LIST OF REGISTRED DRUGS IN ARMENIA (Up to 31.12.2017) · Greece R05CB06 15404 09.03.2016 09.03.2021...

N Trade name

International

nonproprietary

name (generic) or

active ingredients

name

Drug form Dose and packaging Manufacturer Country ATC1 codeRegistration

number

Term of

registration

Legal status for

supplyLicense holder

1 Abaktal

pefloxacin

(pefloxacin

mesylate dihydrate)

tablets film-coated400mg,

in blister (10/1x10/)

Lek Pharmaceuticals

d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia J01MA03 1430810.03.2015

10.03.2020PoM2

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

2 Abasaglar insulin glargine solution for injection100IU/ml,

3ml cartridges (5)

Lilly France S.A.S.,

Zone Industrielle, 2

rue du Colonel Lilly,

67640 Fegersheim

France A10AE04 1653517.03.2017

17.03.2022PoM

Eli Lilly Regional

Operations GmbH.,

Koelblgasse 8-10,

1030, Vienna, Austria

3 Abrobion

ambroxol

(ambroxol

hydrochloride)

syrup6mg/ml,

125ml glass bottle

Help S.A. Pedini,

Ioanninon, Ioannina,

45500

Greece R05CB06 1540409.03.2016

09.03.2021OTC3

Help S.A ,10

Valaoritou str., GR

144 52,

Metamorphosis,

Attika, Greece

4 ACC acetylcysteine

powder for oral

solution with orange

flavour

100mg/5ml,

30g powder in 75ml glass

bottle and measuring

spoon 5ml, 60g powder in

150ml glass bottle and

measuring spoon 5ml

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben-batch

releaser, Allphamed

Pharbil Arzneimittel

GmbH Hildebrandstr.

12, 37081 Gottingen,

Germany-bulk

manufacturer,

packager

Germany R05CB01 1494720.10.2015

20.10.2020OTC

Sandoz

Pharmaceuticals d.d.,

Verovskova Str. 57,

1000 Ljubljana,

Slovenia

LIST OF REGISTRED DRUGS IN ARMENIA

(Up to 31.12.2017)

1

5 ACC 100 acetylcysteine tablets effervescent100mg,

in plastic container (20)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben -

batch releaser

(Hermes Pharma

G.m.b.H., Allgau 36,

A-9400 Wolsberg,

Germany - bulk

manufacturer,

packager)

Germany R05CB01 1396721.11.2014

21.11.2019OTC

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

6 ACC 100 acetylcysteinepowder for oral

solution

100mg,

3g sachets (20)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,


releaser, Lindopharm

GmbH, Neustrasse 82,

D-40721 Hilden,

Germany- bulk

manufacturer,

packager

Germany R05CB01 1443014.04.2015

14.04.2020OTC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

7 ACC 200 acetylcysteine tablets effervescent200mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben -

batch releaser

(Hermes Pharma

G.m.b.H., Allgau 36,

A-9400 Wolsberg,

Germany - bulk

manufacturer,

packager)

Germany R05CB01 1396821.11.2014

21.11.2019OTC

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

2

8 ACC 200 acetylcysteinepowder for oral

solution

200mg,

3g sachets (20)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,




D-40721 Hilden,

Germany- bulk

manufacturer,

packager

Germany R05CB01 1443114.04.2015

14.04.2020OTC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

9 ACC Hot Drink acetylcysteinepowder for oral

solution

200mg,

3g sachets (20)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,




D-40721 Hilden,

Germany- bulk

manufacturer,

packager

Germany R05CB01 1436725.03.2015

25.03.2020OTC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

10 ACC Long acetylcysteine tablets effervescent600mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,


releaser, Hermes

Arzneimittel GmbH,

Hans-Urmiler Ring

52, Wolfratshausen,

Germany-packager,

bulk manufacturer

Germany R05CB01 1436225.03.2015

25.03.2020OTC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

3

11Aceclofenac 100mg

film-coated Tabletsaceclofenac tablets fim-coated

100mg,


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 M01AB16 1485515.09.2015

15.09.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

12 Acellbia rituximabconcentrate for

solution for infusion

10mg/ml,

50ml glass vial

BIOCAD CJSC,

Petrovo-Dalnee,

Krasnogorsky district,

Moscow Region,

143422

Russia L01XC02 1642010.02.2017

10.02.2022PoM

BIOCAD CJSC, 34

bld., lit. A, Svyazi

st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

13 Acellbia rituximabconcentrate for


10mg/ml,

10ml glass vial, in blister

(2/1x2/)

BIOCAD CJSC,

Petrovo-Dalnee,


Moscow Region,

143422

Russia L01XC02 1642110.02.2017

10.02.2022PoM

BIOCAD CJSC, 34


st.,Strelna,

Petrodvortsoviy

district, Saint

Petersburg, 198515,

Russia

14 Acetylsalicylic acid acetylsalicylic acid tablets500mg,

in blister (10)

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region

Ukraine N02BA01 1233409.04.2013

09.04.2018OTC

Technolog PJSC,

Manuylskogo str. 8,

20300 Uman,

Cherkassy region,

UKRAINE

4

15 Acetylsalicylic acid acetylsalicylic acid tablets

500mg,

in blister

(10, 20/2x10/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,

Agregatnaya 2nd str.,

1a/18

Russia N02BA01 1278214.08.2013

14.08.2018OTC

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia


in blister (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, K. Marksa

str., 124

Russia N02BA01 1308709.12.2013

09.12.2018OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN02BA01 13969

21.11.2014

21.11.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-

District, 19 Building,

Republic of Armenia

18 Acetylsalicylic acid acetylsalicylic acid tablets

500mg,

in strip (10/1x10/,

3900/390x10/)

Open joint stock

company "Borisovskiy

zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk region

Belarus N02BA01 16730/104.07.2017

05.06.2022OTC

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

19 Acic aciclovir cream50mg/g,

2g aluminium tube

Salutas Pharma

GmbH, Lange

Goehren 3, 39171

Osterweddingen

Germany D06BB03 1458908.06.2015

08.06.2020OTC

Hexal AG,

Industriestrasse 25, D-

83607 Holzkirchen,

Germany

20 Aciclovir aciclovir cream50mg/g,

2g, 10g aluminium tube

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova D06BB03 1346206.05.2014

06.05.2019OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

5

21 Aciclovir ointment aciclovirointment for

external use

50mg/g,

5g aluminium tube

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus D06BB03 1301825.11.2013

25.11.2018OTC

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

22 Aciclovir-Akri aciclovir tablets200mg,


Akrikhin

Pharmaceuticals Co.,

142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia J05AB01 1441408.04.2015

08.04.2020PoM

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

23 Aciclovir-Akri aciclovir tablets400mg,


Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia J05AB01 1441508.04.2015

08.04.2020PoM

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

24 Aciclovir-Akri aciclovir ointment50mg/g,

5g aluminium tube

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29

Russia D06BB03 1441608.04.2015

08.04.2020OTC

Akrikhin


142450, Moscow

region, Noginsk

district, Staraya

Kupavna, Kirova

street 29, Russia

25 Aciclovir-Belmed aciclovir tablets

200mg,

in blister (10/1x10/,

20/2x10/),

in strip (10/1x10/,

20/2x10/)

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30)

Belarus J05AB01 1291407.10.2013

07.10.2018PoM

Belmedpreparaty

RUE (220007, Minsk,

Fabritsius St., 30,

Belarus)

26Acidum

aminocapronicumaminocaproic acid solution for infusion

50mg/ml,

100ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB02AA01 17095

23.10.2017

23.10.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

6

27 Aclasta zoledronic acid solution for infusion0,05mg/ml,

100ml plastic vial

Novartis Pharma

Stein AG

(Schaffhauserstrasse,

4332 Stein)

Switzerland M05BA08 1290707.10.2013

07.10.2018PoM

Novartis Pharma AG

(Switzerland 56,

Lichtstrasse, 4056

Basel, Switzerland)

28Acnamino MR

100mg Capsules

minocycline

(minocycline

hydrochloride)

capsules hard100mg,


Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch

releaser (dosage form

manufacturer,

packager - Dexcel

Ltd, PO Box 50, Or

Akiva, IL-30600,

Israel)

UK J01AA08 1274926.07.2013

26.07.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

29 Acne Wash salicylic acid soap liquid20mg/ml,

100ml plastic container

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD02AF 13863

18.09.2014

18.09.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

30 A-cnotren isotretinoin capsules soft10mg,


Pharmathen

International S.A.,

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5, Rodopi

69300-batch releaser,

packager, G.A.

Pharmaceuticals S.A.,

(GAP S.A), 46,

Agisilaou str., Agios

Dimitrios Attiki,

17341, Greece-bulk

manufacturer

Greece D10BA01 1494020.10.2015

20.10.2020PoM

Pharmathen S.A.,

Dervenakion 6, 15351

Pallini, Attiki, Greece

7

31 Acorta

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated

10mg,


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

Pharmstandard-

Tomskhimpharm

OJSC, 634009, Tomsk,

Lenina str., 211

Russia C10AA07 1380505.09.2014

05.09.2019PoM

Pharmstandard-

Tomskhimpharm


Lenina str., 211,

Russia

32 Acorta

rosuvastatin

(rosuvastatin

calcium)

tablets film-coated

20mg,


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

Pharmstandard-

Tomskhimpharm


Lenina str., 211

Russia C10AA07 1380605.09.2014

05.09.2019PoM

Pharmstandard-

Tomskhimpharm


Lenina str., 211,

Russia

33 Actemra tocilizumab

concentrate for

solution for i/v

infusion

20mg/ml,

10ml glass vial (1)

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel -

batch releaser (Chugai

Pharma

Manufacturing Co.,

Ltd., 16-3 Kiyohara

Kogyodanchi,Utsuno

miya-city, Tochigi,

321-3231, Japan -

bulk manufacturer,

primary packager),

(F.Hoffmann-La

Roche Ltd.,

Wurmisweg, 4303

Kaiseraugst,

Switzerland -

secondary packager)

Switzerland L04AC07 1376405.09.2014

05.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

8

34 Actemra tocilizumab

concentrate for

solution for i/v

infusion

20mg/ml,

4ml glass vial (1)

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel -

batch releaser (Chugai

Pharma

Manufacturing Co.,

Ltd., 16-3 Kiyohara

Kogyodanchi,Utsuno

miya-city,Tochigi,

321-3231, Japan -

bulk manufacturer,

primary packager),

(F.Hoffmann-La

Roche Ltd.,

Wurmisweg, 4303

Kaiseraugst,

Switzerland -

secondary packager)

Switzerland L04AC07 1376505.09.2014

05.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

35 Activated charcoal activated charcoal tablets250mg,

in strip (10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.


str., 124

Russia A07BA01 1500902.12.2015

02.12.2020OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

36 Actovegin

deproteinised

haemoderivate of

calf blood

solution for injection40mg/ml,

5ml ampoules (5)

Takeda Austria

GmbH, St. Peter

strasse 25, A-4020

Linz

Austria B06AB 13906/128.06.2016

17.10.2019PoM

Takeda

Pharmaceuticals LLC,

Usatcheva str 2 bld. 1,

Moscow 119048,

Russia

37 Actovegin

deproteinised

haemoderivate of

calf blood


10ml ampoules (5)

Takeda Austria

GmbH, St. Peter

strasse 25, A-4020

Linz

Austria B06AB 13907/128.06.2016

17.10.2019PoM

Takeda



Moscow 119048,

Russia

9

38 Actovegin

deproteinised

haemoderivate of

calf blood

tablets coated200mg,

in glass container (50)

Takeda GmbH,

Betriebsstatte

Oranienburg,

Lehnitzstrasse 70-98,

16515 Oranienburg

Germany B06AB 1599015.09.2016

15.09.2021PoM

Takeda


Usacheva str 2, bld. 1,

Moscow 119048,

Russia

39 Actovegin

deproteinised

haemoderivate of

calf blood

solution for injection

40mg/ml,

2ml ampoules,


Takeda Austria

GmbH, St. Peter

strasse 25, A-4020

Linz

Austria B06AB 1599415.09.2016

15.09.2021PoM

Takeda


Usacheva str 2, bld. 1,

Moscow 119048,

Russia

40 Actrapidinsulin human

(recombinant DNA)solution for injection

100IU/ml,

10ml glass vial (1)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AB01 1369924.07.2014

