2176 Ibupar Forte ibuprofen tablets film-coated400mg,

in blister (10/1x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland M01AE01 1630530.12.2016

30.12.2021OTC

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice, Poland

469

Page 130: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2177 Ibuprofen ibuprofen tablets coated

200mg,

in blisters (10, 50/5x10/,

5000/500x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus M01AE01 1684410.07.2017

10.07.2022OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2178 Ibuprofen AKTIV ibuprofen syrup

20mg/ml,

100ml glass bottle and

measuring spoon

Replek Farm Ltd,

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia M01AE01 1357710.06.2014

10.06.2019OTC

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

2179 Ibuprofen AKTIV ibuprofen tablets film-coated200mg,

in blister (30/3x10/)

Replek Farm Ltd,

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia M01AE01 1357810.06.2014

10.06.2019OTC

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

2180 Ibuprofen AKTIV ibuprofen tablets film-coated400mg,

in blister (30/3x10/)

Replek Farm Ltd,

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia M01AE01 1357910.06.2014

10.06.2019OTC

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

2181 Ibuprofen Medana ibuprofensuspension oral with

strawberry flavour

20mg/ml,

100ml and 120ml plastic

container and measuring

syringe

Medana Pharma JSC,

98-200 Sierad., W.

Lokietka 10 - batch

releaser, Medana

Pharma JSC, str.

Polskiej Organizacji

Wojskowej 57, 98-200

Sieradz, Poland-bulk

manufacturer,

packager

Poland M01AE01 1455709.06.2015

09.06.2020OTC

Medana Pharma JSC,

98-200 Sierad., W.

Lokietka 10, Poland

470

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2182 Ibuprofen Sandoz ibuprofen tablets film-coated800mg,

in blister (20/2x10/)

Salutas Pharma

GmbH, Dieselstrasse

5, 70839 Gerlingen -

batch releaser, Salutas

Pharma GmbH, Otto-

von-Guericke-Alle-1,

39179 Barleben,

Germany-packager,

Sandoz Grup Saglik

Ueruenleri Ilaclari

San. ve Tic. A. S.,

Ihsan Dede Cadde No.

900. Sokak, Gebze-

Kocaeli, TR-41480,

Turkey-bulk

manufacturer

Germany M01AE01 1420106.02.2015

06.02.2020PoM

Sandoz

Pharmaceuticals d.d.,

Verevskova 57, SI-

1526 Ljubljana,

Slovenia

2183 Ibuprofen Sandoz ibuprofen tablets film-coated600mg,

in blister (20/2x10/)

Salutas Pharma

GmbH, Dieselstrasse

5, 70839 Gerlingen -

batch releaser, Salutas

Pharma GmbH, Otto-

von-Guericke-Alle-1,

39179 Barleben,

Germany-packager,

Sandoz Grup Saglik

Ueruenleri Ilaclari

San. ve Tic. A. S.,

Ihsan Dede Cadde No.

900. Sokak, Gebze-

Kocaeli, TR-41480,

Turkey-bulk

manufacturer

Germany M01AE01 1420206.02.2015

06.02.2020PoM

Sandoz

Pharmaceuticals d.d.,

Verevskova 57, SI-

1526 Ljubljana,

Slovenia

471

Page 132: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2184Ibuprofen Sandoz

600mgibuprofen tablets film-coated

600mg,

in blister (20/2x10/)

Lek S.A.,16 Podlipie

Str., 95-010 Strykow-

batch releaser,

packager, Sandoz

Grup Saglik

Ueruenleri Ilaclari

San. ve A.S., Gebze

Organized Industrial

Region Ihsan Dede,

Cadde No. 900 Sokak,

TR-41480, Gebze-

Kocaeli, Turkey-bulk

manufacturer

Poland M01AE01 1610410.11.2016

10.11.2021PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1526 Ljubljana,

Slovenia

2185Ibuprofen Sandoz

800mgibuprofen tablets film-coated

800mg,

in blister (20/2x10/)

Lek S.A.,16 Podlipie

Str., 95-010 Strykow-

batch releaser,

packager, Sandoz

Grup Saglik

Ueruenleri Ilaclari

San. ve A.S., Gebze

Organized Industrial

Region Ihsan Dede,

Cadde No. 900 Sokak,

TR-41480, Gebze-

Kocaeli, Turkey-bulk

manufacturer

Poland M01AE01 1610510.11.2016

10.11.2021PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1526 Ljubljana,

Slovenia

2186 Ibuprofen-Asteria ibuprofen tablets film-coated

400mg,

in blister (20/2x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth M01AE01 14420/128.10.2015

08.04.2020OTC

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

472

Page 133: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2187Ibuprofen-

Hemofarmibuprofen tablets film-coated

400mg,

in blister (30/3x10/)

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm d.o.o.,

78000, Banja-Luka,

Novakovici bb, Bosnia

and Herzegovina-bulk

manufacturere,

packager

Serbia M01AE01 1624219.12.2016

19.12.2021OTC

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

2188 Ichthiol ichthammolointment for

external use

100mg/g,

25g aluminium tube

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD10BX01 15283

04.02.2016

04.02.2021OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

2189 Ichthiol ichthammolointment for

external use

200mg/g,

25g aluminium tube

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD10BX01 15284

04.02.2016

04.02.2021OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

2190 Ichtyol ichtyol suppositories rectal200mg

(10/2x5/)

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D10BX01 1267004.07.2013

04.07.2018OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

473

Page 134: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2191 Ilon

larch turpentine,

turpentine oil,

eucalyptus oil

ointment54mg/g+72mg/g+ 12mg/g,

25g aluminium tube

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532-

batch releaser,

packager, etol

Gesundheitspflege-

und Pharmaprodukte

GmbH, Konrad-

Adenauer-Str.3,

Oberkirch, 77704,

Germany- bulk

manufacturer,

packager

GermanyD08;

herbal drug16426

06.03.2017

06.03.2022OTC

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532,

Germany

2192 Immunate

human blood

coagulation factor

VIII, Von

Willebrand

Factor(VWF:RCo)

powder and solvent

for solution for

injection

1000IU+750IU,

(1) glass vial, 10ml glass

vial with solvent, (1)

transfer/filter set, (1)

disposable syringe (10ml),

(1) disposable needle, (1)

winged infusion set

Baxter AG,

Industriestrasse 67, A-

1221 Vienna-batch

releaser, secondary

packager, Baxter AG,

Lange Allee 24, A-

1221 Vienna, Austria-

bulk manufacturer,

primary packager

Austria B02BD06 1472216.07.2015

16.07.2020PoM

Baxter AG,

Industriestrasse 67, A-

1221 Vienna, Austria

2193 Immunate

human blood

coagulation factor

VIII, Von

Willebrand

Factor(VWF:RCo)

powder and solvent

for solution for

injection

250IU+190IU,

(1) glass vial, 5ml glass

vial with solvent, (1)

transfer/filter set, (1)

disposable syringe (5ml),

(1) disposable needle, (1)

winged infusion set

Baxter AG,

Industriestrasse 67, A-

1221 Vienna-batch

releaser, secondary

packager, Baxter AG,

Lange Allee 24, A-

1221 Vienna, Austria-

bulk manufacturer,

primary packager

Austria B02BD06 1472316.07.2015

16.07.2020PoM

Baxter AG,

Industriestrasse 67, A-

1221 Vienna, Austria

474

Page 135: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2194 Immunate

human blood

coagulation factor

VIII, Von

Willebrand

Factor(VWF:RCo)

powder and solvent

for solution for

injection

500IU+375IU,

(1) glass vial, 5ml glass

vial with solvent, (1)

transfer/filter set, (1)

disposable syringe (5ml),

(1) disposable needle, (1)

winged infusion set

Baxter AG,

Industriestrasse 67, A-

1221 Vienna-batch

releaser, secondary

packager, Baxter AG,

Lange Allee 24, A-

1221 Vienna, Austria-

bulk manufacturer,

primary packager

Austria B02BD06 1472416.07.2015

16.07.2020PoM

Baxter AG,

Industriestrasse 67, A-

1221 Vienna, Austria

2195 Immunokind

calcium

carbonicum

Hahnemanni D6,

calcium fluoratum

D6, calcium

phosphoricum D6,

sulfur jodatum D12

tablets

20mg+20mg+

20mg+20mg,

in glass container (150)

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe

Germany

L03A;

homeopathic

drug

1678822.06.2017

22.06.2022OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

2196IMMUNOMAX

BIOpeptidoglycan

powder lyophilized

for solution for i/m

injection

200IU,

glass vial (3)

IMMAPHARMA

LLC, 18/11, st.

Gamaleya, Moscow,

123098

Russia L03 1607326.10.2016

26.10.2021PoM

IMMAPHARMA

LLC, 18/11, st.

Gamaleya, Moscow,

123098, Russia

2197 Imodium

loperamide

(loperamide

hydrochloride)

capsules

2mg,

in blister (6/1x6/,

20/1x20/)

Janssen-Cilag,

Domaine de

Maigremont, 27100

Val De Reuil

France A07DA03 1588223.08.2016

23.08.2021OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

475

Page 136: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2198 Imodium

loperamide

(loperamide

hydrochloride)

tablets orodispersible

2mg,

in blister (6/1x6/,

10/1x10/)

Janssen-Cilag,

Domaine de

Maigremont, 27100

Val de Reuil-

secondary packager,

batch releaser,

Catalent UK Swindon

Zydis Ltd., Frankland

Road, Blagrove,

Swindon, Wiltshire,

SN5 8RU, UK-bulk

manufacturer,

primary packager

France A07DA03 1712123.10.2017

23.10.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

2199 Impaza

affinity purified

antibodies to

endothelial NO

synthase

tablets to be sucked

not more than 10^-

15ng/g,

in blister (20/1x20/)

NPF Materia Medica

Holding LLC, 54,

Buguruslanskaya st.,

Chelyabinsk 454139

Russia

G04BE;

homeopathic

drug

1569922.06.2016

22.06.2021OTC

NPF Materia Medica

Holding LLC, 9 bld.,

3rd Samotyochny

per., Moscow 127473,

Russia

2200Implicor

50mg/5mg

metoprolol

(metoprolol

tartrate), ivabradine

(ivabradine

hydrochloride)

tablets film-coated

50mg+5mg,

in blister (28/2x14/,

56/4x14)

Les Laboratoires

Servier Industrie, 905,

route de Saran, 45520

Gidy

France 1600306.10.2016

06.10.2021PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

2201Implicor

50mg/7.5mg

metoprolol

(metoprolol

tartrate), ivabradine

(ivabradine

hydrochloride)

tablets film-coated

50mg+7,5mg,

in blister (28/2x14/,

56/4x14/)

Les Laboratoires

Servier Industrie, 905,

route de Saran, 45520

Gidy

France 1600206.10.2016

06.10.2021PoM

Les Laboratoires

Servier, 50, Rue

Carnot 92284

Suresnes cedex,

France

2202 Imunobex inosine pranobex capsules

500mg,

in blister (30/3x10/,

50/5x10/)

Minskintercaps U.V.,

26, Inzhenernaya str.,

220075, Minsk

Belarus J05AX05 1728113.12.2017

13.12.2022PoM

Minskintercaps U.V.,

26, Inzhenernaya str.,

220075, Minsk,

Belarus

476

Page 137: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2203 Imunorix pidotimod solution oral400mg/7ml,

glass vials (10)

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1-29016

Cortemaggiore (PC)

Italy L03AX05 1280630.08.2013

30.08.2018PoM

Polichem S.A., 50,

Val Fleuri, L-1526,

Luxembourg,

Luxembourg

2204 Incruse Ellipta

umeclidinium

(umeclidinium

bromide)

powder for

inhalation

62.5mcg/dose, powder in

strip (30 doses) in plastic

inhaler

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03BB07 1624319.12.2016

19.12.2021PoM

Glaxo Group Limited,

980 Great West Road,

Brentford, Middlesex,

TW8 9GS, UK

2205 Indabru 2,5mg indapamide tablets coated2,5mg,

in blister (30/2x15/)

Brupharmexport sprl,

Rue de la Grotte, 14,

B-1020, Brussels -

batch releaser

(Farmalabor Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-

194 Condeixa-a-Nova,

Portugal - bulk

manufacturer,

packager)

Belgium C03BA11 1341914.04.2014

14.04.2019PoM

Brupharmexport sprl,

Rue de la Grotte, 14,

B-1020, Brussels,

Belgium

2206 Indapafon indapamide tablets coated2,5mg,

in blister (30/3x10/)

Open Joint Stock

Company , 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus C03BA11 1283817.09.2013

17.09.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

2207 Indapamid SR indapamidetablets prolonged-

release film-coated

1,5mg,

in blister (28/2x14/,

30/2x15/, 56/4x14/,

60/4x15/)

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska 19,

83-200 Starogard

Gdanski

Poland C03BA11 1583620.07.2016

20.07.2021PoM

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska

19, 83-200 Starogard

Gdanski, Poland

477

Page 138: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2208Indapamide MR

STADAindapamide

tablets prolonged-

release film-coated

1,5mg,

blisters (30/3x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C03BA11 14150/125.07.2016

29.12.2019PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2209Indapamide MR

STADAindapamide

tablets prolonged-

release film-coated

1,5mg,

in blister (30/3x10/)

Makiz-Pharma LLC, 6

Avtomobilny proezd,

buildings 4, 6, 8,

109029, Moscow

Russia C03BA11 1597615.09.2016

15.09.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2210 Indometacin indometacin suppositories rectal50mg,

(6/1x6/, 10/2x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829

Moldova M01AB01 1250601.06.2013

01.06.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829,

Moldova

2211 Indometacin indometacin suppositories rectal100mg

(6/1x6/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829

Moldova M01AB01 1250701.06.2013

01.06.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829,

Moldova

2212 Indometacin indometacin ointment100mg/g,

40g aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus M02AA23 1367608.07.2014

08.07.2019OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

2213Indometacin

Sopharmaindometacin suppositories

50mg,

(6/1x6/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria M01AB01 1713107.11.2017

07.11.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

478

Page 139: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2214

Indometacin

Sopharma 10%

ointment

indometacin ointment100mg/g,

40g aluminium tube

Sopharma JSC (str.

Iliensko shosse 16,

1220 Sofia) - batch

releaser (dosage form

manufacturer -

Sopharma JSC

/Vrabevo vlg. 5660,

district of Lovetch,

Bulgaria/)

Bulgaria M02AA23 1299528.10.2013

28.10.2018OTC

Sopharma JSC (str.

Iliensko shosse 16,

1220 Sofia, Bulgaria)

2215

Indometacin

Sopharma 25mg

gastro-resistant

tablets

indometacintablets gastro-

resistant

25mg,

in blister (30/1x30/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria M01AB01 1649317.03.2017

17.03.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2216 Indopres indapamide tablets film-coated2,5mg,

in blister (30/3x10/)

SIC Borshchahivskiy

chemical-

pharmaceutical plant

PJSC 17, Mira St, Kiev

03134

Ukraine C03BA11 1285017.09.2013

17.09.2018PoM

SIC Borshchahivskiy

chemical-

pharmaceutical plant

PJSC 17, Mira St, Kiev

03134, Ukraine

2217 Indovasinindometacin,

troxerutingel for external use

30mg/g+20mg/g,

45g aluminium tube

Balkanpharma-

Troyan AD,

Krayrechna Str. N1,

5600, Troyan

Bulgaria M01AB51 1683410.07.2017

10.07.2022OTC

Balkanpharma-

Troyan AD,

(ACTAVIS GROUP)

Krayrechna Str. N1,

5600, Troyan,

Bulgaria

2218 Inestom levocarnitine solution oral100mg/ml,

10ml glass vial (10)

Help S.A., Pedini

Ioanninon, Ioannina,

45500

Greece A16AA01 1682910.07.2017

10.07.2022PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

479

Page 140: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2219 Inestom levocarnitine solution for injection200mg/ml,

5ml ampoules (5)

Help S.A., Pedini

Ioanninon, Ioannina,

45500

Greece A16AA01 1683010.07.2017

10.07.2022PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

2220 Infanrix

diphtheria toxoid,

tetanus toxoid,

pertussis toxoid,

filamentous

haemagglutinin,

pertactin

suspenion for

injection

not less than

30IU/dose+not less than

40IU/dose+ 25mcg/dose+

25mcg/dose+ 8mcg/dose,

0.5ml/dose pre-filled glass

syringe and needle

GlaxoSmithKline

Biologicals s.a., Rue

de l Institut, 89 B-

1330 Rixensart- batch

releaser,

GlaxoSmithKline

Biologicals SA, Rue

des Aulnois, 637

59230 Saint-Amand-

Les-Eaux, France-

bulk manufacturer,

packager

Belgium

J07AJ52;

պատվաստ

անյութ

1565508.06.2016

08.06.2021PoM

GlaxoSmithKline

Biologicals s.a., Rue

de l Institut, 89 B-

1330 Rixensart,

Belgium

2221 Infanrix Hexa

diphtheria toxoid,

tetanus toxoid,

pertussis toxoid,

filamentous

haemagglutinin,

pertactin, hepatitis

B surface antigen,

inactivated

poliovirus type 1,

inactivated

poliovirus type 2,

inactivated

poliovirus type 3,

haemophilus

influenzae type b

polysaccharide

(conjugated to

tetanus toxoid)

powder and

suspension for

suspension for

injection

not less than

30IU/dose+not less than

40IU/dose+ 25mcg/dose+

25mcg/dose+ 8mcg/dose+

10mcg/dose+40D-antigen

unit/dose+8D-antigen

unit/dose+32D-antigen

unit/dose+ 10mcg/dose

(25mcg/dose), 0.5ml/dose

glass vial, pre-filled

syringe and (2) needles

GlaxoSmithKline

Biologicals s.a., Rue

de l' Institut, 89 B-

1330 Rixensart-batch

releaser,

GlaxoSmithKline

Biologicals SA, Rue

des Aulnois, 637

59230 Saint-Amand-

Les-Eaux, France-

bulk manufacturer,

packager

BelgiumJ07CA09;

vaccine15925

23.08.2016

23.08.2021PoM

GlaxoSmithKline

Biologicals s.a., Rue

de l` Institut, 89 B-

1330 Rixensart,

Belgium

480

Page 141: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2222 Inflectra infliximab

powder lyophilized

for concentrate for

solution for infusion

100mg,

glass vial (1)

Hospira Enterprises

B.V., Randstad 22-11,

1316 BN Almere -

batch releaser,

Mustafa Nevzat Ilac

Sanayii A.S., Sanayi

Caddesi 13,

Yenibosna, Istanbul,

Turkey -bulk

manufacturer,

primary packager,

Hospira Zagreb d.o.o.,

10000, Prilaz baruna

Filipovica 27/D and

10291, Prigorje

Brdovecko, Prudnicka

cesta 60, Zagreb,

Republic of Croatia-

secondary packager

the Netherlands L04AB02 1426920.02.2015

20.02.2020PoM

Celltrion Healthcare

Co., Ltd., 19,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840,

Republic of Korea

2223 Inflectra infliximab

powder lyophilized

for concentrate for

solution for infusion

100mg,

glass vial (1)

Celltrion, Inc., 20,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840

Korea Sourth L04AB02 1428219.03.2015

19.03.2020PoM

Celltrion Healthcare

Co., Ltd., 19,

Academy-ro 51beon-

gil, Yeonsu-gu,

Incheon, 406-840,

Republic of Korea

2224 Influcid

aconitum trit.D3,

gelsemium trit.D3,

ipecacuanha

trit.D3,phosphorus

trit.D5, bryonia trit.

D2, eupatorium

perfoliatum trit.D1

tablets

25mg+25mg+

25mg+25mg+2

5mg+25mg,

in blister (60/3x20/)

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24 76227

Karlsruhe-batch

releaser, Dr. Willmar

Schwabe GmbH &

Co. KG, Willmar-

Schwabe-Str. 4, 76227

Karlsruhe, Germany-

bulk manufacturer,

packager

Germany

R05X;

homeopathic

drug

1427419.03.2015

19.03.2020OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

481

Page 142: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2225Influvac (season

2015/2016)

influenza vaccine

inactivated (surface

antigen):

A/California/7/2009

/H1N1/pdm09 - like

strain

A/California/7/2009

/NYMC X-181;

A/Switzerland/9715

293/2013/H3N2 -

like strain

A/Switzerland/9715

293/2013, NIB-88;

B/Phuket/3073/201

3

suspension for i/m

and s/c injection

15mcg haemagglutinin/

dose+15mcg

haemagglutinin/

dose+15mcg

haemagglutinin/ dose,

0,5ml pre-filled syringe

(1)

ABBOTT Biologicals

B.V. Veerweg 12,

8121 AA Olst -

packager, batch

releaser (ABBOTT

Biologicals B.V. C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands - bulk

manufacturer)

the NetherlandsJ07BB02;

vaccine13913/1

31.07.2015

29.10.2019PoM

ABBOTT Biologicals

B.V. C.J. van

Houtenlaan 36, 1381

CP Weesp, the

Netherlands

2226 Ingavirin

pentanedioic acid

(pentanedioic acid

imidazolyl

ethanamide)

capsules90mg,

in blister (7/1x7/)

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia J05AX 15652/225.12.2017

07.06.2021OTC

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 3

2227 Ingavirin

pentanedioic acid

(pentanedioic acid

imidazolyl

ethanamide)

capsules60mg,

in blister (7/1x7/)

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

Russia J05AX 16255/125.12.2017

19.12.2021OTC

Valenta Pharm PJSC,

141101, Moscow

Region, Shchelkovo,

Fabrichnaya St., 2

2228 Inlyta axitinib tablets film-coated1mg,

in blister (56/4x14/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany L01XE17 1439316.04.2015

16.04.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

482

Page 143: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2229 Inlyta axitinib tablets film-coated5mg,

in blister (56/4x14/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany L01XE17 1439416.04.2015

16.04.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

2230 Inspra eplerenone tablets film-coated25mg,

in blister (30/3x10/)

Pfizer PGM, Zone

Industrielle, 29 route

des Industries, 37530

Poce-sur-Cisse-

packager, batch

releaser, Pfizer

Pharmaceuticals LLC,

1.9 km Road 689,

Vega Baja, Puerto

Rico 00693, USA-

bulk manufacturer

France C03DA04 1461103.07.2015

03.07.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York, 10017, USA

2231 Inspra eplerenone tablets film-coated50mg,

in blister (30/3x10/)

Pfizer PGM, Zone

Industrielle, 29 route

des Industries, 37530

Poce-sur-Cisse-

packager, batch

releaser, Pfizer

Pharmaceuticals LLC,

1.9 km Road 689,

Vega Baja, Puerto

Rico 00693, USA-

bulk manufacturer

France C03DA04 1461203.07.2015

03.07.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York, 10017, USA

2232 Insty sugar free

salix alba,adhatoda

vasica,viola

odorata,glycyrrhiza

glabra,thea

sinensis,foeniculum

vulgare,eucalyptus

globulus,valeriana

officinalis

granules

750mg+300mg+

100mg+550mg+

125mg+75mg+

35mg+100mg, sachets (5)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900

Pakistan RO5X 1267912.07.2013

12.07.2018OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900,

Pakistan

483

Page 144: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2233 Insulatardinsulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AC01 1370024.07.2014

24.07.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2234 Insulatardinsulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Novo Nordisk

Production SAS, 45

avenue d`Orleans, F-

28000, Chartres

France A10AC01 1716007.11.2017

07.11.2022PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2235 Insulatard Penfill insulin humansuspension for

injection

100IU/ml,

3ml glass cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AC01 13508/102.07.2014

30.05.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2236 Integrilin eptifibatide solution for infusion0,75mg/ml,

100ml glass vial

Glaxo Operations UK

Ltd., Harmire Road

Barnard Castle Co

Durham, DL12 8DT

UK B01AC16 1431110.03.2015

10.03.2020PoM

Glaxo Group Ltd, 980

Great West Road,

Brentford, Middlesex,

TW8 9GS, UK

2237 Integrilin eptifibatide solution for injection2mg/ml,

10ml glass vial (1)

Glaxo Operations UK

Ltd., Harmire Road

Barnard Castle Co

Durham, DL12 8DT

UK B01AC16 1431210.03.2015

10.03.2020PoM

Glaxo Group Ltd,

980 Great West Road,

Brentford, Middlesex,

TW8 9GS, UK

2238 Intellan

ginkgo biloba,

centella asiatica,

herpestis monniera,

coriandrum

sativum, amomum

subulatum, emblica

officinalis

capsules

50mg+500mg+

125mg+200mg+

200mg+400mg,

in plastic container (20,

60)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900

PakistanHN06DX

herbal drug 13942

29.10.2014

29.10.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900,

Pakistan

484

Page 145: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2239 Intellan

ginkgo biloba,

centella asiatica,

herpestis monniera,

coriandrum

sativum, amomum

subulatum, emblica

officinalis

syrup

5mg/ml+50mg/ml+5mg/m

l+15mg/ml+15mg/ml+20

mg/ml, 90ml, 120ml,

150ml glass vial

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900

PakistanHN06DX;

herbal drug14189

06.02.2015

06.02.2020OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

2240 Interflox-100 enrofloxacinsolution for i/m or

s/c injection

100mg/ml,

100ml glass bottle

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray-

secondary packager,

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county,

Estonia- bulk

manufacturer,

primary packager,

batch releaser

the Netherlands

QJ01MA90;

veterinary

drug

1527404.02.2016

04.02.2021PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2241 Intermectin ivermectin solution for injection10mg/ml,

50ml, 100ml glass bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray-batch

releaser, packager,

Interchemie werken

'De Adelaar' Eesti As

ltd, Estonia Vanapre

str. 14, Puunsi,

Viimsi, Harju country-

bulk manufacturer,

primary packager

the Netherlands

QP54AA01;

veterinary

drug

1414129.12.2014

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

485

Page 146: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2242 Intermectin Superivermectin,

clorsulon

solution for s/c

injection

10mg/ml+ 100mg/ml,

50ml and 100ml plastic

vial

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county-

bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QP54AA51;

veterinary

drug

1520330.12.2015

30.12.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2243 Interspectin-L

spectinomycin

(spectinomycin

hydrochloride),

lincomycin

(lincomycin

hydrochloride)

solution for i/m

injection

100mg/ml+ 50mg/ml,

100ml glass bottle

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county-

bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QJ51RF03;

veterinary

drug

1528804.02.2016

04.02.2021PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2244 Intertrim LAsulfadoxine,

trimethoprim

solution for i/m

injection

200mg/ml+ 40mg/ml,

100ml glass vial

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray-

secondary packager,

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county,

Estonia- bulk

manufacturer,

primary packager,

batch releaser

the Netherlands

QJ01EW13;

veterinary

drug

1479004.09.2015

04.09.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

486

Page 147: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2245 Intertrim-480 Oraltrimethoprim,

sulfadiazinesuspenion oral

80mg/ml+ 400mg/ml,

1000ml plasstic bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QP01EW10;

veterinary

drug

1479104.09.2015

04.09.2020PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2246 Intetrix

tiliquinol, tiliquinol-

N-dodecyl sulfate,

tilbroquinol

capsules50mg+50mg+ 200mg,

in blister (20/2x10/)

Beaufour Ipsen

Industrie , Ethe

Virton, 28100 Dreux

France P01A 1422620.02.2015

20.02.2020PoM

Ipsen Pharma, 65

quai Georges Gorse,

92100 Boulogne-

Billancourt, France

2247 Intracox Oral toltrazuril solution oral

25mg/ml,

100ml, 1000ml plastic

bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QP51AJ01;

veterinary

drug

1579320.07.2016

20.07.2021PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2248 Intrafer-200 B12iron,

cyanocobalaminsolution for injection

(200mg+ 200mcg)/ml,

100ml glass bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray-batch

releaser, packager,

Interchemie werken

'De Adelaar' Eesti As

ltd, Estonia Vanapre

str. 14, Puunsi,

Viimsi, Harju country-

bulk manufacturer,

primary packager

the Netherlands

QB03AC90;

veterinary

drug

1413929.12.2014

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

487

Page 148: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2249 Introvit

vitaminA,

vitaminD3,

vitaminE,

vitaminB1,

vitaminB2,

vitaminB6,

vitaminB12, D-

panthenol,

nicotinamide, folic

acid, biotin, choline

chloride, DL-

methionine, L-

lysine

hydrochloride

solution for injection

15000IU/ml+

7500IU+20mg/ml+10mg/

ml+5mg/mg+3mg/ml+

60mcg/ml+ 25mg/ml+

50mg/ml+ 150mcg/ml+

125mcg/ml+ 12.5mg/ml+

5mg/ml+7mg/ml,

50ml,100ml glass bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray-batch

releaser, packager,

Interchemie werken

'De Adelaar' Eesti As

ltd, Estonia Vanapre

str. 14, Puunsi,

Viimsi, Harju country-

bulk manufacturer,

primary packager

the Netherlands

QA11AB;

veterinary

drug

1414029.12.2014

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2250 Invega paliperidonetablets prolonged-

release

6mg,

in blister (28/4x7/)

Janssen-Cilag S.p.A.,

Via C. Janssen, 04100

Borgo San Michele,

Latina-batch releaser,

packager, Janssen

Cilag Manufacturing

LLC., State Road 933-

km 0.1, Mamey

Ward, Gurabo, Puerto

Rico 00778, USA-bulk

manufacturer

Italy N05AX13 1618916.11.2016

16.11.2021PoM

Janssen- Cilag

International NV,

Turnhoutseweg 30, B-

2340 Beerse, Belgium

2251Iodine 5%

alcoholic solutioniodine

solution for external

use

50mg/ml,

10ml, 15ml, 30ml and

250ml glass bottle

Alfa-Pharm CJSC,

Khrimyan Hayrik 62,

Gyumri

Republic of

ArmeniaD08AG03 15931

24.08.2016

24.08.2021OTC

Alfa-Pharm CJSC,

Khrimyan Hayrik 62,

Gyumri, Republic of

Armenia

2252 Iodinol iodinesolution for external

use

1mg/ml,

100ml glass or plastic

bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD08AG03 14945

20.10.2015

20.10.2020OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

488

Page 149: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2253 Iodogel povidone-iodine gel for external use50mg/g,

15g aluminium tube

"LMP" Ltd., 1,

Vietalvas street, Riga,

LV-1009

Latvia D08AG02 1559103.05.2016

03.05.2021OTC

"LMP" Ltd., 1,

Vietalvas street, Riga,

LV-1009, Latvia

2254 Iodomarin 200 potassium iodide tablets200mcg,

in blister (100/4x25/),

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, Menarini-

Von Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany-bulk

manufacturer,

primary and

secondary packager

Germany H03C 1528204.02.2016

04.02.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

2255 Iodomarin 200 potassium iodide tablets200mcg,

in blister (100/4x25/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin-batch

releaser, packager,

Berlin-Chemie AG,

Tempelhofer Weg 83,

12347

Berlin,Germany- bulk

manufacturer

Germany H03C 1622208.12.2016

08.12.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

2256 Iono-Tech

sodium acetate

(sodium acetate

trihydrate), sodium

chloride, potassium

chloride, calcium

chloride (calcium

chloride dihydrate),

magnesium

chloride

(magnesium

chloride

hexahydrate)

solution for infusion

5mg/ml+ 5,85mg/ml+

0,302mg/ml+ 0,36mg/ml+

0,25mg/ml,

50ml, 100ml, 200ml,

250ml, 400ml, 500ml,

1000ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaB05BB01 15094

15.12.2015

15.12.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

489

Page 150: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2257 Ipigrix

ipidacrine

(ipidacrine

hydrochloride)

tablets20mg,

in blister (50/2x25/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia N06DA05 1709123.10.2017

23.10.2022PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2258 Ipigrix 15mg/ml

ipidacrine

(ipidacrine

hydrochloride)

solution for injection 15mg/ml,

1ml ampoules (10/2x5/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga - batch

releaser, HBM

Pharma s.r.o.,

Sklabinska 30, 03680,

Martin, Slovak

Republic - bulk

manufacturer,

packager

Latvia N06DA05 1689508.08.2017

08.08.2022PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2259 Ipigrix 5mg/ml

ipidacrine

(ipidacrine

hydrochloride)

solution for injection 5mg/ml,

1ml ampoules (10/2x5/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga - batch

releaser, HBM

Pharma s.r.o.,

Sklabinska 30, 03680,

Martin, Slovak

Republic - bulk

manufacturer,

packager

Latvia N06DA05 1689608.08.2017

08.08.2022PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2260 Irinotecan

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for infusion

20mg/ml,

5ml glass vial (1)

BIOCAD CJSC,

Petrovo-Dalnee,

Krasnogorsky district,

Moscow Region,

143422

Russia L01XX19 1388606.10.2014

06.10.2019PoM

BIOCAD CJSC, 34

bld., lit. A, Svyazi

st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

490

Page 151: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2261

Irinotecan

Moosmann

20mg/ml

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for infusion

20mg/ml,

2ml glass vial

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01XX19 1711423.10.2017

23.10.2022PoM

Moosmann

Pharmaceuticals LLC,

Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

2262

Irinotecan

Moosmann

20mg/ml

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for infusion

20mg/ml,

5ml glass vial

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01XX19 1711523.10.2017

23.10.2022PoM

Moosmann

Pharmaceuticals LLC,

Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

2263

Irinotecan

Moosmann

20mg/ml

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for infusion

20mg/ml,

15ml glass vial

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01XX19 1711623.10.2017

23.10.2022PoM

Moosmann

Pharmaceuticals LLC,

Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

2264

Irinotecan

Moosmann

20mg/ml

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for infusion

20mg/ml,

25ml glass vial

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01XX19 1711723.10.2017

23.10.2022PoM

Moosmann

Pharmaceuticals LLC,

Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

491

Page 152: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2265 Isla-Mint iceland moos pastilles100mg,

in blister (30/3x10/)

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden-

batch releaser,

primary and

secondary packager,

Bolder Arzneimittel

GmbH & Co. KG,

Rheinische Allee 11,

50858 Koln, Germany-

bulk manufacturer

Germany herbal drug 1520230.12.2015

30.12.2020OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

2266 Isla-Moos iceland moos pastilles80mg,

in blister (30/3x10/)

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden-

batch releaser,

primary and

secondary packager,

Bolder Arzneimittel

GmbH & Co. KG,

Rheinische Allee 11,

50858 Koln, Germany-

bulk manufacturer

Germany herbal drug 1520130.12.2015

30.12.2020OTC

Engelhard

Arzneimittel GmbH&

Co. KG,

Herzbergstrasse 3,

61138

Niederdorfelden,

Germany

2267 Ismigenlyophilized

bacterial lysatetablets sublingual

50mg,

in blister (10/1x10/,

30/3x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi 0165 -

secondary packager,

batch releaser (dosage

form manufacturer,

primary packager -

Bruschettini S.r.l., Via

Isonzo 6, 16147

Genova, Italy)

Georgia L03AX 13026/107.03.2014

25.11.2018PoM

Lallemand Pharm

AG, Via Selva, 2, CH-

6900 Massagno,

Switzerland

492

Page 153: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2268 Isoflurane isoflurane liquid for inhalation100%,

250ml glass bottle

Piramal Enterprises

Limited, Sy.No.7-70,

70/1 & 70/2, Digwal

Village, Kohir

Mandal, Sangareddy

District - 502 321,

Telangana

India N01AB06 1678122.06.2017

22.06.2022PoM

Piramal Enterprises

Limited, Piramal

Towers, Ganpatrao

Kadam Marg, Lower

Parel, Mumbai-

400013, India

2269 Isofraframycetin

(framycetin sulfate)spray nasal

8000U/ml,

15ml plastic vial with

pump dispenser

Sophartex, 21 rue du

Pressoir, 28500

Vernouillet

France R01AX08 1626519.12.2016

19.12.2021PoM

Laboratoires

Bouchara-Recordati,

Immeuble "le

Wilson", 70 avenue

du General de Gaulle,

92800 Puteaux,

France

2270 Isoniazid isoniazid tablets100mg,

in blister (100/10x10)

Macleods

Pharmaceuticals Ltd.,

Plot No 25-27, Sr. No

366, Premier Ind.

Estate, Kachigam,

Daman-396210 (UT)

India J04AC01 1601506.10.2016

06.10.2021PoM

Macleods

Pharmaceuticals Ltd.,

304, Atlanta Arcade,

Marol Church

Road,Andheri (East),

Mumbai-400 059,

India

2271 Isoniazid isoniazid tablets300mg,

in blister (672/24x28/)

Macleods

Pharmaceuticals Ltd.,

Plot No 25-27, Sr. No

366, Premier Ind.

Estate, Kachigam,

Daman-396210 (UT)

India J04AC01 1601606.10.2016

06.10.2021PoM

Macleods

Pharmaceuticals Ltd.,

304, Atlanta Arcade,

Marol Church

Road,Andheri (East),

Mumbai-400 059,

India

493

Page 154: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2272

Isosorbide

mononitrate 20mg

Tablets

isosorbide

mononitratetablets

20mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK C01DA14 1522822.12.2015

22.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2273

Isosorbide

mononitrate 40mg

Tablets

isosorbide

mononitratetablets

40mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK C01DA14 1522922.12.2015

22.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

494

Page 155: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2274 Itracim itraconazole capsules100mg,

in blister (15/3x5/)

Acino Pharma AG,

Birsweg 2, 4253

Liesberg-packager,

batch releaser, bulk-

manufacturer- Intas

Pharmaceuticals

Limited, Plot No 457

& 458 Sarkhej-Bavla

Highway, Matoda

Village, Sanand,

Taluka, District-

Ahmedabad, 382 210,

Gujarat, India

Switzerland J02AC02 1414329.12.2014

29.12.2019PoM

Acino Pharma AG,

Birsweg 2, 4253

Liesberg, Switzerland

2275

Ivermectin

injection 1% w/v

(Vet.)

ivermectin solution for injection

10mg/ml,

10ml, 20ml, 50ml and

100ml vial

Intracin

Pharmaceutical Pvt

Ltd, C-1/B-53,

G.I.D.C., city: Nadiad,

Dist:Kheda, Gujarat

state

India

QP54AA01;

veterinary

drug

1539609.03.2016

09.03.2021PoM

Veejay

Pharmaceuticals Pvt.