24.07.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

41 Actrapid Penfill insulin human solution for injection100IU/ml,

3ml glass cartridges (5)

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd

Denmark A10AB01 13509/102.07.2014

30.05.2019PoM

Novo Nordisk A/S,

Novo Alle, DK-2880

Bagsvaerd, Denmark

42 Acupannefopam (nefopam

hydrochloride)solution for injection

10mg/ml,

2ml ampoules (5)

Biocodex

(1 avenue Blaise

Pascal, 60000

Beauvais)

France N02BG06 1299628.10.2013

28.10.2018PoM

Biocodex

(7 avenue Gallieni

94250 Gentilly,

France)

43 Acurmil 50mg/5ml

atracurium

(atracurium

besylate)

solution for i/v

infusion

10mg/ml,

5ml ampoules (5)

Laboratorio Italiano

Biochimico

Farmaceutico

Lisapharma S.p.A.,

Via Licinio, 11-22036

Erba (CO)

Italy M03AC04 1528704.02.2016

04.02.2021PoM

Laboratorio Italiano

Biochimico

Farmaceutico

Lisapharma S.p.A.,

Via Licinio, 11-22036

Erba (CO), Italy

44 Acyclovir aciclovir ointment50mg/g,

10g aluminium tube

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia D06BB03 1380905.09.2014

05.09.2019OTC

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

10

45Acyclovir Denk

200aciclovir tablets

200mg,


Denk Pharma GmbH

& Co. KG (Goellstr. 1,

84529 Tittmoning)

Germany J05AB01 1294628.10.2013

28.10.2018PoM

Denk Pharma GmbH

& Co. KG

(Prinzregentenstr. 79,

81675 Muenchen,

Germany)

46Acyclovir Denk 5%

Creamaciclovir cream for topical use

50mg/g,

7g aluminium tube

RubiePharm

Arzneimittel GmbH,

Bruder-Grimm-Str.

62, 36396 Steinau an

der Strasse

Germany D06BB03 1567308.06.2016

08.06.2021OTC

Denk Pharma GmbH

& Co. KG,

Prinzregentenstr. 79,

81675 Muenchen,

Germany

47 Adaptol mebicar capsules hard

300mg,


30/3x10/, 40/4x10/)

Olainfarm JSC, 5

Rupnicu Str., Olaine,

LV-2114

Latvia N06BX21 1644006.03.2017

06.03.2022PoM

Olainfarm JSC, 5


LV-2114, Latvia

48 Adaptol mebicar tablets500mg,


Olainfarm JSC, 5


LV-2114

Latvia N06BX21 1644106.03.2017

06.03.2022PoM

Olainfarm JSC, 5


LV-2114, Latvia

49 Adelphane-Esidrex

reserpine,

dihydralazine

sulfate, hydrochloro-

thiazide

tablets0,1g+10mg+10mg, in

blister (250/10x5x5/)

Sandoz Private

Limited, Plot No. 8-

A/2 and 8-B, TTC

Industrial Area,

Kalwe Block, Village

Dighe, Opp. Thane-

Belapur Road, Navi

Mumbai, 400 708

India C02LA51 1358310.06.2014

10.06.2019PoM

Sandoz Private

Limited, Sandoz

House, Dr. Annie

Besant Road, Worli,

Mumbai 400 0018,

India

50 Adenoprosin adenoprosin suppositories rectal250mg

(10/2x5/)

Farmaprim SRL, MD-

4829, v. Porumbeni,

dis. Criuleni, str.

Crinilor, 5

Moldova G04CX 1318610.01.2014

10.01.2019PoM

Farmaprim SRL, MD-

4829, v. Porumbeni,

dis. Criuleni, str.

Crinilor, 5, Moldova

51 Adeno-Ritz

serenoa serrulata,

urtica urens,

pygeum africanum

capsules

160mg+50mg+ 50mg,


60/6x10/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

GeorgiaG04CX

herbal drug13671

08.07.2014

08.07.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi, Georgia

11

52 Adenuric 120mg febuxostat tablets film-coated

120mg,


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

84/6x14/)

Menarini-Von

Heyden GmbH,

Leipziger Strasse 7-13,

01097 Dresden

Germany M04AA03 1637630.12.2016

30.12.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg


120mg,


56/4x14/, 84/6x14/)

Menarini-Von

Heyden GmbH,


01097 Dresden- batch

releaser, packager,

Patheon France, 40

Boulevard de

Champaret, 38 300

Bourgoin Jallieu,

France- bulk

manufacturer

Germany M04AA03 1655803.04.2017

03.04.2022PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg


80mg,


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

84/6x14/)

Menarini-Von

Heyden GmbH,


01097 Dresden

Germany M04AA03 1637730.12.2016

30.12.2021PoM

Menarini

International O. L.

S.A., 1, Avenue de la

Gare, 1611,

Luxembourg


80mg,


56/4x14/)

Menarini-Von

Heyden GmbH,


01097 Dresden- batch

releaser, packager,

Patheon France, 40

Boulevard de

Champaret, 38 300

Bourgoin Jallieu,

France- bulk

manufacturer

Germany M04AA03 1655903.04.2017

03.04.2022PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

12

56 Adiloc adapalene gel1mg/ml,

10ml and 30ml plastic 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

ArmeniaD10AD03 14983

18.11.2015

18.11.2020PoM

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

57 Adiloc adapalene gel3mg/ml,

10ml and 30ml plastic vial

Arsanit Ltd, 110

Yerevanyan str.,

Masis- batch releaser,

secondary packager,

PharmaTech CJSC,

111 Raffi str., 0064,


Armenia-bulk

manufacturer,

primary packager

Republic of


18.11.2015

18.11.2020PoM

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

58 Adipin

amlodipine

(amlodipine

besilate)



GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia C08CA01 1530504.02.2016

04.02.2021PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


59 Adipin

amlodipine

(amlodipine

besilate)



GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia C08CA01 1530604.02.2016

04.02.2021PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


60 Adiupresin

desmopressin

(desmopressin

acetate)

drops nasal

0,1mg/ml,

5ml glass vial with

dropper

Ameda Pharma Pvt.

Ltd., 809, Kerala

Industrial Estate,

G.I.D.C. Near Bavla,

Kerala-Bavla,

Ahmedabad-380 220,

Gujarat

India H01BA02 13397/111.06.2015

04.04.2019PoM

Ameda Pharma Pvt.

Ltd., 502, Shreeji

Chambers, Behind

Cargo Motors, Off. C.,

G., Road,

Navrangpura,

Ahmedabad-380 006,

Gujarat, India

13

61Adrenalin-

Zdorovye

epinephrine

(epinephrine

hydrotartrate)


1,82mg/ml,

1ml ampoules (5, 10), 1ml

ampoules in blister (5,

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

Pharmaceutical

Company "Zdorovye"

LLC, 61013, Kharkov,

Shevchenko str., 22

Ukraine C01CA24 1662025.04.2017

25.04.2022PoM

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22,

Ukraine

62 Advagraf tacrolimuscapsules prolonged-

release

3mg,


Astellas Ireland Co.

Ltd., Kerry County,

Killorglin for Astellas

Pharma Europe B.

V.,Elisabethhof 19,

2353 EW Leiderdorp,

the Netherlands

Ireland L04AD02 1244407.05.2013

07.05.2018PoM

Astellas Pharma

Europe B.

V.,Elisabethhof 19,

2353 EW Leiderdorp,

the Netherlands


release

0,5mg,



Ltd., Kerry County,

Killorglin for

Ireland L04AD02 1415729.12.2014

29.12.2019PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands


release

1mg,



Ltd., Kerry County,

Killorglin for

Ireland L04AD02 1415829.12.2014

29.12.2019PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands


release

5mg,



Ltd., Kerry County,

Killorglin

Ireland L04AD02 1415929.12.2014

29.12.2019PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

66 Advantan

methylprednisolone

(methylpredniso-

lone aceponate)

emulsion for

external use

1mg/g,

20g aluminium laminated

tube

Bayer Healthcare

Manufacturing S.r.l.,

Via E. Schering 21,

20090 Segrate

(Milano)

Italy D07AA01 1510015.12.2015

15.12.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

14

67 Advantan

methylprednisolone

(methylpredniso-

lone aceponate)

cream for external

use

1mg/g,

15g aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy D07AA01 1518630.12.2015

30.12.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

68 Advantan

methylprednisolone

(methylpredniso-

lone aceponate)

ointment for

external use

1mg/g,

15g aluminium tube

Bayer Healthcare


Via E. Schering 21,

20090 Segrate

(Milano)

Italy D07AA01 1540109.03.2016

09.03.2021PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

69 Advate octocog alfa

powder and solvent

for solution for

injection

1000IU,

glass vial with powder (1),

5ml ampoule with solvent

(1), BAXJECT II (1)

Baxalta Belgium

Manufacturing SA,

Boulevard Rene

Branquart 80, B-7860

Lessines-batch

releaser, secondary

packager, Baxalta

Manufacturing Sarl,

Route de Pierre-a-bot

111, 2000 Neuchatel,

Switzerland- bulk

manufacturer,

primary packager

Belgium B02BD02 1670923.05.2017

23.05.2022PoM

Baxter AG,

Industriestrasse 67, A-

1221 Vienna, Austria


powder and solvent

for solution for

injection

500IU,


ampoule with 2ml solvent

(1), BAXJECT II (1)

Baxalta Belgium

Manufacturing SA,

Boulevard Rene


Lessines-batch

releaser, secondary

packager, Baxalta

Manufacturing Sarl,



Switzerland- bulk

manufacturer,

primary packager

Belgium B02BD02 1671023.05.2017

23.05.2022PoM

Baxter AG,



15


powder and solvent

for solution for

injection

250IU,


ampoule with 2ml solvent

(1), BAXJECT II (1)

Baxalta Belgium

Manufacturing SA,

Boulevard Rene


Lessines-batch

releaser, secondary

packager, Baxalta

Manufacturing Sarl,



Switzerland- bulk

manufacturer,

primary packager

Belgium B02BD02 1671123.05.2017

23.05.2022PoM

Baxter AG,



72 Aerius desloratadine syrup

0,5mg/ml,

60ml, 120ml and

measuring spoon

Schering-Plough Labo

N.V., Industriepark

30 B-2220, Heist-op-

den-Berg

Belgium R06AX27 13975/107.10.2016

26.11.2019OTC

Bayer Consumer Care

AG, Peter Merian-

Strasse 84, 4052 Basel,

Switzerland

73 Aerius desloratadine tablets film-coated5mg,

blister (10/1x10/)


N.V., Industriepark


den-Berg

Belgium R06AX27 14507/109.09.2016

15.05.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

74 Aerobreathsalbutamol

(salbutamol sulfate)

suspension,

pressurised

inhalation

100mcg/dose,

8.5g (200 inhalations)

aluminium container

with inhaler and plastic

applicator

Aeropharm GmbH,

Francois-Mitterrand-

Allee 1, 07407

Rudolstadt

Germany R03AC02 1597015.09.2016

15.09.2021PoM

Sandoz


Verovskova Str. 57,

1526 Ljubljana,

Slovenia

75 Aescuvenhorse chestnut

seedstablets coated

30mg,

in bllster (40/2x20/)

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532

GermanyC05CX03;

herbal drug16355

30.12.2016

30.12.2021OTC

Cesra Arzneimittel

GmbH & Co. KG,

Braunmattstr. 20,

Baden-Baden, 76532,

Germany

16

76 Aevit

retinol palmitate

(vitamin A), alpha-

tocopherol acetate

(vitamin E)

capsules55mg (100000IU)+100mg,


"Pharmaceutical

company "MELIGEN"

CJSC, 188676,

Leningrad region,

Vsevolozhsk district,

p.Shcheglovo, 53a

Russia A11JA 1696105.09.2017

05.09.2022OTC

"Pharmaceutical

company "MELIGEN"

CJSC, 188676,

Leningrad region,

Vsevolozhsk district,

p.Shcheglovo, 53a,

Russia

77 Aevit

retinol palmitate

(vitamin A), alfa-

tocopherol acetate

(vitamin E)

capsules

55,036mg (100000IU)+

100mg,


Minskintercaps U.V.,

26/3, Inzhenernaya

str., 220075, Minsk

Belarus A11JA 1718430.11.2017

30.11.2022OTC

Minskintercaps U.V.,

26, Inzhenernaya str.,

220075, Minsk,

Belarus

78 Aevit-AV

retinol palmitate

(vitamin A), alfa-

tocopherol acetate

(vitamin E)

capsules

0.1ml (100000IU)+100mg,

blister (10/1x10/,

30/3x10/)

Altayvitamini CJSC,

659325, The Altay

territory, Biysk, 69

Zavodskaya Str.

Russia A11JA 13088/115.01.2016

09.12.2018OTC

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.,

Russia

79 Afala

antibodies to

prostatospecific

antigen affinity

purified

tablets to be sucked

3mg (not more than 10-

15ng/g),


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

NPF Materia Medica

Holding Ltd., 54,

Buguruslanskaya st.,

Chelyabinsk 454139

Russia

G04CX

homeopathic

drug

12512/121.01.2014

01.06.2018OTC

NPF Materia Medica

Holding Ltd., 9 bld.,

3rd Samotyochny

per., Moscow 127473,

Russia

80 Afinitor everolimus tablets2,5mg,


Novartis Pharma

Stein AG,

Schaffhauserstrasse,

4332 Stein

Switzerland L01XE10 1329604.03.2014

04.03.2019PoM

Novartis Pharma AG,

Lichtstrasse 35, 4056

Basel, Switzerland

81 Afinitor everolimus tablets5mg,


Novartis Pharma

Stein AG,


4332 Stein


12.04.2021PoM

Novartis Pharma AG,

35, Lichtstrasse, 4056

Basel, Switzerland

82 Afinitor everolimus tablets10mg,


Novartis Pharma

Stein AG,


4332 Stein


12.04.2021PoM

Novartis Pharma AG,


Basel, Switzerland

17

83 Aflubin

gentiana D1,

aconitum D6,

bryonia D6, ferrum

phosphoricum D12,

acidum

sacrolacticum D12

drops oral

1ml/100ml+ 10ml/100ml+

10ml/100ml+

10ml/100ml+

10ml/100ml,

20ml, 50ml glass bottle-

dropper

Richard Bittner AG,

Ossiacherstrasse 7, A-

9560 Feldkirchen

Austria

R05X;

homeopathic

drug

1578520.07.2016

20.07.2021OTC

Richard Bittner AG,

Reisnerstrasse 55-57,

A-1030 Wien, Austria

84 Aflubin

gentiana D1,

aconitum D6,

bryonia D6, ferrum

phosphoricum D12,

acidum

sacrolacticum D12

tablets sublingual

3,6mg+37,2mg+

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


24/2x12/, 48/4x12/)

Richard Bittner AG,


9560 Feldkirchen

Austria

R05X;

homeopathic

drug

1578620.07.2016

20.07.2021OTC

Richard Bittner AG,



85 Afobazol

fabomotizole

(fabomotizole

dihydrochloride)

tablets

10mg,

in blisters (30/1x30/,

60/3x20/, 60/2x30/,

90/3x30/, 120/4x30/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N05BX04 14729/227.03.2017

30.07.2020PoM

OTCPharm PJSC,

123317, Moscow,

Testovskaya str., 10,

Russia

86AgmenTRONN

1000

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated875mg+125mg,

in blister (10)

Flamingo

Pharmaceuticals Ltd,

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

Area, Rabale, Navi

Mumbai 400 701

India J01CR02 12175/113.03.2014

01.02.2018PoM

Flamingo


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

Area, Rabale, Navi

Mumbai 400 701,

India

87AgmenTRONN

625

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)


in blister (10)

Flamingo


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

Area, Rabale, Navi

Mumbai 400 701

India J01CR02 12174/113.03.2014

01.02.2018PoM

Flamingo


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

Area, Rabale, Navi

Mumbai 400 701,

India

18

88 AirFluSal Forspiro

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation

50mcg/dose+

500mcg/dose, powder in

blister (60 dose), in plastic

inhaler

Aeropharm GmbH,


Alee 1, 07407

Rudolstadt

Germany R03AK06 1502202.12.2015

02.12.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

89 AirFluSal Forspiro

salmeterol

(salmeterol

xinafoate),

fluticasone

(fluticasone

propionate)

powder for

inhalation

50mcg/dose+


blister (60 dose), in plastic

inhaler

Aeropharm GmbH,


Alee 1, 07407

Rudolstadt

Germany R03AK06 1502302.12.2015

02.12.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

90 Airtal aceclofenac tablets film-coated

100mg,

in blister (20/2x10,

60/6x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M01AB16 1408616.12.2014

16.12.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

91 Airtal aceclofenac cream15mg/g,

60g aluminium tube

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M01AB16 1651417.03.2017

17.03.2022OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

92 Airtal aceclofenacpowder for oral

suspension

100mg,

3g sachet (20)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest - batch

releaser, Industrias

Farmaceuticas

Almirall S.L., Ctra.

Nacional II, Km. 593,

Sant Andreu de la

Barca, Barcelona,

08740, Spain-bulk

manufacturer,

packager

Hungary M01AB16 1651517.03.2017

17.03.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

19

93 Akcipro-500

ciprofloxacin

(ciprofloxacin

hydrochloride)



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 J01MA02 1337404.04.2014

04.04.2019PoM

Akriti


Ltd., 117, Block No2,

Emerald Plaza,

Hiranandani

Meadows, Barrister

Nath Pai Road, Thane

(W) 400 610, India

94 Akistan latanoprost drops eye (solution)0,05mg/ml,

2,5ml plastic vial

Bruschettini S.r.l., Via

Isonzo, 6, 16147

Genova

Italy S01EE01 1223107.03.2013

07.03.2018PoM

Pharmaselect

International

Beteiligungs GmbH,

Ernst-Melchior-Gasse

20 1020 Vienna,

Austria

95 Aksastrol anastrozole tablets film-coated1mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon

street, 3056 Limassol

Cyprus L02BG03 1437225.03.2015

25.03.2020PoM

Grindeks JSC,

Krustpils str. 53, LV-

1057, Riga, Latvia

96 AKSONE Injection

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vial (1)

Akriti


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 J01DD04 1696905.09.2017

05.09.2022PoM

Akriti


Ltd., 117, Block No. 2,

Emerald Plaza,

Hiranandani

Meadows, Barrister

Nath Pai Road, Thane

(West) 400 610, India

97 Alactin cabergoline tablets0,5mg,

in glass container (2, 8)

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p. 305,

747 70 Opava-

Komarov

Czech Republic G02CB03 1327304.03.2014

04.03.2019PoM

TEVA Czech

Industries s.r.o.,

Ostravska 29, c.p.

305, 747 70 Opava-

Komarov, Czech

Republic

20

98 Alamycin aerosol

oxytetracycline

(oxytetracycline

hydrochloride)

aerosol

5g/dose,

140g aluminium

container

Norbrook

Laboratories Limited,

Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QD06AA03

veterinary

drug

1281517.09.2013

17.09.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

99 Alamycin LA

oxytetracycline

(oxytetracycline

dihydrate)


50ml, 100ml glass vial

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QJ01AA06

veterinary

drug

1231322.03.2013

22.03.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

100 Alben albendazole granules

200mg/g,

500g pack,

1000g plastic container

NVT Agrovetzaschita

S-P (AVZ S-P) LLC,

Moscow region,

Sergiyev Posad, 1,

Tsentralnaya Str.,

141300

Russia

QP52AC11;

veterinary

drug

1421312.02.2015

12.02.2020PoM

Scientific and

Implementation

Center

Agrovetzaschita LLC,

Kolskaya str. 1, bldg.

1, Moscow 129329,

Russia

101 Alben albendazole tablets360mg,


NVT Agrovetzaschita

S-P (AVZ S-P) LLC,

Moscow region,

Sergiyev Posad, 1,

Tsentralnaya Str.,

141300

Russia

QP52AC11;

veterinary

drug

1421412.02.2015

12.02.2020PoM

Scientific and

Implementation

Center

Agrovetzaschita LLC,

Kolskaya str. 1, bldg.

1, Moscow 129329,

Russia

102 Albendazole albendazole tablets200mg,


"NOKI" JV LTD Co.,

Nor-Kharberd, Ararat

region

Republic of

ArmeniaP02CA03 15590

12.05.2016

12.05.2021PoM

"NOKI" JV LTD Co.,


region, Republic of

Armenia

103 Albendazole albendazole tablets chewable400mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP02CA03 15949

02.09.2016

02.09.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

21

104 Albendazole 10% albendazole suspension oral100mg/ml,

1l plastic container

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de

Llobregat, Barcelona,

Esmeralda 19

Spain

QP52AC11

veterinary

drug

1300514.11.2013

14.11.2018PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

105 Albenol-100 Oral albendazole suspension oral

100mg/ml,

plastic container 500ml,

1000ml, plastic bottle

100ml

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QP52AC11;

veterinary

drug

14138/111.12.2017

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

106 Albenol-300 bolus albendazole bolus (tablets)300mg,


Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QP52AC11;

veterinary

drug

1501002.12.2015

02.12.2020PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

107 Albucid

sulfacetamide

(sulfacetamide

sodium)

powder for external

use

500mg,

sachets (10)

Esco-Pharm LLC, Nor-

Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaS01AB04 12816

17.09.2013

17.09.2018OTC


Norq, Mikoyan 13,


Armenia

108 Albucid

sulfacetamide

(sulfacetamide

sodium)

powder for external

use

300mg,

sachets (10)


Norq, Mikoyan 13,

Yerevan

Republic of


17.09.2013

17.09.2018OTC


Norq, Mikoyan 13,


Armenia

109 Albucide Liqvo sulfacetamide drops eye200mg/ml,

5ml vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


24.07.2014

24.07.2019OTC

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

110Albumin-

Biopharmaalbumin human solution for infusion

100mg/ml,

50ml glass bottle

BIOPHARMA

PLASMA LLC, 9M.

Amosova St, Kyiv,

03680

Ukraine B05AA01 1724708.12.2017

08.12.2022PoM

BIOPHARMA

PLASMA LLC, 37,

Kyivska St., Bila

Tserkva, Kyiv region,

09100, Ukraine

22

111Albumin-


100mg/ml,

100ml glass bottle

BIOPHARMA

PLASMA LLC, 9M.

Amosova St, Kyiv,

03680

Ukraine B05AA01 1724808.12.2017

08.12.2022PoM

BIOPHARMA

PLASMA LLC, 37,

Kyivska St., Bila


09100, Ukraine

112Albumin-


200mg/ml,

50ml glass bottle

BIOPHARMA

PLASMA LLC, 9M.

Amosova St, Kyiv,

03680

Ukraine B05AA01 1724908.12.2017

08.12.2022PoM

BIOPHARMA

PLASMA LLC, 37,

Kyivska St., Bila


09100, Ukraine

113Albumin-


200mg/ml,

100ml glass bottle

BIOPHARMA

PLASMA LLC, 9M.

Amosova St, Kyiv,

03680

Ukraine B05AA01 1725008.12.2017

08.12.2022PoM

BIOPHARMA

PLASMA LLC, 37,

Kyivska St., Bila


09100, Ukraine

114 Albunorm 20% albumin humansolution for i/v

infusion

200mg/ml,

50ml and 100ml glass

bottle

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B05AA01 1493120.10.2015

20.10.2020PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

115 Albunorm 5% albumin humansolution for i/v

infusion

50mg/ml,

100ml, 250ml, 500ml

glass bottle

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna

Austria B05AA01 1493020.10.2015

20.10.2020PoM

Octapharma

Pharmazeutika

Produktionsges.

m.b.H., Oberlaaer

Strasse 235, A-1100

Vienna, Austria

116 Alcohol medical ethanol solution

70%,

25ml, 30ml, 50ml, 100ml,

250ml, 500ml, 750ml,

1000ml, 5000ml,

10000ml, 20000ml glass

or plastic bottle

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

packager,

PharmaTech CJSC,

0064, Yerevan, Raffi

str. 111, Republic of

Armenia-bulk

manufacturer

Republic of

ArmeniaD08AX08 15487

05.04.2016

05.04.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

23

117 Alcohol medical ethanol solution

96%,

50ml, 100ml, 250ml,

1000ml, 5000ml,

10000ml, 20000ml glass

or plastic bottle

Arsanit Ltd, 110

Yerevanyan str.,

Masis-batch releaser,

packager,

PharmaTech CJSC,



Armenia-bulk

manufacturer

Republic of


05.04.2016

05.04.2021OTC

Arsanit Ltd, 110

Yerevanyan str.,

Masis, Republic of

Armenia

118Alcohol Medical

70%ethanol

solution for external

use

70%,

50ml, 100ml, 250ml glass

and plastic bottles

Lizin OJSC,

Charentsavan, st.