Ltd., D. No 9-

34/6,Plot 8A/P,

Survey No. 302 &

303, Nagaram,

Hyderabad-500083,

India

2276 IVERVETo-1 ivermectin solution for injection10mg/ml,

50ml, 100ml plastic bottle

Laboratoires Biove,

Rue de Lorraine 3,

62510 Arques

France

QP54AA01

veterinary

drug

1325624.02.2014

24.02.2019PoM

V.M.D. n.v., Hoge

Mauw 900, B-2370

Arendonk, Belgium

2277Ivotek Super

Injection

ivermectin,

clorsulon

solution for s/c

injection

10mg/ml+ 100mg/ml,

50ml, 100ml glass vial

Chongqing Bull

Animal

Pharmaceutical Co.

Ltd., Banqiao

Industrial Park,

Rongchang,

Chongqing

China

QP54AA51;

veterinary

drug

1439716.04.2015

16.04.2020PoM

Chongqing Bull

Animal

Pharmaceutical Co.

Ltd., Banqiao

Industrial Park,

Rongchang,

Chongqing, China

2278 Izigel ibuprofen gel for external use50mg/g,

60g aluminium tube

Arafarma Group, S.A.

(C/Fray Gabriel de

San Antonio, 6-10,

Pol. Ind. Del Henares,

19180, Marchamalo,

Guadalajara)

Spain M02AA13 1295128.10.2013

28.10.2018OTC

GM Pharmaceuticals

Ltd (PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia)

495

Page 156: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2279 Izoconazol-Misoconazole

(isoconazole nitrate)suppositories vaginal

600mg,

(1)

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaG01AF07 17190

28.11.2017

28.11.2022PoM

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

2280 Jakavi

ruxolitinib

(ruxolitinib

phosphate)

tablets5mg,

in blister (56/4x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L01XE18 1397726.11.2014

26.11.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

2281 Jakavi

ruxolitinib

(ruxolitinib

phosphate)

tablets15mg,

in blister (56/4x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L01XE18 1397826.11.2014

26.11.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

2282 Jakavi

ruxolitinib

(ruxolitinib

phosphate)

tablets20mg,

in blister (56/4x14/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L01XE18 1397926.11.2014

26.11.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

2283 Janumet

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+850mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Aesica Queenborough

Limited,

Queenborough Kent

ME 11 5EL, UK-bulk

manufacturer

the Netherlands A10BD07 1558012.05.2016

12.05.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

496

Page 157: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2284 Janumet

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+1000mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Aesica Queenborough

Limited,

Queenborough Kent

ME 11 5EL, UK-bulk

manufacturer

the Netherlands A10BD07 1558112.05.2016

12.05.2021PoM

Schering-Plough

Central East Ag,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

2285 Janumet

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+1000mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA- bulk

manufacturer

the Netherlands A10BD07 1706905.10.2017

05.10.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

2286 Janumet

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+500mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA- bulk

manufacturer

the Netherlands A10BD07 1707005.10.2017

05.10.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

497

Page 158: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2287 Janumet

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+850mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA- bulk

manufacturer

the Netherlands A10BD07 1707105.10.2017

05.10.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

2288Janumet

50mg+1000mg

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+1000mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk

manufacturer -

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA)

the Netherlands A10BD07 12436/103.04.2015

07.05.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

2289Janumet

50mg+500mg

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+500mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk

manufacturer -

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA)

the Netherlands A10BD07 12434/103.04.2015

07.05.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

498

Page 159: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2290Janumet

50mg+850mg

sitagliptin

(sitagliptin

phosphate

monohydrate),

metformin

(metformin

hydrochloride)

tablets film-coated50mg+850mg,

in blister (56/4x14/)

Merck Sharp &

Dohme B.V.,

Waarderweg 39, 2031

BN Haarlem -

packager, batch

releaser (bulk

manufacturer -

Patheon Puerto Rico,

Inc., State Road 670

Km. 2,7 Manati,

Puerto Rico, 00674,

USA)

the Netherlands A10BD07 12435/103.04.2015

07.05.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

2291 Januvia

sitagliptin

(sitagliptin

phosphate hydrate)

tablets film-coated100mg,

in blister (28/2x14/)

Merck Sharp &

Dohme Ltd., Shotton

Lane, Cramlington,

Northumberland

NE23 3JU

UK A10BH01 1411729.12.2014

29.12.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

2292 Jeanineethinylestradiol,

dienogesttablets coated

0.03mg+2mg,

in blister (21/1x21/)

Bayer Weimar GmbH

& Co. KG,

Dobereinerstrasse 20,

99427 Weimar

Germany G03AA 1476903.08.2015

03.08.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353 Berlin,

Germany

499

Page 160: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2293 Jene-35 ED

I tablet-cyproterone

(cyproterone

acetate),

ethinylestradiol, II

tablet-inactive

tablets film-coated

2mg+0.035mg, (28/1x28/

21 (I) tablets+ 7(II)

tablets/), in blister

Eris Pharmaceuticals

(Australia) Pty Ltd, 6

Eastern Road, South

Melbourne, Victoria,

3205-batch releaser,

Douglas

Manufacturing Ltd,

Corner Te Pai Place

and Central Park

Drive, Lincoln

Auckland, New

Zealand-bulk

manufacturer,

Douglas

Manufacturing Fiji

Ltd, Brewers Road

Martintar Nadi, Fiji-

primary and

secondary packager

Australia G03HB01 1534226.02.2016

26.02.2021PoM

Eris Pharmaceuticals

(Australia) Pty Ltd, 6

Eastern Road, South

Melbourne, Victoria,

3205, Australia

2294 Jocet

salbutamol

(salbutamol sulfate),

bromhexine

hydrochloride,

guaifenesin,

menthol

(levomenthol)

syrup

1mg/5ml+ 2mg/5ml+

50mg/5ml+ 0,5mg/5ml,

100ml and 200ml plastic

container and measuring

cup 15ml

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.),

Plot No. 128/1,

G.I.D.C. Indastrial

area, Ankleshwar. 393

002: Gujarat State

India R05C 14898/109.10.2015

24.09.2020PoM

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals

Ltd.), Worli, Mumbai-

400 030, India

2295 Jodbalance potassium iodide tablets100mcg,

in blisters (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03CA 13901/123.03.2017

30.09.2019OTC

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

500

Page 161: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2296 Jodbalance potassium iodide tablets200mcg,

in blister (100/4x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany H03CA 1390230.09.2014

30.09.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

2297 Joxpovidone-iodine,

allantoinspray

85mg/ml+ 1mg/ml,

30ml plastic bottle and

dosator

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic R02AA20 1224707.03.2013

07.03.2018OTC

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

2298 Kadcylatrastuzumab

emtansine

powder for

concentrate for

solution for infusion

160mg,

20ml glass vial (1)

F. Hoffmann-La

Roche Ltd. 4303

Kaiseraugst

Switzerland L01XC14 1710923.10.2017

23.10.2022PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

2299 Kadcylatrastuzumab

emtansine

powder for

concentrate for

solution for infusion

100mg,

15ml glass vial (1)

F. Hoffmann-La

Roche Ltd. 4303

Kaiseraugst

Switzerland L01XC14 1711023.10.2017

23.10.2022PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

2300 Kafra ofloxacin tablets film-coated400mg,

in blister (5)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia J01MA01 1301625.11.2013

25.11.2018PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

2301 Kagocel kagocel tablets12mg,

blister (10/1x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse St.

Russia J05AX 13433/207.12.2016

14.04.2019OTC

NEARMEDIC PLUS

LLC,

Aviakonstruktora

Mikoyana St., 12,

Moscow, 125252,

Russia

501

Page 162: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2302 Kagocel kagocel tablets

12mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/)

NEARMEDIC

PHARMA LLC , 6

Kiev highway, near

the village Malagnino,

Borovsky district

249008, Kaluga region

Russia J05AX 1716630.11.2017

30.11.2022OTC

NEARMEDIC PLUS

LLC,

Aviakonstruktora

Mikoyana St., 12,

Moscow, 125252,

Russia

2303 Kalcinova

vitamin A, vitamin

D3, vitamin B6,

vitamin C, calcium,

phosphorus

tablets

1000IU+100IU+

0,4mg+15mg+

100mg+77mg,

in blister (27/3x9/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, KRKA d.d.,

Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia A11AA03 1678422.06.2017

22.06.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2304 Kaletra lopinavir, ritonavir solution oral

80mg/ml+20mg/ml, 60ml

plastic bottle (5) and 5ml

dispenser (5)

Aesica Queenborough

Limited,

Queenborough Kent

ME 11 5EL

UK J05AR10 1623619.12.2016

19.12.2021PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, Postfach 6341

Baar, Switzerland

2305 Kalium chloride potassium chloridesolution for i/v

infusion

40mg/ml,

200ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaA12BA01 15658

08.06.2016

08.06.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

502

Page 163: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2306 Kalymin 60Npyridostigmine

bromidetablets

60mg,

in glass bottle (100)

Merckle GmbH,

Ludwig-Merckle-

Strasse 3, 89143

Blaubeuren - batch

releaser (Klocke

Pharma-Service

GmbH, Strassburger

Str. 77, Appenweier,

77767, Germany -

bulk manufacturer,

packager)

Germany N07AA02 1369824.07.2014

24.07.2019PoM

TEVA

Pharmaceutical

Industries Ltd., 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

2307 Kameton

chlorobutanol

(chlorobutanol

hydrate), camphora,

L-menthol,

eucalyptus oil

aerosol for local use

6,67mg/g+ 6,67mg/g+

6,67mg/g+ 6,67mg/g,

30g and 45g bottle

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia R02AA20 13556/102.07.2014

06.06.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

2308 Kamiren

doxazosin

(doxazosin

mesylate)

tablets4mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C02CA04 1333017.03.2014

17.03.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2309 Kamistad

matricaria

chamomilla,

lidocaine (lidocaine

hydrochloride)

gel for local

application

185mg/g+20mg/g, 10g

aluminium tube

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel

GermanyA01AD11;

herbal drug14069

19.12.2014

19.12.2019OTC

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel

2310 Kanamycinkanamycin

(kanamycin sulfate)

powder for solution

for i/m injection

1000mg,

glass vial (1)

Kievmedpreparat

OJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01GB04 1402326.11.2014

26.11.2019PoM

Kievmedpreparat

OJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

503

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2311 Kapetral capecitabine tablets film-coated150mg,

in blister (60/6x10/)

Remedica Ltd,

Limassol Industrial

Estate, Aharnon

street, 3056 Limassol

Cyprus L01BC06 1468229.06.2015

29.06.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

2312 Kapetral capecitabine tablets film-coated500mg,

in blister (120/12x10/)

Remedica Ltd,

Limassol Industrial

Estate, Aharnon

street, 3056 Limassol

Cyprus L01BC06 1468329.06.2015

29.06.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

2313 Kapikor

meldonium

(meldonium

dihydrate), gamma-

butyrobetaine

(gamma-

butyrobetaine

dihydrate)

capsules

180mg+60mg,

in blister (20/2x10/,

60/6x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia C01EX 1666411.05.2017

11.05.2022PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

2314 Kapron tranexamic acidsolution for

injection/infusion

100mg/ml,

5ml ampoules (6)

Amoun

Pharmaceutical

Company, El-Obour

City, Cairo

Egypt B02AA02 1238119.04.2013

19.04.2018PoM

Amoun

Pharmaceutical

Company, El-Obour

City, Cairo, EGYPT

2315 Kapron tranexamic acid tablets film-coated500mg,

in blister (20/2x10/)

Amoun

Pharmaceutical

Company, El-Obour

City, Cairo

Egypt B02AA02 1238219.04.2013

19.04.2018PoM

Amoun

Pharmaceutical

Company, El-Obour

City, Cairo, EGYPT

2316 Kaptopril captopril tablets25mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA01 12929/109.12.2013

07.10.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2317 Kaptopril captopril tablets50mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA01 1639010.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

504

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2318 Kaptopril captopril tablets12,5mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09AA01 1639110.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2319 Kardiket isosorbide dinitratetablets prolonged-

release

20mg,

in blister (20/2x10/,

50/5x10/)

Aesica

Pharmaceuticals

GmbH, Alfred-Nobel-

Strasse 10, 40789

Monheim - batch

releaser (dosage form

manufacturer - Aesica

Pharmaceuticals

GmbH, Galileistrasse

6, 08056 Zwickau,

Germany) (packager -

Aesica

Pharmaceuticals

GmbH, Mittelstrasse

15, 40789 Monheim,

Germany)

Germany C01DA08 1216101.02.2013

01.02.2018PoM

UCB Pharma GmbH,

Alfred-Nobel-Strasse

10, 40789 Monheim,

Germany

2320 Kardiket isosorbide dinitratetablets prolonged-

release

40mg,

in blister (20/2x10/,

50/5x10/)

Aesica

Pharmaceuticals

GmbH, Alfred-Nobel-

Strasse 10, 40789

Monheim - batch

releaser (dosage form

manufacturer - Aesica

Pharmaceuticals

GmbH, Galileistrasse

6, 08056 Zwickau,

Germany) (packager -

Aesica

Pharmaceuticals

GmbH, Mittelstrasse

15, 40789 Monheim,

Germany)

Germany C01DA08 1216201.02.2013

01.02.2018PoM

UCB Pharma GmbH,

Alfred-Nobel-Strasse

10, 40789 Monheim,

Germany

505

Page 166: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2321 Kardiotex

meldonium

(meldonium

dihydrate)

solution for i/v and

parabulbar injection

100mg/ml,

5ml ampoules, blister

(5/1x5/, 10/2x5/)

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia C01EB22 13323/113.05.2016

17.03.2019PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2322 Karvidil carvedilol tablets25mg,

in blister (28/2x14/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia C07AG02 1623819.12.2016

19.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2323 Karvidil carvedilol tablets12,5mg,

in blister (28/2x14/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia C07AG02 1623919.12.2016

19.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2324 Karvidil carvedilol tablets6,25mg,

in blister (28/2x14/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia C07AG02 1624019.12.2016

19.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2325 Katarax

azapentacene

(azapentacene

polysulfonate

sodium)

drops eye0,15mg/ml,

15ml plastic vial

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania S01XA 1646106.03.2017

06.03.2022PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2326 Katarel tenoxicam

powder lyophilized

and solvent for

solution for i/m/i/v

injection

20mg,

glass vial (1) and 2ml

solvent in ampoule

Anfarm Hellas S.A.,

61st Km National

Road Athens-Lamia,

Sximatari Viotias,

32009

Greece M01AC02 1597115.09.2016

15.09.2021PoM

J&P Pharma UK Ltd,

Ashcombe House, 5

The Crescent,

Leatherhead, Surrey,

KT22 8DY, UK

506

Page 167: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2327 Kefentech plaster ketoprofen plaster transdermal 30mg,

in pack (7)

Jeil Pharmaceutical

Co., Ltd., 7

Cheongganggachang-

ro, Baegam-myeon,

Cheoin-gu, Yongin-si,

Gyeonggi-do

Korea South M01AE03 1690408.08.2017

08.08.2022PoM

Jeil Pharmaceutical

Co., Ltd., 343,

Sapyeong-daero,

Seocho-gu, Seul,

Republic of Korea

2328 Kenalog triamcinolone tablets4mg,

in glass bottle (50)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia H02AB08 1588723.08.2016

23.08.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2329 Kenalog 40

triamcinolone

(triamcinolone

acetonide)

suspension for

injection

40mg/ml,

1ml ampoules (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia H02AB08 1588823.08.2016

23.08.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2330 Keppra levetiracetam tablets film-coated500mg,

in blister (30/3x10/)

UCB Pharma S.A.,

Chemin du Foriest, B-

1420 Braine-l'Alleud

Belgium N03AX14 1497018.11.2015

18.11.2020PoM

UCB Pharma S.A.,

Allee de la Recherche

60, B-1070 Bruxelles,

Belgium

2331 Keppra levetiracetam tablets film-coated250mg,

in blister (30/3x10/)

UCB Pharma S.A.,

Chemin du Foriest, B-

1420 Braine-l'Alleud

Belgium N03AX14 1497118.11.2015

18.11.2020PoM

UCB Pharma S.A.,

Allee de la Recherche

60, B-1070 Bruxelles,

Belgium

2332Kepromec Super

Inj.

ivermectin,

clorsulonsolution for injection

10mg/ml+ 100mg/ml,

10ml, 50ml, 100ml and

250ml plastic container

Kepro BV,

Maagdenburgstraat

17, 7421 ZA Deventer-

secondary packager,

batch releaser, Kepro

BV, Forellenweg 16,

4941SJ

Raamsdonksveer, the

Netherlands- bulk

manufacturer,

primary packager

the Netherlands

QP54AA51;

veterinary

drug

1460603.07.2015

03.07.2020PoM

Kepro BV,

Maagdenburgstra-at

17, 7421 ZA

Deventer, the

Netherlands

507

Page 168: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2333 Kepxan Oral

levamisole

(levamisole

hydrochloride),

oxyclozanide

suspension oral

30mg/ml+60mg/ml,

100ml and 1000ml plastic

container

Kepro BV,

Maagdenburgstraat

17, 7421 ZA Deventer-

secondary packager,

batch releaser, Kepro

BV, Forellenweg 16,

4941SJ

Raamsdonksveer, the

Netherlands- bulk

manufacturer,

primary packager

the Netherlands

QP52AE51;

veterinary

drug

1458009.06.2015

09.06.2020PoM

Kepro BV,

Maagdenburgstraat

17, 7421 ZA

Deventer, the

Netherlands

2334 Kestine ebastine tablets film-coated

10mg,

in blister, (5/1x5/,

10/1x10/)

Industrias

Farmaceuticas

Almirall S.A., Ctra.

Nacional II, Km. 593,

Sant Andreu de la

Barca, Barcelona,

08740

Spain R06AX22 13660/110.10.2017

08.07.2019OTC

Almirall, S.A., Ronda

General Mitre, 151,

08022 Barcelona,

Spain

2335 Kestine ebastine tablets film-coated20mg,

in blister (10/1x10/)

Industrias

Farmaceuticas

Almirall S.A., Ctra.

Nacional II, Km. 593,

08740 Sant Andreu de

la Barca, Barcelona

Spain R06AX22 1699205.09.2017

05.09.2022OTC

for Almirall, S.A.,

Ronda General Mitre,

151, 08022 Barcelona,

Spain

2336 Ketalgin longketorolac (ketorolac

tromethamine)solution for injection

30mg/ml,

1ml ampoules, in blister

(10)(10/2x5/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine M01AB15 1528504.02.2016

04.02.2021PoM

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov,

Ukraine

2337 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated25mg,

in blister (30/3x10/)

Pharmaceutical

Works Polpharma

S.A., str. Pelplinska19,

83-200 Starogard

Gdanski

Poland N05AH04 1215201.02.2013

01.02.2018PoM

Pharmaceutical

Works Polpharma

S.A., str.

Pelplinska19, 83-200

Starogard Gdanski,

Poland

508

Page 169: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2338 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

100mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., str. Pelplinska19,

83-200 Starogard

Gdanski

Poland N05AH04 1215301.02.2013

01.02.2018PoM

Pharmaceutical

Works Polpharma

S.A., str.

Pelplinska19, 83-200

Starogard Gdanski,

Poland

2339 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

200mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., str. Pelplinska19,

83-200 Starogard

Gdanski

Poland N05AH04 1215401.02.2013

01.02.2018PoM

Pharmaceutical

Works Polpharma

S.A., str.

Pelplinska19, 83-200

Starogard Gdanski,

Poland

2340 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

300mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., str. Pelplinska19,

83-200 Starogard

Gdanski

Poland N05AH04 1215501.02.2013

01.02.2018PoM

Pharmaceutical

Works Polpharma

S.A., str.

Pelplinska19, 83-200

Starogard Gdanski,

Poland

2341 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated25mg,

in blister (30/3x10/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski

Poland N05AH04 1696505.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski, Poland

2342 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

100mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski

Poland N05AH04 1696605.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski, Poland

2343 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

200mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski

Poland N05AH04 1696705.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski, Poland

509

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2344 Ketiap

quetiapine

(quetiapine

fumarate)

tablets film-coated

300mg,

in blister (60/6x10/,

90/9x10/)

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski

Poland N05AH04 1696805.09.2017

05.09.2022PoM

Pharmaceutical

Works Polpharma

S.A., 19 Pelplinska

Str., 83-200 Starogard

Gdanski, Poland

2345 Ketilept

quetiapine

(quetiapine

fumarate)

tablets coated

25mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 12376/119.08.2015

19.04.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2346 Ketilept

quetiapine

(quetiapine

fumarate)

tablets coated

100mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 12377/119.08.2015

19.04.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2347 Ketilept

quetiapine

(quetiapine

fumarate)

tablets coated

150mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 12378/119.08.2015

19.04.2018PoM

Egis Pharmaceuticals

PLC 1106 Budapest,

Kereszturi st 30-38,

Hungary

2348 Ketilept

quetiapine

(quetiapine

fumarate)

tablets coated

200mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 12379/119.08.2015

19.04.2018PoM

Egis Pharmaceuticals

PLC 1106 Budapest,

Kereszturi st 30-38,

Hungary

2349 Ketilept

quetiapine

(quetiapine

fumarate)

tablets coated

300mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 12380/119.08.2015

19.04.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

510

Page 171: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2350 Ketilept

quetiapine

(quetiapine

fumarate)

tablets film-coated

100mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 1726813.12.2017

13.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2351 Ketilept

quetiapine

(quetiapine

fumarate)

tablets film-coated

150mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 1726913.12.2017

13.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2352 Ketilept

quetiapine

(quetiapine

fumarate)

tablets film-coated

200mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 1727013.12.2017

13.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2353 Ketilept

quetiapine

(quetiapine

fumarate)

tablets film-coated

300mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 1727113.12.2017

13.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2354 Ketilept

quetiapine

(quetiapine

fumarate)

tablets film-coated

25mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N05AH04 1727213.12.2017

13.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2355 Ketoconazole ketoconazole cream20mg/g,

10g aluminium tube

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova D01AC08 1315910.01.2014

10.01.2019OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

2356 Ketoconazole ketoconazole shampoo20mg/ml,

100ml plastic container

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD01AC08 14871

24.09.2015

24.09.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

511

Page 172: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2357 Ketoconazole ketoconazolecream for external

use

20mg/g,

15g, 25g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD01AC08 15779

11.07.2016

11.07.2021OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2358 Ketonal ketoprofen gel for external use25mg/g,

50g aluminium tube

Salutas Pharma

GmbH, Lange

Goehren 3, 39171

Osterweddingen

Germany M02AA10 1497418.11.2015

18.11.2020PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

2359 Ketonal ketoprofencream for external

use

50mg/g,

30g aluminium tube

Salutas Pharma

GmbH, Lange

Goehren 3, 39171

Osterweddingen

Germany M02AA10 1497518.11.2015

18.11.2020PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

2360Ketonal 100mg

suppositoriesketoprofen suppositories

100mg,

in strip (12/2x6/)

Sandoz Ilac Sanayi ve

Ticaret A.S., Gebze

Plastikciler Organize

Sanayi Boelgesi

Atatturk Bulvari 9,

Cadde No.1, 41400,

Kocaeli

Turkey M01AE03 1414429.12.2014

29.12.2019PoM

Lek d.d., Verovskova

str. 57,1526 Ljubljana,

Slovenia

2361

Ketonal

100mg/2ml

solution for

injection

ketoprofen solution for injection50mg/ml,

2ml ampoules (10/2x5/)

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana

Slovenia M01AE03 1395728.10.2014

28.10.2019PoM

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana,

Slovenia

2362Ketonal 50mg

capsulesketoprofen capsules

50mg,

glass container (25)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia M01AE03 14168/127.04.2017

24.12.2019PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

512

Page 173: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2363 Ketonal DUO ketoprofencapsules modified-

release

150mg,

in blister (20/2x10/,

30/3x10/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia M01AE03 1523523.12.2015

23.12.2020PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

2364

Ketonal Forte

100mg film-coated

tablets

ketoprofen tablets film-coated100mg,

in glass container (20)

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana

Slovenia M01AE03 1416724.12.2014

24.12.2019PoM

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana

2365 Ketonal retard ketoprofentablets prolonged-

release

150mg,

in glass container (20)

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana

Slovenia M01AE03 1395828.10.2014

28.10.2019PoM

Sandoz

Pharmaceuticals d.d.

Verevskova 57, SI-

1526 Ljubljana,

Slovenia

2366 Ketoprofen ketoprofen gel for external use25mg/g,

30g aluminum tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus M02AA10 1628019.12.2016

19.12.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2367Ketoprofen

Rompharmketoprofen

solution for i/v and

i/m injection

50mg/ml,

2ml ampoules,

in blister (5/1x5/, 10/2x5/)

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania M01AE03 1562324.05.2016

24.05.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2368 Ketorol ketorolac tablets film-coated10mg,

in blister (10)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia M01AB15 1253704.12.2013

04.12.2018PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

513

Page 174: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2369 Ketorolacketorolac (ketorolac

trometamol)solution for injection

30mg/ml,

1ml ampoules (10), 1ml

ampoules label banderol

(10),

1ml ampoules dividella

(10)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus M01AB15 1243902.09.2013

02.09.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

2370 Ketorolacketorolac (ketorolac

trometamol)tablets film-coated

10mg,

in blister (10, 20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus M01AB15 1598715.09.2016

15.09.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2371Ketorolac

Rompharm

ketorolac (ketorolac

trometamol)

solution for i/v and

i/m injection

30mg/ml,

1ml ampoules,

in blister (5/1x5/, 10/2x5/)

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania M01AB15 1557512.05.2016

12.05.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2372 Ketotifenketotifen (ketotifen

fumarate)tablets

1mg,

in blister (10/1x10/,

30/3x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus R06AX17 1363627.06.2014

27.06.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2373 Ketotifenketotifen (ketotifen

fumarate)tablets

1mg,

in blister (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus R06AX17 13850/122.01.2015

18.09.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

514

Page 175: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2374

Ketotifen

Sopharma 1mg

tablets

ketotifen (ketotifen

hydrofumarate)tablets

1mg,

in blister (30/3x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria R06AX17 1664425.04.2017

25.04.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2375 KHONDRA-JECT

chondroitin sulfate

(chondroitin sulfate

sodium)

solution for injection100mg/ml,

1ml ampoules (10/2x5/)

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia M01AX25 13161/111.08.2016

10.01.2019PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2376 Kindinorm

chamomilla D12,

kalium

phosphoricum D6,

staphisagria D12,

valeriana D6

granules

25mg+25mg+

25mg+25mg,

glass container

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe

Germany

N06B;

homeopathic

drug

1689308.08.2017

08.08.2022OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

2377 Kivexaabacavir (abacavir

sulfate), lamivudinetablets film-coated

600mg+300mg,

in blister (30/3x10/)

Glaxo Wellcome S.A.,

Avenida

Extremadura, 3,

09400 Aranda de

Duero, Burgos- batch

releaser, packager,

GlaxoSmithKline

Pharmaceuticals S.A.,

189 Grunwaldzka

street, 60-322 Poznan,

Poland-bulk

manufacturer

Spain J05AR02 1557812.05.2016

12.05.2021PoM

ViiV Healthcare UK

Ltd., 980 Great West

Road, Brentford,

Middlesex, TW8 9GS,

UK

515

Page 176: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2378 Klacid clarithromycingranules for oral

suspension

125mg/5ml,

100ml plastic container

and measuring syringe or

measuring spoon

AbbVie S.r.l., S.R. 148

Pontina KM 52, SNC -

Campoverde di

Aprilia (loc. Aprilia)-

04011 Aprilia (LT)

Italy J01FA09 1461503.07.2015

03.07.2020PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2379 Klacid clarithromycingranules for oral

suspension

250mg/5ml,

100ml plastic container

and measuring syringe or

measuring spoon

AbbVie S.r.l., S.R. 148

Pontina KM 52, SNC -

Campoverde di

Aprilia (loc. Aprilia)-

04011 Aprilia (LT)

Italy J01FA09 1461603.07.2015

03.07.2020PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2380 Klacid SR clarithromycintablets modified-

release film-coated

500mg,

in bliister (5/1x5/,

14/1x14/)

Aesica Queenborough

Limited,

Queenborough Kent

ME 11 5 EL

UK J01FA09 1492220.10.2015

20.10.2020PoM

for Abbott

Laboratories GmbH,

Freundallee 9A,

30173 Hannover,

Germany

2381 Klarisens loratadine tablets

10mg,

in blister (7/1x7/,

10/1x10/, 30/3x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia R06AX13 14934/121.04.2016

20.10.2020OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2382 Klerimed clarithromycin tablets film-coated500mg,

in blister (14/2x7/)

Medochemie Ltd

(Factory AZ), 2

Michael Erakleous

street, Agios

Athanassios Industrial

Area, 4101 Agios

Athanassios, Limassol

Cyprus J01FA09 1673905.06.2017

05.06.2022PoM

Medochemie Ltd., 1-

10

Constantinoupoleos

street, 3011 Limassol,

Cyprus

516

Page 177: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2383 Klerimed clarithromycin tablets film-coated250mg,

in blister (14/2x7/)

Medochemie Ltd

(Factory AZ), 2

Michael Erakleous

street, Agios

Athanassios Industrial

Area, 4101 Agios

Athanassios, Limassol

Cyprus J01FA09 1674005.06.2017

05.06.2022PoM

Medochemie Ltd., 1-

10

Constantinoupoleos

street, 3011 Limassol,

Cyprus

2384 Klimaktoplan K

ignatia D3 trit,

cimicifuga D2 trit,

sepia D2 trit,

sanguinaria D6 trit

tablets

25mg+25mg+

25mg+25mg,

in blister (100/5x20/)

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24 76227

Karlsruhe-batch

releaser, Dr. Willmar

Schwabe GmbH &

Co. KG, Willmar-

Schwabe str. 4, 76227

Karlsruhe, Germany-

bulk manufacturer,

packager

Germany

G02C;

homeopathic

drug

1425720.02.2015

20.02.2020OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

2385 Klimalanin beta-alanine tablets

400mg,

blisters (30/3x10/,

30/2x15/)

Laboratoires Bouchara-

Recordati, Parc

Mecatronic 03410

Saint Victor

France G02CX 14000/102.09.2016

26.11.2019OTC

Laboratoires

Bouchara-Recordati,

Immeuble le Wilson,

70 avenue du General

de Gaulle, 92800

Puteaux, France

517

Page 178: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2386 Klimonorm

yellow dragee -

estradiol valerate,

brown dragee -

estradiol valerate,

levonorgestrel

dragee (tablets sugar-

coated)

2mg+2mg+0,15mg, (21/ 9

yellow dragee+12 brown

dragee/) in blister

Jenapharm GmbH &

Co. KG, Otto-Schott-

Strasse 15, D-07745,

Jena - batch relaser

(dosage form

manufacturer - Bayer

Weimar GmbH & Co.

KG, Dobereinerstrasse

20, 99427 Weimar,

Thuringia, Germany)

Germany G03CA53 1261421.06.2013

21.06.2018PoM

Jenapharm GmbH &

Co. KG, Otto-Schott-

Strasse 15, D-07745,

Jena, Germany

2387 Klindacin T

clindamycin

(clindamycin

phosphate)

gel10mg/g,

30g aluminium tube

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw

Poland D10AF01 1623719.12.2016

19.12.2021PoM

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw, Poland

2388 Klindamicin

clindamycin

(clindamycin

hydrochloride)

capsules150mg,

in blister (16/2x8/)

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb

Serbia J01FF01 1360320.06.2014

20.06.2019PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

2389 Klion-D 100

metronidazole,

miconazole

(miconazole nitrate)

tablets vaginal100mg+100mg,

in blister (10/1x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G01AF20 1445504.05.2015

04.05.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2390 Klopidogrel AKTIV

clopidogrel

(clopidogrel

bisulfate)

tablets film-coated

75mg,

in blister (30/3x10/,

90/9x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia B01AC04 1362327.06.2014

27.06.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2391 Kodelak Neobutamirate

(butamirate citrate)syrup

7.5mg/5ml,

100ml glass bottle and

measuring spoon

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia R05DB13 1620908.12.2016

08.12.2021OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

518

Page 179: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2392 Kodelak Neobutamirate

(butamirate citrate)drops oral

5mg/ml,

20ml glass vial-dropper

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia R05DB13 1621008.12.2016

08.12.2021OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2393Kofetamin-

Tatpharm

caffeine (caffeine

anhydrous),

ergotamine

(ergotamine

tartrate)

tablets coated(91,5mg+1mg), blisters

(10/1x10/, 20/2x10/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 261

Russia N02CA52 13682/108.06.2017

08.07.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

2394Konakion MM

paediatric phytomenadione

solution for

injection/oral

2mg/0,2ml,

0,2ml ampoules (5) and

dispenser

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070-batch

releaser, Cenexi SAS,

52 rue Marcel et

Jacques Gaucher,

Fontenay Sous Bois,

94120, France- bulk

manufacturer,

packager

Switzerland B02BA01 1692716.08.2017

16.08.2022PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070,

Switzerland

2395 Korold-Asteria

paracetamol,

pseudoephedrine

(pseudoephedrine

hydrochloride),

chlorphenamine

(chlorphenamine

maleate)

tablets film-coated

500mg+30mg+ 2mg,

in blister (20/2x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth N02BE51 15234/103.02.2016

23.12.2020OTC

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

2396 Kreon 10000

pancreatin (lipase

10000PhEU,

amylase 8000

PhEU, protease 600

PhEU)

capsules gastro-

resistant

150mg,

in blister (20/2x10/) and

in plastic container (20)

Abbott Laboratories

GmbH, Justus-von-

Liebig-Strasse 33,

31535 Neustadt

Germany A09AA02 1498918.11.2015

18.11.2020OTC

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

519

Page 180: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2397 Kreon 25000

pancreatin (lipase

25000PhEU,

amylase 18000

PhEU, protease

1000 PhEU)

capsules gastro-

resistant

300mg; (20/2x10/), in

blister and (20) in plastic

container

Abbott Laboratories

GmbH, Justus-von-

Liebig-Strasse 33,

31535 Neustadt

Germany A09AA02 1499018.11.2015

18.11.2020OTC

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2398 Kreon 40000

pancreatin (lipase

40000PhEU,

amylase 25000

PhEU, protease

1600 PhEU)

capsules gastro-

resistant

400mg,

in blister (20/2x10/) and

in plastic container (20)

Abbott Laboratories

GmbH, Justus-von-

Liebig-Strasse 33,

31535 Neustadt

Germany A09AA02 1498818.11.2015

18.11.2020OTC

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

2399 Ksalatamax latanoprost drops eye0,05mg/ml,

2,5ml plastic vial, (1,3)

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b. - batch releaser

(dosage form

manufacturer - Jadran

Galenski Laboratorij

d.d., Svilno

bb,Cavle,51219,

Croatia)

Croatia S01EE01 1243207.05.2013

07.05.2018PoM

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b., Croatia

2400 Lacipil lacidipine tablets film-coated4mg,

in blister (14/2x7/)

GlaxoSmithKline

Pharmaceuticals

S.A.,189 Grunwaldzka

street, 60-322 Poznan

Poland C08CA09 1274423.07.2013

23.07.2018PoM

GlaxoSmithKline

Export Ltd, 980 Great

West Road,

Brentford, Middlesex,

TW8 9GS, UK

2401 Lactinette desogestrel tablets film-coated

0,075mg,

in blister (28/1x28/,

84(3x28)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AC09 1456509.06.2015

09.06.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

520

Page 181: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2402 Lacto-G

lactobacillus

acidophilus,

bifidobacterium

longum,

bifidobacterium

bifidum,

bifidobacterium

infantis

capsules10x10^9 CFU/g,

in blister (10)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia A07FA01 1247902.10.2013

02.10.2018OTC

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

2403 Laevomycetin chloramphenicolpowder for solution

for injection

1000mg,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01BA01 1597915.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2404 Laevomycetin chloramphenicolpowder for solution

for injection

500mg,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01BA01 1598015.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2405 Laevomycetin chloramphenicol tablets500mg,

in blister (10, 500/50x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01BA01 1606617.10.2016

17.10.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2406 Laevomycetin chloramphenicol tablets250mg,

in blister (10, 500/50x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine J01BA01 1606717.10.2016

17.10.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139, Ukraine

2407 Laferobion interferon alfa-2b

powder lyophilized

for intranasal

solution

100000IU/ml, ampoules

(10)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine L03AB05 1223307.03.2013

07.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

2408 Laferobion interferon alfa-2b suppositories rectal 1000000IU, (5)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine L03AB01 1228322.03.2013

22.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

521

Page 182: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2409 Laferobion interferon alfa-2b suppositories rectal 150000IU, (5)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine L03AB01 1228422.03.2013

22.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

2410 Laferobion interferon alfa-2b suppositories rectal 3000000IU, (5)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine L03AB01 1228522.03.2013

22.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

2411 Laferobion interferon alfa-2b suppositories rectal 500000IU, (5)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine L03AB01 1228622.03.2013

22.03.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

2412 Laferobion interferon alfa-2b

powder lyophilized

for intranasal

solution

100000IU/ml, glass vial in

blister (10/2x5/)

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region

Ukraine L03AB05 1699105.09.2017

05.09.2022PoM

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region, Ukraine

2413 Lamal lamotrigine tablets25mg,

in blister (30/3x10/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N03AX09 1714907.11.2017

07.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

2414 Lamal lamotrigine tablets50mg,

in blister (30/3x10/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N03AX09 1715007.11.2017

07.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

2415 Lamal lamotrigine tablets100mg,

in blister (30/2x15/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N03AX09 1715107.11.2017

07.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

522

Page 183: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2416 Lamal lamotrigine tablets200mg,

in blister (30/2x15/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N03AX09 1715207.11.2017

07.11.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

2417Lamal 100mg

tabletslamotrigine tablets

100mg,

in blister (30/2x15/)

dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia;

batch releaser -

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

Slovenia N03AX09 12413/121.06.2013

23.04.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

2418Lamal 200mg

tabletslamotrigine tablets

200mg,

in blister (30/2x15/)

dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia;

batch releaser -

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

Slovenia N03AX09 12414/121.06.2013

23.04.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

523

Page 184: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2419 Lamal 25mg tablets lamotrigine tablets25mg,

in blister (30/3x10/)

dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia;

batch releaser -

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

Slovenia N03AX09 12411/121.06.2013

23.04.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

2420 Lamal 50mg tablets lamotrigine tablets50mg,

in blister (30/3x10/)

dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia;

batch releaser -

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

Slovenia N03AX09 12412/121.06.2013

23.04.2018PoM

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

2421 Lamictal lamotrigine tablets100mg,

blisters (30/3x10/)

GlaxoSmithKline

Pharmaceuticals

S.A.,189 Grunwaldzka

street, 60-322 Poznan

Poland N03AX09 13680/101.09.2016

08.07.2019PoM

GlaxoSmithKline

Trading CJSC,

119180, Moscow,

Yakimanskaya nab.,

2, Russia

524

Page 185: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2422 Lamictal lamotriginetablets chewable/

dispersible

2mg,

in plastic bottle (30)

GlaxoSmithKline

Pharmaceuticals

S.A.,189 Grunwaldzka

street, 60-322 Poznan-

packager, batch

releaser (bulk

manufacturer-

GlaxoSmithKline

LLC, 1011 North

Arendell Ave,

Zebulon, North

Carolina 27597, USA)

Poland N03AX09 1586327.07.2016

27.07.2021PoM

The Wellcome

Foundation Ltd, 980

Great West Road

Brentford Middlesex

TW8 9GS UK trading

as GlaxoSmithKline

UK, Stockley Park

West Uxbridge,

Middlesex UB11 1BT,

UK

2423 Lamictal lamotriginetablets chewable/

dispersible

5mg,

in blister (28/2x14/)

GlaxoSmithKline

Pharmaceuticals

S.A.,189 Grunwaldzka

street, 60-322 Poznan-

packager, batch

releaser (bulk

manufacturer-

GlaxoSmithKline

LLC, 1011 North

Arendell Ave,

Zebulon, North

Carolina 27597, USA)

Poland N03AX09 1586427.07.2016

27.07.2021PoM

The Wellcome

Foundation Ltd, 980

Great West Road

Brentford Middlesex

TW8 9GS UK trading

as GlaxoSmithKline

UK, Stockley Park

West Uxbridge,

Middlesex UB11 1BT,

UK

2424 Lamifast

terbinafine

(terbinafine

hydrochloride)

tablets250mg,

in blister (14/2x7/)

Birzeit

Pharmaceutical

Company (BPC),

Ramallah,Industrial

Zone

Palestine D01BA02 1381705.09.2014

05.09.2019PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

2425 Lamisil

terbinafine

(terbinafine

hydrochloride)

tablets250mg,

in blister (14)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr/Baden

Germany D01BA02 1302325.11.2013

25.11.2018PoM

Novartis Pharma AG,

56, Lichtstrasse, 4056

Basel, Switzerland

525

Page 186: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2426 Lamisil

terbinafine

(terbinafine

hydrochloride)

cream

10mg/g,

15g aluminium tube, 15g

laminated tube

Novartis Consumer

Health S.A., Route de

I`Etraz, Case postale

269, 1260 Nyon

Switzerland D01AE15 1665311.05.2017

11.05.2022OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, Case postale

269, 1260 Nyon,

Switzerland

2427 Lamisil DermGel terbinafine gel10mg/g,

15g aluminium tube

Novartis Consumer

Health S.A., Route de

I`Etraz, 1260 Nyon

Switzerland D01AE15 1305125.11.2013

25.11.2018OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, 1260 Nyon,

Switzerland

2428 Lamolep lamotrigine tablets25mg,

in blister (30/3x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N03AX09 1311524.12.2013

24.12.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2429 Lamolep lamotrigine tablets50mg,

in blister (30/3x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N03AX09 1311624.12.2013

24.12.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2430 Lamolep lamotrigine tablets100mg,

in blister (30/3x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N03AX09 1311724.12.2013

24.12.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

526

Page 187: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2431

Lamotrigine

Accord 100mg

Tablets

lamotrigine tablets100mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK N03AX09 1515917.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2432

Lamotrigine

Accord 200mg

Tablets

lamotrigine tablets200mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK N03AX09 1515817.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

527

Page 188: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2433

Lamotrigine

Accord 25mg

Tablets

lamotrigine tablets25mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK N03AX09 1515717.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2434

Lamotrigine

Accord 50mg

Tablets

lamotrigine tablets50mg,

in blister (56/4x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK N03AX09 1516017.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2435 Lansoptol lansoprazole capsules30mg,

in blister (14/2x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BC03 1230922.03.2013

22.03.2018PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

528

Page 189: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2436 Lantus insulin glarginesolution for s/c

injection

100U/ml,

3ml cartridges (5)

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,

Bruningstrasse 50, D-

65926 , Frankfurt am

Main

Germany

A10AE04;

new

indication

12393/119.04.2013

19.04.2018PoM

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,

Bruningstrasse 50, D-

65926 , Frankfurt am

Main, Germany

2437 Lantus insulin glarginesolution for s/c

injection

100U/ml, 3ml

cartridges(5), in SoloStar

pen-syringes

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,

Bruningstrasse 50, D-

65926 , Frankfurt am

Main

Germany

A10AE04;

new

indication

13119/124.12.2013

24.12.2018PoM

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,

Bruningstrasse 50, D-

65926 , Frankfurt am

Main, Germany

2438 Lasix furosemide tablets40mg,

in strip (45/3x15/)

Sanofi India Limited,

Plot No.-3501, 3503-

15, 6310B-14,

G.I.D.C. ESTATE,

Post Box No 136,

Ankleshwar, Bharuch

India C03CA01 1718928.11.2017

28.11.2022PoM

Sanofi India Limited,

54/A, Sir Mathuradas

Vasanji Road,

Andheri (East)

Mumbai 400093,

India

2439 Lasolvan

ambroxol

(ambroxol

hydrochloride)

solution for

inhalation

7,5mg/ml,

100ml glass bottle and

measuring cup

Istituto de Angeli

S.R.L. Loc. Prulli,

103/C 50066 Reggello,

Firenze

Italy R05CB06 12132/107.06.2016

01.02.2018OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

2440 Lasolvan

ambroxol

(ambroxol

hydrochloride)

tablets

30mg,

in blister (20/2x10/,

50/5x10/)

Boehringer Ingelheim

Ellas A.E., 5th km,

Paiania-Markopoulo,

194 00 Koropi

Greece R05CB06 1308609.12.2013

09.12.2018OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

529

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2441Lasolvan syrup

15mg/5ml

ambroxol

(ambroxol

hydrochloride)

syrup

15mg/5ml,

100ml glass bottle and

measuring cup

Boehringer Ingelheim

Espana S.A., Prat de la

Riba, 50, 08174 Sant

Cugat del Valles,

Barcelona

Spain R05CB06 1675005.06.2017

05.06.2022OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

2442Lasolvan syrup

30mg/5ml

ambroxol

(ambroxol

hydrochloride)

syrup

30mg/5ml,

100ml glass bottle and

measuring cup

Boehringer Ingelheim

Espana S.A., Prat de la

Riba, 50, 08174 Sant

Cugat del Valles,

Barcelona

Spain R05CB06 1674905.06.2017

05.06.2022OTC

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

2443 La-Son

hydroxyzine

(hydroxyzine

hyrochloride)

tablets film-coated25mg,

in blister (20/2x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05BB01 12709

23.07.2013

23.07.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

2444 Lasoprol lansoprazole capsules30mg,

in blister (14/2x7/)

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia

Cyprus A02BC03 12683/102.12.2014

17.07.2018PoM

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

2445 Laticort

hydrocortisone

(hydrocortisone 17-

n-butyrate)

ointment for

external use

1mg/g,

15g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AB02 1611210.11.2016

10.11.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2446 Laticort

hydrocortisone

(hydrocortisone 17-

n-butyrate)

solution for external

use

1mg/ml,

20ml plastic vial

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AB02 1611310.11.2016

10.11.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

530

Page 191: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2447 Lavmox 0.6

amoxicillin

(amoxicillin

sodium), clavulanic

acid (potassium

clavulanate)

powder for solution

for injection

500mg+100mg, 10ml

glass vial (1)

Reyoung

Pharmaceutical Co.

Ltd., No 6 Erlangshan

Road, Yiyuan County,

Shandong Province

China J01CR02 1529704.02.2016

04.02.2021PoM

Veejay

Pharmaceuticals Pvt.

Ltd., D. No 9-34/6,

Plot 8A, SV Nagar,

Kessara (M), Nagaram

(V), SV Road No 6,

OPP To Gayatri

Nivas, Near Vijaya

Hospitals Ecil X

Roads, Secunderabaad

AP, 500083, India

2448 Lavmox 1.2

amoxicillin

(amoxicillin

sodium), clavulanic

acid (potassium

clavulanate)

powder for solution

for injection

1000mg+200mg, 20ml

glass vial (1)

Reyoung

Pharmaceutical Co.

Ltd., No 6 Erlangshan

Road, Yiyuan County,

Shandong Province

China J01CR02 1529804.02.2016

04.02.2021PoM

Veejay

Pharmaceuticals Pvt.

Ltd., D. No 9-34/6,

Plot 8A, SV Nagar,

Kessara (M), Nagaram

(V), SV Road No 6,

OPP To Gayatri

Nivas, Near Vijaya

Hospitals Ecil X

Roads, Secunderabaad

AP, 500083, India

2449 Lavomaxtilorone (tilorone

dihydrochloride)tablets coated

125mg,

blister (6, 10)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia J05AX 13071/127.01.2017

09.12.2018OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

2450 Laxalac lactulose solution oral

670mg/ml,

100ml glass bottle and

measuring cup, 200ml,

250ml plastic bottle and

measuring cup

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of

ArmeniaA06AD11 13472

06.05.2014

06.05.2019OTC

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22, Republic of

Armenia

531

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2451 Lecrolyn

cromoglicic acid

(sodium

cromoglicate)

drops eye40mg/ml,

5ml plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01GX01 1243123.07.2013

23.07.2018OTC

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

2452 Lecrolyn

cromoglicic acid

(sodium

cromoglicate)

drops eye40mg/ml,

5ml plastic vial (1)

Santen Oy,

Niittyhaankatu 20,

33720 Tampere-

batch releaser,

secondary packager,

Santen

Pharmaceutical

(China) Co., Ltd., No.

169 Tinglan Road,

Suzhou Industrial

Park, Suzhou, Jiangsu

Province, China- bulk

manufacturer,

primary packager

Finland S01GX01 1726613.12.2017

13.12.2022OTC

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

2453Lefluonia 20mg

film-coated tabletsleflunomide tablets film-coated

20mg,

in blister (30/3x10/)

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki

Greece L04AA13 1307609.12.2013

09.12.2018PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

2454 Legalon 140 silymarin capsules

140mg,

in blister (20/2x10/,

30/3x10/, 60/6x10/)

Madaus GmbH,

Luetticher Strasse

5,Troisdorf, 53842

Germany A05BA03 1715507.11.2017

07.11.2022OTC

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg,

Germany

532

Page 193: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2455 Legalon SIL silibininpowder for solution

for infusion

350mg,

glass vials (4)

Madaus GmbH, 51101

Cologne - secondary

packager, batch

releaser (primary

packager, bulk

manufacturer - BAG

Health Care GmbH,

Amtsgerichtsstrasse 1-

5, 35423 Lich,

Germany)

Germany

V03AX

new

indication

1324424.02.2014

24.02.2019PoM

Madaus GmbH,

51101 Cologne,

Germany

2456 Lekoklar 500mg clarithromycin tablets film-coated500mg,

in blister (14/2x7/)

S.C. Sandoz S.R.L., str.

Livezeni nr. 7A,

540472, Targu Mures

Romania J01FA09 1379505.09.2014

05.09.2019PoM

Sandoz d.d.,

Verovskova 57, SI-

1526 Ljubljana,

Slovenia

2457 Lekoklar XL clarithromycintablets prolonged-

release film-coated

500mg,

in blister (7/1x7/)

S.C. Sandoz S.R.L., str.

Livezeni nr. 7A,

540472, Targu Mures

Romania J01FA09 14965/115.12.2015

18.11.2020PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1526 Ljubljana,

Slovenia

2458 Lemoks

levofloxacin

(levofloxacin

hemihydrate)

tablets film-coated

500mg,

in blister (5/1x5/,

10/1x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi-secondary

packager, batch

releaser (Arafarma

Group, S.A., C/Fray

Gabriel de San

Antonio, 6-10, Pol.

Ind. Del Henares,

19180, Marchamalo

(Guadalajara), Spain-

bulk manufacturer,

primary packager)

Georgia J01MA12 1585320.07.2016

20.07.2021PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

533

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2459 Lendacin

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection/infusion

1000mg,

glass vials (1, 5)

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl

Austria J01DD04 1441308.04.2015

08.04.2020PoM

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

2460 Lerkamen 10

lercanidipine

(lercanidipine

hydrochloride)

tablets film-coated

10mg,

in blister (7/1x7/,

14/1x14/, 28/2x14,

60/4x15, 90/6x15)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany C08CA13 1534926.02.2016

26.02.2021PoM

Menarini

International O. L.

S.A., 1, Avenue de la

Gare, 1611,

Luxembourg

2461 Leron

furosemide,

amiloride

(amiloride

hydrochloride)

tablets40mg+5mg,

in blister (50/5x10/)

Aversi-Rational Ltd,

(0198 Tbilisi,

Chirnakhuli str. 14) -

batch releaser,

packager (dosage form

manufacturer - Geno

Pharmaceuticals Ltd

/Karaswada Mapusa,

Goa 403526, India/)

Georgia C03EB01 1292707.10.2013

07.10.2018PoM

Aversi-Rational Ltd

(0198 Tbilisi,

Chirnakhuli str. 14,

Georgia)

2462 Lescol XLfluvastatin

(fluvastatin sodium)tablets film-coated

80mg,

blisters (28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria, 158, 08210

Barbera del Valles,

Barcelona

Spain C10AA04 12580/113.06.2016

23.06.2018PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

534

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2463 Lespefril lespedeza bicolor solution oral

708mg/ml,

100ml glass or plastic

bottle

VIFITEH CJSC,

SCRAM, Obolensk v.,

corp. 84, corp. 87,

build. 90, Serpukhov

district, Moscow

region,142279

Russia G04BX 1508515.12.2015

15.12.2020OTC

VIFITEH CJSC,

SCRAM, Obolensk v.,

Serpukhov district,

Moscow

region,142279, Russia

2464 Letiram levetiracetam tablets coated

500mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Rontis Hellas S.A.,

P.O. Box 3012, Larisa

Industrial Area, 41004

Larisa, Greece-bulk

manufacturer,

packager

Hungary N03AX14 1530704.02.2016

04.02.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2465 Letiram levetiracetam tablets coated

250mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Rontis Hellas S.A.,

P.O. Box 3012, Larisa

Industrial Area, 41004

Larisa, Greece-bulk

manufacturer,

packager

Hungary N03AX14 1530804.02.2016

04.02.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2466 Letiram levetiracetam tablets coated

750mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Rontis Hellas S.A.,

P.O. Box 3012, Larisa

Industrial Area, 41004

Larisa, Greece-bulk

manufacturer,

packager

Hungary N03AX14 1530904.02.2016

04.02.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

535

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2467 Letiram levetiracetam tablets coated

1000mg,

in blister (30/3x10/,

60/6x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

Rontis Hellas S.A.,

P.O. Box 3012, Larisa

Industrial Area, 41004

Larisa, Greece-bulk

manufacturer,

packager

Hungary N03AX14 1531004.02.2016

04.02.2021PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2468 Letizencetirizine (cetirizine

dihydrochloride)tablets film-coated

10mg,

in blister (10/1x10/,

20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R06AE07 1477803.08.2015

03.08.2020OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2469 Letromara letrozole tablets film-coated2,5mg,

in blister (30/3x10/)

PJSC "Farmak", 74

Frunze str., Kiev,

04080

Ukraine L02BG04 1619208.12.2016

08.12.2021PoM

PJSC "Farmak", 63

Frunze str., Kiev,

04080, Ukraine

536

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2470

Letrozole 2.5mg

Film-coated

Tablets

letrozole tablets film-coated2,5mg,

in blister (28/2x14/)

Wessling BRS Hungary

Limited, 1047 Budapest,

Foti ut. 56 - batch

releaser, Intas

Pharmaceuticals

Limited, Plot No 457 &

458 & 191/218 P,

Sarkhej-Bavla Highway,

Matoda Village, Sanand,

District-Ahmedabad,

382 210, Gujarat, India-

bulk manufacturer,

Accord Healthcare

Limited, Unit C & D,

Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

Hungary L02BG04 1516117.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2471

Letrozole 2.5mg

Film-coated

Tablets

letrozole tablets film-coated2,5mg,

in blister (28/2x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK L02BG04 1516217.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2472 Letrozole Denk 2.5 letrozole tablets film-coated2,5mg,

in blister (30/3x10/)

Haupt Pharma

Munster GmbH,

Schleebruggenkamp

15, 48159 Munster

Germany L02BG04 1577304.07.2016

04.07.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

537

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2473 Leukeran chlorambucil tablets film-coated2mg,

glass bottle (25)

EXCELLA GmbH &

Co.KG, Nuernberger

st. 12, 90537 Feucht

Germany L01AA02 13320/224.07.2017

04.03.2019PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

2474 Levemir FlexPeninsulin detemir

(recombinant)solution for injection

100IU/ml,

3ml pre-filled syringe-

pen (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AE05 1287117.09.2013

17.09.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2475 Levemir Penfillinsulin detemir

(recombinant)solution for injection

100IU/ml,

3ml cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AE05 1287017.09.2013

17.09.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2476 Levitra

vardenafil

(vardenafil

hydrochloride

trihydrate)

tablets film-coated20mg,

in blister (1,4)

Bayer Pharma AG, D-

51368 Leverkusen Germany G04BE09 13124

10.01.2014

10.01.2019PoM

Bayer Pharma AG, D-

13342, Berlin,

Germany

2477LeViTRONN oral

solution

levofloxacin

(levofloxacin

hemihydrate)

solution oral25mg/ml,

100ml glass bottle

Incepta

Pharmaceuticals Ltd.,

Dewan Idris Road,

Zirabo, Sevar Dhaka

Bangladesh J01MA12 1286017.09.2013

17.09.2018PoM

Incepta

Pharmaceuticals Ltd.,

Dewan Idris Road,

Zirabo, Sevar Dhaka,

Bangladesh

2478

LeViTRONN

solution for i/v

infusion

levofloxacin

(levofloxacin

hemihydrate)

solution for i/v

infusion

5mg/ml,

100ml plastic pack

Incepta

Pharmaceuticals Ltd.,

Dewan Idris Road,

Zirabo, Sevar Dhaka

Bangladesh J01MA12 1286117.09.2013

17.09.2018PoM

Incepta

Pharmaceuticals Ltd.,

Dewan Idris Road,

Zirabo, Sevar Dhaka,

Bangladesh

2479 Levo-Denk 250

levofloxacin

(levofloxacin

hemihydrate)

tablets film-coated250mg,

in blister (10)

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh

Germany J01MA12 1223907.03.2013

07.03.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

538

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2480 Levo-Denk 500

levofloxacin

(levofloxacin

hemihydrate)

tablets film-coated500mg,

in blister (10)

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh

Germany J01MA12 1224007.03.2013

07.03.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

2481 Levofloxacin 0.5%

levofloxacin

(levofloxacin

hemihydrate)

solution for infusion 5mg/ml

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaJ01MA12 14713

16.07.2015

16.07.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

2482Levofloxacin-

Asterialevofloxacin tablets film-coated

500mg,

in blister (10/1x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth J01MA12 1525429.12.2015

29.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

2483 Levomecolchloramphenicol,

methyluracilointment

7,5mg/g+40mg/g, 30g, 40g

aluminium tube

SIC Borshchahivskiy

Chemical-

Pharmaceutical Plant

PJSC, 17, Mira St,

Kiev 03134

UkraineD03AX,

D06AX0212792

14.08.2013

14.08.2018OTC

SIC Borshchahivskiy

Chemical-

Pharmaceutical Plant

PJSC, 17, Mira St,

Kiev 03134, Ukraine

2484 Levomecol

chloramphenicol,

dioxomethyltetrahy

dropyramidine

ointment for

external use

7.5mg/g+40mg/g, 25g

aluminium tube

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD06C 14110

29.12.2014

29.12.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

2485 Levomecolchloramphenicol,

methyluracil

ointment for

external use

7,5mg/g+40mg/g, 25g

aluminium tube

'Lubnypharm' PJSC,

37500, Poltava region,

Lubny, Petrovskogo

str. 16

Ukraine D03AX 1548102.04.2016

02.04.2021OTC

'Lubnypharm' PJSC,

37500, Poltava region,

Lubny, Petrovskogo

str. 16

539

Page 200: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2486 Levomecolchloramphenicol,

methyluracil

ointment for

external use

7,5mg/g+40mg/g, 40g

aluminium tube

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia D06C 1719608.12.2017

08.12.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

2487 Levomepromazine

levomepromazine

(levomepromazine

maleate)

tablets coated25mg,

in blister (50/5x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AA02 16771

27.06.2017

27.06.2022PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2488Levomicetin-

Darnitsachloramphenicol tablets

250mg,

in blister (10)

Darnitsa

Pharmaceutical Firm

CJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine J01BA01 1234809.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

2489Levomicetin-

Darnitsachloramphenicol tablets

500mg,

in blister (10)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine J01BA01 1234909.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

2490 Levomycetin chloramphenicol tablets500mg,

in blister (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia J01BA01 1270823.07.2013

23.07.2018PoM

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

2491 Levomycetin chloramphenicol tablets

500mg,

strip (10),

blister (10)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia J01BA01 14153/108.06.2017

08.06.2022PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

540

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2492Levomycetin

Tatpharmchloramphenicol drops eye

2,5mg/ml,

5ml glass vial-dropper,

5ml plastic vial-dropper,

10ml plastic vial-dropper

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia S01AA01 13812/125.07.2017

05.09.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

2493 Libexin

prenoxdiazine

(prenoxdiazine

hydrochloride)

tablets100mg,

in blister (20/1x20/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary R05DB18 1712224.10.2017

24.10.2022OTC

Sanofi-Aventis

Private Co. Ltd.,1045

Budapest, To u. 1-5,

Hungary

2494 Licopidglucosamine

muramyl dipeptidetablets

1mg,

in blister (10)

Peptek JSC, 16/10

Miklukho-Maklaya

St., Moscow, 117997

Russia L03A 12355/125.12.2017

09.04.2018PoM

Peptek JSC, 16/10

Miklukho-Maklaya

St., Moscow, 117997,

Russia

2495 Licopidglucosamine

muramyl dipeptidetablets

10mg,

in blister (10)

Peptek JSC, 16/10

Miklukho-Maklaya

St., Moscow, 117997

Russia L03A 12392/125.12.2017

19.04.2018PoM

Peptek JSC, 16/10

Miklukho-Maklaya

St., Moscow, 117997,

Russia

2496 Lidasa-Belmed hyaluronidase

powder lyophilized

for solution for i/m

and s/c injection

725IU; (5) glass vial

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus B06AA03 1585020.07.2016

20.07.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2497 Lidocain lidocaineaerosol for external

use

4.6mg/dose,

38g glass vial with

measuring pump

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary D04AB01 1639710.02.2017

10.02.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

541

Page 202: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2498Lidocain

hydrochlorid

lidocaine (lidocaine

hydrochloride)solution for injection

10mg/ml,

5ml ampoules (10), 5ml

ampoules, label-banderol

(10), 5ml ampoules,

dividella (10)

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str., Borisov

222120, Minsk oblast)

Belarus N01BB02 1295428.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus)

2499 Lidocaine lidocaine spray50mg/ml,

15ml plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN01BB02 12461

13.05.2013

13.05.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2500Lidocaine 5%

ointmentlidocaine ointment

50mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN01BB02 14484

18.05.2015

18.05.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2501Lidocaine

hydrochloride

lidocaine (lidocaine

hydrochloride)solution for injection

20mg/ml,

2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaN01BB02 16685

31.05.2017

31.05.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

2502 Lidocaine-Liqvolidocaine (lidocaine

hydrochloride)solution for injection

10mg/ml; (1) and (10)

glass vials 20ml

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaN01BB02 12800/1

28.11.2014

23.08.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2503 Lidocaine-Liqvolidocaine (lidocaine

hydrochloride)solution for injection

20mg/ml; (1) and (10)

glass vials 20ml

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaN01BB02 12801/1

28.11.2014

23.08.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

542

Page 203: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2504Lidocaine-Liqvo

with epinephrine

lidocaine (lidocaine

hydrochloride),

epinephrine

solution for injection20mg/ml+0.01mg/ml; (1)

and (10) glass vials 20ml

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaN01BB52 13383/1

28.11.2014

04.04.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2505Lidocaine-

Zdorovye

lidocaine (lidocaine

hydrochloride)solution for injection

20mg/ml,

2ml ampoules (10), 2ml

ampoules,

in blister (10/2x5/,

10/1x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine N01BB02 1636630.12.2016

30.12.2021PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

2506Lidocaine-

Zdorovye

lidocaine (lidocaine

hydrochloride)solution for injection

100mg/ml; (10) ampoules

2ml, (5/1x5/), (10/2x5/)

and (10/1x10/) ampoules

2ml, in blister

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine C01BB01 1642806.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

2507 Lignospan special

lidocaine (lidocaine

hydrochloride),

adrenaline

(adrenaline tartrate)

solution for injection

20mg/ml+ 12,5mcg/ml,

1,8ml cartridges

(50/5x10/)

Septodont, 58 rue du

Pont de Creteil,

94100 Saint- Maur-

des- Fosses

France N01BB52 1417716.01.2015

16.01.2020PoM

Septodont, 58 rue du

Pont de Creteil,

94100 Saint- Maur-

des- Fosses, France

2508 Limoxin-200LA

oxytetracycline

(oxytetracycline

dihydrate)

solution for injection200mg/ml,

50ml, 100ml glass bottle

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray-batch

releaser, packager,

Interchemie werken

'De Adelaar' Eesti As

ltd, Estonia Vanapre

str. 14, Puunsi,

Viimsi, Harju country-

bulk manufacturer,

primary packager

the Netherlands

QJ01AA06;

veterinary

drug

1414629.12.2014

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

543

Page 204: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2509

Lincomycine-

Spectinomycine

5/10

lincomycin

(lincomycin

hydrochloride),

spectinomycin

(spectinomycin

hydrochloride)

solution for injection50mg/ml+ 100mg/ml,

100ml glass vials (12)

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden

the Netherlands

QJ51RF03;

veterinary

drug

1469416.07.2015

16.07.2020PoM

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden,

the Netherlands

2510 Lindynette 20ethinylestradiol,

gestodenetablets coated

0.02mg+0.075mg, in

blister

(21, 63/3x21/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA10 1277114.08.2013

14.08.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2511 Lindynette 30ethinylestradiol,

gestodenetablets coated

0.03mg+0.075mg, in

blister

(21, 63/3x21/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA10 1277214.08.2013

14.08.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2512 Linex

lyophilized viable

lactic acid bacterias

(Lactobacillus

acidophilus,

Bifidobacterium

infantis,

Enterococcus

faecium)

capsules hard

1,2x10^7,

in glass container (16),

in blister (16/2x8/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana-

batch releaser, Lek

Pharmaceuticals d.d.,

Kolodvorska cesta 27,

Menges, 1234,

Slovenia-bulk

manufacturer,

packager

Slovenia A07FA01 1458509.06.2015

09.06.2020OTC

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

2513 Linex forte

lyophilized viable

lactic acid bacterias

(Lactobacillus

acidophilus,

Bifidobacterium

animalis subsp.

lactis)

capsules

2x10^9,

in blister (14/2x7/,

28/4x7/),

in glass container (28)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana-

batch releaser, Lek

Pharmaceuticals d.d.,

Kolodvorska cesta 27,

Menges, 1234,

Slovenia-bulk

manufacturer,

packager

Slovenia A07FA01 1460018.06.2015

18.06.2020OTC

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

544

Page 205: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2514Liniment balsamic

(by Vishnevsky)birch tar, xeroform liniment

30mg/g+30mg/g, 30g

aluminium tube

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

Russia D08AX 1305825.11.2013

25.11.2018OTC

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.,

Russia

2515 Linkus

adhadota vasica,

glycyrrhiza glabra,

piper longum, viola

odorata, hyssopus

officinalis, alpinia

galangal, cordial

latifolia, altaea

officinalis, zizyphus

jujube, onosma

bracteata

syrup sugar free

60mg/ml+ 7,5mg/ml+

10mg/ml+ 2,5mg/ml+

5mg/ml+5mg/ml+

10mg/ml+ 10mg/ml+

10mg/ml+10mg/ml,

90ml,120ml, 150ml glass

bottle

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900

Pakistan R05CA10 1322224.02.2014

24.02.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

2516 Linkus

adhadota vasica,

glycyrrhiza glabra,

piper longum, viola

odorata, hyssopus

officinalis, alpinia

galangal, cordial

latifolia, altaea

officinalis, zizyphus

jujube, onosma

bracteata

syrup

60mg/ml+ 7,5mg/ml+

10mg/ml+ 2,5mg/ml+

5mg/ml+5mg/ml+

10mg/ml+ 10mg/ml+

10mg/ml+10mg/ml,

90ml,120ml, 150ml glass

bottle

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900

Pakistan R05CA10 1322324.02.2014

24.02.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

2517 Linkus balsam

menthol, eucaliptus

oil, camphor,

turpentine oil,

clove oil

ointment

200mg+60mg+

70mg+20mg+ 40mg,

25g in plastic bottle

Herbion Pakistan Pvt.

Ltd., Plot 30, Sector

28,Korangi Industrial

Area,Karachi-74900

Pakistan R05CA10 1262921.06.2013

21.06.2018OTC

Herbion Pakistan Pvt.

Ltd., Plot 30, Sector

28,Korangi Industrial

Area,Karachi-74900,

Pakistan

2518 Linkus lozenges

adhadota vasica,

glycyrrhiza glabra,

piper longum, viola

odorata, hyssopus

officinalis, alpinia

galanga

lozenges with lemon-

honey flavour

30mg+7mg+6mg+2mg+3

mg+3mg,

in blister (16/2x8/)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900

Pakistan R05CA10 1321924.02.2014

24.02.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900,

Pakistan

545

Page 206: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2519 Linkus lozenges

adhadota vasica,

glycyrrhiza glabra,

piper longum, viola

odorata, hyssopus

officinalis, alpinia

galanga

lozenges with mint

flavour

30mg+7mg+6mg+2mg+3

mg+3mg,

in blister (16/2x8/)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900

Pakistan R05CA10 1322024.02.2014

24.02.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900,

Pakistan

2520 Linkus lozenges

adhadota

vasica,glycyrrhiza

glabra,piper

longum,viola

odorata,hyssopus

officinalis,alpinia

galanga

lozenges with orange

flavour

30mg+7mg+6mg+2mg+3

mg+3mg,

in blister (16/2x8/)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900

Pakistan R05CA10 1322124.02.2014

24.02.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial

Area,Karachi-74900,

Pakistan

2521Linkus ORVI

granules

salix alba, adhatoda

vasika, glycyrrhiza

glabra, viola

odorata, valeriana

officinalis,

foeniculum vulgare,

eucalyptus

globulus, thea

sinensis

granules

750mg+300mg+

550mg+100mg+

100mg+75mg+

35mg+125mg,

5,6g sachets (5, 10)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900

Pakistan A02AD04 13315/108.07.2014

04.03.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

2522Linkus ORVI

granules

salix alba, adhatoda

vasika, glycyrrhiza

glabra, viola

odorata, valeriana

officinalis,

foeniculum vulgare,

eucalyptus

globulus, thea

sinensis

granules with lemon

flavour

750mg+300mg+

550mg+100mg+

100mg+75mg+

35mg+125mg, sachets

5,6g (5, 10)

Herbion Pakistan Pvt.

Ltd., Plot 30, Sector

28,Korangi Industrial

Area, Karachi-74900

Pakistan A02AD04 13316/108.07.2014

04.03.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

546

Page 207: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2523Linkus Plus

Expectorant

solanum

xanthocarpum,

adhatoda vasica,

glycyrrhiza glabra,

ocimum basilicum,

cordia latifolia,

piper longum,

althaea officinalis,

illicium verum

syrup

30mg+70mg+

15mg+30mg+

10mg+10mg+

15mg+50mg,

120ml glass bottle and

measuring cup

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900

PakistanR05CA10

herbal drug13730

24.07.2014

24.07.2019OTC

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial Area,

Karachi-74900,

Pakistan

2524 Lioton 1000 heparin sodium gel for external use

1000IU/g,

30g, 50g and100g

aluminium tube

A. Menarini

Manufacturing

Logistics and Services

S.r.l., Via Sette Santi,

3 50131 Firenze

Italy C05BA03 1606817.10.2016

17.10.2021OTC

A. Menarini Industrie

Farmaceutiche

Riunite S.r.l.