Gortsaranayin 14

Republic of


06.05.2014

06.05.2019OTC

Lizin OJSC,

Charentsavan, st.

Gortsaranayin 14,

Republic of Armenia

119Alcohol Medical

96%ethanol


use

96%,

50ml, 100ml, 250ml,

500ml, 1000ml glass and

plastic bottles

Lizin OJSC,

Charentsavan, st.

Gortsaranayin 14

Republic of


06.05.2014

06.05.2019OTC

Lizin OJSC,

Charentsavan, st.

Gortsaranayin 14,

Republic of Armenia

120 Aldara imiquimod cream for local use50mg/g,

250mg sachets (12)

3M Health Care

Limited, Derby Road,

Loughborough

Leicestershire LE11

5SF

UK D06BB10 1586701.08.2016

01.08.2021PoM

Meda AB, Pipersvag

2A, 170 73 Solna,

Sweden

24

121

Alendronic Acid

Once weekly 70mg

Tablets

alendronic acid tablets70mg,

in blister (4/1x4/)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK M05BA04 1485415.09.2015

15.09.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

122 Aler-Gcetirizine (cetirizine

dihydrochloride)tablets film-coated

10mg,

in blister (20)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia R06AE07 1301525.11.2013

25.11.2018OTC

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


123 Alexan cytarabine solution for injection20mg/ml,

5ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, A-

4866 Unterach am

Attersee

Austria L01BC01 1361627.06.2014

27.06.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

124 Alexan cytarabine solution for injection50mg/ml,

10ml glass vial (1)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01BC01 13617/120.11.2015

27.06.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

125 Alfa Normix rifaximin tablets film-coated200mg,

in blister (12)

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno

Italy A07AA11 12499/104.09.2013

01.06.2018PoM

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno, Italy

25

126 Alfa Normix rifaximin tablets film-coated200mg,


Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno

Italy A07AA11 1712424.10.2017

24.10.2022PoM

Alfa Wassermann

S.p.A., Via Enrico

Fermi, 1-65020,

Alanno, Italy

127 Alfagin

panax ginseng,

eleutherococcus

senticosus ,

medicago sativa,

emblica officinalis,

trigonella foenum-

graecum

capsules

50mg+200mg+

500mg+800mg+ 500mg,

in plastic container, (20,

60)

Herbion Pakistan Pvt.

Ltd., 30/28, Korangi

Industrial area,

Karachi-74900

Pakistan herbal drug 1524225.12.2015

25.12.2020OTC



Industrial area,

Karachi-74900,

Pakistan

128 Alfagin

panax ginseng,

eleutherococcus

senticosus,

medicago sativa,


trigonella foenum-

graecum

syrup

25mg/5ml+ 100mg/5ml+

250mg/5ml+ 400mg/5ml+

250mg/5ml,


bottle



Industrial area,

Karachi-74900

Pakistan herbal drug 1667711.05.2017

11.05.2022OTC



Industrial area,

Karachi-74900,

Pakistan

129 Alfamec 1% ivermectin solution for injection

10mg/ml,

50ml glass vial (15),

100ml glass vial (12),

250ml glass vial (6)

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden

the Netherlands

QP54AA01;

veterinary

drug

1458409.06.2015

09.06.2020PoM

Alfasan International

B.V., Kuipersweg 9-

3449 JA Woerden,

the Netherlands

130Alfa-tokopherol

acetate

tocopherol acetate

(vitamin E)capsules

100mg,

in blister (10/1x10/) and

(30/3x10/)

Marbiopharm JSC,

424006, the Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx 121

Russia A11HA03 13639/116.07.2014

27.06.2019OTC

Marbiopharm JSC,


of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

26

131 Alflutop

bioactive

concentrate from

small sea fish


0,1ml/ml,

2ml ampoules,

in blister (5/1x5/)

S.C.Biotehnos S.A.,

Str. Gorunului nr. 3-

5, Otopeni, Jud. Ilfov,

075100- batch

releaser, secondary

packager, S.C. Zentiva

S.A., Theodor Pallady

Blvd nr. 50, sector 3,

032266 Bucharest,

Romania- bulk

manufacturer,

primary packager

Romania M09AX02 1645306.03.2017

06.03.2022PoM

S.C.Biotehnos S.A.,



075100, Romania

132 Alflutop

bioactive

concentrate from

small sea fish


0,1ml/ml,

1ml ampoules,


S.C.Biotehnos S.A.,



075100- batch

releaser, secondary

packager, S.C. Zentiva

S.A., Theodor Pallady

Blvd nr. 50, sector 3,

032266 Bucharest,

Romania- bulk

manufacturer,

primary packager

Romania M09AX02 1645406.03.2017

06.03.2022PoM

S.C.Biotehnos S.A.,



075100, Romania

133 Algavak Minactivated antigen

of hepatitis A

suspension for i/m

injection

not less than 25 ELISA

U/0,5ml(1dose for

children); (10/2x5/)

ampoules 0.5ml (10 doses)

Vector-BiAlgam JSC,

Industrial site of State

Research Center of

VB "Vector", building

N104, Koltsovo,

Novosibirsk oblast,

630559

RussiaJ07BC02;

vaccine17229

08.12.2017

08.12.2022PoM

Vector-BiAlgam JSC,


Research Center of


N104, Koltsovo,

Novosibirsk oblast,

630559, Russia

134 Algavak Minactivated antigen

of hepatitis A

suspension for i/m

injection

not less than 50 ELISA

U/1ml (1dose for adult or

2 dose for children);

(10/2x5/) ampoules 1ml

(10 doses) or (10/2x5/)

ampoules 1ml (20 doses)

Vector-BiAlgam JSC,


Research Center of


N104, Koltsovo,

Novosibirsk oblast,

630559

RussiaJ07BC02;

vaccine17230

08.12.2017

08.12.2022PoM

Vector-BiAlgam JSC,


Research Center of


N104, Koltsovo,

Novosibirsk oblast,

630559, Russia

27

135 Algeroncepeginterferon alfa-

2b

solution for s/c

injection

200mcg/ml,

0.5ml glass syringes in

blister (1, 4/4x1/)

BIOCAD CJSC,

Petrovo-Dalnee,


Moscow Region,

143422

Russia L03AB 1403119.12.2014

19.12.2019PoM

BIOCAD CJSC, 34


st.,Strelna,

Petrodvortsoviy

district, Saint

Peterburg, 198515,

Russia


2b

solution for s/c

injection

200mcg/ml,

0.6ml glass syringes in

blister (1, 4/4x1/)

BIOCAD CJSC,

Petrovo-Dalnee,


Moscow Region,

143422

Russia L03AB 1403219.12.2014

19.12.2019PoM

BIOCAD CJSC, 34


st.,Strelna,

Petrodvortsoviy

district, Saint

Peterburg, 198515,

Russia


2b

solution for s/c

injection

200mcg/ml,

0.8ml glass syringe in

blister (1, 4/4x1/)

BIOCAD CJSC,

Petrovo-Dalnee,


Moscow Region,

143422

Russia L03AB 1403319.12.2014

19.12.2019PoM

BIOCAD CJSC, 34


st.,Strelna,

Petrodvortsoviy

district, Saint

Peterburg, 198515,

Russia

138 Alimta

pemetrexed

(pemetrexed

disodium

heptahydrate)

powder lyophilized

for solution for

infusion

500mg,

glass vial

Lilly France S.A.S., 2,


67640 Fegersheim

France L01BA04 1227022.03.2013

22.03.2018PoM

Eli Lilly Nederland

B.V., Grootslag 1-5,

NL-3991, RA Houten,

the Netherlands

139 Alimta

pemetrexed

(pemetrexed

disodium

heptahydrate)

powder for

concentrate for


500mg,

glass vial

Lilly France (S.A.S)., 2


67640 Fegersheim -

secondary packager,

batch releaser (bulk

manufacturer,

primary packager-Eli

Lilly and Company,

Indianapolis 46285,

Indiana, USA)

France L01BA04 14035/129.05.2015

19.12.2019PoM

Eli Lilly Nederland


NL-3991, RA

Houteen, the

Netherlands

28

140 Alimta

pemetrexed

(pemetrexed

disodium

heptahydrate)

powder for

concentrate for


100mg,

glass vial (1)

Lilly France, (S.A.S).,

2 rue du Colonel

Lilly, F-67640

Fegersheim -

secondary packager,

batch releaser, Eli

Lilly and Company,

Indianapolis, IN

46285, USA-bulk

manufacturer,

primary packager

France L01BA04 1521930.12.2015

30.12.2020PoM

Eli Lilly Nederland


NL-3991, RA Houten,

the Netherlands

141 Alkadipin

amlodipine

(amlodipine

besilate)

tablets5mg,


Alkaloid AD-Skopje,

bul. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C08CA01 1252601.06.2013

01.06.2018PoM

Alkaloid AD-Skopje,

bul. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

142 Alkadipin

amlodipine

(amlodipine

besilate)

tablets10mg,


Alkaloid AD-Skopje,

bul. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia C08CA01 1252701.06.2013

01.06.2018PoM

Alkaloid AD-Skopje,

bul. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

143 Alka-Seltzer

acetylsalicylic acid,

citric acid, sodium

bicarbonate

tablets effervescent324mg+965mg+ 1625mg,

in strip (10/5x2/)

Bayer Bitterfeld

GmbH, Ortsteil

Greppin Salegaster

Chaussee 1, 06803

Bitterfeld-Wolfen

Germany N02BA51 1283517.09.2013

17.09.2018OTC

Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

144 Alkeran melphalan tablets film-coated2mg,

glass container (25)

EXCELLA GmbH &

Co.KG, Nuernberger

st. 12, 90537 Feucht

Germany L01AA03 12884/224.07.2017

27.09.2018PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

29

145 Allergodil

azelastine

(azelastine

hydrochloride)

spray nasal

1mg/1ml,

10ml glass vial with pump

dispenser

MEDA Pharma

GmbH & Co. KG,

Benzstrasse 1, 61352

Bad Homburg - batch

releaser; MEDA

Manufacturing

GmbH, Neurather

Ring 1, Cologne,

51063, Germany -

bulk manufacturer,

packager

Germany R01AC03 15872/209.12.2016

11.08.2021OTC

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

146 Allergodil

azelastine

(azelastine

hydrochloride)

drops eye0,5mg/ml,

6ml plastic vial-dropper

MEDA Pharma

GmbH & Co. KG,


Bad Homburg - batch

releaser; Tubilux

Pharma S.p.A., Via

Costarica, 20/22,

00040 Pomezia/Rome,

Italy - bulk

manufacturer,

packager

Germany S01GX07 15873/124.09.2016

11.08.2021OTC

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

147 Allergosan

chloropyramine

(chloropyramine

hydrochloride)

ointment for

external use

10mg/g,

18g aluminium tube

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

Bulgaria D04AA09 1489524.09.2015

24.09.2020OTC

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia, Bulgaria

30

148 Allergosan

chloropyramine

(chloropyramine

hydrochloride)

cream for external

use

10mg/g,

18g aluminium tube

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

Bulgaria D04AA09 1489624.09.2015

24.09.2020OTC

Sopharma JSC, str.

Iliensko shosse 16,


149Allergosan 25mg

coated tablets

chloropyramine

(chloropyramine

hydrochloride)

tablets coated25mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria R06AC03 1540709.03.2016

09.03.2021OTC

Sopharma JSC, str.