(Menarini Group),

Via Sette Santi, 3

50131 Firenze, Italy

2525 Lipertance

atorvastatin

(atorvastatin

calcium trihydrate),

perindopril

arginine,

amlodipine

(amlodipine

besilate)

tablets film-coated10mg+5mg+5mg, in

plastic container (30, 100)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C10BX 1582420.07.2016

20.07.2021PoM

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

2526 Lipertance

atorvastatin

(atorvastatin

calcium trihydrate),

perindopril

arginine,

amlodipine

(amlodipine

besilate)

tablets film-coated20mg+5mg+5mg, in

plastic container (30, 100)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C10BX 1582520.07.2016

20.07.2021PoM

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

547

Page 208: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2527 Lipertance

atorvastatin

(atorvastatin

calcium trihydrate),

perindopril

arginine,

amlodipine

(amlodipine

besilate)

tablets film-coated20mg+10mg+5mg, in

plastic container (30, 100)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C10BX 1582620.07.2016

20.07.2021PoM

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

2528 Lipertance

atorvastatin

(atorvastatin

calcium trihydrate),

perindopril

arginine,

amlodipine

(amlodipine

besilate)

tablets film-coated

20mg+10mg+ 10mg,

in plastic container (30,

100)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C10BX 1582720.07.2016

20.07.2021PoM

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

2529 Lipertance

atorvastatin

(atorvastatin

calcium trihydrate),

perindopril

arginine,

amlodipine

(amlodipine

besilate)

tablets film-coated

40mg+10mg+ 10mg,

in plastic container (30,

100)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C10BX 1582820.07.2016

20.07.2021PoM

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

2530 Liprazid 10

lisinopril (lisinopril

dihydrate),

hydrochlorothiazid

e

tablets10mg+12,5mg,

in blister (30/3x10/)

SIC "Borshchahivskiy

Chemical-

Pharmaceutical Plant"

PJSC, 17, Mira St,

Kyiv, 03134

Ukraine C09BA03 1648909.03.2017

09.03.2022PoM

SIC "Borshchahivskiy

Chemical-

Pharmaceutical

Plant" PJSC, 17, Mira

St, Kyiv, 03134,

Ukraine

548

Page 209: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2531 Liprazid 20

lisinopril (lisinopril

dihydrate),

hydrochlorothiazid

e

tablets20mg+12,5mg,

in blister (30/3x10/)

SIC "Borshchahivskiy

Chemical-

Pharmaceutical Plant"

PJSC, 17, Mira St,

Kyiv, 03134

Ukraine C09BA03 1648809.03.2017

09.03.2022PoM

SIC "Borshchahivskiy

Chemical-

Pharmaceutical

Plant" PJSC, 17, Mira

St, Kyiv, 03134,

Ukraine

2532 Liprimar atorvastatin tablets film-coated10mg,

blisters (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mosswaldalee 1,

79090 Frieburg -

packager (dosage form

manufacturer - Pfizer

Pharmaceuticals

LLC,Km 1.9,Road 689

Vega Baja,PR 00693

Puerto Rico, USA)

Germany C10AA05 12253/111.08.2016

07.03.2018PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street, New

York 10017, USA

2533 Liprimar atorvastatin tablets film-coated20mg,

blisters (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mosswaldalee 1,

79090 Frieburg -

packager (dosage form

manufacturer - Pfizer

Pharmaceuticals

LLC,Km 1.9,Road 689

Vega Baja,PR 00693

Puerto Rico, USA)

Germany C10AA05 12254/111.08.2016

07.03.2018PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street, New

York 10017, USA

549

Page 210: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2534 Liprimar atorvastatin tablets film-coated40mg,

blisters (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mosswaldalee 1,

79090 Frieburg -

packager (dosage form

manufacturer - Pfizer

Pharmaceuticals

LLC,Km 1.9,Road 689

Vega Baja,PR 00693

Puerto Rico, USA)

Germany C10AA05 12255/111.08.2016

07.03.2018PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street, New

York 10017, USA

2535 Liprimar atorvastatin tablets film-coated80mg,

blisters (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mosswaldalee 1,

79090 Frieburg -

packager (dosage form

manufacturer - Pfizer

Pharmaceuticals

LLC,Km 1.9,Road 689

Vega Baja,PR 00693

Puerto Rico, USA)

Germany C10AA05 12256/111.08.2016

07.03.2018PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street,

New York 10017,

USA

2536 Lirra pregabalin capsules75mg,

in blister (30/3x10/)

Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208

Bangladesh N03AX16 1367208.07.2014

08.07.2019PoM

Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

2537 Lisinocorlisinopril (lisinopril

dihydrate)tablets coated

5mg,

in blister (20/2x10/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia C09AA03 1659610.04.2017

10.04.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi, Georgia

550

Page 211: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2538 Lisinocorlisinopril (lisinopril

dihydrate)tablets coated

10mg,

in blister (20/2x10/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia C09AA03 1659710.04.2017

10.04.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi, Georgia

2539 Lisinoprillisinopril (lisinopril

dihydrate)tablets

10mg,

in blister (24/1x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC09AA03 13436

14.04.2014

14.04.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2540 Lisinoprillisinopril (lisinopril

dihydrate)tablets

5mg,

in blister (24/1x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC09AA03 14869

24.09.2015

24.09.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2541 Lisinopril lisinopril tablets5mg,

in blister (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus C09AA03 1633430.12.2016

30.12.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2542 Lisinopril lisinopril tablets10mg,

in blister (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus C09AA03 1633530.12.2016

30.12.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

551

Page 212: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2543 Liv-52

capparis spinosa,

cichorium intybus,

ferric oxide,

solanum nigrum,

terminalia arjuna,

cassia occidentalis,

achillea

millefolium,

tamarix gallica

tablets

65mg+65mg+

33mg+32mg+

32mg+16mg+

16mg+16mg,

in plastic container (100)

Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123

India A05C 1261821.06.2013

21.06.2018PoM

Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123,

India

2544 Livarole ketoconazole suppositories vaginal400mg,

(5/1x5/, 10/2x5/)

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia G01AF11 1538126.02.2016

26.02.2021PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2545 Lizinoprillisinopril (lisinopril

dihydrate)tablets

5mg,

in blister (20/2x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09АA03 1335604.04.2014

04.04.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2546 Lizinoprillisinopril (lisinopril

dihydrate)tablets

10mg,

in blister (20/2x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09АA03 1335704.04.2014

04.04.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2547 Lizinoprillisinopril (lisinopril

dihydrate)tablets

20mg,

in blister (20/2x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C09АA03 1335804.04.2014

04.04.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2548 L-lysine aescinat l-lysine aescinate solution for injection

1mg/ml,

5ml ampoules, in blister

(10/2x5/)

Halychpharm JSC,

79024, city of Lviv, st.

Opryshkovskaya, 6/8

Ukraine C05CX 1373224.07.2014

24.07.2019PoM

Halychpharm JSC,

79024, city of Lviv, st.

Opryshkovskaya, 6/8,

Ukraine

552

Page 213: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2549 Locoid

hydrocortisone

(hydrocortisone 17-

butyrate)

ointment for topical

use

1mg/g,

30g aluminium tube

Temmler Italia S.r.L.,

Via delle Industrie 2,

20061 Carugate (MI)

Italy D07AB02 14333/108.06.2017

25.03.2020OTC

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

2550 Locoid

hydrocortisone

(hydrocortisone 17-

butyrate)

cream for topical use1mg/g,

30g aluminium tube

Temmler Italia S.r.L.,

Via delle Industrie 2,

20061 Carugate (MI)

Italy D07AB02 14341/108.06.2017

25.03.2020OTC

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

2551 Locoid Crelo

hydrocortisone

(hydrocortisone 17-

butyrate)

emulsion cutaneous

1mg/g,

30g plastic vial with

dropper

Temmler Italia S.r.L.,

Via delle Industrie 2,

20061 Carugate (MI)

Italy D07AB02 1446304.05.2015

04.05.2020OTC

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

2552 Locoid Lipocream

hydrocortisone

(hydrocortisone 17-

butyrate)

cream for topical use1mg/g,

30g aluminium tube

Temmler Italia S.r.L.,

Via delle Industrie 2,

20061 Carugate (MI)

Italy D07AB02 14340/108.06.2017

25.03.2020OTC

LEO Pharma A/S,

Industriparken 55,

DK-2750 Ballerup,

Denmark

2553 Lodigrel

clopidogrel

(clopidogrel

hydrosulfate)

tablets film-coated

75mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary B01AC04 13661/120.02.2015

08.07.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2554 Lodoz

bisoprolol

(bisoprolol

fumarate),

hydrochlorothia-

zide

tablets film-coated5mg+6,25mg,

in blister (30/3x10/)

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany C07BB07 1445004.05.2015

04.05.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

2555 Lodoz

bisoprolol

(bisoprolol

fumarate),

hydrochlorothia-

zide

tablets film-coated2,5mg+6,25mg,

in blister (30/3x10/)

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany C07BB07 1445104.05.2015

04.05.2020PoM

Merck Sante s.a.s., 37

rue Saint Romain -

69379 Lyon Cedex

08, France

553

Page 214: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2556 Lomexin

fenticonazole

(fenticonazole

nitrate)

capsules vaginal200mg,

in blister (6)

Catalent Italy S.p.A.,

Via Nettunense km.

20,100, Aprilia, 04011

Italy G01AF12 1469002.07.2015

02.07.2020PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

2557 Lomexin

fenticonazole

(fenticonazole

nitrate)

capsules vaginal600mg,

in blister (1, 2)

Catalent Italy S.p.A.,

Via Nettunense km.

20,100, Aprilia, 04011

Italy G01AF12 1469102.07.2015

02.07.2020PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

2558 Lomexin

fenticonazole

(fenticonazole

nitrate)

capsules vaginal1000mg,

in blister (1, 2)

Catalent Italy S.p.A.,

Via Nettunense km.

20,100, Aprilia, 04011

Italy G01AF12 1469202.07.2015

02.07.2020PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

2559 Lomexin

fenticonazole

(fenticonazole

nitrate)

cream for vaginal

and external use

20mg/g; 30g aluminium

tube, 78g aluminium tube

and dispenser

Recordati Industria

Chimica e

Farmaceutica S.p.A.,

Via Civitali, 1-20148

Milano

Italy

G01AC12,

D01AF12;

new

indication

14858/118.09.2015

18.09.2020PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

2560 Lomilan loratadine tablets10mg,

in blister (10/1x10/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia R06AX13 1676809.06.2017

09.06.2022OTC

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

2561 Loperamide loperamide capsules

2mg,

in blister (10/1x10/,

20/2x10/)

Biocom JSC (54

Chapaevsky Cr.,

Stavropol, 355016)

Russia A07DA03 1298728.10.2013

28.10.2018OTC

Biocom JSC (54

Chapaevsky Cr.,

Stavropol, 355016,

Russia)

2562 Loperamide

loperamide

(loperamide

hydrochloride)

capsules2mg,

in blister (10/1x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA07DA03 13865

18.09.2014

18.09.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

554

Page 215: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2563Loperamide

Grindeks

loperamide

(loperamide

hydrochloride)

capsules2mg,

in blister (10/1x10/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia A07DA03 1640710.02.2017

10.02.2022OTC

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2564Loperamide

hydrochloride

loperamide

(loperamide

hydrochloride)

capsules

2mg,

in blister (10/1x10/,

20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A07DA03 13854/116.05.2016

18.09.2019OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2565Loperamide-

Zdorovye

loperamide

(loperamide

hydrochloride)

tablets

2mg,

in blister (10/1x10/,

20/2x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine A07DA03 1675205.06.2017

05.06.2022OTC

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

2566 Lopirel

clopidogrel

(clopidogrel

bisulfate)

tablets film-coated

75mg,

in blister (14/2x7/,

28/4x7/, 90/9x10/)

Actavis Ltd., BLB 015,

BLB 016, Bulebel

Industrial Estate,

Zejtun, ZTN 3000

Malta B01AC04 1696405.09.2017

05.09.2022PoM

"Actavis Group PTC

ehf",

Reykjavikurvegur 76-

78, IS-220

Hafnarfjordur,

Iceland

2567 Lopraxer

citalopram

(citalopram

hydrochloride)

drops oral (solution)40mg/ml; 15ml glass

bottle

Help S.A., Pedini

Ioanninon, Ioannina,

45500

Greece N06AB04 1704928.09.2017

28.09.2022PoM

Help S.A., 10

Valaoritou str., GR

14452

Metamorphosis,

Attica, Greece

2568L-Optic

Rompharmlevofloxacin drops eye

5mg/ml,

5ml bottle-dropper

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania S01AE05 1432925.03.2015

25.03.2020PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

555

Page 216: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2569 Loranex desloratadine solution oral

0,5mg/ml,

150ml glass vial and

measuring device

Laboratorios Basi-

Industria

Farmaceutica, S.A.,

Parque Industrial

Manuel Lourenco

Ferreira, lote 15, 3450-

232 Mortagua

Portugal R06AX27 1663225.04.2017

25.04.2022OTC

GM Pharmaceuticals

Ltd, 65,Phonichala

str., Tbilisi, Georgia

2570 Loratadine loratadine tablets10mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR06AX13 12848

17.09.2013

17.09.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2571 Loratadine loratadine tablets10mg,

in blister (10/1x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64a No4,

ul. Chapaeva, Borisov,

Minsk region

Belarus R06AX13 1662825.04.2017

25.04.2022OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2572 Loratadine STADA loratadine tablets10mg,

in blister (10/1x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse

Russia R06AX13 1591323.08.2016

23.08.2021OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2573Loratadine-

Zdorovyeloratadine tablets

10mg,

in blister (10/1x10/,

20/2x10/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine R06AX13 1643006.03.2017

06.03.2022OTC

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

556

Page 217: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2574 Lorazepam lorazepam tablets2mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05BA06 12717

23.07.2013

23.07.2018PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

2575 Lorazepam lorazepam tablets1mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05BA06 12724

23.07.2013

23.07.2018PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

2576 Lordestin

desloratadine

(desloratadine

hemisulfate)

tablets film-coated

5mg,

in blister (10/1x10/,

30/3x10/)

Gedeon Richter-RUS

JSC, Lesnaya st. 40,

Shuvoye, Moscow

region, Yegoriyevsky

district, 140342

Russia R06AX27 1671823.05.2017

23.05.2022OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2577 Lorinden A

flumetasone

(flumetasone

pivalate), salicylic

acid

ointment for

external use

0,2mg/g+30mg/g, 15g

aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07XB01 1627319.12.2016

19.12.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2578 Lorinden C

flumetasone

(flumetasone

pivalate), clioquinol

ointment for

external use

0,2mg/g+30mg/g, 15g

aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07BB01 1599115.09.2016

15.09.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2579 Loristalosartan (losartan

potassium)tablets film-coated

25mg,

in blister (28/2x14/,

28/4x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA01 1393529.10.2014

29.10.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

557

Page 218: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2580 Loristalosartan (losartan

potassium)tablets film-coated

50mg,

in blister (28/2x14/,

28/4x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA01 1393629.10.2014

29.10.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2581 Loristalosartan (losartan

potassium)tablets film-coated

100mg; (28/2x14/) in

blister

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09CA01 1694205.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

2582 Lorista H

losartan (losartan

potassium),

hydrochloro-

thiazide

tablets film-coated

50mg+12,5mg,

in blister (28/2x14/,

28/4x7/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA01 1393429.10.2014

29.10.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2583 Lorista H 100

losartan (losartan

potassium),

hydrochlorothia-

zide

tablets film-coated100mg+12,5mg,

in blister (28/2x14/)

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto)

Slovenia C09DA01 1291807.10.2013

07.10.2018PoM

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia)

2584 Lorista HD

losartan (losartan

potassium),

hydrochlorothia-

zide

tablets film-coated100mg+25mg,

in blister (28/2x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09DA01 14781/119.05.2016

03.08.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2585 Lortenza

amlodipine

(amlodipine

besilate), losartan

(losartan potassium)

tablets film-coated5mg+50mg,

in blister (30/3x10/)

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C09DB06 1590623.08.2016

23.08.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500, Russia

2586 Lortenza

amlodipine

(amlodipine

besilate), losartan

(losartan potassium)

tablets film-coated10mg+50mg,

in blister (30/3x10/)

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C09DB06 1590723.08.2016

23.08.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500, Russia

558

Page 219: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2587 Lortenza

amlodipine

(amlodipine

besilate), losartan

(losartan potassium)

tablets film-coated5mg+100mg,

in blister (30/3x10/)

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C09DB06 1590823.08.2016

23.08.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500, Russia

2588 Lortenza

amlodipine

(amlodipine

besilate), losartan

(losartan potassium)

tablets film-coated10mg+100mg,

in blister (30/3x10/)

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C09DB06 1590923.08.2016

23.08.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500, Russia

2589 Losar-Denk 100losartan (losartan

potassium)tablets film-coated

100mg,

in blister (28/2x14/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany C09CA01 1613910.11.2016

10.11.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2590 Losar-Denk 25losartan (losartan

potassium)tablets film-coated

25mg,

in blister (28/2x14/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany C09CA01 1320110.01.2014

10.01.2019PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2591 Losar-Denk 50losartan (losartan

potassium)tablets film-coated

50mg,

in blister (28/2x14/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany C09CA01 1614010.11.2016

10.11.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2592 Losartanlosartan (losartan

potassium)tablets coated

50mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C09CA01 1385618.09.2014

18.09.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

559

Page 220: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2593 Lotarlosartan (losartan

potassium)tablets film-coated

50mg,

in blister (30/3x10/)

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch

releaser (dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia)

Slovenia C09DA01 1242529.04.2013

29.04.2018PoM

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

2594 Lotarlosartan (losartan

potassium)tablets film-coated

100mg,

in blister (30/2x15/)

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch

releaser (dosage form

manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia)

Slovenia C09DA01 1242629.04.2013

29.04.2018PoM

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

2595 Lotarlosartan (losartan

potassium)tablets film-coated

100mg,

in blister (30/2x15/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C09CA01 1722508.12.2017

08.12.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

2596 Lotarlosartan (losartan

potassium)tablets film-coated

50mg,

in blister (30/3x10/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C09CA01 1722608.12.2017

08.12.2022PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

560

Page 221: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2597 Lotosonic

Rhizmata

Dioscoreae, Semina

Nelumbinis,

Plumula

Nelumbinis, Semina

Biotae, Semina

Ziziphi jujubae,

Folia mori, Folia

Erythrinae, Fructus

Euphoria longanae

tablets coated

183mg+175mg+

15mg+91,25mg+

91,25mg+ 91,25mg+

91,25mg+ 91,25mg,

in blister

(10, 20/2x10/)

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Thanh Khe

Dist., Da Nang city

VietnamN05CM

herbal drug12758

14.08.2013

14.08.2018OTC

Danapha

Pharmaceutical JSC,

253 Dung Si Thanh

Khe str., Thanh Khe

Dist., Da Nang city,

Vietnam

2598 Lozaplosartan (losartan

potassium)tablets film-coated

50mg,

in blister (30/3x10/)

Saneca

Pharmaceuticals. a.s.,

Nitrianska 100, 920 27

Hlohovec

Slovak Republic C09CA01 1683910.07.2017

10.07.2022PoM

Zentiva a.s.,

Einsteinova 24, 851

01 Bratislava, Slovak

Republic

2599 Lozaplosartan (losartan

potassium)tablets film-coated

100mg,

in blister (30/3x10/)

Saneca

Pharmaceuticals. a.s.,

Nitrianska 100, 920 27

Hlohovec

Slovak Republic C09CA01 1684010.07.2017

10.07.2022PoM

Zentiva a.s.,

Einsteinova 24, 851

01 Bratislava, Slovak

Republic

2600 Lozap Plus

losartan (losartan

potassium),

hydrochlorothia-

zide

tablets film-coated50mg+12,5mg,

in blister (30/3x10/)

Zentiva, k.s., U

kabelovny 130, 102 37

Praha 10, Dolni

Mecholupy

Czech Republic C09DA01 1243307.05.2013

07.05.2018PoM

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

2601L-Thyroxin 100

Berlin-Chemie

levothyroxine

sodiumtablets

100mcg,

in blisters (50/2x25/,

100/4x25/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany H03AA01 15391/106.04.2016

26.02.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

561

Page 222: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2602L-Thyroxin 125

Berlin-Chemie

levothyroxine

sodiumtablets

125mcg,

in blister (50/2x25/) and

(100/4x25/)

Berlin-Chemie A.G.,

Glienicker Weg 125 D-

12489 Berlin

Germany H03AA01 1719808.12.2017

08.12.2022PoM

Berlin-Chemie A.G.,

Glienicker Weg 125

D-12489 Berlin,

Germany

2603L-Thyroxin 150

Berlin-Chemie

levothyroxine

sodiumtablets

150mcg,

in blister (50/2x25,

100/4x25/)

Berlin-Chemie A.G.,

Glienicker Weg 125 D-

12489 Berlin

Germany H03AA01 1719708.12.2017

08.12.2022PoM

Berlin-Chemie A.G.,

Glienicker Weg 125

D-12489 Berlin,

Germany

2604L-Thyroxin 50

Berlin-Chemie

levothyroxine

(levothyroxine

sodium)

tablets

50mcg,

in blister (25/1x25/,

50/2x25/, 100/4x25/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, packager

(dosage form

manufacturer - Berlin-

Chemie AG,

Tempelhofer Weg 83,

12347 Berlin,

Germany)

Germany H03AA01 1340009.04.2014

09.04.2019PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

2605L-Thyroxin 75

Berlin-Chemie

levothyroxine

sodiumtablets

75mcg,

in blister (50/2x25/) and

(100/4x25/)

Berlin-Chemie A.G.,

Glienicker Weg 125 D-

12489 Berlin

Germany H03AA01 1719908.12.2017

08.12.2022PoM

Berlin-Chemie A.G.,

Glienicker Weg 125

D-12489 Berlin,

Germany

2606 Lucentis ranibizumab solution for injection

10mg/ml,

0.23ml glass vial (1),

syringe (1) and needle (2)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland S01LA04 1659003.04.2017

03.04.2022PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

2607 Lucetam piracetam film-coated tablets800mg,

glass container (30)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary N06BX03 12563/225.04.2017

06.06.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

562

Page 223: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2608 Lucetam piracetam film tablets coated1200mg,

glass container (20)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary N06BX03 12564/225.04.2017

06.06.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2609 Lucetam piracetam solution for injection

200mg/ml,

15ml ampoules,

in blister, (4/1x4/,

20/5x4/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N06BX03 1723508.12.2017

08.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2610 Lucetam piracetam solution for injection

200mg/ml,

5ml ampoules, in blister

(10/2x5/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary N06BX03 1723608.12.2017

08.12.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2611 Lydasa-Biopharma hyaluronidasepowder for solution

for injection

64IU,

glass vial, in blister

(10/2x5/)

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region

Ukraine B06AA03 1680922.06.2017

22.06.2022PoM

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region, Ukraine

2612 Lyrica pregabalin capsules hard

75mg,

in blister (14/1x14/,

56/4x14/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany N03AX16 1463203.07.2015

03.07.2020PoM/UC

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

2613 Lyrica pregabalin capsules hard

150mg,

in blister (14/1x14/,

56/4x14/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany N03AX16 1463303.07.2015

03.07.2020PoM/UC

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

563

Page 224: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2614 Lyrica pregabalin capsules hard300mg,

in blister (14, 56/4x14/)

Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany N03AX16 1463403.07.2015

03.07.2020PoM/UC

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

2615 Lysobact

lysozyme (lysozyme

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride)

lozenges compressed

20mg+10mg,

in blister (10/1x10/,

30/3x10/)

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaA01AD11 17078

05.10.2017

05.10.2022OTC

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo, Bosnia And

Herzegovina

2616 Maalox

aluminium

hydroxide,

magnesium

hydroxide

suspension oral35mg/ml+40mg/ml,

250ml glass bottle

Sanofi-Aventis S.p.a.,

Viale Europa 11,

21040 Origgio (VA)

Italy A02AX 1524830.12.2015

30.12.2020OTC

Sanofi-Aventis

France, 1-13

boulevard Romain

Rolland, 75014 Paris,

France

2617 Maalox

aluminium

hydroxide,

magnesium

hydroxide

suspension oral

525mg/15ml+

600mg/15ml,

15ml sachets (30)

Pharmatis, Zone

dactivites Est No.1,

BP 60190 Estress Saint

Denis

France A02AX 1539526.02.2016

26.02.2021OTC

Sanofi-Aventis

France, 1-13

boulevard Romain

Rolland, 75014 Paris,

France

2618 Maalox

aluminium

hydroxide,

magnesium

hydroxide

tablets chewable400mg+400mg,

in blister (40/4x10/)

Sanofi-Aventis S.p.A.,

Strada Statale N17-

km22, 67019 Scoppito

Italy A02AX 1554712.04.2016

12.04.2021OTC

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014 Paris,

France

564

Page 225: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2619 MabThera rituximabconcentrate for

solution for infusion

100mg/10ml,

10ml glass vials (2)

F. Hoffmann-La

Roche Ltd.

Wurmisweg CH-4303

Kaiseraugst-batch

releaser, secondary

packager, Roche

Diagnostics GmbH,

Sandhofer Strasse 116,

D-68305 Mannheim,

Germany-bulk

manufacturer,

primary packager

Switzerland L01XC02 1407516.12.2014

16.12.2019PoM

F. Hoffmann La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070,

Switzerland

2620 Macmiror nifuratel tablets coated200mg,

in blister (20/2x10/)

Doppel Farmaceutici

S.R.L., Via Volturno,

48-Quinto de` Stampi-

20089 Rozzano Milan

(MI)

Italy G01AX05 1524630.12.2015

30.12.2020PoM

Polichem S.r.l., Via

Giuseppe Marcora, 11-

20121 Milan (MI),

Italy

2621 Macmiror complex nifuratel, nystatine cream vaginal

10g/100g+

4000000IU/100g, 30g

aluminium tube and

dosing syringe applicator

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1-29016

Cortemaggiore (PC)

Italy G01AX05 1524430.12.2015

30.12.2020PoM

Polichem S.r.l., Via

Giuseppe Marcora, 11-

20121 Milan (MI),

Italy

2622 Macmiror complex nifuratel, nystatin suppositories vaginal500mg+200000IU,

in blister (8/1x8/)

Doppel Farmaceutici

S.R.L., Via Volturno,

48-Quinto de` Stampi-

20089 Rozzano Milan

(MI)

Italy G01AX05 1524530.12.2015

30.12.2020PoM

Polichem S.r.l., Via

Giuseppe Marcora, 11-

20121 Milan (MI),

Italy

565

Page 226: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2623 Macrolan-200tylosin (tylosin

tartrate)solution for injection

200mg/ml,

100ml glass bottle

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray-

secondary packager,

Interchemie werken

De Adelaar Eesti AS,

Vanapere tee 14,

Viimsi, Harju county,

Estonia- bulk

manufacturer,

primary packager,

batch releaser

the Netherlands

QJ01FA90;

veterinary

drug

1419906.02.2015

06.02.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

2624 Macropen midecamycin tablets film-coated400mg,

in blister (16/2x8/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

Merck KGaA & Co.,

Werk Spittal,

Hosslgasse 20, 9800

Spittal an der Drau,

Austria- bulk

manufacturer,

packager

Slovenia J01FA03 1720608.12.2017

08.12.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2625 Macropen

midecamycin

(midecamycin

acetate)

granules for oral

suspension

175mg/5ml,

115ml glass bottle and

measuring spoon

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto - batch

releaser, KRKA d.d.,

Novo mesto, Ulica

Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk

manufacturer,

packager

Slovenia J01FA03 1689408.08.2017

08.08.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

566

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2626 Madopar

levodopa,

benserazide

(benserazide

hydrochloride)

capsules hard100mg+25mg,

in glass bottle (100)

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel-

batch releaser (Roche

S.p.A., Via Morelli 2,

Segrate, 20090, Milan,

Italy-bulk

manufacturer) (F.

Hoffmann-La Roche

Ltd., Wurmisweg, CH-

4303, Kaiseraugst,

Switzerland-primary

and secondary

packager)

Switzerland N04BA02 1478814.08.2015

14.08.2020PoM

F. Hoffmann-La

Roche Ltd.,

Greenzacherstrasse,

124, CH-4070, Basel,

Switzerland

2627 Madopar

levodopa,

benserazide

(benserazide

hydrochloride)

tablets200mg+50mg,

in glass bottle (100)

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel-

batch releaser, Roche

S.p.A., Via Morelli 2,

Segrate, 20090, Milan,

Italy- bulk

manufacturer, F.

Hoffmann-La Roche

Ltd., Wurmisweg, CH-

4303, Kaiseraugst,

Switzerland-packager

Switzerland N04BA02 1517617.12.2015

17.12.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

2628 Magne B6

magnesium lactate

dihydrate,

pyridoxine

hydrochloride

tablets coated 470mg+5mg,

in blister (50/5x10/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary A12 1690608.08.2017

08.08.2022OTC

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5, Hungary

567

Page 228: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2629 Magne-B6

magnesium lactate

dihydrate,

pyridoxine

hydrochloride

tablets coated470mg+5mg,

in blister (50/5x10/)

Sanofi Winthrop

Industrie, 6,

Boulevard de l Europe

21800 Quetigny

France A12 1478430.07.2015

30.07.2020OTC

Sanofi-Aventis

France, 1-13,

boulevard Romain

Rolland, 75014 Paris,

France

2630 Magnefar B6

magnesium

hydroaspartate(mag

nesium

hydroasparaginate

tetrahydrate),

pyridoxine

(pyridoxine

hydrochloride)

tablets500mg+5mg,

in blister (60/6x10/)

Biofarm Sp. z o.o., 13,

Walbrzyska Str., 60-

198, Poznan

Poland A12CC05 1549405.04.2016

05.04.2021OTC

Biofarm Sp. z o.o., 13,

Walbrzyska Str., 60-

198, Poznan, Poland

2631 Magnelis B6

magnesium

(magnesium

lactate), pyridoxine

(pyridoxine

hydrochloride)

tablets coated

48mg+5mg,

in plastic container (90),

in blister (50/5x10/)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A12C 15199/102.05.2016

30.12.2020OTC

Otcpharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2632 Magnerot

magnesium orotate

(magnesium orotate

dihydrate)

tablets

500mg,

in blister (20/2x10/,

50/5x10/)

Mauermann

Arzneimittel KG,

Heinrich-Knote str. 2,

82343 Pocking,

Bavaria

Germany A12CC09 1257406.06.2013

06.06.2018OTC

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

2633 Magnesium sulfate magnesium sulfate solution for injection250mg/ml,

5ml ampoules (10)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk region

Belarus B05XA05 1419706.02.2015

06.02.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222120, Minsk

region, Belarus

568

Page 229: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2634 Magnesium sulfate magnesium sulfate solution for injection250mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaB05XA05 17048

25.09.2017

25.09.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

2635Magnesium sulfate-

Darnitsamagnesium sulfate solution for injection

250mg/ml,

5ml ampoules,

in blister (10, 10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine B05XA05 1245407.05.2013

07.05.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

2636Magnesium sulfate-

Darnitsamagnesium sulfate solution for injection

250mg/ml,

10ml ampoules,

in blister (10, 10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine B05XA05 1245507.05.2013

07.05.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

2637Magnesium

sulphatemagnesium sulfate

powder for oral

solution

25g,

25g sachets

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaA06AD04 13947

29.10.2014

29.10.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

2638 Magnetolux

gadopentetic acid

(gadopentetate

dimeglumine)

solution for injection

469mg/ml

(500micromol/ml), 20ml

glass vial (1)

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 7, A-

2491 Neufeld/Leitha-

batch releaser, bulk

manufacturer,

primary packager,

Sanochemia

Pharmazeutika AG,

Landeggerstrasse 33,

A-2491

Neufeld/Leitha,

Austria-secondary

packager

Austria V08CA01 1426520.02.2015

20.02.2020PoM

Sanochemia

Pharmazeutika AG,

Boltzmanngasse 9-11,

A-1090 Vienna,

Austria

569

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2639 Magnevist

gadopentetic acid

(gadopentetate

dimeglumine)

solution for injection469mg/ml,

20ml glass vials (10)

Bayer Schering

Pharma AG, D-13342

Berlin

Germany V08CA01 1248023.07.2013

23.07.2018PoM

Bayer Vital GmbH,

51368 Leverkusen,

Germany

2640 Manni-Tech 10% mannitol solution for infusion

100mg/ml,

200ml, 250ml, 400ml and

500ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaB05BC01 15897

23.08.2016

23.08.2021PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

2641 Mannitol mannitol solution for infusion100mg/ml,

500ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05BC01 13437

14.04.2014

14.04.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2642 Maraslavin

artemisia pontica,

satureja hortensis,

syzygium

aromaticum, piper

nigrum, zingiber

officinale

solution for local use

41,96mg/ml+ 7,28mg/ml+

36,46mg/ml+

11,99mg/ml+

41,96mg/ml,

100ml glass bottle

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia-batch

releaser, Sopharma

JSC, Vrabevo vlg.

5660, district of

Lovetch, Bulgaria-

bulk manufacturer,

primary and

secondary packager

BulgariaA01AD11;

herbal drug15034

02.12.2015

02.12.2020OTC

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2643 Marion

ceftriaxone

(ceftriaxone

sodium)

powder and solvent

for solution for i/m

injection

1000mg,

glass vial (1) and 3.5ml

solvent in ampoule

Anfarm Hellas S.A.,

61st Km National

Road Athens-Lamia,

Sximatari Viotias,

32009

Greece J01DD04 1606217.10.2016

17.10.2021PoM

J&P Pharma UK Ltd,

Ashcombe House, 5

The Crescent,

Leatherhead, Surrey,

KT22 8DY, UK

2644 Marion

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection/infusion

1000mg,

glass vial (1)

Anfarm Hellas S.A.,

61st Km National

Road Athens-Lamia,

Sximatari Viotias,

32009

Greece J01DD04 1606317.10.2016

17.10.2021PoM

J&P Pharma UK Ltd,

Ashcombe House, 5

The Crescent,

Leatherhead, Surrey,

KT22 8DY, UK

570

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2645 Mastilex

cephalexin

(cephalexin

monohydrate),

gentamicin

(gentamicin sulfate)

suspension oily

350mg/10ml+

35mg/10ml,

10ml syringes

(4, 24)

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

Spain

QJ1RD01

veterinary

drug

1257706.06.2013

06.06.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19, Spain

2646 Mastodynon

agnus castus,

caulophyllum

thalictroides D4,

cyclamen D4,

ignatia D6, iris D2,

lilium tigrinum D3

tablets

162mg+81mg+

81mg+81mg+

162mg+81mg,

in blister (60/3x20/)

Bionorica SE,

Kerschensteinerstr. 11-

15, 92318 Neumarkt

Germany

G02CX;

homeopathic

drug

1540509.03.2016

09.03.2021PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

2647 Mastomycin

gentamicin

(gentamicin

sulfate),

clindamycin

(clindamycin

phosphate),

lidocaine (lidocaine

hydrochloride)

gel

15mg/ml+20mg/ml+50mg

/ml,

10ml pre-filled syringes

(20)

Nita-Farm LLC,

410010, Saratov,

Osipova st.1

Russia

QN01BB52;

veterinary

drug

12401/106.02.2015

19.04.2018PoM

Nita-Farm LLC,

410010, Saratov,

Osipova st.1, Russia

2648 Mataren Plus

meloxicam, peper

siliculose fruits

tincture

cream

(30mg/g+100mg/g)

15g aluminum or plastic

tube

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia M02AX 13589/107.07.2017

10.06.2019PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2649Matever 250mg

film-coated tabletslevetiracetam tablets film-coated

250mg,

in blister (30/3x10/)

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki

Greece N03AX14 1307409.12.2013

09.12.2018PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

2650Matever 500mg

film-coated tabletslevetiracetam tablets film-coated

500mg,

in blister (30/3x10/)

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki

Greece N03AX14 1307509.12.2013

09.12.2018PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

571

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2651 Maxibiotic

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate), bacitracin

zinc

ointment

5mg/g+5000IU/g+400IU/g

,

3g, 5g, 15g aluminium

tube

Emo-Farm Sp.z o.o.,

52 Lodzka St., 95-054

Ksawerow

Poland D06A 14070/123.12.2016

19.12.2019OTC

Valeant LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2652 Maxicold Rhino

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid, paracetamol

powder for oral

solution with orange

flavour

10mg+20mg+50mg+325m

g,

15g sachets (5, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02BE51 13740/111.08.2016

24.07.2019OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2653 Maxicold Rhino

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid, paracetamol

powder for oral

solution with lemon

flavour

10mg+20mg+50mg+325m

g,

15g sachets (5, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02BE51 13741/111.08.2016

24.07.2019OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2654 Maxicold Rhino

phenylephrine

(phenylephrine

hydrochloride),

pheniramine

(pheniramine

maleate), ascorbic

acid, paracetamol

powder for oral

solution with

raspberry flavour

10mg+20mg+50mg+325m

g,

15g sachets (5, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02BE51 13742/111.08.2016

24.07.2019OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2655 Maxidex dexamethasonedrops eye

(suspension)

1mg/ml,

5ml plastic dropper-vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01BA01 1388406.10.2014

06.10.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

572

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2656 Maxitrol

dexamethasone,

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate)

drops eye

(suspension)

1mg/ml+3,5IU/ml+6IU/m

l.

5ml vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01CA01 1355306.06.2014

06.06.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

2657 Mebendazole mebendazole tablets100mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP02CA01 12872

17.09.2013

17.09.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2658 Mebendazole mebendazole tablets500mg,

in plastic container (1)

Arpimed LLC (Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building)

Republic of

ArmeniaP02CA01 12961

28.10.2013

28.10.2018PoM

Arpimed LLC

(Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia)

2659 Mecolchloramphenicol,

methyluracil

ointment for

external use

7.5mg/g+40mg/g, 40g

aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus D06C 1578320.07.2016

20.07.2021OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2660 Medacomb Cream

triamcinolone

(triamcinolone

acetonide),

nystatin,

gramicidin,

neomycin

(neomycin sulfate)

cream

1mg/g+ 100000IU/g+

0,25mg/g+ 2,5mg/g,

30g aluminium tube

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

Emirates

D01AA01,

D07AB09,

D06AX04,

R02AB30

1381305.09.2014

05.09.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

573

Page 234: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2661 Medical Alcohol ethanol solution

40%,

50ml, 100ml, 250ml,

500ml, 1000ml, 5000ml,

10000ml plastic bottle

Alex-Grig LLC,

Arshakunyac 127/21,

Yerevan

Republic of

ArmeniaD08AX08 13063

25.11.2013

25.11.2018OTC

Natali Pharm LLC,

Tichina str. Lane 3,

2/2, 0065, Yerevan,

Republic of Armenia

2662 Medical Alcohol ethanol solution

70%,

50ml, 100ml, 250ml,

500ml, 1000ml, 5000ml,

10000ml plastic bottle

Alex-Grig LLC,

Arshakunyac 127/21,

Yerevan

Republic of

ArmeniaD08AX08 13064

25.11.2013

25.11.2018OTC

Natali Pharm LLC,

Tichina str. Lane 3,

2/2, 0065, Yerevan,

Republic of Armenia

2663 Medical Alcohol ethanol solution

96%,

50ml, 100ml, 250ml,

500ml, 1000ml, 5000ml,

10000ml plastic bottle

Alex-Grig LLC,

Arshakunyac 127/21,

Yerevan

Republic of

ArmeniaD08AX08 13065

25.11.2013

25.11.2018OTC

Natali Pharm LLC,

Tichina str. Lane 3,

2/2, 0065, Yerevan,

Republic of Armenia

2664 Medomexiethylmethylhydrox

ypiridine succinate

solution for i/v and

i/m injection

50mg/ml,

2ml ampoules, in blister

(10/2x5/)

FSUE Moscow

Endocrine Plant, 25,

Novokhokhlovskaya

st., Moscow, 109052

Russia N07XX 1483904.09.2015

04.09.2020PoM

PROMOMED

HOLDINGS

(CYPRUS) LIMITED,

Themistokli Dervi,

15, MARGARITA

HOUSE, 5th floor,

Flat/Office 502, 1066

Nicosia, Cyprus

2665 Medomexiethylmethylhydrox

ypiridine succinate

solution for i/v and

i/m injection

50mg/ml,

5ml ampoules, in blister

(5/1x5/)

FSUE Moscow

Endocrine Plant, 25,

Novokhokhlovskaya

st., Moscow, 109052

Russia N07XX 1484004.09.2015

04.09.2020PoM

PROMOMED

HOLDINGS

(CYPRUS) LIMITED,

Themistokli Dervi,

15, MARGARITA

HOUSE, 5th floor,

Flat/Office 502, 1066

Nicosia, Cyprus

574

Page 235: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2666 Medomexiethylmethylhydrox

ypyridine succinatetablets film-coated

125mg,

in blister (30/3x10/)

Ozon LLC, build. 6,

Gidrostroiteley str.,

Zhigulevsk town,

Samara region,

445351

Russia N07XX 1505402.12.2015

02.12.2020PoM

PROMOMED

HOLDINGS

(CYPRUS) LIMITED,

Themistokli Dervi,

15, MARGARITA

HOUSE, 5th floor,

Flat/Office 502, 1066

Nicosia, Cyprus

2667 Medrolmethylpredni-

solonetablets

4mg,

in blister (30/3x10/)

Pfizer Italia S.R.L.,

Localita Marino del

Tronto 63100 Ascoli

Piceno

Italy H02AB04 1240419.04.2013

19.04.2018PoM

Pfizer Italia s.r.l., Via

Isonzo, 71-04100

Lataina, Italy

2668 Megaplatin carboplatinsolution for i/v

infusion

10mg/ml,

15ml glass vial

Genepharm S.A., 18th

km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L01XA02 1372224.07.2014

24.07.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51

Pallini Attiki, Greece

2669 Megaray Inj.

gadopentetic acid

(meglumine

gadopentetate)

solution for injection469,01mg/ml,

20ml glass vial

DongKook

Pharmaceutical Co.,

Ltd., 488-5, Jukhyeon-

ri, Gwanghyewon-

myeon, Jincheon-gun,

Choongcheongbuk-

do, Korea

Korea Sourth V08CA01 1252501.06.2013

01.06.2018PoM

DongKook

Pharmaceutical Co.,

Ltd., 488-5, Jukhyeon-

ri, Gwanghyewon-

myeon, Jincheon-

gun,

Choongcheongbuk-

do, Korea

2670 Melaxen melatonin tablets coated

3mg,

in blister (12/1x12/,

24/2x12/)

Unipharm Inc. 200

Hick str., Westbury,

New York 11590

USA N05CH01 1349630.05.2014

30.05.2019OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York, N.Y.

10118, USA

575

Page 236: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2671 Melfor

meldonium

(meldonuim

dihydrate)

capsules250mg,

in blister (40/4x10/)

Ozon LLC, build. 6,

Gidrostroiteley str.,

Zhigulevsk town,

Samara region,

445351

Russia C01EB22 1505602.12.2015

02.12.2020PoM

PROMOMED

HOLDINGS

(CYPRUS) LIMITED,

Themistokli Dervi,

15, MARGARITA

HOUSE, 5th floor,

Flat/Office 502, 1066

Nicosia, Cyprus

2672 Melitor agomelatine tablets film-coated25mg,

in blister (28/2x14/)

Les Laboratoires

Servier Industrie, 905,

route de Saran, 45520

Gidy

France N06AX22 1495623.10.2015

23.10.2020PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

2673 Melitor agomelatine tablets film-coated25mg,

in blister (28/2x14/)

Servier (Ireland)

Industries Ltd, Gorey

Road, Arklow-Co

Wicklow

Ireland N06AX22 1495723.10.2015

23.10.2020PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

2674 Meloflam meloxicam tablets

7,5mg,

in blister (10/1x10/,

20/2x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - packager, batch

releaser (bulk

manufacturer - Egis

Pharmaceuticals PLC,

9900, Kormend,

Matyas kiraly st. 65,

Hungary)

Hungary M01AC06 12258/128.10.2015

07.03.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

576

Page 237: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2675 Meloflam meloxicam tablets

15mg,

in blister (10/1x10/,

20/2x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser,

packager, Egis

Pharmaceuticals PLC,

9900, Kormend,

Matyas Kiraly u. 65,

Hungary- bulk

manufacturer

Hungary M01AC06 1714007.11.2017

07.11.2022PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

2676 Meloflex meloxicamsolution for i/m

injection

10mg/ml,

1,5ml ampoules, (3, 5)

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania M01AC06 1581920.07.2016

20.07.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2677 Melon

ambroxol

(ambroxol

hydrochloride),

salbutamol

(salbutamol sulfate),

guaifenesin

syrup

15mg/5ml+ 1mg/5ml+

50mg/5ml,

100ml plastic bottle

Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14

Georgia R03CK 1219001.02.2013

01.02.2018PoM

Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14,

GEORGIA

2678 Melon

ambroxol

(ambroxol

hydrochloride),

salbutamol

(salbutamol sulfate),

guaifenesin

tablets15mg+2mg+ 100mg,

in blister (30/3x10/)

Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14

Georgia R03CK 1219101.02.2013

01.02.2018PoM

Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14,

GEORGIA

577

Page 238: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2679 Melotex meloxicamsolution for i/m

injection

10mg/ml,

1.5ml ampoules (3, 5)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia M01AC06 1680322.06.2017

22.06.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2680 Melotex meloxicam tablets15mg,

in blister (20/2x10/)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345- secondary

packager, batch

releaser, Replek Farm

Ltd.-Skopje, 188 str.

Kozle, 1000 Skopje,

Macedonia- bulk

manufacturer,

primary packager

Russia M01AC06 1710723.10.2017

23.10.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2681 Meloxicam meloxicam tablets7,5mg,

in blister (20/2x10/)

Chanelle Medical,

Loughrea, Co. Galway-

packager, batch

releaser, Cipla Ltd,,

Manufacturing

Division, Plot No D-7,

MIDC Industrial

Area, Kurkumbh

Village, Taluka

Daund, District-Pune

(Maharashtra), India-

bulk manufacturer

Ireland M01AC06 1333917.03.2014

17.03.2019PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Republic of

Armenia

578

Page 239: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2682 Meloxicam meloxicam tablets15mg,

in blister (20/2x10/)

Chanelle Medical,

Loughrea, Co. Galway-

packager, batch

releaser, Cipla Ltd,,

Manufacturing

Division, Plot No D-7,

MIDC Industrial

Area, Kurkumbh

Village, Taluka

Daund, District-Pune

(Maharashtra), India-

bulk manufacturer

Ireland M01AC06 1334017.03.2014

17.03.2019PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Republic of

Armenia

2683 Meloxicam meloxicam tablets7,5mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus M01AC06 1449915.05.2015

15.05.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2684 Meloxicam meloxicam tablets15mg,

in blister (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus M01AC06 1450015.05.2015

15.05.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2685 Meloxicam meloxicamsolution for i/m

injection

10mg/ml,

1.5ml ampoules, in blister

(3/1x3/)

FSUE "State Plant of

Medical

Preparations", 111024,

23, Enthusiasts

highway, Moscow

Russia M01AC06 1558912.05.2016

12.05.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

579

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2686 Meloxicam meloxicamsolution for i/m

injection

10mg/ml,

1.5ml ampoules (5)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus M01AC06 1715807.11.2017

07.11.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2687 Meloxicam DC meloxicam tablets

7,5mg,

in blister (10/1x10/),

(20/2x10/)

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thuong

Kiet, Dist. 11, Ho Chi

Minh

Vietnam M01AC06 1393929.10.2014

29.10.2019PoM

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thuong

Kiet, Dist. 11, Ho Chi

Minh, Vietnam

2688 Meloxicam DC meloxicam tablets

15mg,

in blister (10/1x10/),

(20/2x10/)

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thuong

Kiet, Dist. 11, Ho Chi

Minh

Vietnam M01AC06 1394029.10.2014

29.10.2019PoM

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thuong

Kiet, Dist. 11, Ho Chi

Minh, Vietnam

2689 Meloxicam DC meloxicam solution for injection10mg/ml,

1.5ml ampoules (3)

Zhangjiakou Kaiwei

Pharmaceutical Co.

Ltd., No 27, Lingyuan

Road, Zhangjiakou,

Heibei Province

China M01AC06 1432625.03.2015

25.03.2020PoM

Dahnson Trading

Pharmaceutical

Company Limited,

HoChiMinh city, 44A

Dang Dung street,

Tan Dinh ward,

District 1, Vietnam

2690Meloxicam STADA

tablets 15mgmeloxicam tablets

15mg,

in blister (20/2x10/)

Makiz-Pharma LLC,

109029, Moscow, 6

Avtomobilny proezd

Russia M01AC06 1260521.06.2013

21.06.2018PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

580

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2691Meloxicam STADA

tablets 15mgmeloxicam tablets

15mg,

in blister (20/2x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse St.

Russia M01AC06 1279014.08.2013

14.08.2018PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2692 Memantine Canon

memantine

(memantine

hydrochloride)

tablets film-coated

10mg,

in blister (30/3x10/,

30/1x30/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N06DX01 15993/107.07.2017

15.09.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

2693 Menogon menohropin

powder lyophilized

for solution for

injecton

75IU,

ampoules (10), 1ml

solvent in ampoules(10)

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel -

powder dosage form

manufacturer, primary

packager, batch releaser

(solvent dosage form

manufacturer, primary

packager - Haupt

PharmaWulfing GmbH,

Bethelner Landstr. 18,

31028 Gronau/Leine,

Germany) (secondary

packager - Ferring

International Center

SA, Chemin de la

Vergognausaz 50, 1162

Saint-Prex, Switzerland)

Germany G03GA02 1319210.01.2014

10.01.2019PoM

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel,

Germany

581

Page 242: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2694 Menopur menotropin

powder lyophilized

for solution for

injection

75IU,

glass vials (10), 1ml

solvent in ampoules (10)

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel -

batch releaser (solvent

bulk manufacturer,

primary packager -

Haupt Pharma

Wulfing GmbH

Bethelner Landstr. 18,

31028 Gronau/Leine,

Germany) (powder

bulk manufacturer,

primary packager -

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel,

Germany) secondary

packager - Ferring

International Center

SA, Chemin de la

Vergognausaz 50,

1162 Saint-Prex,

Switzerland

Germany G03GA02 13078/102.06.2015

09.12.2018PoM

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel,

Germany

2695 Menovazine

menthol racemic,

procaine (procaine

hydrochloride),

benzocaine

solution for external

use

25mg/ml+

10mg/ml+10mg/ml, 30ml

glass vial (1)

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaM02AX10 14960

18.11.2015

18.11.2020OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

2696 Mepivastesin

mepivacaine

(mepivacaine

hydrochloride)

solution for injection30mg/ml,

1,7ml cartridges (50)

3M Deutschland

GmbH (ESPE Platz

82229 Seefeld)

Germany N01BB03 1294321.10.2013

21.10.2018PoM

3M Deutschland

GmbH (Carl-Schurz

Strasse 1, 42453

Neuss, Germany)

582

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2697Mercazolyl-

Zdorovyethiamazole tablets

5mg,

in blister (50/5x10/,

100/10x10/),

in plastic container (50,

100)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine H03BB02 1643406.03.2017

06.03.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

2698Meropenem-

Asteriameropenem

powder for solution

for i/v

injection/infusion

500mg,

glass vials (1, 5, 10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth J01DH02 1517817.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

2699 Mertenil

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated20mg,

in blister (30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C10AA07 1590323.08.2016

23.08.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2700 Mertenil

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated10mg,

in blister (30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C10AA07 1590423.08.2016

23.08.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2701 Mertenil

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated5mg,

in blister (30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C10AA07 1590523.08.2016

23.08.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2702 Mesatone

phenylephrine

(phenylephrine

hydrochloride)

solution for i/m, i/v

and s/c injection

10mg/ml,

1ml ampoules (10/1x10/,

10/2x5/)

Pharmaceutical

Company "Zdorovye"

LLC, str. Shevchenko,

22, Kharkov

Ukraine C01CA06 15774/109.08.2016

04.07.2021PoM

Experimental Plant

"GNCLS" LLC, 61075,

Kharkov, Vorobyov

str., 8, Ukraine

583

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2703 Metabet SR

metformin

(metformin

hydrochloride)

tablets prolonged-

release

500mg,

in blister (28/2x14/)

Morningside

Pharmaceuticals Ltd,

5 Pavilion Way,

Loughborough,

Le115GW -batch

releaser, USV Ltd, H-

17/ H-18, IDC,

Mahatma Gandhi,

Udyog Nagar, Dabhel,

Daman, 396210, India-

bulk manufacturer,

packager

UK A10BA02 1420827.01.2015

27.01.2020PoM

Morningside

Healthcare Ltd, 115

Narborough Road,

Leicester LE30PA

(UK)

2704 Metabet SR

metformin

(metformin

hydrochloride)

tablets prolonged-

release

1000mg,

in blister (28/2x14/)

Morningside

Pharmaceuticals Ltd,

5 Pavilion Way,

Loughborough,

Le115GW -batch

releaser, USV Ltd, H-

17/ H-18, IDC,

Mahatma Gandhi,

Udyog Nagar, Dabhel,

Daman, 396210, India-

bulk manufacturer,

packager

UK A10BA02 1420927.01.2015

27.01.2020PoM

Morningside

Healthcare Ltd, 115

Narborough Road,

Leicester LE30PA

(UK)

2705 Metadon Alkaloid

methadone

(methadone

hydrochloride)

solution oral

10mg/ml,

100ml glass bottle and

graduated pipette,

1000ml glass bottle

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N07BC02 1726713.12.2017

13.12.2022PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

2706 Metagard CR-35

trimetazidine

(trimetazidine

hydrochloride)

tablets controlled-

release coated

35mg,

in blister (30/3x10/)

Ipca Laboratories

Limited, P.O. Sejavta,

Dist. Ratlam 457 002,

Madhya Pradesh

India C01EB15 1214701.02.2013

01.02.2018PoM

Ipca Laboratories Ltd,

48, Kandivli Ind.

Estate, Mumbai 400

067, India

584

Page 245: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2707 Meteospasmyl

alverine (alverine

citrate),

simethicone

capsules60mg+300mg,

in blister (30/3x10/)

Laboratoires Mayoly

Spindler, 6 avenue de

l`Europe B.P.

5178401 Chatou

Cedex -batch releaser,

packager, L.G.V.

Capsules, 20, rue

Louis-Charles Vernin,

77190 Dammarie-les-

Lys, France-bulk

manufacturer

France A03AX58 1499106.11.2015

06.11.2020OTC

Laboratoires Mayoly

Spindler, 6 avenue de

l`Europe B.P.

5178401 Chatou

Cedex, France

2708 Metfogamma

metformin

(metformin

hydrochloride)

tablets film-coated

850mg,

in blister (30/3x10/,

120/12x10/)

Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1 D-

29439, Luchow

Germany A10BA02 1283917.09.2013

17.09.2018PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

2709 Metfogamma 1000

metformin

(metformin

hydrochloride)

tablets film-coated

1000mg,

in blister (30/2x15/,

120/8x15/)

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Bavaria

Germany A10BA02 1341314.04.2014

14.04.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

2710 Metfogamma 500

metformin

(metformin

hydrochloride)

tablets film-coated

500mg,

in blister

(30/3x10/, 120/12x10/)

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Bavaria

Germany A10BA02 1327204.03.2014

04.03.2019PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

2711 Metfogamma 850

metformin

(metformin

hydrochloride)

tablets film-coated850mg,

in blister (30/3x10/)

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Bavaria

Germany A10BA02 1229722.03.2013

22.03.2018PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

585

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2712 Metformin

metformin

(metformin

hydrochloride)

tablets500mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BA02 12134

01.02.2013

01.02.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2713 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated1000mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BA02 12675

04.07.2013

04.07.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

2714 Metformin

metformin

(metformin

hydrochloride)

tablets1000mg,

blisters (30/2x15/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BA02 13434/1

14.07.2016

14.04.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2715 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated500mg,

in blister (30/3x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia A10BA02 1371924.07.2014

24.07.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2716 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated850mg,

in blister (30/3x10/)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia A10BA02 1372024.07.2014

24.07.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

2717 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated1000mg,

glass bottle (30)

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia A10BA02 1372124.07.2014

24.07.2019PoM

Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje,

Macedonia

586

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2718 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated500mg,

in blister (60/6x10/)

Lek S.A.,16 Podlipie

Str., 95-010 Strykow Poland A10BA02 16445

06.03.2017

06.03.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

2719 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated1000mg,

in blister (60/4x15/)

Lek S.A.,16 Podlipie

Str., 95-010 Strykow Poland A10BA02 16446

06.03.2017

06.03.2022PoM

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

2720 Metformin

metformin

(metformin

hydrochloride)

tablets500mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BA02 17252

12.12.2017

12.12.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2721 Metformin

metformin

(metformin

hydrochloride)

tablets film-coated

500mg,

in blister (10/1x10/,

30/3x10/)

Belmedpreparaty

RUE, 220006, Minsk,

1 Mayakovskogo st.

Belarus A10BA02 1688208.08.2017

08.08.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2722 Metformin

metformin

(metformin

hydrochloride)

tablets coated 500mg,

in blisters (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64a, ul.

Chapaeva, Borisov,

Minsk region

Belarus A10BA02 1691208.08.2017

08.08.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64, ul.

Chapaeva, Borisov,

Minsk region, Belarus

587

Page 248: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2723 Metformin

metformin

(metformin

hydrochloride)

tablets coated 1000mg,

in blisters (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64a, ul.

Chapaeva, Borisov,

Minsk region

Belarus A10BA02 1691308.08.2017

08.08.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64, ul.

Chapaeva, Borisov,

Minsk region, Belarus

2724 Metformin

metformin

(metformin

hydrochloride)

tablets coated 850mg,

in blisters (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64a, ul.

Chapaeva, Borisov,

Minsk region

Belarus A10BA02 1691408.08.2017

08.08.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov", 64, ul.

Chapaeva, Borisov,

Minsk region, Belarus

2725Metformin Denk

1000

metformin

(metformin

hydrochloride)

tablets film-coated1000mg,

in blister (30/2x15/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany A10BA02 1623005.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2726Metformin Denk

500

metformin

(metformin

hydrochloride)

tablets film-coated

500mg,

in blister (30/3x10/,

100/10x10/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany A10BA02 1433725.03.2015

25.03.2020PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

2727Metformin Denk

850

metformin

(metformin

hydrochloride)

tablets film-coated850mg,

in blister (30/2x15/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany A10BA02 1622905.12.2016

05.12.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

588

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2728Methadone

Hydrochloride

methadone

(methadone

hydrochloride)

concentrate for oral

solution

25mg/ml,

150ml glass bottle

Rusan Pharma Ltd.,

Khasra No122MI,

Central Hope Town,

Selaqui, Dehradun

248 197, Uttarakhand

India N07BC02 1587523.08.2016

23.08.2021PoM/UC

Rusan Pharma Ltd.,

58-D, Govt. Ind.

Estate Charkop,

Kandivli (West)

Mumbai-400 067,

India

2729

Methadone

hydrochloride

tablets USP

methadone

(methadone

hydrochloride)

tablets5mg, (100) in plastic

container

Mallinckrodt Inc., 172

Railroad ave.,Hobart,

NY 13788

USA N07BC02 1399526.11.2014

26.11.2019PoM/UC

Mallinckrodt Inc.,

675 McDonnell

Boulevard,

Hazelwood, MO

63042, USA

2730

Methadone

hydrochloride

tablets USP

methadone

(methadone

hydrochloride)

tablets10mg; (100) in plastic

container

Mallinckrodt Inc., 172

Railroad ave.,Hobart,

NY 13788

USA N07BC02 1399626.11.2014

26.11.2019PoM/UC

Mallinckrodt Inc.,

675 McDonnell

Boulevard,

Hazelwood, MO

63042, USA

2731

Methadose

dispersible tablets

USP

methadone

(methadone

hydrochloride)

tablets for oral

suspension

40mg; (100) in plastic

container

Mallinckrodt Inc., 172

Railroad ave.,Hobart,

NY 13788

USA N07BC02 1399726.11.2014

26.11.2019PoM/UC

Mallinckrodt Inc.,

675 McDonnell

Boulevard,

Hazelwood, MO

63042, USA

2732 Methionine methionine tablets film-coated250mg,

in blister (50/5x10/)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A05BA 1460503.07.2015

03.07.2020PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

2733Methotrexat

"Ebewe"methotrexate

solution for

injection/infusion

10mg/ml,

1ml ampoules (10)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BA01 1605217.10.2016

17.10.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

589

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2734Methotrexat

"Ebewe"methotrexate

solution for

injection/infusion

10mg/ml,

5ml ampoules (5)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BA01 1605317.10.2016

17.10.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

2735 Methotrexate methotrexate tablets film-coated2,5mg,

in blister (20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BA01 1418606.02.2015

06.02.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2736 Methotrexate methotrexate tablets film-coated5mg,

in blister (20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BA01 1418706.02.2015

06.02.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2737 Methotrexate

methotrexate

(methotrexate

sodium)

powder lyophilized

for solution for

injection

50mg,

glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BA01 1579020.07.2016

20.07.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

2738Methotrexate

Ebewemethotrexate tablets

5mg,

in plastic container (50)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee - batch

releaser, Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany-

bulk manufacturer,

packager

Austria L01BA01 1455409.06.2015

09.06.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

590

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2739Methotrexate

Ebewemethotrexate tablets

2,5mg,

in plastic container (50)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee - batch

releaser, Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany-

bulk manufacturer,

packager

Austria L01BA01 1455509.06.2015

09.06.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

2740Methotrexate

Ebewemethotrexate tablets

10mg,

in plastic container (50)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee - batch

releaser, Haupt

Pharma Amareg

GmbH, Donaustaufer

Strasse 378, 93055

Regensburg, Germany-

bulk manufacturer,

packager

Austria L01BA01 1455609.06.2015

09.06.2020PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

2741Methotrexate

Orionmethotrexate tablets

2,5mg,

in plastic container (30,

100)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser

(Orion Corporation,

Tengstrominkatu 8,

20360 Turku, Finland-

bulk manufacturer,

packager)

Finland L01BA01 1448518.05.2015

18.05.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

591

Page 252: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2742Methotrexate

Orionmethotrexate tablets

10mg,

in plastic container (30,

100)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser

(Orion Corporation,

Tengstrominkatu 8,

20360 Turku, Finland-

bulk manufacturer,

packager)

Finland L01BA01 1448618.05.2015

18.05.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

2743 Methyluracil methyluracil suppositories rectal500mg

(10/2x5/)

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia L03AX 1256802.10.2013

02.10.2018PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2744 Methyluracil methyluracilointment for

external use

100mg/g,

15g aluminum tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus D03AX 1363427.06.2014

27.06.2019OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

2745 Methypred

methylprednisolon

(methylpredniso-

lone acetate)

suspension depot for

injection

40mg/ml,

1ml glass vial

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland H02AB04 1249117.05.2013

17.05.2018PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

2746 Methypred methylprednisolone tablets4mg,

in plastic container (30)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland H02AB04 1425420.02.2015

20.02.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

2747 Methypred methylprednisolone tablets16mg,

in plastic container (30)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland H02AB04 1426720.02.2015

20.02.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

592

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2748 Methypred

methylprednisolone

(methylprednisolon

e sodium succinate)

powder for solution

for injection

250mg,

glass vial (1)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser,

secondary packager,

Hikma Farmaceutica,

Estrada do Rio da Mo

n.8, 8A e 8B,

Fervenca, 2705-906

Terrugem SNT,

Portugal-bulk

manufacturer,

primary packager

Finland H02AB04 1628319.12.2016

19.12.2021PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

2749 Methypred

methylprednisolone

(methylprednisolon

e sodium succinate)

powder for solution

for injection

1000mg,

glass vial (1)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser,

secondary packager,

Hikma Farmaceutica,

Estrada do Rio da Mo

n.8, 8A e 8B,

Fervenca, 2705-906

Terrugem SNT,

Portugal-bulk

manufacturer,

primary packager

Finland H02AB04 1628419.12.2016

19.12.2021PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

2750 Metoclopramide

metoclopramide

(metoclopramide

hydrochloride)

solution for injection

5mg/ml,

2ml ampoules,

in blister (10, 10/1x10/)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus A03FA01 1235309.04.2013

09.04.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

593

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2751 Metoclopramide

metoclopramide

(metoclopramide

hydrochloride)

solution for injection5mg/ml,

2ml ampoules (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA03FA01 13314

04.03.2014

04.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2752 Metoclopramide

metoclopramide

(metoclopramide

hydrochloride)

tablets10mg,

in blister (50/5x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A03FA01 1455809.06.2015

09.06.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2753 Metoclopramide

metoclopramide

(metoclopramide

hydrochloride)

solution for injection

5mg/ml,

2ml ampoules (10), 2ml,

ampoules,

in blister (10/1x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus A03FA01 1694605.09.2017

05.09.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2754 Metoject

methotrexate

(methotrexate

disodium)

solution for injection

10mg/ml,

0,75ml glass pre-filled

measuring syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13162/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

594

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2755 Metoject

methotrexate

(methotrexate

disodium)

solution for injection

10mg/ml,

1ml glass pre-filled

measuring syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13163/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

2756 Metoject

methotrexate

(methotrexate

disodium)

solution for injection

10mg/ml,

1,5ml glass pre-filled

measuring syringe,

blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13164/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

2757 Metoject

methotrexate

(methotrexate

disodium)

solution for injection

10mg/ml,

2ml glass pre-filled

measuring syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13165/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

595

Page 256: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2758 Metoject

methotrexate

(methotrexate

disodium)

solution for injection

10mg/ml,

2,5ml glass pre-filled

measuring syringe, blister

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

packager, batch

releaser (dosage form

manufacturer -

Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany)

Germany L01BA01 13166/122.11.2016

10.01.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

2759 Metoprolol

metoprolol

(metoprolol

tartrate)

tablets50mg,

in blister (30/3x10/)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia C07AB02 1373324.07.2014

24.07.2019PoM

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

2760 Metoprolol

metoprolol

(metoprolol

tartrate)

tablets100mg,

in blister (30/3x10/)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia C07AB02 1373424.07.2014

24.07.2019PoM

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

2761 Metoprolol

metoprolol

(metoprolol

tartrate)

tablets50mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC07AB02 14885

24.09.2015

24.09.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2762

Metoprolol

Tartrate Injection,

USP

metoprolol

(metoprolol

tartrate)

solution for

injection/infusion

1mg/ml,

5ml glass vials (10)

Agila Specialties

Private Limited,

Strides House, Opp.

IIM, Bilekahali,

Bannerghatta Road,

Banglore- 560 076

India C07AB02 1349315.05.2014

15.05.2019PoM

Sagent

Pharmaceuticals Inc,

1901 N. Roselle Road,

Suite 700 USA

596

Page 257: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2763 Metpure-XL 25

metoprolol

(metoprolol

succinate)

tablets prolonged

release film-coated

25mg; (30/3x10/) in

blister

Emcure

Pharmaceuticals Ltd.,

Lane No. 3, Phase II,

SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India C07AB02 1333117.03.2014

17.03.2019PoM

Emcure

Pharmaceuticals Ltd.,

T-184, M.I.D.C.,

Bhosari, Pune-

411026, Maharashtra,

India

2764 Metrogyl metronidazolesolution for i/v

injection

5mg/ml,

100ml plastic bottle

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.)

(Plot No 4, Phase IV,

G.I.D.C. Industrial

Area, Panoli: 394 116,

Gujarat State)

India J01XD01 1300128.10.2013

28.10.2018PoM

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.)

(B, Wing, 4-th Floor,

Hind Cycle

Road,Worli, Mumbai

400 030, India)

2765 Metrogyl metronidazolesolution for i/v

injection

5mg/ml,

100ml plastic bottle

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.)

(Plot No 304-308,

Phase IV, G.I.D.C.

Industrial Area,

Panoli: 394 116,

Gujarat State)

India J01XD01 1300228.10.2013

28.10.2018PoM

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.)

(Neelam Centre, B ,

Wing, 4-th Floor,

Hind Cycle

Road,Worli, Mumbai

400 030, India)

597

Page 258: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2766 Metrogyl metronidazole gel for external use

10mg/g,

30g aluminium or

laminated plastic tube

Unique

Pharmaceutical

Laboratories, Plot N

304-308, G.I.D.C.

Industrial Area,

Panoli: 394 116,

Gujarat State

India D06BX01 1463803.07.2015

03.07.2020PoM

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.)

Worli, Mumbai-400

030, India

2767 Metrogyl denta

metronidazole

(metronidazole

benzoate),

chlorhexidine

digluconate

(chlorhexidine

digluconate 20%

solution)

gel dental 10mg/g+0,5mg/g, 5g, 10g

and 20g plastic tube

Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.),

Plot No. 304-308,

G.I.D.C. Industrial

Area, Panoli: 394 116,

Gujarat State

India A01AB11 1693223.08.2017

23.08.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

2768 Metromezol-Dent

metronidazole,

chlorhexidine

(chlorhexidine

digluconate)

gel10mg/g+0,5mg/g, 20g

aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus A01AB11 1385218.09.2014

18.09.2019OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

2769 Metromicon Forte

metronidazole,

miconazole(micona

zole nitrate)

suppositories vaginal

(pessaries)750mg+200mg, (7/1x7/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF20 1562424.05.2016

24.05.2021PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

598

Page 259: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2770 Metromikon-Neometronidazole,

miconazole nitratesuppositories vaginal 500mg+100mg (14/2x7/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF20 1353830.05.2014

30.05.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

2771Metronidazol

Nycomedmetronidazole tablets film-coated

500mg,

in glass container (20)

Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde -

packager, batch

releaser (dosage form

manufacturer -

Nycomed Danmark

ApS, Adelgade 18 A,

DK-9500 Hobro,

Denmark)

Denmark P01AB01 1243707.05.2013

07.05.2018PoM

Nycomed Danmark

ApS, Langebjerg 1,

DK-4000 Roskilde,

Denmark

2772 Metronidazole metronidazole suppositories vaginal500mg

(10/2x5)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF01 1259021.06.2013

21.06.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

2773 Metronidazole metronidazole tablets250mg,

in blister (20/1x20/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia P01AB01 1409218.12.2014

18.12.2019PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

2774 Metronidazole metronidazolesolution fori/v

infusion

5mg/ml,

100ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaJ01XD01 14148

29.12.2014

29.12.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

599

Page 260: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2775 Metronidazole metronidazole tablets

250mg,

in blister (10),

in blister/10/ (300)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus P01AB01 1697505.09.2017

05.09.2022PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

2776Metronidazole

0,5%metronidazole solution for infusion

5mg/ml,

100ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaJ01XD01 12633

21.06.2013

21.06.2018PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Armenia

2777Metronidazole 1%

gelmetronidazole gel

10mg/g,

20g tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD06BX01 13487

30.04.2014

30.04.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2778Metronidazole

Denta

metronidazole

(metronidazole

benzoate),

chlorhexidine

(chlorhexidine

gluconate 20%

solution)

gel for gums10mg/g+0,5mg/g, 20g

aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA01AB11 14079

16.12.2014

16.12.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2779Metronidazole

Nycomedmetronidazole tablets film-coated

500mg,

in glass container (20)

Takeda Pharma AS,

Jaama 55b Polva,

Polva county 63308-

batch releaser,

packager, Takeda

Pharma

A/S,Apotekerstien 9,

9500 Hobro, Denmark-

bulk manufacturer

Estonia P01AB01 1641210.02.2017

10.02.2022PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

600

Page 261: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2780Metronidazole-

Asteriametronidazole tablets

500mg,

in blister (30/3x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth P01AB01 14424/228.10.2015

14.04.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

2781 Metvixmethyl

aminolevulinate

cream for external

use

160mg/g,

2g aluminium tube

Laboratoires

Galderma Z.I.

Montdesir, 74540

Alby-sur-Cheran

France L01XD03 1608910.11.2016

10.11.2021PoM

Galderma SA,

Zugerstrasse 8, CH-

6330 Cham,

Switzerland

2782 Mexicam meloxicam tablets film-coated15mg,

in strip (20/2x10/)

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city

Egypt M01AC06 1425220.02.2015

20.02.2020PoM

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city, Egypt

2783 Mexicam

meloxicam,

lidocaine (lidocaine

hydrochloride)

solution for i/m

injection

5mg/ml+3mg/ml, 3ml

ampoules (6)

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city

Egypt M01AC06 1511315.12.2015

15.12.2020PoM

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city, Egypt

2784 Mexidolethylmethylhydrox

ypyridine succinatetablets film-coated

125mg,

blisters (30/3x10/,

50/5x10/)

ZAO Zio-Zdorove,

142103, Moscow

region, Podolsk, str.

Zheleznodorozhnaya,

2

Russia N07XX 13818/116.02.2016

10.09.2019PoM

JSC NPK

PHARMASOFT,

115280, Moscow,

Avtozavodskaya str.,

17, b. 3, office 4,

Russia

2785 Mexidolethylmethylhydrox

ypiridine succinate

solution for i/v and

i/m injection

50mg/ml,

5ml ampoules (5)

OOO Ellara, 601122,

Vladimir reg.,

Petushinsky district,

Pokrov, str. Franza

Shtolverka, b. 20/2

Russia N07XX 13819/108.12.2015

10.09.2019PoM

OOO NPK

PHARMASOFT,

115280, Moscow,

Avtozavodskaya str.,

17, b. 3, office 4,

Russia

601

Page 262: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2786 Mexidolethylmethylhydrox

ypiridine succinate

solution for i/v and

i/m injection

50mg/ml,

2ml ampoules, in blister

(10/2x5/)

OOO Ellara, 601122,

Vladimir reg.,

Petushinsky district,

Pokrov, str. Franza

Shtolverka, b. 20/2

Russia N07XX 13820/108.12.2015

10.09.2019PoM

OOO NPK

PHARMASOFT,

115280, Moscow,

Avtozavodskaya str.,

17, b. 3, office 4,

Russia

2787 Mexidolethylmethylhydrox

ypyridine succinate

solution for i/v and

i/m injection

50mg/ml,

2ml ampoules , in blister

(10/2x5/)

FKP Armavirskaya

biofabrika, 352212,

Krasnodar reg.,

Novokubanskiy

district, Progress

settlement, str.

Mechnikova, b. 11

Russia N07XX 14834/118.01.2016

04.09.2020PoM

LLC NPK

PHARMASOFT,

115280,

Moscow,Avtozavodsk

aya str., 17, b. 3,

office 4, Russia

2788 Mexidolethylmethylhydrox

ypyridine succinate

solution for i/v and

i/m injection

50mg/ml,

5ml ampoules, in blister

(5/1x5/)

FKP Armavirskaya

biofabrika, 352212,

Krasnodar reg.,

Novokubanskiy

district, Progress

settlement, str.

Mechnikova, b. 11

Russia N07XX 14835/118.01.2016

04.09.2020PoM

LLC NPK

PHARMASOFT,

115280,

Moscow,Avtozavodsk

aya str., 17, b. 3,

office 4, Russia

2789 Mexilethylmethylhydrox

ypiridine succinatecapsules

125mg,

in blister (30/3x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN07XX 13264

10.03.2014

10.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2790 Mexilethylmethylhydrox

ypyridine succinate

solution for i/v and

i/m injection

50mg/ml; (10/2x5/)

ampoules 2ml, in blister

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN07XX 15281

04.02.2016

04.02.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

602

Page 263: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2791 Mexipam

ethylmethylhydrox

y-pyridine

succinate

solution for i/v and

i/m injection

50mg/ml,

2ml glass vials (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaN07XX 15977

15.09.2016

15.09.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2792 Mexiprimethylmethylhydrox

ypyridine succinate

solution for i/v and

i/m injection

50mg/ml,

5ml ampoules, in blister

(5/1x5/)

Scientific

Technological

Pharmaceutical Firm

POLISAN LLC, lit. A,

building 2, Salova st.

72, Saint Petersburg,

192102

Russia N07XX 1457209.06.2015

09.06.2020PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2793 Mexiprimethylmethylhydrox

ypyridine succinate

solution for i/v and

i/m injection

50mg/ml,

2ml ampoules, in blister

(10/2x5/)

Scientific

Technological

Pharmaceutical Firm

POLISAN LLC, lit. A,

building 2, Salova st.