Iliensko shosse 16,


150 Allochol

cattle bile dried,

dried garlic,

charcoal activated,

nettle leaves

tablets film-coated

80mg+40mg+25mg+ 5mg,


50/5x10/)

SIC Borshchahivskiy

Chemical-

Pharmaceutical Plant

PJSC, 17 Mira st.,

Kiev, 03134

Ukraine A05AX10 12844/104.05.2015

17.09.2018OTC

SIC Borshchahivskiy

Chemical-


PJSC, 17 Mira st.,

Kiev, 03134, Ukraine

151 Allochol

cattle bile dried,

dried garlic,

charcoal activated,

nettle leaves

tablets film-coated80mg+40mg+25mg+ 5mg,

in blister (10, 10/1x10/)

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211

Russia A05AX 12952/122.01.2015

28.10.2018OTC

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

152 Allochol

cattle bile dried,

dried garlic,

charcoal activated,

nettle leaves

tablets coated

(80mg+40mg+

25mg+5mg),

in blister (10/1x10/),


Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.


str., 124

Russia A05AX 1358810.06.2014

10.06.2019OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

153 Allopurinol allopurinol tablets300mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaM04AA01 12465

02.10.2013

02.10.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

31

154 Allopurinol allopurinol tablets100mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaM04AA01 12865

17.09.2013

17.09.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

155 Almagel

aluminium

hydroxide,

magnesium

hydroxide

suspension oral

43,6mg/ml+ 70mg/ml,

170ml glass or plastic


spoon 5ml, 10ml sachets

(10, 20)

Balkanpharma-

Troyan AD

(Krayrechna Str. N1,

5600, Troyan)

Bulgaria A02AB10 1297428.10.2013

28.10.2018OTC

Balkanpharma-

Troyan AD,

(ACTAVIS GROUP)

(Krayrechna Str. N1,

5600, Troyan,

Bulgaria)

156 Almagel A

aluminium

hydroxide,

magnesium

hydroxide,

benzocaine

suspension oral

436mg/ml+ 70mg/ml+

21,8mg/ml,



spoon 5ml, 10ml sachets

(10, 20)

Balkanpharma-

Troyan AD,

Krayrechna Str. N1,

5600, Troyan

Bulgaria A02AB10 1301725.11.2013

25.11.2018OTC

Balkanpharma-

Troyan AD,

(ACTAVIS GROUP)

Krayrechna Str. N1,

5600, Troyan,

Bulgaria

157 Almagel NEO

aluminium

hydroxide,

magnesium

hydroxide,

simethicone

suspension oral

340mg/5ml+ 395mg/5ml+

36mg/5ml,

170ml plastic bottle and

measuring spoon,

10ml sachets (10, 20)

Balkanpharma-

Troyan AD,

Krayrechna Str. N1,

5600, Troyan

Bulgaria A02AF02 1669123.05.2017

23.05.2022OTC

Balkanpharma-

Troyan AD,

(ACTAVIS GROUP)

Krayrechna Str. N1,

5600, Troyan,

Bulgaria

158 Alotendin

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets

5mg+5mg,

in blister, (28/4x7/,

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

90/9x10/)

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-

120

Hungary C07FB 1404619.12.2014

19.12.2019PoM


PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary

159 Alotendin

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets

5mg+10mg,


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

90/9x10/)


PLC, 1165 Budapest,


120

Hungary C07FB 1404719.12.2014

19.12.2019PoM


PLC, 1106 Budapest,


Hungary

32

160 Alotendin

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets

10mg+5mg,


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

90/9x10/)


PLC, 1165 Budapest,


120

Hungary C07FB 1404819.12.2014

19.12.2019PoM


PLC, 1106 Budapest,


Hungary

161 Alotendin

bisoprolol

(bisoprolol

fumarate),

amlodipine

(amlodipine

besilate)

tablets

10mg+10mg,


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

90/9x10/)


PLC, 1165 Budapest,


121

Hungary C07FB 1404919.12.2014

19.12.2019PoM


PLC, 1106 Budapest,


Hungary

162 Altargo retapamulin ointment10mg/g,

5g aluminium tube

Glaxo Operations UK

Ltd. (trading as Glaxo

Wellcome

Operations), Harmire

Road, Barnard Castle,

Durham, DL12 8DT

UK D06AX13 1334913.03.2014

13.03.2019PoM

Glaxo Group Ltd.,

980 Great West Road,

Brentford, Middlesex,

TW8 9GS, UK

163 Altemarshmallow root

extractsyrup

349mg/g,

125g glass or plastic bottle

and measuring cup

Pharmaceutical

Manufacturing

Enterprise GEMI, 05-

480 Karczew,

Mickiewicza 36 str.

PolandR05CA05;

herbal drug14588

08.06.2015

08.06.2020OTC

Pharmaceutical

Manufacturing

Enterprise GEMI, 05-

480 Karczew,

Mickiewicza 36 str.,

Poland

164 Alteyka Arteriumalthaeae radix dry

extractsyrup

7,5mg/5ml,

100ml plastic or glass


spoon, 100ml plastic or

glass container and

measuring spoon, 200ml

plastic or glass bottle and

measuring spoon

Halychpharm JSC,

79024, city of Lviv, st.

Oprishkovskaya, 6/8

UkraineR05CA05;

herbal drug17207

08.12.2017

08.12.2022OTC

Halychpharm JSC,

79024, city of Lviv, st.

Oprishkovskaya, 6/8,

Ukraine

33

165 Aluvia lopinavir, ritonavir tablets film-coated100mg+25mg,


AbbVie Deutschland

GmbH & Co. KG,

Knolstrasse, 67061

Ludwigshafen

Germany J05AE06 1525229.12.2015

29.12.2020PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, 6341 Baar,

Switzerland

166 Aluvia lopinavir, ritonavir tablets film-coated 200mg+50mg,


AbbVie Deutschland

GmbH & Co. KG,

Knolstrasse, 67061

Ludwigshafen

Germany J05AR10 1693023.08.2017

23.08.2022PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, 6341 Baar,

Switzerland

167 Alzepil

donepezil

(donepezil

hydrochloride)

tablets coated

5mg,


56/4x14/)


PLC, 1165 Budapest,


120

Hungary N06DA02 13710/115.10.2015

24.07.2019PoM


PLC, 1106 Budapest,


Hungary

168 Alzepil

donepezil

(donepezil

hydrochloride)

tablets coated

10mg,


56/4x14/)


PLC, 1165 Budapest,


120

Hungary N06DA02 13711/115.10.2015

24.07.2019PoM


PLC, 1106 Budapest,


Hungary

169 Amaryl glimepiride tablets 1mg,


SANOFI S.P.A., S.S.

17 km 22, 67019

Scoppito (AQ)

Italy A10BB12 1692109.08.2017

09.08.2022PoM

Sanofi-Aventis

Deutschland GmbH,

Bruningstrasse 50, D-

65926 Frankfurt am

Main, Germany



SANOFI S.P.A., S.S.

17 km 22, 67019

Scoppito (AQ)

Italy A10BB12 1692209.08.2017

09.08.2022PoM

Sanofi-Aventis

Deutschland GmbH,


65926 Frankfurt am

Main, Germany



SANOFI S.P.A., S.S.

17 km 22, 67019

Scoppito (AQ)

Italy A10BB12 1692309.08.2017

09.08.2022PoM

Sanofi-Aventis

Deutschland GmbH,


65926 Frankfurt am

Main, Germany

34



SANOFI S.P.A., S.S.

17 km 22, 67019

Scoppito (AQ)

Italy A10BB12 1692409.08.2017

09.08.2022PoM

Sanofi-Aventis

Deutschland GmbH,


65926 Frankfurt am

Main, Germany

173 Amaryl M

glimepiride,

metformin

(metformin

hydrochloride)

tablets film-coated2mg+500mg, blisters

(30/3x10/)

Handok Inc., 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do,

Korea South

Korea South A10AE04 14305/125.07.2016

03.03.2020PoM

Sanofi-aventis group,

54, rue La Boetie,

75008 Paris, France

174 Amaryl M SR

glimepiride,

metformin

(metformin

hydrochloride)

tablets prolonged-

release film-coated

2mg+500mg,


Handok

Pharmaceuticals Co.

Ltd., 37, Daepung-ri,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth A10BD02 1249301.06.2013

01.06.2018PoM

Sanofi-Aventis, 20

avenue Raymond

Aron, 92165 Antony

Cedex, France

175 Ambrohexal

ambroxol

(ambroxol

hydrochloride)

tablets30mg,

blisters (20/1x20/)

Salutas Pharma

GmbH, Otto-von-

Guericke Allee 1,

39179 Barleben

Germany R05CB06 14171/130.01.2017

16.01.2020OTC

Hexal AG,


83607 Holzkirchen,

Germany

176 Ambrohexal syrup

ambroxol

(ambroxol

hydrochloride)

syrup

3mg/ml,


measuring spoon

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben-

batch releaser,

Lichtenheldt GmbH,

Pharmazeutische

Fabrik,

Industriestrasse 7-10,

23812 Wahlstedt,

Germany-bulk

manufacturer,

packager

Germany R05CB06 14368/120.05.2017

25.03.2020OTC

Hexal AG,


83607, Holzkirchen,

Germany

177 Ambroton

ambroxol

(ambroxol

hydrochloride)

syrup

15mg/5ml,


measuring spoon

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR05CB06 15663

08.06.2016

08.06.2021OTC

"Tonus-Les " LLC,

Yerevan, 1 Yervand

Kochar str., 0070,

Republic of Armenia

35

178 Ambroxol

ambroxol

(ambroxol

hydrochloride)

tablets30mg,

blisters (20/2x10/)

Kievmedpreparat

PJSC, 01032, Kiev,

Saksaganskogo street,

139

Ukraine R05CB06 12840/127.01.2017

17.09.2018OTC

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

179 Ambroxol

ambroxol

(ambroxol

hydrochloride)

tablets30mg,


Open joint stock


zavod medicinskikh

preparatov" 64,

Chapaev str., Borisov


Belarus R05CB06 1580020.07.2016

20.07.2021OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

180 Ambroxol

ambroxol

(ambroxol

hydrochloride)

syrup

3mg/ml,


measuring spoon

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100

Otopeni, Str. Eroilor,

Nr. 1A

Romania R05CB06 1715707.11.2017

07.11.2022OTC

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

181Ambroxol

hydrochloride

ambroxol

(ambroxol

hydrochloride)

tablets30mg,


SIC "Borshchahivskiy

Chemical-

Pharmaceutical Plant"

PJSC, 17, Mira St,

Kyiv, 03134

Ukraine R05CB06 1648301.03.2017

01.03.2022OTC

SIC "Borshchahivskiy

Chemical-

Pharmaceutical

Plant" PJSC, 17, Mira

St, Kyiv, 03134,

Ukraine

182

AMBROXOL

SOPHARMA

15mg/5ml syrup

ambroxol

(ambroxol

hydrochloride)

syrup

15mg/5ml,


plastic measuring cup,


plastic measuring cup

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia - batch

releaser, Sopharma

JSC, Vrabevo vlg.

5660, district of

Lovetch, Bulgaria-

bulk manufacturer,

packager

Bulgaria R05CB06 15460/109.12.2016

02.04.2021OTC

Sopharma JSC, str.

Iliensko shosse 16,


36

183Ambroxol-

Hemofarm

ambroxol

(ambroxol

hydrochloride)

syrup

15mg/5ml,


5ml measuring spoon

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 R05CB06 1551719.04.2016

19.04.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

184 Amikacinamikacin (amikacin

sulfate)

powder for solution

for i/v and i/m

injection

500mg,


"Sintez" OJSC, Pr.