72, Saint Petersburg,

192102

Russia N07XX 1457309.06.2015

09.06.2020PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2794 Mexiprimethylmethylhydrox

ypyridine succinate

solution for i/m and

i/v injection

50mg/ml,

2ml ampoules, in blister

(10/2x5/)

FSUE Moscow

Endocrine Plant, 25,

Novokhokhlovskaya

st., Moscow, 109052

Russia N07XX 1627019.12.2016

19.12.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2795 Mezym Fortepancreatin (lipase,

amylase, protease)tablets film-coated

(3500IU+4200IU+250IU),

in blister (20/1x20/,

40/2x20/, 80/4x20/,

100/5x20/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser (dosage form

manufacturer,

packager - Menarini-

Von Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany)

Germany A09AA02 1260021.06.2013

21.06.2018OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

603

Page 264: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2796 Mezym Fortepancreatin (lipase,

amylase, protease)tablets film-coated

(3500IU+4200IU+250IU),

in blister (20/1x20/,

40/2x20/, 80/4x20/,

100/5x20/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, packager

(dosage form

manufacturer - Berlin-

Chemie AG,

Tempelhofer Weg 83,

12347 Berlin,

Germany)

Germany A09AA02 1260121.06.2013

21.06.2018OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

2797 Mezym forte 10000pancreatin (lipase,

amylase, protease)

tablets gastro-

resistant

not less than 10000U+not

less than 7500U+not less

than 375U,

in blister (10/1x10/,

20/2x10/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany-bulk

manufacturer,

packager

Germany A09AA02 1613610.11.2016

10.11.2021OTC

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin,

Germany

2798 Mezym forte 10000pancreatin (lipase,

amylase, protease)

tablets gastro-

resistant

not less than 10000U+not

less than 7500U+not less

than-375U,

in blister (10/1x10/,

20/2x10/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany A09AA02 1666511.05.2017

11.05.2022OTC

Berlin-Chemie A.G.,

Glienicker Weg 125,

12489 Berlin,

Germany

2799 Miacalcic

calcitonin

(calcitonin salmon

synthetic)

solution for injection100IU/ml,

1ml ampoules (5)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland H05BA01 1634730.12.2016

30.12.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

604

Page 265: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2800 MicoCortisone

miconazole

(miconazole

nitrate),

hydrocortisone

cream20mg/g+10mg/g, 10g

aluminium tube

Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208

Bangladesh D01AC52 14349/121.10.2015

25.03.2020PoM

Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

2801 Micoflu fluconazole capsules150mg,

in blister (1)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia J02AC01 1430419.03.2015

19.03.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

2802 Miconazolmiconazole

(miconazole nitrate)suppositories vaginal

100mg

(7/1x7/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF04 1675305.06.2017

05.06.2022PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

2803 Miconazolemiconazole

(miconazole nitrate)

cream for external

use

20mg/g,

15g aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk region

Belarus D01AC02 1580420.07.2016

20.07.2021OTC

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64/27,

Chapaev str., Borisov

222120, Minsk

region, Belarus

2804

Miconazole 2%

cream for topical

use

miconazole

(miconazole nitrate)cream for topical use

20mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD01AC02 12128

01.02.2013

01.02.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2805 Microlax

sodium citrate,

sodium

laurylsulfoacetate,

sorbitol solution

solution rectal

90mg/ml+9mg/ml+

893mg/ml,

5ml microenema (4, 12)

Famar Orleans, 5

avenue de Concyr,

45071 Orleans, Cedex

2

France A06AG11 1649917.03.2017

17.03.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

605

Page 266: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2806 Midazem midazolam solution for injection5mg/ml,

3ml ampoules (5)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland N05CD08 1553319.04.2016

19.04.2021PoM/UC

Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw,

Poland

2807 Midianadrospirenone,

ethinylestradioltablets film-coated

3mg+0,03mg,

in blister (21/1x21/,

63/3x21/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA12 1522330.12.2015

30.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

2808 Midromax

meldonium

(meldonium

dihydrate)

solution for i/v

injection

100mg/ml,

5ml ampoules,

in blister (10/2x5/)

British-Georgian

Factory EuroMedical

Ltd, Natakhtari, 3300,

Mtskheta

Georgia C01CX 1485304.09.2015

04.09.2020PoM

Unimed Group Corp.

Ltd, No29, 61

Mitskevich str., Vake-

saburtalo, Tbilisi,

Georgia

2809 MIG 400 ibuprofen tablets film-coated

400mg,

in blister

(10, 20/2x10/, 30/3x10/,

50/5x10/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, packager

(dosage form

manufacturer - Berlin-

Chemie AG,

Tempelhofer Weg 83,

12347 Berlin,

Germany)

Germany M01AE01 1302425.11.2013

25.11.2018OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

2810 MIG 400 ibuprofen tablets film-coated

400mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/,

50/5x10/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser (bulk

manufacturer -

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden,

Germany)

Germany M01AE01 1319910.01.2014

10.01.2019OTC

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

606

Page 267: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2811 MIG for children ibuprofen suspension oral

20mg/ml,

100ml plastic bottle and

5ml measuring syringe

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin -

batch releaser (dosage

form manufacturer,

packager -

Farmasierra

Manufacturing S.L.,

Ctra. Irun, Km. 26,

200, San Sebastian de

los Reyes 28700,

Madrid, Spain)

Germany M01AE01 1276014.08.2013

14.08.2018OTC

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin,

Germany

2812 MIG for children ibuprofen suspension oral

20mg/ml,

100ml plastic bottle and

5ml measuring syringe

Farmasierra

Manufacturing S.L.,

Ctra. Irun, Km. 26,

200, San Sebastian de

los Reyes 28700,

Madrid

Spain M01AE01 1276114.08.2013

14.08.2018OTC

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin,

Germany

2813MIG for children

forteibuprofen suspension oral

40mg/ml,

100ml plastic bottle and

measuring syringe 5ml

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin -

batch releaser (dosage

form manufacturer,

packager -

Farmasierra

Manufacturing S.L.,

Ctra. Irun, Km. 26,

200, San Sebastian de

los Reyes 28700,

Madrid, Spain)

Germany M01AE01 1377305.09.2014

05.09.2019OTC

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin,

Germany

2814MIG for children

forteibuprofen suspension oral

40mg/ml,

100ml plastic bottle and

measuring syringe 5ml

Farmasierra

Manufacturing S.L.,

Ctra. Irun, Km. 26,

200, San Sebastian de

los Reyes 28700,

Madrid

Spain M01AE01 1377405.09.2014

05.09.2019OTC

Berline-Chemie AG,

Glienicker Weg

125,12489 Berlin,

Germany

607

Page 268: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2815 MigaDol 400 ibuprofen tablets film-coated

400mg,

in blister (10/1x10/,

100/10x10/)

Flamingo

Pharmaceuticals Ltd,

R-662,T.T.C. Ind.

Area, Rabale, Navi

Mumbai 400 701

India M01AE01 12451/220.06.2014

07.05.2018OTC

Flamingo

Pharmaceuticals Ltd,

P.O. Box No

27257,Mumbai 400

071, India

2816 Mildronat meldonium capsules

500mg,

in blister (20/2x10/,

60/6x10/)

Grindex JSC, Krustpils

street 53, LV-1057,

Riga

Latvia C01EB22 1221307.03.2013

07.03.2018PoM

Grindex JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2817 Mildronat meldonium solution for injection

100mg/ml,

5ml ampoules, in blister

(10/2x5/)

HBM Pharma s.r.o.,

Sklabinska 30, 03680,

Martin

Slovakia C01EB22 1302525.11.2013

25.11.2018PoM

Grindex JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2818 Mildronat

meldonium

(meldonium

dihydrate)

capsules250mg,

in blister (40/4x10/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia C01EB22 1629930.12.2016

30.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2819 Mildronat

meldonium

(meldonium

dihydrate)

solution for injection

100mg/ml,

5ml ampoules, in blister

(10/2x5/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga- batch

releaser, Santonika

UAB, 134B Veiveriu

street,Kaunas, LT-

46352, Lithuania-bulk

manufacturer,

packager

Latvia C01EB22 1630030.12.2016

30.12.2021PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2820 Mildronat

meldonium

(meldonium

dihydrate)

capsules

500mg,

in blister (20/2x10/,

60/6x10/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia C01EB22 1718530.11.2017

30.11.2022PoM

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

608

Page 269: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2821 Mildronat Neo

meldonium

(meldonium

phosphate)

tablets

500mg,

in blister (30/5x6/,

60/10x6/)

Grindex JSC, Krustpils

street 53, LV-1057,

Riga

Latvia C01EB22 1323724.02.2014

24.02.2019PoM

Grindex JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

2822 Milgamma

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,

lidocaine(lidocaine

hydrochloride)

solution for i/m

injection

100mg/2ml+ 100mg/2ml+

1mg/2ml+ 20mg/2ml,

2ml ampoules (5)

Solupharm

Pharmazeutische

Erzeugnisse GmbH,

Industriestrasse 3, D-

34212 Melsungen

Germany A11DB 1702426.09.2017

26.09.2022PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen, Germany

2823 Milgamma

benfotiamine,

pyridoxinbe

(pyridoxine

hydrochloride)

tablets coated

100mg+100mg,

in blisters (30/2x15/,

60/4x15/)

Mauermann -

Arzneimittel KG

Heinrich-Knote-

Strasse 2, Poecking,

Bayern, 82343 - batch

releaser, bulk

manufacturer,

Mauermann -

Arzneimittel KG,

Sankt-Sebastian-

Strasse 13, Aschering,

82343, Germany -

primary packager,

secondary packager

Germany A11DB 1690508.08.2017

08.08.2022PoM

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

2824 Milgamma protekt benfotiamine tablets film-coated

300mg,

in blister (30/3x10/,

60/6x10/, 90/9x10/,

100/10x10/)

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning

Germany A11DA03 1471816.07.2015

16.07.2020OTC

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen, Germany

609

Page 270: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2825 Milorex

amiloride

(amiloride

hydrochloride),

hydrochlorothia-

zide

tablets5mg+50mg,

in blister (30/3x10/)

Remedica Ltd,

Limassol Industrial

Estate, Aharnon

street, 3056 Limassol

Cyprus C03EA01 1468903.07.2015

03.07.2020PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

2826 Minidiab glipizide tablets5mg,

in blister (30/2x15/)

Pfizer Italia S.r.l.

Localita Marino del

Tronto, 63100 Ascoli

Piceno

Italy A10BB07 1478914.08.2015

14.08.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York, 10017, USA

2827 Minirin

desmopressin

(desmopressin

acetate)

tablets0,1mg,

in plastic container (30)

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel -

batch releaser

(Ferring International

Center SA, Chemin

de la Vergognausaz

50, 1162 Saint-Prex,

Switzerland - bulk

manufacturer,

packager)

Germany H01BA02 1399226.11.2014

26.11.2019PoM

Ferring International

Center SA, Chemin

de la Vergognausaz

50, 1162 Saint-Prex,

Switzerland

2828 Minirin

desmopressin

(desmopressin

acetate)

tablets0,2mg,

in plastic container (30)

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel -

batch releaser

(Ferring International

Center SA, Chemin

de la Vergognausaz

50, 1162 Saint-Prex,

Switzerland - bulk

manufacturer,

packager)

Germany H01BA02 1399326.11.2014

26.11.2019PoM

Ferring International

Center SA, Chemin

de la Vergognausaz

50, 1162 Saint-Prex,

Switzerland

610

Page 271: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2829 Mircera

methoxy

polyethylene glycol-

epoetin beta

solution for s/c and

i/v injection

0,05mg/0,3ml, 0,3ml pre-

filled syringe (1)

Roche Diagnostics

GmbH Sandhofer

Strasse 116 D-68305

Mannheim

Germany B03XA03 1369524.07.2014

24.07.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse 124

CH-4070 Basel,

Switzerland

2830 Mirena levonorgestrelintrauterine delivery

system

52mg,

in blister (1)

Bayer Oy, Pansiontie

47, Turku, FI-20210Finland G02BA03 15649

19.05.2016

19.05.2021PoM

Bayer Oy, Pansiontie

47, Turku, FI-20210,

Finland

2831 Mirolute misoprostol tablets

200mcg,

in blister (4),

in plastic container (4)

Obninsk Chemical

Pharmaceutical

Company CJSC,

Kaluga reg.,

Kiyevskoe str.,b.103,

b.107, Obninsk

Russia G02AD06 1703426.09.2017

26.09.2022PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

2832 Miropriston mifepristone tablets200mg,

in blister (3/1x3/)

Obninsk Chemical

Pharmaceutical

Company CJSC,

249036, 4 Koroleva

str., Obninsk, Kaluga

region

Russia G03XB01 1642310.02.2017

10.02.2022PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2833 Mirtazapine Canon mirtazapine tablets film-coated

30mg,

in blister, (30/3x10/,

30/1x30/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N06AX11 1527604.02.2016

04.02.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

2834 Mirtazapine Canon mirtazapine tablets film-coated45mg,

in blister (30/3x10/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N06AX11 1527704.02.2016

04.02.2021PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

611

Page 272: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2835 Mirvaso 3mg/g gel

brimonidine

(brimonidine

tartrate)

gel

3,3mg/g,

2g, 10g and 30g laminated

or polyfoil plastic tube

Laboratoires

Galderma Z.I.

Montdesir, 74540

Alby-sur-Cheran

France D11AX21 1502702.12.2015

02.12.2020PoM

Galderma SA,

Zugerstrasse 8, CH-

6330 Cham,

Switzerland

2836Mitoxantron

Ebewe 2mg/ml

mitoxantrone

(mitoxantrone

hydrochloride)

concentrate for

solution for infusion

2mg/ml,

10ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01DB07 1617423.11.2016

23.11.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

2837Mitoxantron

Ebewe 2mg/ml

mitoxantrone

(mitoxantrone

hydrochloride)

concentrate for

solution for infusion

2mg/ml,

5ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01DB07 1617523.11.2016

23.11.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee, Austria

2838 Mixtard 30insulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AD01 1370124.07.2014

24.07.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2839 Mixtard 30insulin human

(recombinant DNA)

suspension for

injection

100IU/ml,

10ml glass vial (1)

Novo Nordisk

Production SAS, 45

avenue d`Orleans, F-

28000, Chartres

France A10AD01 1715907.11.2017

07.11.2022PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2840 Mixtard 30 Penfill insulin humansuspension for

injection

100IU/ml,

3ml glass cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AD01 13510/102.07.2014

30.05.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

2841 Moditen depo

fluphenazine

(fluphenazine

decanoate)

solution for i/m

injection

25mg/ml,

1ml ampoules, in blister

(5/1x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N05AB02 1616723.11.2016

23.11.2021PoM/UC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

612

Page 273: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2842 Momederm

mometasone

(mometasone

furoate)

cream1mg/g,

15g, 30g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AC13 12221/105.09.2014

07.03.2018PoM

Valeant LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2843 Momederm

mometasone

(mometasone

furoate)

ointment for

external use

1mg/g,

15g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AC13 1636530.12.2016

30.12.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

2844 Mononine 1000

human blood

coagulation factor

IX

powder and solvent

for solution for

injection or infusion

1000IU; I pack (glass vial

with powder and 10ml

glass vial with solvent), II

pack ( filter transfer

device 20/20, N1 syringe

10ml, N1 venipuncture

set, N2 alcohol swabs, N1

non-sterile plaster)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg-batch

releaser, CSL Behring

L.L.C., 1201 N Kinzie

Ave, Bradley, Illinois

(IL) 60915, USA-bulk

manufacturer,

packager

Germany B02BD04 1536826.02.2016

26.02.2021PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

2845 Mononine 500

human blood

coagulation factor

IX

powder and solvent

for solution for

injection or infusion

500IU; I pack (glass vial

with powder and 5ml

glass vial with solvent), II

pack ( filter transfer

device 20/20, N1 syringe

10ml, N1 venipuncture

set, N2 alcohol swabs, N1

non-sterile plaster)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg-batch

releaser, CSL Behring

L.L.C., 1201 N Kinzie

Ave, Bradley, Illinois

(IL) 60915, USA-bulk

manufacturer,

packager

Germany B02BD04 1536926.02.2016

26.02.2021PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

613

Page 274: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2846

Monosorb XL

60mg Prolonged-

Release Tablets

isosorbide

mononitrate

tablets prolonged-

release

60mg,

in blister (28/2x14/)

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch

releaser (dosage form

manufacturer,

packager - Dexcel

Ltd., 1 Dexcel St., Or-

Akiva 30600, Israel)

UK C01DA14 1258607.06.2013

07.06.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

2847Montelukast 10mg

film-coated tablets

montelukast

(montelukast

sodium)

tablets film-coated10mg,

in blister (28/2x14/)

Accord Healthcare

Limited, Sage House,319

Pinner Road, North

Harrow, Middlesex, HA1

4HF- batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK R03DC03 1485615.09.2015

15.09.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2848 Montevizin

tetryzoline

(tetryzoline

hydrochloride)

drops eye

0,5mg/ml,

10ml glass vial and

measuring dropper

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemomont d.o.o.,

81000,Podgorica, Ilije

Plamenca str. bb,

Montenegro-bulk

manufacturer,

packager

Serbia S01GA02 1627619.12.2016

19.12.2021OTC

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

614

Page 275: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2849 Montezim-10

montelukast

(montelukast

sodium)

tablets10mg,

in blister (30/3x10/)

Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India R03DC03 1519530.12.2015

30.12.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

2850 Montezim-5

montelukast

(montelukast

sodium)

tablets chewable5mg,

in blister (30/3x10/)

Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India R03DC03 1527804.02.2016

04.02.2021PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

2851 Montol

montelukast

(montelukast

sodium)

tablets chewable5mg,

in blister (28/4x7/)

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia - batch

releaser (bulk

manufacturer -

Pharmacare Pcl,

Beitunia Industrial

Zone, P.O. Box. 677,

Raballah, Palestine)

Cyprus R03DC03 12684/118.12.2014

17.07.2018PoM

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

615

Page 276: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2852 Montol

montelukast

(montelukast

sodium)

tablets chewable10mg,

in blister (28/4x7/)

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia - batch

releaser (bulk

manufacturer -

Pharmacare Pcl,

Beitunia Industrial

Zone, P.O. Box. 677,

Raballah, Palestine)

Cyprus R03DC03 12685/118.12.2014

17.07.2018PoM

Delorbis

Pharmaceuticals Ltd.,

17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

2853 Monural

fosfomycin

(fosfomycin

trometamol)

granules for oral

solution

3g,

8g sachets (1, 2)

Zambon Switzerland

Ltd., Via Industria 13,

CH-6814, Cadempino

Switzerland J01XX01 14688/130.06.2016

29.06.2020PoM

Zambon S.P.A., Via

Lillo Del Duca, 10,

Bresso, 20091, Italy

2854 Moreal plus dexpanthenol spray nasal

10mg/ml,

20ml plastic container

(140 dose)

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel -

batch releaser (dosage

form manufacturer,

packager - Ursapharm

Arzneimittel GmbH,

Industriestrasse 66129

Saarbrucken,

Germany)

Germany R01AX10 1278514.08.2013

14.08.2018OTC

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel,

Germany

616

Page 277: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2855

Morfina

hydrohlorids-

Kalceks

morphine

hydrochloride

solution for i/v, i/m

and s/c injection

10mg/ml,

1ml ampoules in blister

(10/2x5/)

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057 - batch

releaser (HBM

Pharma s.r.o.,

Sklabinska 30, 03680

Martin, Slovakia-bulk

manufacturer,

packager)

Latvia N02AA01 1375605.08.2014

05.08.2019PoM/UC

Kalceks JSC, 53

Krustpils Street, Riga,

LV-1057, Latvia

2856Morphine

hydrochloride

morphine

(morphine

hydrochloride)

solution for injection

10mg/ml,

1ml ampoules,

in blister (100/20x5/)

"KPE" Zdorovje

narodu" LLC, 61002,

Kharkov, Melnikova

str. 41

Ukraine N02AA01 1627119.12.2016

19.12.2021PoM/UC

"KPE" Zdorovje

narodu" LLC, 61013,

Kharkov, Sevchenko

str. 22, Ukraine

2857 Motilium domperidone tablets film-coated

10mg,

in blister (10/1x10/,

30/1x30/)

Janssen-Cilag,

Domaine de

Maigremont, 27100

Val de Reuil

France A03FA03 1418306.02.2015

06.02.2020PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

2858 Motoricum domperidone tablets10mg,

in blister (30/3x10/)

Medochemie Ltd., 2

Michael Eracleous

Street, Agios

Athanasios Industrial

Area, 4101, Agios

Athanassios, Limassol

Cyprus A03FA03 1231422.03.2013

22.03.2018PoM

Medochemie Ltd.,

P.O. Box 51409, 3505

Limassol, Cyprus

2859 Movalis meloxicam tablets7,5mg,

in blister (20/2x10/)

Boehringer Ingelheim

Ellas A.E., 5th km,

Paiania-Markopoulo,

194 00 Koropi

Greece M01AC06 1650617.03.2017

17.03.2022PoM

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

617

Page 278: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2860 Movalis meloxicam tablets15mg,

in blister (20/2x10/)

Boehringer Ingelheim

Ellas A.E., 5th km,

Paiania-Markopoulo,

194 00 Koropi

Greece M01AC06 1650717.03.2017

17.03.2022PoM

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

2861 Movalis meloxicamsolution for i/m

injection

15mg/1,5ml,

1,5ml ampoules (3)

Boehringer Ingelheim

Espana S.A., Prat de la

Riba, 50, 08174 Sant

Cugat del Valles,

Barcelona

Spain M01AC06 1716230.11.2017

30.11.2022PoM

Boehringer Ingelheim

International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

2862 Moviprep

sachet A-macrogol

(macrogol 3350),

sodium sulfate,

sodium chloride,

potassium chloride;

sachet B-ascorbic

acid, sodium

ascorbate

powder for oral

solution

sachet A-100g+7.5g+

2.691g+1.015g, sachet B-

4.7g+5.9g,

(4/(2) sachetA(111.896 g)

+ (2) sachetB(10.6 g)/)

Norgine Limited,

New Road, Tir-Y-

Berth, Hengoed, Mid

Glamorgan, CF82 8SJ

UK A06AD 1480804.09.2015

04.09.2020PoM

Norgine B.V.,

Hogehilweg 7,

1101CA Amsterdam

ZO, the Netherlands

2863 Movix meloxicam tablets7,5mg,

in blister (20/2x10/)

Unipharm JSC, 3

Traiko Stanoev Str.,

Sofia 1797

Bulgaria M01AC06 1673105.06.2017

05.06.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2864 Movix meloxicam tablets15mg,

in blister (20/2x10/)

Unipharm JSC, 3

Traiko Stanoev Str.,

Sofia 1797

Bulgaria M01AC06 1673205.06.2017

05.06.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2865 Moxicin

moxifloxacin

(moxifloxacin

hydrochloride)

drops eye5mg/ml,

5ml plastic vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01AE07 14715

16.07.2015

16.07.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

618

Page 279: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2866 Moxicin

moxifloxacin

(moxifloxacin

hydrochloride)

solution for infusion

400mg/250ml, 250ml

plastic pack, in light-proof

bag

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaJ01MA14 14716

16.07.2015

16.07.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2867 Moxin

moxifloxacin

(moxifloxacin

hydrochloride)

tablets coated400mg,

in blister (5/1x5/)

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi

Georgia J01MA14 1667211.05.2017

11.05.2022PoM

GM Pharmaceuticals

Ltd, Phonichala 65,

0165 Tbilisi, Georgia

2868 Moxi-Tech

moxifloxacin

(moxifloxacin

hydrochloride)

solution for infusion1,6mg/ml,

250ml plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaJ01MA14 14270

20.02.2015

20.02.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

2869 Mucaltin althaeae officinalis tablets50mg,

in strip (10)

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

RussiaR05CA;

herbal drug14071

19.12.2014

19.12.2019OTC

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

2870 Mucaltin althaea officinalis tablets

50mg,

in strip (10),

in plastic bottle (30)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

UkraineR05CA;

herbal drug16950

05.09.2017

05.09.2022OTC

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

2871 Mucosat-Belmed

chondroitin sulfate

(chondroitin sulfate

sodium)

solution for i/m

injection

100mg/ml,

2ml ampoules (5/1x5/,

10/2x5/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus M01AX25 1713507.11.2017

07.11.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

619

Page 280: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2872 Multimax vitamins, minerals tablets film-coated

1mg+5mcg+10mg+60mg+

1,5mg+ 1,7mg+2mg+

20mg+6mcg+

10mg+10mcg+

400mcg+35,5mg+20mg+9

mg+10mg+1mg+15mg+

12,5mcg+12,5mcg+2,5mg

+5mcg+ 2,5mÖ�g+5mcg+

5mcg+12,5mcg+

150mcg+20mg+

22mg+125mcg,

in blister (30/1x30/,

60/2x30/)

Unipharm Inc., 200

Hick str., Westbury,

New York 11590

USA A11AA04 1213701.02.2013

01.02.2018OTC

Unipharm Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

2873 Multivitamin

vitamin A, vitamin

D3, vitaminE,

vitamin B1,vitamin

B2, vitamin B6,

nicotinamide,

vitamin B12, D-

panthenol

solution for injection

15,000IU+

1,000IU+20mg+

10mg+6.85mg+

3mg+35mg+

0.05mg+25mg, 100ml

glass vial (12)

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden

the Netherlands

QA11B;

veterinary

drug

1449815.05.2015

15.05.2020PoM

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden,

the Netherlands

2874

Multivitamin

solution for

injection

vitamin A, vitamin

D3, vitamin E,

vitamin B1, vitamin

B2, vitamin B6,

nicotinamide,

dexpanthenol,

vitamin B12

solution for injection

15000IU/ml+ 25mcg/ml+

20mg/ml+ 10mg/ml+

5mg/ml+3mg/ml+

35mg/ml+ 25mg/ml+

25mcg/ml, 100ml glass

bottle

Norbrook

Laboratories Limited,

Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QA11BA

veterinary

drug

1301325.11.2013

25.11.2018PoM

Norbrook

Laboratories Limited,

Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

620

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2875 Mycamine

micafungin

(micafungin

sodium)

powder lyophilized

for solution for

infusion

100mg,

glass vial (1)

Astellas Ireland Co.,

Kerry County,

Killorglin- batch

releaser, secondary

packager, Astellas

Pharma Tech Co.,

Ltd., 30 Toidesakae-

machi, Takaoka city,

Toyama 939-1118,

Japan-bulk

manufacturer,

primary packager

Ireland J02AX05 1525029.12.2015

29.12.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

2876 Mycamine

micafungin

(micafungin

sodium)

powder lyophilized

for solution for

infusion

50mg,

glass vial (1)

Astellas Ireland Co.,

Kerry County,

Killorglin- batch

releaser, secondary

packager, Astellas

Pharma Tech Co.,

Ltd., 30 Toidesakae-

machi, Takaoka city,

Toyama 939-1118,

Japan-bulk

manufacturer,

primary packager

Ireland J02AX05 1525129.12.2015

29.12.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

2877 Mycoseptinundecylenic acid,

zinc undecylinateointment

1500mg+6000mg, 30g

aluminium tube

Zentiva, k.s., U

kabelovny 130, 102 37

Praha 10, Dolni

Mecholupy

Czech Republic D01AE54 1311824.12.2013

24.12.2018OTC

Zentiva, k.s., U

kabelovny 130, 102

37 Praha 10, Dolni

Mecholupy, Czech

Republic

2878 Mycosyst fluconazole capsules50mg,

in blister (7)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary J02AC01 1470016.07.2015

16.07.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

621

Page 282: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2879 Mycosyst fluconazole capsules100mg,

in blister (28/4x7/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary J02AC01 1470116.07.2015

16.07.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2880 Mycosyst fluconazole capsules150mg,

in blister (1, 2)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary J02AC01 1470216.07.2015

16.07.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2881 Mycosyst fluconazole solution for infusion2mg/ml,

100ml glass vial

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary J02AC01 1470316.07.2015

16.07.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2882 Mydocalm

tolperisone

(tolperisone

hydrochloride)

tablets film-coated50mg,

in blister (30/3x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M03BX04 1306025.11.2013

25.11.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2883 Mydocalm

tolperisone

(tolperisone

hydrochloride)

tablets film-coated150mg,

in blister (30/3x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M03BX04 1306125.11.2013

25.11.2018PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

2884Mydocalm solution

for injection

tolperisone

(tolperisone

hydrochloride),

lidocaine (lidocaine

hydrochloride)

solution for injection100mg/ml+ 2,5mg/ml,

1ml ampoules (5)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M03BX04 1442714.04.2015

14.04.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

2885 Mydoptic

phenylephrine

(phenylephrine

hydrochloride)

drops eye25mg/ml; (1) and (10)

plastic vial-droppers 10ml

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01FB01 12686/1

28.11.2014

17.07.2018PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

622

Page 283: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2886 Myfortic

mycophenolic acid

(mycophenolate

sodium)

tablets gastro-

resistant

180mg,

in blister (120/12x10/)

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L04AA06 1370424.07.2014

24.07.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

2887 Myfortic

mycophenolic acid

(mycophenolate

sodium)

tablets gastro-

resistant

180mg,

in blister (120/12x10/)

Novartis Pharma

Produktions GmbH,

Oeflinger Strasse 44,

79664 Wehr

Germany L04AA06 1697705.09.2017

05.09.2022PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

2888 Myoxant

cisatracurium

(cisatracurium

besylate)

solution for i/v

injection

2mg/ml,

2.5ml glass vials (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaM03AC11 14495

15.05.2015

15.05.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

2889 Mythro 500

azithromycin

(azithromycin

dihydrate)

tablets film-coated500mg,

in blister (3/1x3/)

Akriti

Pharmaceuticals Pvt.

Ltd., Plot No. D-10, D-

11, M.I.D.C. Indl.

Estate, Nira Road,

Jejuri, Tal. Purandar

(Saswad), Dist. Pune-

412 303, Maharashtra

India J01FA10 1613510.11.2016

10.11.2021PoM

Akriti

Pharmaceuticals Pvt.

Ltd., 117, Block No. 2,

Emerald Plaza,

Hiranandani

Meadows, Barrister

Nath Pai Road, Thane

(West) 400 610, India

2890 5-NOK nitroxoline tablets coated50mg,

in plastic container (50)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana-

batch releaser, Lek

Pharmaceuticals d.d.,

Kolodvorska cesta 27,

Menges, 1234,

Slovenia-bulk

manufacturer,

packager

Slovenia J01XX07 1435025.03.2015

25.03.2020PoM

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana,

Slovenia

623

Page 284: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2891 Najatox

Naja venom,

Methylsalicylate,

Camphora, Eucalipt

oil

ointment for

external use

12MU/100g+ 4g/100g+

3g/100g+2g/100g, 20g

aluminium tube

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thoung Kiet

Street, Ward 15,

District 11, Ho Chi

Minh

VietnamM02AC

herbal drug12788

14.08.2013

14.08.2018OTC

Mekophar Chemical-

Pharmaceutical JSC,

297/5 Ly Thoung Kiet

Street, Ward 15,

District 11, Ho Chi

Minh, Vietnam

2892 Naklofen

diclofenac

(diclofenac

diethylamine)

gel10mg/g,

60g aluminium tube

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M02AA15 1352330.05.2014

30.05.2019OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2893 Naklofendiclofenac

(diclofenac sodium)

tablets prolonged

release film-coated

100mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01A B05 1357410.06.2014

10.06.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2894 Naklofendiclofenac

(diclofenac sodium)

tablets gastro-

resistant

50mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AB05 1652217.03.2017

17.03.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2895 Naklofendiclofenac

(diclofenac sodium)suppositories rectal

50mg,

in strip (10/2x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AB05 1662525.04.2017

25.04.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2896 Naklofendiclofenac

(diclofenac sodium)solution for injection

75mg/3ml,

3ml ampoules (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AB05 1667511.05.2017

11.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2897 Naklofen duodiclofenac

(diclofenac sodium)

capsules prolonged-

release

75mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AB05 1536726.02.2016

26.02.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

624

Page 285: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2898 Nakom levodopa, carbidopa tablets250mg+25mg,

in blister (100/10x10/)

Lek d.d., Verovskova

Str. 57, 1526 LjubljanaSlovenia N04BA02 14166

24.12.2014

24.12.2019PoM

Lek d.d., Verovskova

Str. 57, 1526

Ljubljana, Slovenia

2899 Nalgesinnaproxen (naproxen

sodium)tablets film-coated

275mg,

in blister (10/1x10/,

20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AE02 1564824.05.2016

24.05.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2900 Nalgesin fortenaproxen (naproxen

sodium)tablets film-coated

550mg,

in blister (10/1x10/,

20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia M01AE02 1580620.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2901

NANIPRUS 30mg

powder and

solvent for solution

for infusion

nitroprusside

(nitroprusside

sodium)

powder and solvent

for solution for

infusion

30mg,

ampoule with powder (1),

5ml solvent in ampoule

and black light-proof

plastic bag

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C02DD01 1541109.03.2016

09.03.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

2902 Naphthizin

naphazoline

(naphazoline

nitrate)

drops nasal0,5mg/ml,

10ml plastic vial

PJSC "Farmak",

04080, Kiev, Frunze

str. 74

Ukraine R01AA08 1254706.06.2013

06.06.2018OTC

PJSC "Farmak",

04080, Kiev, Frunze

str. 63, Ukraine

2903 Naphthizin

naphazoline

(naphazoline

nitrate)

drops nasal0,1mg/ml,

10ml plastic vial

PJSC "Farmak",

04080, Kiev, Frunze

str. 74

Ukraine R01AA08 1254806.06.2013

06.06.2018OTC

PJSC "Farmak",

04080, Kiev, Frunze

str. 63, Ukraine

625

Page 286: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2904Naphthyzin-

Arsanitnaphazoline spray nasal

1mg/ml,

10ml glass or plastic vial

and dispenser

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 15124

15.12.2015

15.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2905Naphthyzin-

Arsanitnaphazoline drops nasal

1mg/ml,

5ml and 10ml plastic vial-

dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 16124

10.11.2016

10.11.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2906Naphthyzin-

Arsanitnaphazoline drops nasal

0.5mg/ml,

5ml and 10ml plastic vial-

dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 16125

10.11.2016

10.11.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

626

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2907Naphthyzin-

Arsanit-Snaphazoline drops nasal

0.5mg/ml,

10ml glass vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 15122

15.12.2015

15.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2908Naphthyzin-

Arsanit-Snaphazoline drops nasal

1mg/ml,

10ml glass vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,

Yerevan, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA08 15123

15.12.2015

15.12.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2909Naproxen 250mg

Tabletsnaproxen tablets

250mg,

in blister (28/2x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK M01AE02 1522622.12.2015

22.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

627

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2910Naproxen 500mg

Tabletsnaproxen tablets

500mg,

in blister (28/2x14/)

Accord Healthcare

Limited, Sage House, 319

Pinner Road, North

Harrow, Middlesex, HA1

4HF - batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK M01AE02 1522722.12.2015

22.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

2911 Naproxen-Akri naproxen tablets250mg,

in blister (30/3x10/)

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia M01AE02 1523023.12.2015

23.12.2020PoM

Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

2912 Naratriptan

naratriptan

(naratriptan

hydrochloride)

tablets film-coated2,5mg,

in blister (2/2x1/, 6/6x1/)

Chanelle Medical,

Loughrea, Co. Galway Ireland N02CC02 12542

06.06.2013

06.06.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Armenia

2913 Nasivin

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal0,25mg/ml,

10ml glass bottle

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany R01AA05 1549005.04.2016

05.04.2021OTC

Mecrk

Selbstmedikation

GmbH,

Roesslerstrasse 96,

64293, Darmstadt,

Germany

628

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2914 Nasivin

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal0,1mg/ml,

5ml glass bottle

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany R01AA05 1549105.04.2016

05.04.2021OTC

Mecrk

Selbstmedikation

GmbH,

Roesslerstrasse 96,

64293, Darmstadt,

Germany

2915 Nasivin

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal0,5mg/ml,

10ml glass bottle

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany R01AA05 1549205.04.2016

05.04.2021OTC

Mecrk

Selbstmedikation

GmbH,

Roesslerstrasse 96,

64293, Darmstadt,

Germany

2916 Nasivin

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal0,5mg/ml,

10ml plastic bottle

Merck KGaA,

Frankfurter Strasse

250, 64 293

Darmstadt

Germany R01AA05 1549305.04.2016

05.04.2021OTC

Mecrk

Selbstmedikation

GmbH,

Roesslerstrasse 96,

64293, Darmstadt,

Germany

2917 Nasonex

mometasone

(mometasone

furoate)

spray nasal

(suspension)

50mcg/dose,

18g (140 dose) plastic

bottle with spray pump

Schering-Plough Labo

N.V., Industriepark

30 B-2220, Heist-op-

den-Berg

Belgium R01AD09 1445604.05.2015

04.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

2918 Natalsid sodium alginate suppositories rectal250mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia B02BC 1663725.04.2017

25.04.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

2919 Nature Tears Liqvodextran (dextran

70), hypromellosedrops eye

1mg/ml+3mg/ml, 10ml

vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01XA20 15447

02.04.2016

02.04.2021OTC

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

629

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2920 Navoproxin Plus

meclizine

hydrochloride,

pyridoxine

hydrochloride

tablets25mg+50mg,

in blister (20/2x10/)

Delta Pharma S.A.E.,

Industrial zone B4,

10th of Ramadan city

Egypt R06AE05 1506702.12.2015

02.12.2020PoM

Delta Pharma S.A.E.,

Industrial zone B4,

10th of Ramadan city,

Egypt

2921 Naxogin nimorazole tablets500mg,

glass vial (6)

Pfizer Italia S.r.l.

Localita Marino del

Tronto, 63100 Ascoli

Piceno

Italy P01AB06 1485918.09.2015

18.09.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York, 10017, USA

2922 Naziloc

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal0.5mg/ml,

10ml plastic bottle

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA05 14773

03.08.2015

03.08.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2923 Naziloc

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal

0.5mg/ml,

5ml and 10ml plastic

bottle-dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA05 14775

03.08.2015

03.08.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

630

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2924 Naziloc

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal

0.25mg/ml,

5ml and 10ml plastic

bottle-dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA05 14776

03.08.2015

03.08.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2925 Naziloc

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal0.25mg/ml,

10ml plastic bottle

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA05 14777

03.08.2015

03.08.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2926 Naziloc Baby

oxymetazoline

(oxymetazoline

hydrochloride)

drops nasal

0.1mg/ml,

5ml and 10ml plastic

bottle-dropper

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

secondary packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer,

primary packager

Republic of

ArmeniaR01AA05 14774

03.08.2015

03.08.2020OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

2927 Nazol

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml, 30ml plastic vial

with pump dispencer

Istituto De Angeli

S.r.l., 50066 Reggello

(Florence),

Loc.,Prulli, 103/c

Italy R01AA05 1554825.04.2016

25.04.2021OTC

Bayer Consumer Care

AG, Peter Merian-

Strasse 84, 4052 Basel,

Switzerland

631

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2928 Nazol Advance

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal0,5mg/ml,

15ml, 30ml plastic bottle

Istituto De Angeli

S.r.l., 50066 Reggello

(Florence),

Loc.,Prulli, 103/c

Italy R01AA05 1554925.04.2016

25.04.2021OTC

Bayer Consumer Care

AG, Peter Merian

Strasse 84, 4052 Basel,

Switzerland

2929 Nazol Baby

phenylephrine

(phenylephrine

hydrochloride)

drops nasal

1,25mg/ml,

10ml, 15ml plastic bottle

(1)

Istituto De Angeli

S.r.l., 50066 Reggello

(Florence),

Loc.,Prulli, 103/c

Italy R01AA04 12156/118.06.2015

01.02.2018OTC

Bayer Consumer Care

AG, Peter Merian

Strasse 84, 4052 Basel,

Switzerland

2930 Nazol Kids

phenylephrine

(phenylephrine

hydrochloride)

spray nasal with

eucalypt

2,5mg/ml, 10ml plastic

bottle (1) and 15ml plastic

bottle (1)

Istituto De Angeli

S.r.l., 50066 Reggello

(Florence),

Loc.,Prulli, 103/c

Italy R01AA04 12157/125.08.2015

01.02.2018OTC

Bayer Consumer Care

AG, Peter Merian-

Strasse 84, 4052 Basel,

Switzerland

2931 Nebido

testosterone

(testosterone

undecanoate)

solution for injection250mg/ml,

4ml ampoule

Bayer Pharma AG, D-

13342 Berlin Germany G03BA03 12645

04.07.2013

04.07.2018PoM

Bayer Pharma AG,

Mullerstrasse 178,

13342 Berlin,

Germany

2932 Nebiletnebivolol (nebivolol

hydrochloride)tablets

5mg,

in blister (7/1x7/,

14/1x14/, 28/2x14/)

Berlin-Chemie A.G.,

Glienicker Weg 125 D-

12489 Berlin -

packager, batch

releaser (Berlin-

Chemie AG,

Tempelhofer Weg 83,

D-12347 Berlin,

Germany - bulk

manufacturer)

Germany C07AB12 1383618.09.2014

18.09.2019PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

632

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2933 Nebilet Plus 5/12.5

nebivolol (nebivolol

hydrochloride),

hydrochloro-

thiazide

tablets film-coated5mg+12,5mg,

in blister (28/2x14/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany C07BB12 1625719.12.2016

19.12.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

2934 Nebilet Plus 5/25

nebivolol (nebivolol

hydrochloride),

hydrochloro-

thiazide

tablets film-coated5mg+25mg,

in blister (28/2x14/)

Berlin-Chemie

A.G.,Glienicker Weg

125, D-12489 Berlin-

batch releaser,

packager, Berlin-

Chemie A.G.,

Tempelhofer Weg 83,

D-12347

Berlin,Germany-bulk

manufacturer

Germany C07BB12 1625819.12.2016

19.12.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

2935 Nebivolol STADAnebivolol (nebivolol

hydrochloride)tablets

5mg,

in blisters (100/10x10/)

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel

Germany C07AB12 13215/125.12.2017

24.02.2019PoM

STADA Arzneimittel

AG, Stadastrasse 2-18,

D-61118 Bad Vilbel,

Germany

2936 Neiromidin

ipidacrine

(ipidacrine

hydrochloride)

tablets20mg,

in blister (50/5x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06DA05 1571922.06.2016

22.06.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

633

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2937 Neiromidin

ipidacrine

(ipidacrine

hydrochloride)

solution for i/m and

s/c injection

5mg/ml,

1ml ampoules (10)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114-batch

releaser, Sopharma

JSC, str. Iliensko

shosse 16, 1220 Sofia,

Bulgaria-bulk

manufacturer,

packager

Latvia N06DA05 1575704.07.2016

04.07.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

2938 Neiromidin

ipidacrine

(ipidacrine

hydrochloride)

solution for i/m and

s/c injection

15mg/ml,

1ml ampoules (10)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114-batch

releaser, Sopharma

JSC, str. Iliensko

shosse 16, 1220 Sofia,

Bulgaria-bulk

manufacturer,

packager

Latvia N06DA05 1575804.07.2016

04.07.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

2939Nelsons Sootha

ChildrenBryonia dioica syrup

6C,

150ml plastic bottle and

measuring cup

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

R05X

homeopathic

drug

1351230.05.2014

30.05.2019PoM

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH,

UK

2940 Nemotan nimodipine tablets film-coated30mg,

in blister (30/3x10/)

Medochemie Ltd

(Factory AZ), 2

Michael Erakleous

street, Agios

Athanassios Industrial

Area, 4101 Agios

Athanassios, Limassol

Cyprus C08CA06 1706105.10.2017

05.10.2022PoM

Medochemie Ltd., 1-

10

Constantinoupoleos

street, 3011 Limassol,

Cyprus

2941 Nemozole albendazole tablets film-coated400mg,

in blister (1)

Ipca Laboratories Ltd,

P.O. Sejavta, Dist.

Ratlam 457 002,

Madhya Pradesh

India P02CA03 1358110.06.2014

10.06.2019PoM

Ipca Laboratories Ltd,

48, Kandivli Ind.

Estate, Mumbai 400

067, India

634

Page 295: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2942 Nemozole albendazole suspension oral20mg/ml,

20ml plastic container

Ipca Laboratories Ltd,

P.O. Sejavta, Dist.

Ratlam 457 002,

Madhya Pradesh

India P02CA03 1358210.06.2014

10.06.2019PoM

Ipca Laboratories Ltd,

48, Kandivli Ind.

Estate, Mumbai 400

067, India

2943 Neoderm

gramicidin,

neomycin

(neomycin sulfate),

nystatin,

triamcinolone

acetonide

cream

0,25mg/g+ 2,5mg/g+

100000IU/g+ 1mg/g,

10g and 20g aluminium

tube

Birzeit

Pharmaceutical

Company (BPC),

Ramallah,Industrial

Zone

Palestine D07X 1402926.11.2014

26.11.2019PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

2944 Neosmectin

diosmectite

(smectite

dioctaedric)

powder for oral

suspension with

orange flavour

3000mg,

3,76g sachets (3, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A07BC05 12656/122.06.2015

04.07.2018OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2945 Neosmectin

diosmectite

(smectite

dioctaedric)

powder for oral

suspension with

vanilla flavour

3000mg,

3,76g sachets (3, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/19

Russia A07BC05 12657/122.06.2015

04.07.2018OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2946 Neosmectin

diosmectite

(smectite

dioctaedric)

powder for oral

suspension with

rasberry flavour

3000mg,

3,76g sachets (3, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/20

Russia A07BC05 12658/122.06.2015

04.07.2018OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2947 Neosmectin

diosmectite

(smectite

dioctaedric)

powder for oral

suspension with

lemon flavour

3000mg,

3,76g sachets (3, 10)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/21

Russia A07BC05 12659/122.06.2015

04.07.2018OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

635

Page 296: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2948 Neoton

phosphocreatine

(phosphocreatine

sodium)

powder lyophilized

for solution for

infusion

1000mg,

50ml glass vial, solvent in

glass vial, infusion system

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno

Italy C01EB06 1409518.12.2014

18.12.2019PoM

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno, Italy

2949 Neoviroxodihydroacridiny

lacetate sodium

solution for i/m

injection

125mg/ml,

2ml ampoules (5)

FSBI Russian

Cardiology Research

and Production

Complex of the

Ministry of Health of

the Russian

Federation-

Experimental

production of

biomedical

preparations, 15-a,

3rd Cherepkovskaya

St., 121552, Moscow

Russia L03A 1437716.04.2015

16.04.2020PoM

Pharmsynthez OJSC,

188663, Leningrad

region, Vsevolzhsky

district, urban

settlement

Kuzmolovsky,

Kapitolovo station, N

134, letter 1, Russia

2950 Neranolketoprofen,

omeprazole

capsules modified-

release

100mg+20mg,

in plastic container (30)

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg - batch

releaser (packager -

Rottendorf Pharma

GmbH, Am

Fleigendahl 3, 59320

Ennigerloh,

Germany)

Germany M01AE53 1227922.03.2013

22.03.2018PoM

MEDA

Pharmaceuticals

Limited, Skyway

House, Parsonage

Road, Takeley, Bishop

636

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2951 Neranolketoprofen,

omeprazole

capsules hard

modified-release

200mg+20mg,

in plastic container (30)

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg - batch

releaser (packager -

Rottendorf Pharma

GmbH, Am

Fleigendahl 3, 59320

Ennigerloh,

Germany)

Germany M01AE53 1228022.03.2013

22.03.2018PoM

MEDA

Pharmaceuticals

Limited, Skyway

House, Parsonage

Road, Takeley, Bishop

2952 Nervomix

valerianae radix,

melissae folium,

lupuli strobilus,

hyperici herba

capsules hard

210mg+52,5mg+

52,5mg+35mg, blisters

(30/3x10/, 60/3x20/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

PolandN05CM09;

herbal drug12133/2

09.06.2016

01.02.2018OTC

Adamed Consumer

Healthcare S.A.,

Pienkow 149, 05-152

Czosnow, Poland

2953 Nervomix

valerianae radix,

melissae folium,

lupuli strobilus,

hyperici herba

capsules hard

210mg+52,5mg+

52,5mg+35mg,

in blister (30/3x10/,

60/3x20/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

PolandN05CM;

herbal drug17085

16.10.2017

16.10.2022OTC

Adamed Consumer

Healthcare S.A.,

Pienkow 149, 05-152

Czosnow, Poland

2954 Neuromultivitvitamin B1, vitamin

B6, vitamin B12tablets film-coated

100mg+200mg+ 0,2mg,

in blister (20/1x20/,

100/5x20/)

G.L. Pharma GmbH,

Schlossplatz 1, 8502

Lannach -batch

releaser, G.L. Pharma

GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria A11DB 1508815.12.2015

15.12.2020OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

637

Page 298: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2955 Nevanac nepafenacdrops eye

(suspension)

1mg/ml,

5ml plastic bottle

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01BC10 1519830.12.2015

30.12.2020PoM

Alcon Laboratories

(UK) Ltd., Frimley

Business Park,

Frimley Camberley

Surrey, GU16 7SR,

UK

2956 Nevigramon nalidixic acid capsules500mg,

in plastic container (56)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary J01MB02 1314010.01.2014

10.01.2019PoM

Sanofi-Aventis

Private Co. Ltd.,1045

Budapest, To u. 1-5,

Hungary

2957 Nevralgin

acetylsalicylic acid,

paracetamol,

caffeine

tablets250mg+200mg+ 50mg,

in blister (20/2x10/)

NOKI JV LTD Co.,

Nor-Kharberd, Ararat

region

Republic of

ArmeniaN02BA51 15313

04.02.2016

04.02.2021OTC

NOKI JV LTD Co.,

Nor-Kharberd, Ararat

region, Republic of

Armenia

2958 Nevrolek

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,

lidocaine (lidocaine

hydrochloride)

solution for i/m

injection

50mg/ml+ 50mg/ml+

0,5mg/ml+ 10mg/ml, 2ml

ampoules (5),

2ml ampoules , in blister

(5/1x5/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine A11DB 1551919.04.2016

19.04.2021PoM

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov,

Ukraine

2959 Nextibuprofen,

paracetamoltablets film-coated

400mg+200mg,

in blisters (2/1x2/, 4/2x2/,

6/1x6/, 10/1x10/,

12/1x12/, 12/2x6/,

20/2x10/, 24/2x12/)

Pharmstandard-

Tomskchimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211

Russia N02BE51 13807/130.06.2016

05.09.2019OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2960 Nextibuprofen,

paracetamoltablets film-coated

400mg+200mg,

in blister (2/1x2/, 4/2x2/,

6/1x6/, 10/1x10/,

12/1x12/, 12/2x6/,

20/2x10/, 24/2x12/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02BE51 1662725.04.2017

25.04.2022OTC

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

638

Page 299: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2961 Neyrodolonflupirtine

(flupirtine maleate)capsules

100mg,

in blister (15/1x15/) and

(45/3x15/)

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo

Russia N02BG07 1711823.10.2017

23.10.2022PoM

CJSC Canonpharma

production, 105,

Zarechnaya str.

141100 Moskow

region, Schelkovo,

Russia

2962 Neyrotexethylmethylhydrox

ypyridine succinate

solution for i/m and

i/v injection

50mg/ml,

5ml ampoules,

in blister (5)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia N07XX 1648124.02.2017

24.02.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2963 Neyrotexethylmethylhydrox

ypyridine succinate

solution for i/m and

i/v injection

50mg/ml,

2ml ampoules,

in blister (10/2x5/,

50/10x5)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia N07XX 1648224.02.2017

24.02.2022PoM

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

2964 Niclosamide niclosamide tablets chewable500mg,

in plastic container (4)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP02DA01 15953

02.09.2016

02.09.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

2965 Nicoflex

capsaicin, ethyl

nicotinate,

ethylenglycol

salicylate

ointment for

external use

0.15mg/g+20mg/g+90mg/

g,

50g aluminium tube

Reanal Private Co

Ltd., Telepes u. 54-

56., Budapest, 1147

Hungary M02A 1608710.11.2016

10.11.2021OTC

Medimpex Trading

Private Company

Limited, 1134

Budapest, Lehel utca

11, Hungary

639

Page 300: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2966Nicorandil 10mg

Tabletsnicorandil tablets

10mg,

in blister (60/6x10/)

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields,

Daventry,

Northamptonshire,

NN11 8PB - batch

releaser, Dexcel Ltd.,

1 Dexcel Street, Or-

Akiva 30600, Israel-

bulk manufacturer,

packager

UK C01DX16 1539026.02.2016

26.02.2021PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields,

Daventry,

Northamptonshire,

NN11 8PB, UK

2967Nicorandil 20mg

Tabletsnicorandil tablets

20mg,

in blister (60/6x10/)

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields,

Daventry,

Northamptonshire,

NN11 8PB - batch

releaser, Dexcel Ltd.,

1 Dexcel Street, Or-

Akiva 30600, Israel-

bulk manufacturer,

packager

UK C01DX16 1538926.02.2016

26.02.2021PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields,

Daventry,

Northamptonshire,

NN11 8PB, UK

2968 Nicorette nicotinegum chewing with

menthol flavour

4mg,

in blister (15/1x15/,

30/2x15/, 105/7x15/)

McNeil AB

Norrbroplatsen 2,

Helsingborg, 25109

Sweden N07BA01 1664602.05.2017

02.05.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

2969 Nicorette nicotinegum chewing with

menthol flavour

2mg,

in blister (15/1x15/,

30/2x15/, 105/7x15/)

McNeil AB

Norrbroplatsen 2,

Helsingborg, 25109

Sweden N07BA01 1664702.05.2017

02.05.2022OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

640

Page 301: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2970Nicotinic acid-

Darnitsanicotinic acid solution for injection

10mg/ml,

1ml ampoules,

in blister (10, 10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13

Ukraine C10AC01 12570/130.08.2013

06.06.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13,

Ukraine

2971 Nidol nimesulidepowder for oral

suspension

100mg,

2g sachets (6, 10)

Polipharm Co., Ltd.,

109 Bangna-Trad

Road, Bang Phli

District, Samut

Prakan 10540

Thailand M01AX17 1266604.07.2013

04.07.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

2972 Nidol Gel nimesulide gel20mg/g,

30g aluminium tube

Polipharm Co., Ltd.,

109 Bangna-Trad

Road, Bang Phli

District, Samut

Prakan 10540

Thailand M02AA26 12714/110.12.2013

23.07.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

2973Nifedi-Denk10

Retardnifedipine

tablets extended-

release film-coated

10mg,

in blister (100/10x10/)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C08CA05 1222907.03.2013

07.03.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

2974Nifedi-Denk20

Retardnifedipine tablets film-coated

20mg,

in blister (100/10x10/)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C08CA05 1223007.03.2013

07.03.2018PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Munchen,

Germany

2975 Nifedipin nifedipine tablets coated10mg,

in blister (50/5x10/)

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine C08CA05 1722808.12.2017

08.12.2022PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

641

Page 302: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2976 Nifuromed nifuroxazide suspension oral44mg/ml,

100ml glass bottle

Medical Horizon Ltd

(Masis, Masis Station,

Gordzaranayin 22)

Republic of

ArmeniaA07AX03 12993

28.10.2013

28.10.2018PoM

Medical Horizon Ltd

(Masis, Masis Station,

Gordzaranayin 22,

Republic of Armenia)

2977 Nifuroxazide nifuroxazide tablets100mg,

in blister (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A07AX03 1562924.05.2016

24.05.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

2978 Nimelid nimesulidegranules for oral

suspension

100mg,

2g sachets (10, 30)

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania M01AX17 1492120.10.2015

20.10.2020PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A, Romania

2979 Nimesil nimesulidegranules for oral

suspension

100mg,

2g sachets

(9, 15, 30)

Laboratorios Menarini

S.A., str. Alfonso XII,

587 08918 Badalona

(Barcelona)

Spain M01AX17 1406219.12.2014

19.12.2019PoM

Laboratori Guidotti

S.p.A., Via Livornese,

897 56122 La

Vettola(Pisa), Italy

2980 Nimesil nimesulidegranules for oral

suspension

100mg,

2g sachets

(9, 15, 30)

Fine Foods and

Pharmaceuticals

N.T.M. S.P.A., Via

dell Artigianato, 8/10

24041

Brembate(Bergamo)

Italy M01AX17 1406319.12.2014

19.12.2019PoM

Laboratori Guidotti

S.p.A., Via Livornese,

897 56122 La

Vettola(Pisa), Italy

2981 Nimesubel nimesulide tablets100mg,

in blister (20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus M01AX17 1402626.11.2014

26.11.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

642

Page 303: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2982 Nimotop nimodipine tablets film-coated30mg,

in blister (100/10x10/)

Bayer Pharma AG, D-

51368 Germany C08CA06 13955

28.10.2014

28.10.2019PoM

Bayer Pharma AG, D-

13342,Berlin,

Germany

2983Nimotop solution

for infusionnimodipine solution for infusion

10mg/50ml,

50ml glass vial

Bayer Pharma AG, D-

51368 Germany C08CA06 13956

28.10.2014

28.10.2019PoM

Bayer Pharma AG, D-

13342,Berlin,

Germany

2984 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated10mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07AB07 1552519.04.2016

19.04.2021PoM

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500,

Russia

2985 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated2,5mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07AB07 1552619.04.2016

19.04.2021PoM

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500,

Russia

2986 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated5mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07AB07 1552719.04.2016

19.04.2021PoM

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500,

Russia

2987 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated5mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AB07 1671423.05.2017

23.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2988 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated10mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AB07 1671523.05.2017

23.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

643

Page 304: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

2989 Niperten

bisoprolol

(bisoprolol

fumarate)

tablets film-coated2,5mg,

in blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AB07 1671623.05.2017

23.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2990 Niperten Combi

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets10mg+10mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07FB07 1698405.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2991 Niperten Combi

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets5mg+5mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07FB07 1698505.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2992 Niperten Combi

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets5mg+10mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07FB07 1698605.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2993 Niperten Combi

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets10mg+5mg,

in blister (30/3x10/)

KRKA-RUS LLC, 50

Moskovskaya Str.,

Istra, Moscow

Region,143500

Russia C07FB07 1698705.09.2017

05.09.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

2994 Nitro nitroglycerinconcentrate for

solution for infusion

5mg/ml,

2ml ampoules (5)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland C01DA02 1350630.05.2014

30.05.2019PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

644

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2995 Nitrocor nitroglycerin tablets sublingual0,5mg,

plastic container (40)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia C01DA02 13490/110.10.2017

15.05.2019PoM

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

2996 Nitroglycerin nitroglycerin tablets sublingual0,5mg,

in plastic container (40)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia C01DA02 1323824.02.2014

24.02.2019PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

2997Nitroglycerin

PH&T

glyceryl (glyceryl

trinitrate)

concentrate for

solution for infusion

5mg/ml,

1ml ampoules (10)

Laboratorio Italiano

Biochimico

Farmaceutico

Lisapharma S.p.A.,

Via Licinio, 11-22036

Erba (CO)

Italy C01DA02 1365908.07.2014

08.07.2019PoM

PH&T S.p.A, Via

Marostica, 1-20146

Milan, Italy

2998 Nitroglycerin-AM nitroglycerin tablets sublingual0,5mg,

in plastic container (40)

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region

Ukraine C01DA02 1234109.04.2013

09.04.2018PoM

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region,

UKRAINE

2999 Nitromint nitroglycerinaerosol sublingual

dosed

0,4mg/dose,

10g aluminium tube (180

doses) and and 10g COC

tube (180 doses)

Egis Pharmaceuticals

PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary C01DA02 12784/108.04.2015

14.08.2018PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

3000 Nitrospray nitroglycerinspray sublingual

dosed

0,4mg/dose,

10ml plastic container

(200 doses)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia C01DA02 1368108.07.2014

08.07.2019PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

645

Page 306: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3001 Nitroxoline nitroxoline tablets coated50mg,

in blister (50/5x10/)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia J01XX07 1520030.12.2015

30.12.2020PoM

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

3002 Nitroxoline nitroxoline tablets film-coated50mg,

in blister (50/5x10/)

SIC "Borshchahivskiy

Chemical-

Pharmaceutical Plant"

PJSC, 17, Mira St,

Kyiv, 03134

Ukraine J01XX07 1648709.03.2017

09.03.2022PoM

SIC "Borshchahivskiy

Chemical-

Pharmaceutical

Plant" PJSC, 17, Mira

St, Kyiv, 03134,

Ukraine

3003 Nivalin

galantamine

(galantamine

hydrobromide)

tablets

10mg,

in blister (10/1x10/,

20/2x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1670323.05.2017

23.05.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3004 Nivalin

galantamine

(galantamine

hydrobromide)

tablets

5mg,

in blister (10/1x10/,

20/1x20/, 60/3x20/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1670423.05.2017

23.05.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3005

Nivalin 10mg/ml

solution for

injection

galantamine

(galantamine

hydrobromide)

solution for injection10mg/ml,

1ml ampoules (10)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1698205.09.2017

05.09.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3006

Nivalin 1mg/ml

solution for

injection

galantamine

(galantamine

hydrobromide)

solution for injection1mg/ml,

1ml ampoules (10)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1698005.09.2017

05.09.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3007

Nivalin 2,5mg/ml

solution for

injection

galantamine

(galantamine

hydrobromide)

solution for injection2,5mg/ml,

1ml ampoules (10)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1697905.09.2017

05.09.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

646

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3008

Nivalin 5mg/ml

solution for

injection

galantamine

(galantamine

hydrobromide)

solution for injection5mg/ml,

1ml ampoules (10)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N06DA04 1698105.09.2017

05.09.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

3009 Nixar bilastin tablets

20mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/,

50/5x10/)

A.Menarini

Manufacturing

Logistics and Services

S.r.l.,Via Campo Di

Pile, 67100 L` Aquila

Italy R06AX29 1706505.10.2017

05.10.2022PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

3010 Nizoral ketoconazole shampoo20mg/g,

60ml plastic bottle

Janssen

Pharmaceutica N.V.,

Turnhoutseweg 30, B-

2340 Beerse

Belgium D01AC08 14325/125.09.2017

25.03.2020OTC

Johnson & Johnson,

121614, Moscow,

Krylatskaya str., 17,

building 2, Russia

3011 Nizoral ketoconazolecream for external

use

20mg/g,

15g aluminium tube

Janssen

Pharmaceutica N.V.,

Turnhoutseweg 30, B-

2340 Beerse

Belgium D01AC08 1536326.02.2016

26.02.2021OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

3012 Noctura

Kali brom, Coffea,

Passiflora, Avena

sativa, Alfalfa,

Valeriana

tablets6C+6C+6C+6C+6C+6C,

in blister (72/3x24/)

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

N05CM

homeopathic

drug

1351730.05.2014

30.05.2019PoM

A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH,

UK

3013 No-Dol Broncho

glycyrrhiza glabra,

menthol,

eucalyptus oil, anise

oil, peppermint oil,

pepper oil, pine oil

tablets orodispersible

27.5mg+10mg+

100mcg+100mcg+

50mcg+ 50mcg+25mcg,

in strip (100/25x4/)

Nabros Pharma Pvt.

Ltd., N.H. No. 8

Kajipura, Kheda,

387411, Gujarat

IndiaR05CA10;

herbal drug16226

05.12.2016

05.12.2021OTC

Nabros Pharma Pvt.

Ltd., N.H. No. 8

Kajipura, Kheda,

387411, Gujarat,

India

647

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3014 No-Dol Flu

paracetamol,caffein

e, phenylephrine

(phenylephrine

hydrochloride),

chlorphenamine

(chlorphenamine

maleate)

tablets500mg+30mg+ 5mg+2mg,

in strip (200/50x4/)

Nabros Pharma Pvt.

Ltd., N.H. No. 8

Kajipura, Kheda,

387411, Gujarat

India N02BE51 1622705.12.2016

05.12.2021OTC

Nabros Pharma Pvt.

Ltd., N.H. No. 8

Kajipura, Kheda,

387411, Gujarat,

India

3015 NO-DOL-EMMSIL nimesulide tablets dispersible100mg,

in blister (4, 10)

Protech Biosystems

Pvt Ltd.,Plot No 145-

146, Pace City-1,

Sector-37 Gurgaon,

Haryana

India M01AX17 1236819.04.2013

19.04.2018PoM

Protech Biosystems

Pvt Ltd.,Plot No 145-

146, Pace City-1,

Sector-37 Gurgaon,

Haryana, India

3016 Noflux

rabeprazole

(rabeprazole

sodium)

tablets gastro-

resistant

10mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser

(Laboratorios Liconsa

S.A., Avda.

Miralcampo, No7,

Poligono Industrial

Miralcampo 19200

Azuqueca de Henares

(Guadalajara), Spain -

bulk manufacturer,

packager)

Hungary A02BC04; 13712/114.08.2015

24.07.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

3017 Noflux

rabeprazole

(rabeprazole

sodium)

tablets gastro-

resistant

20mg,

in blister (14/2x7/,

28/4x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120 - batch releaser

(Laboratorios Liconsa

S.A., Avda.

Miralcampo, No7,

Poligono Industrial

Miralcampo 19200

Azuqueca de Henares

(Guadalajara), Spain -

bulk manufacturer,

packager)

Hungary A02BC04 13713/114.08.2015

24.07.2019PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

648

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3018 Nofung fluconazole capsules50mg,

in blister (7/1x7/, 14/2x7/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary J02AC01 1421920.02.2015

20.02.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

3019 Nofung fluconazole capsules150mg,

in blister (1, 4/1x4/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary J02AC01 1422020.02.2015

20.02.2020PoM

Egis Pharmaceuticals

PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

3020 Nolicin norfloxacin tablets film-coated400mg,

in blister (20/2x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA06 1706305.10.2017

05.10.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3021 Noliprel arginine

perindopril

arginine,

indapamide

tablets film-coated2,5mg+0,625mg,

in plastic container (30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BA04 1680622.06.2017

22.06.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3022 Noliprel Bi-Forte

perindopril

(perindopril

arginine),

indapamide

tablets film-coated10mg+2,5mg,

in plastic container (30)

Servier (Ireland)

Industries Ltd, Gorey

Road, Arklow-Co

Wicklow

Ireland C09BA04 1667311.05.2017

11.05.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

3023Noliprel Forte

arginine

perindopril

arginine,

indapamide

tablets film-coated5mg+1,25mg,

in plastic container (30)

Les Laboratoires

Servier Industrie 905,

route de Saran, 45520

Gidy

France C09BA04 1680722.06.2017

22.06.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

649

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3024 Nolpaza

pantoprazole

(pantoprazole

sodium)

powder for solution

for injection

40mg,

glass vial (1, 5,10)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

secondary packager,

Valdepharm, Parc

Industriel d incaville-

BP 606, 27100 Val de

Reuil Cedex, France-

bulk manufacturer,

primary packager

Slovenia A02BC02 1465703.07.2015

03.07.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3025 Nolpaza

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

20mg,

in blister (14/1x14,

28/2x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BC02 15914/110.11.2016

23.08.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3026 Nolpaza

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

40mg,

in blister (14/1x14/,

28/2x14/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia A02BC02 1591523.08.2016

23.08.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

3027 Nonpres eplerenone tablets film-coated

50mg,

in blister (20/2x10/,

30/3x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland C03DA04 15107/113.05.2016

15.12.2020PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice, Poland

3028 Nonpres eplerenone tablets film-coated

25mg,

in blister (20/2x10/,

30/3x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland C03DA04 15108/113.05.2016

15.12.2020PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice, Poland

650

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3029 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

capsules250mg,

in blister (20/2x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1617923.11.2016

23.11.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

3030 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

capsules500mg,

in blister (24/4x6/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1618023.11.2016

23.11.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

3031 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

powder for oral

solution

100mg,

1g sachets (15)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1626919.12.2016

19.12.2021PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

3032 Noofen

gamma-amino-beta-

phenylbutyric acid

hydrochloride

powder for oral

solution

500mg,

2.5g sachet (5)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX22 1657503.04.2017

03.04.2022PoM

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114, Latvia

3033 Nootropil piracetamsolution for i/v and

i/m injection

200mg/ml,

5ml ampoules (12)

Aesica

Pharmaceuticals S.r.l.,

Via Praglia, 15-10044

Pianezza (TO)

Italy N06BX03 1535926.02.2016

26.02.2021PoM

UCB Pharma S.A.,

Allee de la Recherche

60, B-1070 Bruxelles,

Belgium

3034 Nootropil piracetam tablets film-coated800mg,

in blister (30/2x15/)

UCB Pharma S.A.,

Chemin du Foriest, B-

1420 Braine-l'Alleud

Belgium N06BX03 1538426.02.2016

26.02.2021PoM

UCB Pharma S.A.,

Allee de la Recherche

60, B-1070 Bruxelles,

Belgium

3035 Norcolut norethisterone tablets5mg,

in blister (20/2x10/)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03DC02 1506402.12.2015

02.12.2020PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

651

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3036Norditropin

NordiLetsomatropin

solution for s/c

injection

6,7mg/ml,

1,5ml pre-filled pen

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd - batch

releaser (bulk

manufacturer,

packager - Novo

Nordisk A/S,

Denmark

Hagedornsvej 1, DK-

2820 Gentofte,

Denmark)

Denmark H01AC01 1398526.11.2014

26.11.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3037 Normodipine

amlodipine

(amlodipine

besilate)

tablets5mg,

in blister (30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C08CA01 1491920.10.2015

20.10.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3038 Normodipine

amlodipine

(amlodipine

besilate)

tablets10mg,

in blister (30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C08CA01 1492020.10.2015

20.10.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3039 Nortivan valsartan tablets film-coated80mg,

in blister (30/3x10/)

Gedeon Richter

Polska Sp.z o.o.,

ul.Graniczna 35,

Grodzisk Mazowiecki,

05-825

Poland C09CA03 1604317.10.2016

17.10.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3040 Nortivan valsartan tablets film-coated160mg,

in blister (30/3x10/)

Gedeon Richter

Polska Sp.z o.o.,

ul.Graniczna 35,

Grodzisk Mazowiecki,

05-825

Poland C09CA03 1604417.10.2016

17.10.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3041 Norvasc

amlodipine

(amlodipine

besilate)

tablets5mg,

in blister (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Heinrich-Mack-Str.

35, 89257, Illertissen

Germany C08CA01 1396128.10.2014

28.10.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd str., New

York 10017, USA

652

Page 313: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3042 Norvasc

amlodipine

(amlodipine

besilate)

tablets10mg,

in blister (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Heinrich-Mack-Str.

35, 89257, Illertissen

Germany C08CA01 1396228.10.2014

28.10.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd str., New

York 10017, USA

3043 Norvasc

amlodipine

(amlodipine

besilate)

tablets5mg,

in blister (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Heinrich-Mack-Str.

35, 89257, Illertissen -

packager, batch

releaser (Pfizer

Pharmaceuticals LLC,

Road #2, km 58.2

Barceloneta, 00617,

Puerto Rico, USA -

bulk manufacturer)

Germany C08CA01 1398826.11.2014

26.11.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd str., New

York 10017, USA

3044 Norvasc

amlodipine

(amlodipine

besilate)

tablets10mg,

in blister (30/3x10/)

Pfizer Manufacturing

Deutschland GmbH,

Heinrich-Mack-Str.

35, 89257, Illertissen -

packager, batch

releaser (Pfizer

Pharmaceuticals LLC,

Road #2, km 58.2

Barceloneta, 00617,

Puerto Rico, USA -

bulk manufacturer)

for Pfizer H.C.P.

Corporation, 235, East

42nd str., New York

10017, USA

Germany C08CA01 1398926.11.2014

26.11.2019PoM

3045 Norvir ritonavir tablets film-coated

100mg,

in plastic container (30,

60)

AbbVie Deutschland

GmbH & Co. KG,

Knollstrasse, 67061

Ludwigshafen

Germany J05AE03 1528004.02.2016

04.02.2021PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23,Postfach 6341

Baar, Switzerland

653

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3046 Nosacare

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml plastic vial with

pump dispenser

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine R01AA05 1726113.12.2017

13.12.2022OTC

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

3047 Nosacare Baby

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,25mg/ml,

15ml plastic vial with

pump dispenser

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine R01AA05 1725913.12.2017

13.12.2022OTC

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

3048Nosacare Extra

Moisturizing

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml plastic vial with

pump dispenser

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine R01AA05 1726213.12.2017

13.12.2022OTC

Pharmacare Int. Co.