Konstitutsii, No. 7,

Kurgan, 640008

Russia J01GB06 1713307.11.2017

07.11.2022PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

185 Amikacinamikacin (amikacin

sulfate)

powder for solution

for i/v and i/m

injection

1000mg,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01GB06 1713407.11.2017

07.11.2022PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

186Amikaton

500mg/2ml

amikacin (amikacin

sulfate)

solution for

injection/infusion

500mg/2ml,

2ml ampoules (10)

Medochemie Ltd., 48

Iapetou street, Agios

Athanassios Industrial

Area, 4101 Agios

Athanassios, Limassol

Cyprus J01GB06 1496418.11.2015

18.11.2020PoM

Medochemie Ltd., 1-

10

Constantinoupoleos

street, 3011 Limassol,

Cyprus

187 Amiksin tilorone tablets film-coated125mg,

blister (6/1x6/, 10/1x10/)

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211

Russia J05AX 14563/120.07.2016

09.06.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

188 Amiksin tilorone tablets film-coated60mg,

blister (10/1x10/)

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211

Russia J05AX 14564/120.07.2016

09.06.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

37

189 Amiksin tilorone tablets film-coated

125mg,

in blister (3/1x3/, 6/1x6/,

10/1x10/, 6/2x3/, 12/2x6/,

20/2x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia J05AX 1687708.08.2017

08.08.2022OTC

OTCPharm PJSC,

123317, Moscow,


Russia

190 Amiksin tilorone tablets film-coated

60mg,

in blister (6/1x6/,

10/1x10/, 12/2x6/,

20/2x10/)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia J05AX 1687808.08.2017

08.08.2022OTC

OTCPharm PJSC,

123317, Moscow,


Russia

191Aminazin-

Zdorovye

chlorpromazine

(chlorpromazine

hydrochloride)

tablets film-coated

25mg,

in blister (20, 20/1x20/,

20/2x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine N05AA01 1694505.09.2017

05.09.2022PoM/UC4

Pharmaceutical

Company "Zdorovye"



Ukraine

192Aminoplasmal

B.Braun E10

isoleucine, leucine,

lysine (lysine

hydrochloride),

methionine,

phenylalanine,

threonine,

tryptophan, valine,

arginine, histidine,

alanine, glycine,

aspartic acid,

glutamic acid,

proline, serine,

tyrosine, sodium

acetate trihydrate,

sodium hydroxide,

potassium acetate,

magnesium

chloride

hexahydrate,

disodium phosphate

dodecahydrate


5mg/ml+8.9mg/ml+8.56m

g/ml+ 4.4mg/ml+

4.7mg/ml+ 4.2mg/ml+

1.6mg/ml+ 6.2mg/ml+

11.5mg/ml+ 3mg/ml+

10.5mg/ml+ 12mg/ml+

5.6mg/ml+ 7.2mg/ml+

5.5mg/ml+ 2.3mg/ml+

0.4mg/ml+ 2.858mg/ml+

0.36mg/ml+ 2.453mg/ml+

0.508mg/ml+

3.581mg/ml, 500ml glass

bottles (10)

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen

Germany B05BA10 1567708.06.2016

08.06.2021PoM

B.Braun Melsungen

AG, Carl-Braun-

Strasse 1, 34212

Melsungen, Germany

38

193 Aminosalicylic acid

sodium 4-

aminosalicylic acid

(sodium 4-

aminosalicylate

dihydrate)

powder lyophilized

for solution for

infusion

13490mg,

500ml glass vial 13,49g

Sanjivani Paranteral

Limited R-40, T.T.C.

Rabele, Thane-

Belapur Road, Navi

Mumbai Pin 400 701

India J04AA01 1223407.03.2013

07.03.2018PoM


Limited, 205, P.N.

Kothari Industrial

Estate, L.B.S. Marg,

Bhandup (W),

Mumbai-400 078,

India

194 Aminosol-Neo

L-isoleucine, L-

leucine, L-valine, L-

lysine (L-lysine

monoacetate), L-

methionine, L-

threonine, L-

phenylalanine, L-

alanine, L-arginine,

glicine, L-histidine,

L-proline, L-serine,

L-tyrosine, taurine,

L-tryptophan


5mg/ml+7.4mg/ml+6.2mg

/ml+ 6.6mg/ml+

4.3mg/ml+ 4.4mg/ml+

5.1mg/ml+

14mg/ml+12mg/ml+11mg

/ml+3mg/ml+ 11.2mg/ml+

6.5mg/ml+ 0.4mg/ml+

1mg/ml+2mg/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 1625919.12.2016

19.12.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

195 Aminoven

L-isoleucine, L-

leucine, L-lysine

(lysine acetate), L-

methionine, L-

phenylalanine, L-

threonine, L-

triyptophan, L-

valine, L-arginine, L-

histidine, L-alanine,

glycine, L-proline,

L-serine, L-

tyrosine, taurine



/ml+ 4.3mg/ml+

5.1mg/ml+ 4.4mg/ml+

2mg/ml+ 6.2mg/ml+

12mg/ml+

3mg/ml+14mg/ml+

11mg/ml+ 11.2mg/ml+

6.5mg/ml+

0.4mg/ml+1mg/ml, 500ml

glass bottle (10)

Fresenius Kabi

Austria GmbH,

Hafnerstrasse 36, 8055

Graz

Germany B05BA01 1464303.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

39

196 Aminoven

L-isoleucine, L-

leucine, L-lysine

(lysine acetate), L-

methionine, L-

phenylalanine, L-

threonine, L-

triyptophan, L-


histidine, L-alanine,

glycine, L-proline,

L-serine, L-

tyrosine, taurine


5.2mg/ml+ 8.9mg/ml+

11.1mg/ml+ 3.8mg/ml+

5.5mg/ml+ 8.6mg/ml+

1.6mg/ml+ 5.5mg/ml+

20mg/ml+ 7.3mg/ml+

25mg/ml+ 18.5mg/ml+

17mg/ml+ 9.6mg/ml+

0.4mg/ml+2mg/ml,

500ml glass bottles (10)

Fresenius Kabi

Austria GmbH,


Graz

Germany B05BA01 1464403.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

197 Aminoven infant

L-isoleucine, L-

leucine, L-lysine

(lysine

monoacetate), L-

methionine, L-

phenylalanine, L-

threonine, L-

triyptophan, L-


histidine, glycine, L-

alanine, L-proline,

L-serine, taurine, L-

cysteine (N-acetyl L-

cysteine), L-

tyrosine (N-acetyl L-

tyrosine), L-malic

acid


8mg/ml+13mg/ml+8.51m

g/ml+ 3.12mg/ml+


2.01mg/ml+ 9mg/ml+



9.71mg/ml+ 7.67mg/ml+


4.2mg/ml+ 2.62mg/ml,

100ml glass bottle (10)

Fresenius Kabi

Austria GmbH,


Graz

Germany B05BA01 1464203.07.2015

03.07.2020PoM

Fresenius Kabi

Deutschland GmbH,

61346 Bad Homburg,

v.d.H, Germany

198 Amiodaron

amiodarone

(amiodarone

hydrochloride)


50mg/ml,

3ml ampoules (10/2x5/,

10) label banderol, 3ml

ampoules dividella (10)

Open Joint Stock

Company , 64/27,

Chapayev str., Borisov

222120, Minsk oblast

Belarus C01BD01 1282917.09.2013

17.09.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus

40

199Amiodarone

100mg Tablets

amiodarone

(amiodarone

hydrochloride)

tablets100mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C01BD01 1514317.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

200Amiodarone

200mg Tablets

amiodarone

(amiodarone

hydrochloride)

tablets200mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C01BD01 1514417.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

201 Amipol-T amitraz, timolol strips wooden

6,75mg+0,8mg,

in aluminum pouch

(10/1x10/)

Agrobioprom CJSC,

143985, Moscow,

Balashikhinski

district, Novo-Milet

r/d, Poltevskoe shosse,

4

Russia

QP53AD51;

veterinary

drug

1676402.06.2017

02.06.2022OTC

Agrobioprom CJSC,

107139, Moscow,

pereulok

Orlikov,house 3,

Russia

41

202Amitriptylin

hydrochloride

amitriptyline

(amitriptyline

hydrochloride)

tablets25mg,


KPE' Zdorovye

narodu' LLC,

Melnikova str., 41,

61002, Kharkov

Ukraine N06AA09 12869/118.01.2016

17.09.2018PoM

'KPE' Zdorovye

narodu' LLC,

Sevchenko str. 22,

61013, Kharkov,

Ukraine

203Amitriptylin

Zentiva

amitriptyline

(amitriptyline

hydrochloride)



Saneca

Pharmaceuticals. a.s.,

Nitrianska 100, 920 27

Hlohovec

Slovak Republic N06AA09 1719308.12.2017

08.12.2022PoM

Zentiva a.s.,

Einsteinova 24, 851

01 Bratislava, Slovak

Republic

204 Amitriptyline

amitriptyline

(amitriptyline

hydrochloride)

tablets coated25mg,


Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8

Ukraine N06AA09 1303825.11.2013

25.11.2018PoM

Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8, Ukraine

205 Amitriptyline

amitriptyline

(amitriptyline

hydrochloride)

tablets coated25mg,


PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine N06AA09 1358710.06.2014

10.06.2019PoM

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

206 Amitriptyline

amitriptyline

(amitriptyline

hydrochloride)

tablets coated25mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN06AA09 13964

04.11.2014

04.11.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

42

207

Amitriptyline

10mg Film-coated

Tablets

amitriptyline

(amitriptyline

hydrochloride)



Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK N06AA09 1514017.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

208

Amitriptyline

25mg Film-coated

Tablets

amitriptyline

(amitriptyline

hydrochloride)



Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK N06AA09 1513917.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

43

209 Amivit-Asteria

DL-methionine, L-

leucine, L-valine, L-

isoleucine, L-

threonine, L-

tryptophan, L-

phenylalanine, L-

lysine (L-lysine

hydrochloride),

vitamin A, vitamin

D2, vitamin E,

vitamin B1, vitamin

B2, vitamin B3,

vitamin B6, calcium

pantothenate,

vitamin B12, folic

acid, vitamin C

capsules

9,2mg+9,15mg+

5mg+5mg+5mg+

5mg+5mg+25mg+

1000IU+100IU+

10mg+2,5mg+

1,5mg+10mg+

5mg+2.5mg+

0,5mcg+100mcg+ 25mg,


Hankook Korus

Pharm Co., Ltd, 30,

Gangjeo-ro, Jecheon-

Si, Chungcheongbuk-

do

Korea South A11JC 1643506.03.2017

06.03.2022OTC

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

210 Amlessa

perindopril

(perindopril tert-

butylamine),

amlodipine

(amlodipine

besilate)

tablets4mg+5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BB04 1314710.01.2014

10.01.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

211 Amlessa

perindopril

(perindopril tert-

butylamine),

amlodipine

(amlodipine

besilate)

tablets4mg+10mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BB04 1314810.01.2014

10.01.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

212 Amlessa

perindopril

(perindopril tert-

butylamine),

amlodipine

(amlodipine

besilate)

tablets8mg+5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BB04 1314910.01.2014

10.01.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

44

213 Amlessa

perindopril

(perindopril tert-

butylamine),

amlodipine

(amlodipine

besilate)

tablets8mg+10mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BB04 1315010.01.2014

10.01.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

214 Amlocim 10mg

amlodipine

(amlodipine

besilate)

tablets

10mg,


100/10x10/)

Acino Pharma AG,

Birsweg 2, 4253

Liesberg - packager,

batch releaser (dosage

form manufacturer -

Unichem Laboratories

Ltd., 17/18 Pilerne

Industrial Estate 403

511, Pilerne, Bardez,

India)

Switzerland C08CA01 13056/129.06.2015

25.11.2018PoM

Acino Pharma AG,

Birsweg 2, 4253

Liesberg, Switzerland

215 Amlocim 5mg

amlodipine

(amlodipine

besilate)

tablets

5mg,


100/10x10/)

Acino Pharma AG,

Birsweg 2, 4253

Liesberg - packager,


form manufacturer -

Unichem Laboratories

Ltd., 17/18 Pilerne

Industrial Estate 403

511, Pilerne, Bardez,

India)

Switzerland C08CA01 13055/129.06.2015

25.11.2018PoM

Acino Pharma AG,

Birsweg 2, 4253


216 Amlocor

amlodipine

(amlodipine

besilate)

tablets5mg,


ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700

Bulgaria C08CA01 1346506.05.2014

06.05.2019PoM

ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700, Bulgaria

217 Amlocor

amlodipine

(amlodipine

besilate)

tablets10mg,


ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700

Bulgaria C08CA01 1346606.05.2014

06.05.2019PoM

ADIPHARM EAD,

130 Simeonovsko

shose Blvd., Sofia

1700, Bulgaria

45

218 Amlo-Denk 10

amlodipine

(amlodipine

mesilate

monohydrate)

tablets10mg,


Denk Pharma GmbH

& Co. KG, Goellstr. 1,

84529 Tittmoning

Germany C08CA01 1613210.11.2016

10.11.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

219 Amlo-Denk 5

amlodipine

(amlodipine

mesilate

monohydrate)

tablets5mg,


Denk Pharma GmbH


84529 Tittmoning

Germany C08CA01 1613310.11.2016

10.11.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

220 Amlodigamma

amlodipine

(amlodipine

besilate)

tablets

5mg,


100/10x10/)

Woerwag Pharma

GmbH & Co. KG,

Calwer str. 7, 71034

Boblingen - batch

releaser (bulk

manufacturer,

packager - S.C.

Magistra C & C S.R.L.,

82A Aurel Vlaicu

Blvd. 900055

Constata, Romania)

Germany C08CA01 13270/102.06.2015

04.03.2019PoM

Woerwag Pharma

GmbH & Co. KG,


Boblingen, Germany

221 Amlodigamma

amlodipine

(amlodipine

besilate)

tablets

10mg,


100/10x10/)

Woerwag Pharma

GmbH & Co. KG,


Boblingen - batch

releaser (bulk

manufacturer,

packager - S.C.

Magistra C & C S.R.L.,

82A Aurel Vlaicu

Blvd. 900055

Constata, Romania)

Germany C08CA01 13271/102.06.2015

04.03.2019PoM

Woerwag Pharma

GmbH & Co. KG,


Boblingen, Germany

222 Amlodipin

amlodipine

(amlodipine

besilate)

tablets5mg,


Replek Farm Ltd.-

Skopje, 188 str. Kozle,

1000 Skopje

Macedonia C08CA01 1328804.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

46

223 Amlodipin

amlodipine

(amlodipine

besilate)

tablets10mg,


Replek Farm Ltd.-

Skopje Kozle 188,

1000 Skopje

Macedonia C08CA01 1328904.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

224 Amlodipine

amlodipine

(amlodipine

besilate)

tablets10mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC08CA01 13435

14.04.2014

14.04.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

225 Amlodipine

amlodipine

(amlodipine

besilate)

tablets

5mg,


30/3x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C08CA01 1379805.09.2014

05.09.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

226 Amlodipine

amlodipine

(amlodipine

besilate)

tablets5mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC08CA01 14870

24.09.2015

24.09.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

227 Amlodipine

amlodipine

(amlodipine

besilate)

tablets5mg,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus C08CA01 1590023.08.2016

23.08.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

228 Amlodipine

amlodipine

(amlodipine

besilate)

tablets10mg,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus C08CA01 1590123.08.2016

23.08.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

47

229Amlodipine 10mg

tablets

amlodipine

(amlodipine

besilate)

tablets10mg,


Lek Pharmaceuticals

d.d.,Trimlini 2D,

Lendava, 9220 -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

Slovenia C08CA01 1680222.06.2017

22.06.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

230Amlodipine 5mg

tablets

amlodipine

(amlodipine

besilate)

tablets5mg,


Lek Pharmaceuticals

d.d.,Trimlini 2D,


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

Slovenia C08CA01 1680122.06.2017

22.06.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

231Amlodipine-

Biocom

amlodipine

(amlodipine

besilate)

tablets

5mg,


12/1x12/, 20/2x10/,

24/2x12/, (30/3x10/,

36/3x12/, 40/4x10/,

48/4x12/, 50/5x10/,

60/5x12/, 60/6x10/,

(72/6x12/, 90/9x10/,

108/9x12/)

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016

Russia C08CA01 12905/117.11.2014

07.10.2018PoM

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016,

Russia

48

232Amlodipine-

Biocom

amlodipine

(amlodipine

besilate)

tablets

10mg,


12/1x12/, 20/2x10/,

24/2x12/, (30/3x10/,

36/3x12/, 40/4x10/,

48/4x12/, 50/5x10/,

60/5x12/, 60/6x10/,

(72/6x12/, 90/9x10/,

108/9x12/)

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016

Russia C08CA01 12906/117.11.2014

07.10.2018PoM

Biocom JSC, 54

Chapaevsky Cr.,

Stavropol, 355016,

Russia

233

Amlodipine-

Perindopril-

Richter

amlodipine

(amlodipine

besilate), perindipril

(perindopril tert-

butylamine)

tablets10mg+8mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BB04 1497918.11.2015

18.11.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

234

Amlodipine-

Perindopril-

Richter

amlodipine

(amlodipine

besilate),

perindopril

(perindopril tert-

butylamine)

tablets10mg+4mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BB04 1498018.11.2015

18.11.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

49

235

Amlodipine-

Perindopril-

Richter

amlodipine

(amlodipine

besilate),

perindopril

(perindopril tert-

butylamine)

tablets5mg+8mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BB04 1498118.11.2015

18.11.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

236

Amlodipine-

Perindopril-

Richter

amlodipine

(amlodipine

besilate),

perindopril

(perindopril tert-

butylamine)

tablets5mg+4mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BB04 1498218.11.2015

18.11.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

237Amlodipine-

Zdorovye

amlodipine

(amlodipine

besilate)

tablets

5mg,


30/3x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C08CA01 1657103.04.2017

03.04.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

238Amlodipine-

Zdorovye

amlodipine

(amlodipine

besilate)

tablets

10mg,


30/3x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C08CA01 1657203.04.2017

03.04.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

50

239 Amlofil 10

amlodipine

(amlodipine

besilate)

tablets

10mg,

in strip (50/5x10/,

100/10x10/)

Fourrts (India)

Laboratories Pvt. Ltd.,

Vandalur Road,

Kelambakkam,

Kancheepuram-603

103, Tamilnadu

India C08CA01 1381605.09.2014

05.09.2019PoM

Fourrts (India)

Laboratories Pvt.

Ltd., Vandalur Road,

Kelambakkam,

Kancheepuram-603

103, Tamilnadu, India

240 Amlofil 5

amlodipine

(amlodipine

besilate)

tablets

5mg,

in strip (50/5x10/,

100/10x10/)

Fourrts (India)

Laboratories Pvt. Ltd.,

Vandalur Road,

Kelambakkam,

Kancheepuram-603

103, Tamilnadu

India

D01AA01,

D07AB09,

D06AX04

1381505.09.2014

05.09.2019PoM

Fourrts (India)

Laboratories Pvt.

Ltd., Vandalur Road,

Kelambakkam,

Kancheepuram-603

103, Tamilnadu, India

241 Amlonor

amlodipine

(amlodipine

besilate)

tablets10mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.

Pilsudskiego Str., 95-

200 Pabianice

Poland C08CA01 1615023.11.2016

23.11.2021PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice, Poland

242 Amlonor

amlodipine

(amlodipine

besilate)

tablets5mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland C08CA01 1615123.11.2016

23.11.2021PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.



243 Amlotenolatenolol,

amlodipinetablets

50mg+5mg,


Orion Pharma Ltd.,

Orion House, 153-154

Tejgaon Industrial

Area, Dhaka-1208

Bangladesh C07FB03 13629/101.09.2014

27.06.2019PoM

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

51

244 Amlotop

amlodipine

(amlodipine

besilate)

tablets5mg,

in blister (30)

Makiz-Pharma LLC,

109029, Moscow, 6-5

Avtomobilny proezd

Russia C08CA01 1278014.08.2013

14.08.2018PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

245 Amlotop

amlodipine

(amlodipine

besilate)

tablets10mg,

in blister (30)

Makiz-Pharma LLC,

109029, Moscow, 6-5

Avtomobilny proezd

Russia C08CA01 1278114.08.2013

14.08.2018PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

246 Amlotop

amlodipine

(amlodipine

besilate)

tablets5mg,


Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C08CA01 1389006.10.2014

06.10.2019PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

247 Amlotop

amlodipine

(amlodipine

besilate)

tablets10mg,


Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye highway

Russia C08CA01 1389106.10.2014

06.10.2019PoM

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

248

Amoksiklav

156.25mg/5ml

powder for oral

suspension

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

125mg/5ml+

31,25mg/5ml,

glass bottle 100ml and

measuring spoon

Lek d.d., Perzonali 47,

2391 Prevalje Slovenia J01CR02 14320/1

02.06.2017

09.03.2020PoM

Lek d.d., Verovskova

str. 57, 1526

Ljubljana, Slovenia

249Amoksiklav

2x1000mg tablets

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated

875mg+125mg,


14/2x7/)


2391 Prevalje Slovenia J01CR02 13909

17.10.2014

17.10.2019PoM


str. 57, 1526

Ljubljana, Slovenia

52

250Amoksiklav

2x625mg tablets

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated

500mg+125mg,


14/2x7/)



17.10.2014

17.10.2019PoM


str. 57, 1526

Ljubljana, Slovenia

251Amoksiklav

312,5mg/5ml forte

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

250mg/5ml+ 62,5mg/5ml,


measuring spoon



25.03.2015

25.03.2020PoM


str. 57, 1526

Ljubljana, Slovenia

252Amoksiklav 375mg

film-coated tablets

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated250mg+125mg, glass

bottle (15)



02.06.2017

09.03.2020PoM


str. 57, 1526

Ljubljana, Slovenia

253Amoksiklav 625mg

film-coated tablets

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated500mg+125mg, glass

bottle (15)



02.06.2017

09.03.2020PoM


str. 57, 1526

Ljubljana, Slovenia

254

Amoksiklav

powder for

solution for

injection 1000mg

/200mg

amoxicillin

(amoxicillin

sodium), clavulanic

acid (potassium

clavulanate)

powder for solution

for injection

1000mg+200mg, glass

vial (5)

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl

Austria J01CR02 1607426.10.2016

26.10.2021PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

255

Amoksiklav

powder for

solution for

injection

500mg/100mg

amoxicillin

(amoxicillin

sodium), clavulanic

acid (potassium

clavulanate)

powder for solution

for injection

500mg+100mg, glass vial

(5)

Sandoz GmbH,


A-6250 Kundl

Austria J01CR02 1607526.10.2016

26.10.2021PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

53

256Amoxicilin 250mg

capsules

amoxicillin

(amoxicillin

trihydrate)

capsules250mg,


Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical

Factory,No 109 Xuefu

Road,Nangang

District., Harbin

China J01CA04 1266004.07.2013

04.07.2018PoM

Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical


Road,Nangang

District., Harbin,

China

257Amoxicilin 500mg

capsules

amoxicillin

(amoxicillin

trihydrate)

capsules500mg,


Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical


Road,Nangang

District., Harbin

China J01CA04 1266104.07.2013

04.07.2018PoM

Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical


Road,Nangang

District., Harbin,

China

258 Amoxicillin amoxicillingranules for oral

suspension

250mg/5ml,

40g granules in 100ml

glass bottle and measuring

spoon 5ml

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.,

Vrsac, 26224,

Dubovac, str. Cara

Lazara bb, Serbia-bulk

manufacturere,

packager

Serbia J01CA04 1617123.11.2016

23.11.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

259 Amoxicillin

amoxicillin

(amoxicillin

trihydrate)

capsules500mg,


Rusan Pharma Ltd.,

Plot No. 59 to 65,

Sector II, Kandla

Special Economic

Zone, Gandhidham,

Kutch, Gujarat State,

370230

India J01CA04 1686925.07.2017

25.07.2022PoM

Rusan Pharma Ltd.,

58-D, Government

Industrial Estate,

Charkop, Kandivali

(W), Mumbai 400

067, India

260 Amoxicillin

amoxicillin

(amoxicillin

trihydrate)

capsules 500mg,


NOKI JV LTD Co.,


region

Republic of

Armenia J01CA04 16919

08.08.2017

08.08.2022PoM

NOKI JV LTD Co.,


region, Republic of

Armenia

54

261 Amoxicillin 250mg

amoxicillin

(amoxicillin

trihydrate)

capsules250mg,

in bliste (100/10x10/)

Medopharm Private

Limited, No. 50

Kayarambedu Village,

Guduvanchery,

Chennai-603202

India J01CA04 1686410.07.2017

10.07.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

262Amoxicillin

250mg/5ml

amoxicillin

(amoxicillin

trihydrate)

granules for oral

suspension

250mg/5ml,

40g granules in glass vial

for 100ml suspension

Hemofarm A.D.,

26224, Dubovac, str.