/German Palestinian

Joint Venture,

Ramallah-Elmasion,

Emil habibi st.17,

Palestine

3049 Nosacare Mentho

oxymetazoline

(oxymetazoline

hydrochloride)

spray nasal

0,5mg/ml,

15ml plastic vial with

pump dispenser

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine R01AA05 1726013.12.2017

13.12.2022OTC

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

3050 Nosh-ARPI

drotaverine

(drotaverine

hydrochloride)

tablets40mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA03AD02 13382

04.04.2014

04.04.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

3051 No-spa

drotaverine

(drotaverine

hydrochloride)

solution for injection40mg/2ml,

2ml ampoules (25/5x5/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd. 3510

Miskolc,

Csanyikvolgy

Hungary A03AD02 1686711.07.2017

11.07.2022PoM

Sanofi-Aventis

Private Co. Ltd.,1045

Budapest, To u. 1-5,

Hungary

654

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3052 No-spa

drotaverine

(drotaverine

hydrochloride)

tablets

40mg,

in blister (24/1x24/),

plastic container (100)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary A03AD02 1686811.07.2017

11.07.2022OTC

Sanofi-Aventis

Private Co. Ltd., 1045

Budapest, To u. 1-5,

Hungary

3053 No-spa forte

drotaverine

(drotaverine

hydrochloride)

tablets80mg,

in blister (24/1x24/)

Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary A03AD02 1437125.03.2015

25.03.2020OTC

Sanofi-Aventis

Private Co. Ltd., 1045

Budapest, To u. 1-5,

Hungary

3054 Novocainprocaine (procaine

hydrochloride)solution for injection

5mg/ml,

5ml ampoules (10), 5ml

ampoules, dividella (10),

5ml ampoules , label

banderol (10)

Open Joint Stock

Company

"Borisovskiy zavod

Medicinskikh

Preparatov" (64/27,

Chapayev str., Borisov

222120, Minsk oblast)

Belarus N01BA02 1296728.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus)

3055 Novocainprocaine (procaine

hydrochloride)solution for injection

5mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaN01BA02 16484

01.03.2017

01.03.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3056 Novocainprocaine (procaine

hydrochloride)solution for injection

5mg/ml,

2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaN01BA02 16485

01.03.2017

01.03.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

655

Page 316: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3057 Novocainprocaine (procaine

hydrochloride)solution for injection

20mg/ml,

2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2 Line,

No6

Republic of

ArmeniaN01BA02 16486/1

13.03.2017

01.03.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

3058 Novocain-Darnitsaprocaine (procaine

hydrochloride)solution for injection

5mg/ml,

2ml ampoules

(10, (10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC (02093, Kiev,

Borispolskaya Str.,13)

Ukraine N01BA02 1296528.10.2013

28.10.2013PoM

Darnitsa

Pharmaceutical Firm

PrJSC (02093, Kiev,

Borispolskaya Str.,13,

Ukraine)

3059 Novocain-Darnitsaprocaine (procaine

hydrochloride)solution for injection

20mg/ml,

2ml ampoules

(10, 10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC (02093, Kiev,

Borispolskaya Str.,13)

Ukraine N01BA02 1296628.10.2013

28.10.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC (02093, Kiev,

Borispolskaya Str.,13,

Ukraine)

3060 Novocain-Darnitsaprocaine (procaine

hydrochloride)solution for injection

5mg/ml,

5ml ampoules (10), 5ml

ampoules, in blister

(10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13

Ukraine N01BA02 1542316.03.2016

16.03.2021PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13,

Ukraine

3061Novocaine solution

0,5%

procaine (procaine

hydrochloride)solution for injection

5mg/ml,

100ml, 200ml and 250ml,

in plastic pack

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaN01BA02 15687

08.06.2016

08.06.2021PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

656

Page 317: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3062Novocain-

Zdorovye

procaine (procaine

hydrochloride)solution for injection

5mg/ml,

2ml ampoules (10), 2ml

ampoules, in blister

(5/1x5/, 10/2x5/,

10/1x10/),

5ml ampoules (10), 5ml

ampoules, in blister

(5/1x5/, 10/2x5/)

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine N01BA02 1662125.04.2017

25.04.2022PoM

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22,

Ukraine

3063NovoMix 30

FlexPen

insulin aspart

(recombinant)

suspension for

injection

100U/ml,

3ml pre-filled pen (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AD05 1276614.08.2013

14.08.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3064 NovoMix 30 Penfillinsulin aspart

(recombinant)

suspension for

injection

100U/ml,

3ml cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AD05 1276714.08.2013

14.08.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3065 NovoNorm repaglinide tablets0,5mg,

in blister (30/2x15/)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, Boehringer

Ingelheim Pharma

GmbH & Co. KG,

Binger Strasse 173, D-

55216 Ingelheim am

Rhein, Germany-bulk

manufacturer,

Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1 und

2, 73614, Schorndorf,

Germany-packager

Denmark A10BX02 1560224.05.2016

24.05.2021PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

657

Page 318: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3066 NovoNorm repaglinide tablets2mg,

in blister (30/2x15/)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, Boehringer

Ingelheim Pharma

GmbH & Co. KG,

Binger Strasse 173, D-

55216 Ingelheim am

Rhein, Germany-bulk

manufacturer,

Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1 und

2, 73614, Schorndorf,

Germany-packager

Denmark A10BX02 1560324.05.2016

24.05.2021PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3067 NovoNorm repaglinide tablets1mg,

in blister (30/2x15/)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, Boehringer

Ingelheim Pharma

GmbH & Co. KG,

Binger Strasse 173, D-

55216 Ingelheim am

Rhein, Germany-bulk

manufacturer,

Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1 und

2, 73614, Schorndorf,

Germany-packager

Denmark A10BX02 1560424.05.2016

24.05.2021PoM

Նովո Նորդիսկ Ա/Ս,

Նովո Ալլե, ԴԿ-2880

Բագսվաերդ,

Դանիա

658

Page 319: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3068NovoRapid

FlexPeninsulin aspart

solution for s/c or i/v

injection

100U/ml,

3ml pre-filled pens (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd-batch

releaser, bulk

manufacturer,

primary packager,

Novo Nordisk A/S,

Brennum Park, DK-

3400 Hillerod,

Denmark- secondary

packager

Denmark A10AB05 1544102.04.2016

02.04.2021PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3069 NovoRapid Penfill insulin aspartsolution for s/c or i/v

injection

100U/ml,

3ml glass cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd - batch

releaser, bulk

manufacturer,

primary packager,

Novo Nordisk A/S,

Hallas Alle, DK-4400

Kalundborg, Denmark-

secondary packager

Denmark A10AB05 1544002.04.2016

02.04.2021PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3070 NovoSeveneptacog alfa

(activated)

powder for solution

for injection

1mg (50 KIU),

2ml glass vial (1), 1,1ml

solvent in glass vial

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd - batch

releaser (bulk

manufacturer,

packager - Novo

Nordisk A/S,

Denmark

Hagedornsvej 1, DK-

2820 Gentofte,

Denmark)

Denmark B02BD08 1310509.12.2013

09.12.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

659

Page 320: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3071 NovoSeveneptacog alfa

(activated)

powder for solution

for injection

2mg (100 KIU), 2ml glass

vial (1), 2,1ml solvent in

glass vial

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd - batch

releaser (bulk

manufacturer,

packager - Novo

Nordisk A/S,

Denmark

Hagedornsvej 1, DK-

2820 Gentofte,

Denmark)

Denmark B02BD08 1310609.12.2013

09.12.2018PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

3072 Novynettedesogestrel,

ethinylestradioltablets film-coated

0,15mg+0,02mg,

in blister (21/1x21/,

63/3x21/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA09 1713707.11.2017

07.11.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

3073 Nozemacid

oxytetracycline

(oxytetracycline

hydrochloride),

metronidazole

powder60%+30%,

2,5g and 5g sachet

Agrobioprom CJSC,

143985, Moscow,

Balashikhinski

district, Novo-Milet

r/d, Poltevskoe shosse,

4

Russia

QJ01AA56;

veterinary

drug

1676502.06.2017

02.06.2022OTC

Agrobioprom CJSC,

107139, Moscow,

pereulok

Orlikov,house 3,

Russia

3074 Nucleo CMP Forte

cytidine-5-

disodium

monophosphate+

(uridine-5-

trisodium

triphosphate,

uridine-5-disodium

diphosphate,

uridine-5-disodium

monophosphate)

capsules5mg+3mg,

in blister (30/2x15/)

Ferrer International,

SA., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain M09AX 1231822.03.2013

22.03.2018OTC

Ferrer International,

SA., Joan Gran Via

Carlos III, 94 08028,

Barcelona, Spain

660

Page 321: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3075 Nucleo CMP Forte

cytidine-5-

disodium

monophosphate +

(uridine-5-

trisodium

triphosphate,

uridine-5-disodium

diphosphate,

uridine-5-disodium

monophosphate)

powder lyophilized

for solution for

injection

10mg+6mg, ampoules (3),

2ml solvent in ampoules

(3)

Ferrer Internacional

S.A. Joan Buscalla, 1-9

08173 Sant Cugat del

Valles

Spain M09AX 1231922.03.2013

22.03.2018PoM

Ferrer Internacional

S.A., Spain Joan Gran

Via Carlos III, 97

08028

3076 Nulox speeditabs meloxicam tablets orodispersible

7,5mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/)

Alpex Pharma SA,

Via Cantonale, CH

6805 Mezzovico

Switzerland M01AC06 1250401.06.2013

01.06.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

3077 Nulox speedtabs meloxicam tablets orodispersible

15mg,

in blister (10/1x10/,

20/2x10/, 30/3x10/)

Alpex Pharma SA,

Via Cantonale, CH

6805 Mezzovico

Switzerland M01AC06 1250501.06.2013

01.06.2018PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

3078 Nurofen ibuprofen gel for external use50mg/g,

50g in aluminium tube

Farmasierra

Manufacturing S.L.,

Ctra. Irun, Km. 26,

200, San Sebastian de

los Reyes 28700,

Madrid

Spain M02AA13 12878/101.02.2014

19.09.2018OTC

Reckitt Benckiser

HealthCare Limited,

Dansom Lane, Hull,

East Yorkshire, XI08

7DS, UK

3079 Nurofen ibuprofen tablets coated

200mg,

in blister (6/x16/), (8/1x8/,

10/1x10/, 12/1x12/,

20/2x10/, 24/2x12/)

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB

UK M01AE01 1491309.10.2015

09.10.2020OTC

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB, UK

661

Page 322: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3080 Nurofen Express ibuprofen capsules soft200mg,

in blister (8/1x8/, 16/2x8/)

Banner Pharmacaps

Europe B.V., De

Posthoornstraat 7,

Tilburg, 5048AS

the Netherlands M01AE01 1580120.07.2016

20.07.2021OTC

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB, UK

3081Nurofen Express

NEO

ibuprofen (sodium

ibuprofen dihydrate)tablets coated

200mg,

blister (6/1x6/, 12/1x12/,

24/2x12/)

Reckitt Benckiser

Healthcare

International Limited,

Nottingham site, Thane

Road, Nottingham,

Nottinghamshire, NG90

2DB

UK M01AE01 1369024.07.2014

24.07.2019OTC

Reckitt Benckiser

Healthcare

International Limited,

Nottingham site, Thane

Road, Nottingham,

Nottinghamshire, NG90

2DB, UK

3082Nurofen for

childrenibuprofen

suspension oral with

strawberry flavour

20mg/ml,

100ml and 150ml plastic

bottle and measuring

syringe

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS

UK M01AE01 1547602.04.2016

02.04.2021OTC

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB, UK

3083Nurofen for

childrenibuprofen

suspension oral with

orage flavour

20mg/ml,

100ml and 150ml plastic

bottle and measuring

syringe

Reckitt Benckiser

HealthCare (UK)

Limited, Dansom

Lane, Hull, East

Yorkshire, HU8 7DS

UK M01AE01 1547702.04.2016

02.04.2021OTC

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB, UK

3084Nurofen for

childrenibuprofen suppositories rectal

60mg,

(10/2x5/)

Famar A.V.E., 49km

National Road Athens-

Lamia, 190 11,

Avlonas

Greece M01AE01 1598915.09.2016

15.09.2021OTC

Reckitt Benckiser

Healthcare

International Ltd,

Thane Road,

Nottingham, NG90

2DB, UK

662

Page 323: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3085 Nurofen forte ibuprofen tablets coated400mg,

in blister (12/1x12/)

Reckitt Benckiser

Healthcare

International Limited,

Nottingham site,

Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB

UK M01AE01 1361027.06.2014

27.06.2019OTC

Reckitt Benckiser

Healthcare

International

Limited, Nottingham

site, Thane Road,

Nottingham,

Nottinghamshire,

NG90 2DB, UK

3086 Nuroton Zero ibuprofen suspension oral

100mg/5ml,

100ml plastic bottle and

measuring cup

Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus M01AE01 1701526.09.2017

26.09.2022OTC

Giga Farm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

3087 Nuvaringetonogestrel,

ethinylestradiol

vaginal delivery

system (vaginal ring)11,7mg+2,7mg, sachet (1)

Organon (Ireland)

Limited, P.O. Box

2857, Drynam Road,

Swords, Co. Dublin -

secondary packager,

batch releaser (dosage

form manufacturer,

primary packager -

N.V. Organon,

Molenstraat 110, 5342

CC OSS, the

Netherlands)

Ireland G02BB01 12250/126.03.2014

07.03.2018PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

3088 Nuvaringetonogestrel,

ethinylestradiol

vaginal delivery

system (vaginal ring)11,7mg+2,7mg, sachet (1)

N.V. Organon,

Kloosterstraat 6, 5349

AB Oss

the Netherlands G02BB01 1397426.11.2014

26.11.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

3089 Nystatin nystatin tablets film-coated500000IU,

in blister (20/2x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus A07AA02 12762/122.01.2015

14.08.2018PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

663

Page 324: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3090 Nystatin nystatin tablets coated500000IU,

in blisters (20/2x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A07AA02 13584/116.11.2017

10.06.2019PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

3091 Nystatin nystatin ointment100000U/g,

15g aluminium tube

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus D01AA01 1424520.02.2015

20.02.2020PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

3092 Nystatin nystatin tablets film-coated500000IU,

in blister (20/2x10/)

Belmedpreparaty

RUE, 220006, Minsk,

Mayakovskogo st. 1

Belarus A07AA02 1726313.12.2017

13.12.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

3093 Octagamimmunoglobulin

human normalsolution for infusion

50mg/ml,

20ml, 50ml, 100ml,

200ml glass vial

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna

Austria J06BA 1254906.06.2013

06.06.2018PoM

Octapharma

Pharmazeutica

Produktionsges.

m.b.H. Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3094 Octanate 1000IU

human blood

coagulation factor

VIII

powder lyophilized

for solution for

injection

1000IU/vial,

glass vial, 10ml glass vial

with solvent, disposable

syringe, double-ended

needle, filter needle,

injection needle and (2)

alcohol swabs

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD02 1406819.12.2014

19.12.2019PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

664

Page 325: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3095 Octanate 250IU

human blood

coagulation factor

VIII

powder lyophilized

for solution for

injection

250IU/vial,

glass vial, 5ml glass vial

with solvent, disposable

syringe, double-ended

needle, filter needle,

injection needle and (2)

alcohol swabs

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD02 1406619.12.2014

19.12.2019PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3096 Octanate 500IU

human blood

coagulation factor

VIII

powder lyophilized

for solution for

injection

500IU/vial,

glass vial, 10ml glass vial

with solvent, disposable

syringe, double-ended

needle, filter needle,

injection needle and (2)

alcohol swabs

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD02 1406719.12.2014

19.12.2019PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3097 Octanine F

human blood

coagulation factor

IX

powder and solvent

for solution for

injection

1000IU,

glass vial, 10ml solvent in

glass vial, disposable

syringe, transfer set

(double-ended needle,

filter needle), infusion set,

alcohol swabs (2)

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD04 1670723.05.2017

23.05.2022PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3098 Octanine F

human blood

coagulation factor

IX

powder and solvent

for solution for

injection

500IU,

glass vial, 5ml solvent in

glass vial, disposable

syringe, transfer set

(double-ended needle,

filter needle), infusion set,

alcohol swabs (2)

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD04 1670823.05.2017

23.05.2022PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

665

Page 326: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3099 Octanine F

human blood

coagulation factor

IX

powder and solvent

for solution for

injection

250IU,

glass vial, 5ml solvent in

glass vial, disposable

syringe, transfer set

(double-ended needle,

filter needle), infusion set,

N2 alcohol swabs

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD04 1681022.06.2017

22.06.2022PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3100 Octaplex

human blood

coagulation factor

II, human blood

coagulation factor

VII, human blood

coagulation factor

IX, human blood

coagulation factor

X, protein C,

protein S

powder and solvent

for solution for

infusion

14-38IU/ml+9-

24IU/ml+25IU/ml+18-

30IU/ml+13-31IU/ml+12-

32IU/ml,

glass vial with powder (1),

20ml glass vial with

solvent (1), transfer set

(1), disposable syringe

(1), infusion set (1),

alcohol swabs (2)

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B02BD01 1616923.11.2016

23.11.2021PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

3101 Octolipentioctic acid ( alfa-

lipoic acid)capsules

300mg,

in blister (30/3x10/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia A16AX01 1272823.07.2013

23.07.2018PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

3102 Octolipenthioctic acid (alpha-

lipoic acid)tablets film-coated

600mg,

in blister (30/3x10/,

60/6x10/)

Pharmstandard-

Tomskhimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211

Russia A16AX01 1646206.03.2017

06.03.2022PoM

Pharmstandard-

Tomskhimpharm

OJSC, 634009, Tomsk,

avenue Lenina, 211,

Russia

3103 Octolipenthioctic acid (alfa-

lipoic acid)

concentrate for

solution for infusion

30mg/ml,

10ml ampoules (10/2x5/)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A16AX01 1676102.06.2017

02.06.2022PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

666

Page 327: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3104 Odeston hymecromone tablets200mg,

in blister (50/5x10/)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland A05AX02 1425620.02.2015

20.02.2020OTC

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice, Poland

3105 Oestrogelestradiol (estradiol

hemihydrate)gel transdermal

0,6mg/g,

80g aluminium tube

Besins Manufacturing

Belgium, Groot-

Bijgaardenstraat ,128-

1620, Drogenbos

Belgium G03CA03 1234309.04.2013

09.04.2018PoM

Besins Healthcare SA

, Avenue Louise 287,

1050 Brussels,

Belgium

3106 Oestrogelestradiol (estradiol

hemihydrate)gel transdermal

0,6mg/g,

80g plastic bottle

Besins Manufacturing

Belgium, Groot-

Bijgaardenstraat ,128-

1620, Drogenbos

Belgium G03CA03 1400126.11.2014

26.11.2019PoM

Besins Healthcare SA

, Avenue Louise 287,

1050 Brussels,

Belgium

3107

Oestrophan

0.25mg/ml

injection solution

cloprostenol

(cloprostenol

sodium)

solution for injection

0,25mg/ml,

2ml ampoules (10), 10ml

vial (1)

Bioveta a.s.,

Komenskeho 212,

68323 Ivanovice na

Hane

Czech Republic

QG02AD90;

veterinary

drug

1475203.08.2015

03.08.2020PoM

Bioveta a.s.,

Komenskeho 212,

68323 Ivanovice na

Hane, Czech

Republic

3108 Ofloxacin ofloxacin tablets coated200mg,

in blister (10)

Open Joint Stock

Company , 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus J01MA01 1281217.09.2013

17.09.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

3109 Ofloxacin ofloxacin tablets coated200mg,

in blister (10)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia J01MA01 1305325.11.2013

25.11.2018PoM

Pharmstandard-

Leksredstva JSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18, Russia

667

Page 328: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3110 Ofloxacin 0.2% ofloxacin solution for infusion

2mg/ml,

50ml, 100ml and 200ml

plastic packs, in light-

proof bag

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111

Republic of

ArmeniaJ01MA01 14491

15.05.2015

15.05.2020PoM

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia

3111 Oftagel carbomer 974P gel eye2,5mg/g,

10g plastic vial-dropper

Santen Oy,

Niittyhaankatu 20,

33720 Tampere-batch

releaser, Ursapharm

Arzneimittel GmbH,

Industriestrasse 35,

66129 Saarbrucken,

Germany-bulk

manufacturer,

primary and

secondary packager

Finland S01XA20 1511115.12.2015

15.12.2020OTC

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3112 Oftalmoferon

interferon alfa-2b,

diphenhydramine

(diphenhydramine

hydrochloride)

drops eye

not less than

10000IU/ml+ 1mg/ml,

5ml plastic vial-

dropper,10ml plastic vial-

dropper

"FIRN M" CJSC, 4,

Dzerzhinskogo str.,

Kokoshkino

Settlement, Naro-

Fominsky district,

Moskow region,

143390

Russia S01AD 1627919.12.2016

19.12.2021PoM

"FIRN M" CJSC, 15/1,

entrance "B", Borby

square, Moscow,

127055, Russia

3113 Oftan Catachrom

cytochrome C,

adenosine,

nicotinamide

drops eye

0,675mg/ml+

2mg/ml+20mg/ml, 10ml

plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01XA 1266504.07.2013

04.07.2018PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3114Oftan

Dexamethason

dexamethasone

(dexamethasone

sodium phosphate)

drops eye1mg/ml,

5ml plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01BA01 1251923.07.2013

23.07.2018PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

668

Page 329: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3115Oftan

Dexamethason

dexamethasone

(dexamethasone

sodium phosphate)

drops eye1mg/ml,

5ml plastic bottle-dropper

Santen Oy,

Niittyhaankatu 20,

33720 Tampere-

batch releaser,

secondary packager,

Santen

Pharmaceutical

(China) Co., Ltd., No.

169 Tinglan Road,

Suzhou Industrial

Park, Suzhou, Jiangsu

Province, China- bulk

manufacturer,

primary packager

Finland S01BA01 1727913.12.2017

13.12.2022PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3116 Oftan Timololtimolol (timolol

maleate)drops eye

5mg/ml,

5ml plastic vial

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01ED01 1237119.04.2013

19.04.2018PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3117 Oftan Timololtimolol (timolol

maleate)drops eye

5mg/ml,

5ml plastic vial-dropper

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01ED01 1728013.12.2017

13.12.2022PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3118 Oftaquix

levofloxacin

(levofloxacin

hemihydrate)

drops eye (solution)5mg/ml,

5ml plastic vial-dropper

Santen Oy,

Niittyhaankatu 20,

33720 Tampere

Finland S01AE05 1553219.04.2016

19.04.2021PoM

Santen Oy,

Niittyhaankatu 20,

33720 Tampere,

Finland

3119 Olankline olanzapine tablets film-coated5mg,

in blister (28/4x7/)

Dr. Reddy's

Laboratories Limited,

Andrha Pradesh

500900

India N05AH03 1213501.02.2013

01.02.2018PoM

Dr. Reddy's

Laboratories Limited,

Andrha Pradesh

500900, India

3120 Olankline olanzapine tablets film-coated10mg,

in blister (28/4x7/)

Dr. Reddy's

Laboratories Limited,

Andrha Pradesh

500900

India N05AH03 1213601.02.2013

01.02.2018PoM

Dr. Reddy's

Laboratories Limited,

Andrha Pradesh

500900, India

669

Page 330: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3121 Olanzapine olanzapine tablets coated5mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AH03 12515

01.06.2013

01.06.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Armenia

3122 Olanzapine olanzapine tablets film-coated10mg,

in blister (30/3x10/)

Arpimed LLC (Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building)

Republic of

ArmeniaN05AH03 12900

07.10.2013

07.10.2018PoM

Arpimed LLC

(Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia)

3123 Olazol

hippopheae oil,

chloramphenicol,

benzocaine, boric

acid

aerosol for external

use

0,09g+0,027g+

0,027g+0,0045g, 60g, 80g

aluminium container

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

Russia D08AX 13030/115.01.2016

25.11.2018OTC

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.,

Russia

3124 Olestezin-AV

concentrate of sea

buckthorn oil,

sulfaetidol,

benzocaine

suppositories rectal330mg+50mg+ 100mg,

(10/2x5/)

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

Russia C05AX 13243/115.01.2016

24.02.2019OTC

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.,

Russia

3125 Olfen Geldiclofenac

(diclofenac sodium)gel

10mg/g,

20g, 50g aluminium tube

Merckle GmbH,

Ludwig-Merckle-

Strasse 3, 89143

Blaubeuren - batch

releaser (Merckle

GmbH, Graf-Arco-

Strasse 3, 89079 Ulm,

Baden-Wurttemberg,

Germany - bulk

manufacturer)

Germany M02A A15 1344806.05.2014

06.05.2019OTC

TEVA

Pharmaceutical

Industries LTD, 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

670

Page 331: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3126 Olicard Retardisosorbide-5-

mononitrate

capsules hard

prolonged-release

40mg,

in blister (20/2x10/)

Temmler Pharma

GmbH & Co. KG,

Temmlerstrasse 2,

35039 Marburg -

packager, batch

releaser, (dosage form

manufacturer -

Valpharma

International S.P.A.,

Via G. Morgagni, 2-

47864 Pennabilli

(RN), Italy)

Germany C01DA14 12398/129.07.2014

19.04.2018PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

3127 Olicard Retardisosorbide-5-

mononitrate

capsules hard

prolonged-release

60mg,

in blister (20/2x10/)

Temmler Pharma

GmbH & Co. KG,

Temmlerstrasse 2,

35039 Marburg -

packager, batch

releaser, (dosage form

manufacturer -

Valpharma

International S.P.A.,

Via G. Morgagni, 2-

47864 Pennabilli

(RN), Italy)

Germany C01DA14 12399/129.07.2014

19.04.2018PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

3128 Olicard Retardisosorbide-5-

mononitrate

capsules hard

prolonged-release

40mg,

in blister (20/2x10/)

Temmler Pharma

GmbH & Co. KG,

Temmlerstrasse 2,

35039 Marburg -

packager, batch

relaser (dosage form

manufacturer -

Aptalis Pharma S.r.l.,

Via Martin Luther

King, 13, 20060

Pessano con Bornago

(MI), Italy)

Germany C01DA14 12615/129.07.2014

21.06.2018PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

671

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3129 Olicard Retardisosorbide-5-

mononitrate

capsules hard

prolonged-release

60mg,

in blister (20/2x10/)

Temmler Pharma

GmbH & Co. KG,

Temmlerstrasse 2,

35039 Marburg -

packager, batch

relaser (dosage form

manufacturer -

Aptalis Pharma S.r.l.,

Via Martin Luther

King, 13, 20060

Pessano con Bornago

(MI), Italy)

Germany C01DA14 12616/129.07.2014

21.06.2018PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

3130 Oligovit

vitamin A,

cholecalciferol,

tocopherol acetate,

thiamine (thiamine

hydrochloride),

riboflavin, nicotinamide,

calcium pantotenate,

pyridoxine (pyridoxine

hydrochloride),

cyanocobalamin,

ascorbic acid, calcium

hydrogen phosphate

dihydrate, iron (iron

sulfate), magnesium

(magnesium oxide),

potassium (potassium

sulfate), zinc (zinc

sulfate heptahydrate),

copper (copper sulfate

pentahydrate),

manganese (manganese

sulfate monohydrate),

fluor (sodium fluoride),

molybdenum (sodium

molybdate dihydrate),

cobalt (cobalt sulfate)

tablets coated

5000IU+500IU+

12.5mg+5mg+

5mg+50mg+10mg+2.5mg

+0.0025mg+100mg+200m

g+ 10mg+3mg+

2.5mg+0.75mg+

0.5mg+0.5mg+

0.5mg+0.1mg+ 0.05mg,

in blister (30/3x10/),

Galenika a.d.,

Batajnicki drum bb,

11080 Belgrade

Serbia A11AA03 1476203.08.2015

03.08.2020OTC

Galenika a.d.,

Batajnicki drum bb,

11080 Belgrade,

Serbia

672

Page 333: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3131 Omacoromega-3

triglyceridescapsules soft

1000mg,

plastic container (28)

Abbott Laboratories

GmbH, Justus-von-

Liebig-Strasse 33,

31535 Neustadt -

batch releaser (

packager - GMPack

ApS, Plastvaenget 9,

9560 Hadsund,

Denmark) (bulk

manufacturer -

Patheon Softgels B.V.,

De Posthoornstraat 7,

5048 AS Tilburg, the

Netherlands)

Germany C10AX06 12364/229.12.2017

19.04.2018PoM

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

3132 Omaronpiracetam,

cinnarizinetablets

400mg+25mg, blisters

(30/3x10/, 60/6x10/,

90/9x10/)

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia N06BX 12131/103.02.2016

01.02.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

3133 Omaronpiracetam,

cinnarizinetablets

400mg+25mg,

in blister (30/3x10,

60/6x10, 90/9x10)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia N06BX 1716730.11.2017

30.11.2022PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

3134 Omep-20 omeprazolecapsules gastro-

resistant

20mg,

in strip (100/10x10/),

in blister (30/3x10/)

Akriti

Pharmaceuticals Pvt.

Ltd., Plot No. D-10, D-

11, M.I.D.C. Indl.

Estate, Nira Road,

Jejuri, Tal. Purandhar

(Saswad), Dist. Pune-

412 303, Maharashtra

India A02BC01 1312010.01.2014

10.01.2019PoM

Akriti

Pharmaceuticals Pvt.

Ltd., 117, Block N0. 2,

Emerald Plaza,

Hiranandai Meadows,

Barrister Nath Pai

Road, Thane (West)

400 610, India

673

Page 334: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3135 Omeprazol omeprazolecapsules gastro-

resistant, hard

20mg,

in blister (30/3x10/)

Balkanpharma-

Razgrad AD, 68,

Aprilsko vastanie

Blvd, 7200 Razgrad

Bulgaria A02BC01 1682710.07.2017

10.07.2022PoM

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko

Shosse" N3, Dupnitsa

2600, Bulgaria

3136 Omeprazole omeprazole capsules20mg; (28) in plastic

container

Teva Pharma, S.L.U.

C/C, n0 4, Poligono

Industrial Malpica,

Zaragoza, 50016

Spain A02BC01 11625/104.11.2014

29.10.2019PoM

Somex Pharma, 600

High Road, Seven

Kings Ilford, Essex

IG3 8BS, UK

3137 Omeprazole omeprazolecapsules gastro-

resistant

20mg,

in blister (100/10x10/)

Medicamen Biotech

Ltd, SP-1192 A&B,

Phase IV,Industrial

Area,Bhiwadi,Dist.

Alwar (Rajasthan)

India A02BC01 1217001.02.2013

01.02.2018PoM

Troge Medical

GmbH, Milchstrasse

19, D-20148

Hamburg, Germany

3138 Omeprazole omeprazole capsules20mg,

in blister (30/3x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk region

Belarus A02BC01 1561124.05.2016

24.05.2021PoM

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov

222518, Minsk

region, Belarus

3139 Omeprazole omeprazole capsules20mg,

in blister (20/2x10/)

"NOKI" JV LTD Co.,

Nor-Kharberd, Ararat

region

Republic of

ArmeniaA02BC01 16143

10.11.2016

10.11.2021PoM

"NOKI" JV LTD Co.,

Nor-Kharberd, Ararat

region, Republic of

Armenia

674

Page 335: 40mg, KRKA d.d., Novo 06.02.2015 06.02.2020 60/6x10/) · Emoxypine-Belmed emoxypine solution for i/v and i/m injection 30mg/ml, 5ml ampoules (5/1x5/, 10/2x5/) Belmedpreparaty RUE,

3140

Omeprazole

Delayed-Release

Capsule 20mg

omeprazolecapsules delayed-

release

20mg,

in blister (100/10x10/)

Intas Pharmaceuticals

Ltd., Plot No 457, 458

Village- Matoda, Tal-

Sanand, City- Matoda -

382 210, Dist.-

Ahmedabad

India A02BC01 1353430.05.2014

30.05.2019PoM

Intas Pharmaceuticals

Ltd.,Chinubhai

Centre, Off. Nehru

bridge, Ashram Road,

Ahmedabad, India

3141Omeprazole-

Asteria Cap. 20mgomeprazole capsules

20mg,

in blister (30/3x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

si, Chungcheongbuk-

do

Korea Sourth A02BC01 12391/206.11.2015

19.04.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

3142Omeprazole-

Asteria Cap. 20mgomeprazole capsules

20mg,

in blister (30/3x10/,

100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

Si, Chungcheongbuk-

do

Korea South A02BC01 1672905.06.2017

05.06.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

3143 Omeprez omeprazole capsules20mg,

in blister (30/3x10/)

S.C. Rompharm

Company S.R.L.,

Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A

Romania A02BC01 1234209.04.2013

09.04.2018PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A,

ROMANIA

3144 Omnadren 250

testosterone

(testosterone

propionate),

testosterone

(testosterone

phenylpropionate),

testosterone

(testosterone

isocaproate),

testosterone

(testosterone

decanoate)

solution for i/m

injection, oily

30mg/ml+

60mg/ml+60mg/ml+100m

g/ml,

1ml ampoules (5)

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland G03BA03 1603117.10.2016

17.10.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

675

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3145 Omnic

tamsulosin

(tamsulosin

hydrochloride)

capsules modified-

release

0,4mg,

in blister (10/1x10/,

30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands G04CA02 1486118.09.2015

18.09.2020PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

3146 Omnic Ocas

tamsulosin

(tamsulosin

hydrochloride)

tablets prolonged-

release coated

0,4mg,

in blister (10/1x10/,

30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands G04CA02 1486218.09.2015

18.09.2020PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

3147 Omnipaque iohexol solution for injection350mg iodine/ml, 100ml

plastic vial (10)

GE Healthcare

Ireland Limited, IDA

Business Park,

Carrigtohill Co. Cork

Ireland V08AB02 1722108.12.2017

08.12.2022PoM

GE Healthcare AS,

Nycoveien 1-2, P.O.

Box 4220 Nydalen,

NO-0401 Oslo,

Norway

3148 Omnipaque iohexol solution for injection350mg iodine/ml, 50ml

plastic vial (10)

GE Healthcare

Ireland Limited, IDA

Business Park,

Carrigtohill Co. Cork

Ireland V08AB02 1722208.12.2017

08.12.2022PoM

GE Healthcare AS,

Nycoveien 1-2, P.O.

Box 4220 Nydalen,

NO-0401 Oslo,

Norway

3149 Omniscan gadodiamidesolution for i/v

injection

287mg/ml (0.5mmol/ml),

20ml glass vial (1), 20ml

glass vials (10)

GE Healthcare

Ireland, IDA Business

Park, Carrigtohill Co.

Cork

Ireland V08CA03 1427126.02.2015

26.02.2020PoM

GE Healthcare AS,

Nycoveien 1-2, P.O.

Box 4220 Nydalen,

NO-0401 Oslo,

Norway

676

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3150 Omnitusbutamirate

(butamirate citrate)syrup

0,8mg/ml,

200ml glass bottle and

measuring spoon

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm D.O.O.

Sabac, 15000, Sabac,

Hajduk Veljkova str.

No: bb-bulk

manufacturer,

packager

Serbia R05DB13 1419806.02.2015

06.02.2020OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

3151 Omnopon-ZN

morphine

(morphine

hydrochloride),

noscapine,

papaverine

(papaverine

hydrochloride),

codeine, thebaine

solution for injection

11,5mg/ml+ 5.4mg/ml+

0.72mg/ml+ 1.44mg/ml+

0,1mg/ml,

1ml ampoules, in blister

(100/20x5/)

"KPE" Zdorovje

narodu" LLC, 61002,

Kharkov, Melnikova

str. 41

Ukraine N02AA51 1627219.12.2016

19.12.2021PoM/UC

"KPE" Zdorovje

narodu" LLC, 61013,

Kharkov, Sevchenko

str. 22, Ukraine

3152 Ompra-20 omeprazolecapsules gastro-

resistant

20mg,

in strip (100/10x10/)

Medicamen Biotech

Ltd.,SP-1192, A&B,

Phase-4, Industrial

Area, Bhiwadi, Distt.

Alwar, Rajasthan

301019

India A02BC01 1519430.12.2015

30.12.2020PoM

Veejay

Pharmaceutical Pvt.

Ltd., D. No 9-34/6,

Plot 8A, SV Nagar,

Kessara (M), Nagaram

(V), SV Road No 6,

OPP To Gayatri

Nivas, Near Vijaya

Hospitals Ecil X

Roads, Secunderabaad

Ap, 500083, India

3153On.setron-Denk

4mg ODTondansetron tablets orodispersible

4mg,

in blister (6/1x6/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany A04AA01 1474103.08.2015

03.08.2020PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

677

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3154On.setron-Denk

8mg ODTondansetron tablets orodispersible

8mg,

in blister (6/1x6/)

Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany A04AA01 1544902.04.2016

02.04.2021PoM

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

3155 Onbrez Breezhaler

indacaterol

(indacaterol

maleate)

powder for

inhalation, hard

capsules

150mcg,

in blister and inhaler

(10/1x10/, 30/3x10/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona-batch

releaser, packager,

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein,

Switzerland- bulk

manufacturer

Spain R03AC18 1623419.12.2016

19.12.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

3156 Onbrez Breezhaler

indacaterol

(indacaterol

maleate)

powder for

inhalation, hard

capsules

300mcg,

in blister and inhaler

(10/1x10/, 30/3x10/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona-batch

releaser, packager,

Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein,

Switzerland- bulk

manufacturer

Spain R03AC18 1623519.12.2016

19.12.2021PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

3157 Ondansetron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection

2mg/ml,

2ml ampoules (5), 2ml

ampoules in blister

(5/1x5/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine A04AA01 1222507.03.2013

07.03.2018PoM

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov,

Ukraine

678

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3158 Ondansetron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection

2mg/ml,

4ml ampoules (5), 4ml

ampoules in blister

(5/1x5/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine A04AA01 1222607.03.2013

07.03.2018PoM

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov,

Ukraine

3159 Ondansetron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection

2mg/ml,

4ml ampoules, (5) 4ml

ampoules,

in blister (5/1x5/)

Lekhim-Kharkiv

PrJSC, 36, Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv

Ukraine A04AA01 1716930.11.2017

30.11.2022PoM

Lekhim-Kharkiv

PrJSC, 36, Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv,

Ukraine

3160 Ondansetron

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection

2mg/ml,

2ml ampoules, (5) 2ml

ampoules,

in blister (5/1x5/)

Lekhim-Kharkiv

PrJSC, 36, Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv

Ukraine A04AA01 1717030.11.2017

30.11.2022PoM

Lekhim-Kharkiv

PrJSC, 36, Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv,

Ukraine

3161

Ondansetron

2mg/ml Solution

for Injection or

Infusion

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for

injection/infusion

2mg/ml,

4ml ampoules (5)

Accord Healthcare

Limited, Sage House,319

Pinner Road, North

Harrow, Middlesex, HA1

4HF- batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK A04AA01 1514117.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

679

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3162

Ondansetron

2mg/ml Solution

for Injection or

Infusion

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for

injection/infusion

2mg/ml,

2ml ampoules (5)

Accord Healthcare

Limited, Sage House,319

Pinner Road, North

Harrow, Middlesex, HA1

4HF- batch releaser, Intas

Pharmaceuticals Limited,

Plot No 457 & 458 &

191/218 P, Sarkhej-Bavla

Highway, Matoda Village,

Sanand, District-

Ahmedabad, 382 210,

Gujarat, India- bulk

manufacturer, Accord

Healthcare Limited, Unit C

& D, Homefield Business

Park, Homefield Road,

Haverhill, CB9 8QP, UK-

primary and secondary

packager

UK A04AA01 1514217.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

3163

Ondansetron-

Asteria Inj.

8mg/4ml

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for i/m and

/i/v injection

2mg/ml,

4ml ampoules (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth A04AA01 12998/120.08.2015

28.10.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

3164

Ondansetron-

Asteria Inj.

8mg/4ml

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for i/m and

i/v injection

2mg/ml,

4ml ampoules (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South A04AA01 1684210.07.2017

10.07.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, Korea South

3165 Ondansetron-Teva

ondansetron

(ondansetron

hydrochloride

dihydrate)

solution for injection2mg/ml,

2ml ampoules (5)

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,

Tancsics Mihaly ut 82

Hungary A04AA01 1255306.06.2013

06.06.2018PoM

Teva Pharmaceutical

Industries Ltd., 5

Basel str., P.O. Box

3190, Petach Tikva,

49131, Israel

680