Cara Lazara bb

Serbia J01CA04 1355506.06.2014

06.06.2019PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

263 Amoxicillin 500mg

amoxicillin

(amoxicillin

trihydrate)

capsules500mg,


Medopharm Private

Limited, No. 50

Kayarambedu Village,

Guduvanchery,

Chennai-603202

India J01CA04 1686510.07.2017

10.07.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

264Amoxicillin-

Asteria Cap. 250mg

amoxicillin

(amoxicillin

trihydrate)

capsules250mg,


Chong Kun Dang

Pharmaceutical Corp,

15-20, Osaekdang-ri,

Seonggeo-Eup,

Cheonan-

si,Chungcheongnam-

do, 330-831

Korea Sourth J01CA04 1244107.05.2013

07.05.2018PoM

GL Corporation,

Woori Venture

Tower 201, 82-29,

MoonRae-Dong 3Ga,

YoungDeungPo-Ku,

Seoul, Korea (by

license of Hankook

Korus Pharm Co.,

Ltd, 1181, Geodu-ri,

Dongnae-myeon,

Chuncheon-si,

Gangwon-do, Korea)

265Amoxicillin-

Asteria Cap. 500mg

amoxicillin

(amoxicillin

trihydrate)

capsules500mg,


Chong Kun Dang

Pharmaceutical Corp,

15-20, Osaekdang-ri,

Seonggeo-Eup,

Cheonan-

si,Chungcheongnam-

do, 330-831 (by

license of Hankook

Korus Pharm Co., Ltd,

30, Gangjeo-ro,

Jecheon-si,

Chungcheongbuk-do,

Korea South)

Korea Sourth J01CA04 12442/106.07.2015

07.05.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

55

266AmoxiClav-Denk

1000/125

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

1000mg+125mg, 3g

sachets, (8, 12)

PenCef Pharma

GmbH,

Breitenbachstrasse

13,13509 Berlin

Germany J01CR02 1600019.09.2016

19.09.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

267AmoxiClav-Denk

500/62,5

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets film-coated500mg+62,5mg,


PenCef Pharma

GmbH,

Breitenbachstrasse

13,13509 Berlin

Germany J01CR02 1599919.09.2016

19.09.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

268 Amoxil

amoxicillin

(amoxicillin

trihydrate)

tablets250mg,


Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine J01CA04 1229522.03.2013

22.03.2018PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

269 Amoxil

amoxicillin

(amoxicillin

trihydrate)

tablets500mg,


Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine J01CA04 1229622.03.2013

22.03.2018PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

270 Amoxil

amoxicillin

(amoxicillin

trihydrate)

tablets500mg,


Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CA04 1721408.12.2017

08.12.2022PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

271 Amoxil

amoxicillin

(amoxicillin

trihydrate)

tablets250mg,


Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CA04 1721508.12.2017

08.12.2022PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

56

272Ampicilin sodium

for injection 1,0g

ampicillin

(ampicillin sodium)

powder for solution

for injection

1000mg,

glass vials (50)

Harbin

Pharmaceutical

Group Co., Ltd.

General

Pharmaceutical

Factory, No 109

Xuefu Road, Nangang

District., Harbin

China J01CA01 1372924.07.2014

24.07.2019PoM

Harbin

Pharmaceutical

Group Co., Ltd.

General

Pharmaceutical

Factory, No 109

Xuefu Road, Nangang

District., Harbin,

China

273 Ampicillinampicillin

(ampicillin sodium)

powder for solution

for injection

500mg,

glass vials (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CA01 1596415.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine


(ampicillin sodium)

powder for solution

for injection

1000mg,

glass vials (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CA01 1596515.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine


(ampicillin sodium)

powder for solution

for i/v and i/m

injection

500mg,

10ml glass vial (1, 50)

"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CA01 1679122.06.2017

22.06.2022PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia


(ampicillin sodium)

powder for solution

for i/v and i/m

injection

1000mg,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CA01 1679222.06.2017

22.06.2022PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

277Ampicillin

trihydrate

ampicillin

(ampicillin

trihydrate)

tablets250mg,

in blister (10)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,



Belarus J01CA01 1245007.05.2013

07.05.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,


57

278 Amprilan ramipril tablets1,25mg,


KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto)

Slovenia C09AA05 1288707.10.2013

07.10.2018PoM

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia)

279 Amprilan ramipril tablets2,5mg,


KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto)

Slovenia C09AA05 1288807.10.2013

07.10.2018PoM

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia)

280 Amprilan ramipril tablets5mg,


KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto)

Slovenia C09AA05 1288907.10.2013

07.10.2018PoM

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia)

281 Amprilan ramipril tablets10mg,


KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto)

Slovenia C09AA05 1289007.10.2013

07.10.2018PoM

KRKA d.d., Novo

mesto (Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia)

282 Amprilan HD

ramipril,

hydrochloro-

thiazide

tablets5mg+25mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA05 1362227.06.2014

27.06.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

283 Amprilan HL

ramipril,

hydrochloro-

thiazide

tablets2,5mg+12,5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA05 1362127.06.2014

27.06.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

284 Anaesthesol

benzocaine,

bismuth subgallate,

zinc oxyde,

levomenthol

suppositories rectal100mg+40mg+

20mg+4mg, (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia C05A 1665411.05.2017

11.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

285 Anaferon

affinity purified

antibodies to

human interferon

gamma


not more than 10^-15

ng/g,


NPF Materia Medica

Holding LLC, 54,


Chelyabinsk 454139

Russia

L03;

homeopathic

drug

1570722.06.2016

22.06.2021OTC

NPF Materia Medica

Holding LLC, 9 bld.,

3rd Samotyochny


Russia

58

286 Anaferon kids

affinity purified

antibodies to

human interferon

gamma


not more than 10^-

16ng/g; (20/1x20/), in

blister

NPF Materia Medica

Holding LLC, 54,


Chelyabinsk 454139

Russia

L03;

homeopathic

drug

1570022.06.2016

22.06.2021OTC

NPF Materia Medica


3rd Samotyochny


Russia

287 Analgin

metamizole

(metamizole

sodium)

tablets500mg,

in blister (10)

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia N02BB02 1239419.04.2013

19.04.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, RUSSIA

288 Analgin

metamizole

(metamizole

sodium)


2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC (Yerevan,

Ajaryan street, 2 Line,

No6)

Republic of

ArmeniaN02BB02 12934

07.10.2013

07.10.2018PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC (Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia)

289 Analgin

metamizole

(metamizole

sodium)

tablets

500mg,

in blister (10),

in strip (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


21.11.2014

21.11.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

290 Analgin

metamizole

(metamizole

sodium)

tablets500mg,


Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N02BB02 1437025.03.2015

25.03.2020OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

291 Analgin

metamizole

(metamizole

sodium)

tablets

500mg,

in blister (10) and in strip

(10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.


str., 124

Russia N02BB02 1500802.12.2015

02.12.2020OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

59

292 Analgin

metamizole

(metamizole

sodium)

solution for i/v and

i/m injection

500mg/ml,

2ml ampoules (10)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus N02BB02 1545002.04.2016

02.04.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

293 Analgin

metamizole

(metamizole

sodium)

tablets500mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N02BB02 1684110.07.2017

10.07.2022OTC

Sopharma JSC, str.

Iliensko shosse 16,


294 Analgin

metamizole

(metamizole

sodium)

tablets

500mg,

in blister (10),

in strip (10)

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia N02BB02 12947/1 03.08.2017

28.10.2018OTC

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

295 Analgin-Darnitsa

metamizole

(metamizole

sodium)


500mg/ml,

2ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya Str.,13

Ukraine N02BB02 1234409.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

296 Analgin-Darnitsa

metamizole

(metamizole

sodium)

tablets500mg,

in blister (10)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13

Ukraine N02BB02 12569/130.08.2013

06.06.2018OTC

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13,

Ukraine

297 Analgin-Zdorovye

metamizole

(metamizole

sodium)

tablets

500mg,

in blister (6/1x6/,

10/1x10/, 6, 10)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine N02BB02 1631030.12.2016

30.12.2021OTC

Pharmaceutical

Company "Zdorovye"



Ukraine

60

298 Anaprilin

propranolol

(propranolol

hydrochloride)

tablets

10mg,

blisters (50/5x10/,

50/2x25/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C07AA05 13810/130.05.2017

05.09.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

299 Anaprilin

propranolol

(propranolol

hydrochloride)

tablets

40mg,

blisters (50/5x10/,

50/2x25/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C07AA05 13811/130.05.2017

05.09.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

300 Anaprilin

propranolol

(propranolol

hydrochloride)

tablets40mg,


Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus C07AA05 1659910.04.2017

10.04.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

301Anaprilin-

Zdorovye

propranolol

(propranolol

hydrochloride)

tablets

10mg,


50/5x10/),


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C07AA05 1651617.03.2017

17.03.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

302Anaprilin-

Zdorovye

propranolol

(propranolol

hydrochloride)

tablets

40mg,


50/5x10/),


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C07AA05 1651717.03.2017

17.03.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

303 Anastrozole anastrozole tablets film-coated 1mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany L02BG03 1688508.08.2017

08.08.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

61

304Anastrozole

Denk 1anastrozole tablets film-coated

1mg,


Haupt Pharma

Munster GmbH

(Schleebruggenkamp

15, 48159 Munster)

Germany L02BG03 1298228.10.2013

28.10.2018PoM

Denk Pharma GmbH

& Co. KG

(Prinzregentenstr. 79,

81675 Munchen,

Germany)

305Anastrozole 1mg

film-coated tabletsanastrozole tablets film-coated

1mg,


Accord Healthcare


Pinner Road, North


4HF-batch releaser, Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L02BG03 1449018.05.2015

18.05.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

306 Anauran

lidocaine (lidocaine

hydrochloride),

neomycin

(neomycin sulfate),

polymyxin B

(polymyxin B

sulfate)

drops ear

4g/100ml+

0.5g(375000IU)/ 100ml+

1000000IU/100ml 25ml

glass bottle

Zambon S.P.A., Via

Della Chimica, 9,

Vicenza, 36100

Italy S02 1549612.04.2016

12.04.2021PoM

Zambon S.P.A., Via

Lillo Del Duca, 10,

Bresso, 20091, Italy

307 Ancodex 02

dexamethasone

(dexamethasone

sodium phosphate)


2,64mg/ml,


vial

KELA Laboratoria

NV, Sint-

Lenaartseweg 48,

Hoogstraten, 2320

Belgium

QH02AB02;

veterinary

drug

1703726.09.2017

26.09.2022PoM

Anupco LTD, IP7 6

RD, Suffolk,

Hadleigh, Crockatt

Road, Lady Lane

Industrial Estate, UK

62

308 Ancodoxin 75

doxycycline

(doxycycline

hyclate)

powder for oral

solution

750mg/g,

100g,1kg, 7.5kg pack

KELA Laboratoria

NV, Sint-

Lenaartseweg 48,

Hoogstraten, 2320

Belgium

QJ01AA02;

veterinary

drug

1703826.09.2017

26.09.2022PoM

Anupco LTD, IP7 6

RD, Suffolk,

Hadleigh, Crockatt

Road, Lady Lane


309Ancomycine

200LA

oxytetracycline

(oxytetracycline

hydrochloride)


200mg/ml,


vial

KELA Laboratoria

NV, Sint-

Lenaartseweg 48,

Hoogstraten, 2320

Belgium

QG01AA07;

veterinary

drug

1703926.09.2017

26.09.2022PoM

Anupco LTD, IP7 6

RD, Suffolk,

Hadleigh, Crockatt

Road, Lady Lane


310 Andipal

metamizole

(metamizole

sodium),

phenobarbital,

bendazol (bendazol

hydrochloride),

papaverine

(papaverine

hydrochloride)

tablets

250mg+20mg+

20mg+20mg,


Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.


str., 124

Russia N02BB52 1363827.06.2014

27.06.2019OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

311 Androcur

cyproterone

(cyproterone

acetate)

tablets10mg,


Bayer Weimer GmbH

und Co.KG,

Doebereinerstrasse

20, 99427, Weimer

Germany G03HA01 1442914.04.2015

14.04.2020PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

312 Androgel testosterone gel for external use10mg/g,

5g sachets (30)

Besins Manufacturing

Belgium SA, Groot

Bijgaardenstraat 128,

Drogenbos, B-1620 -

dosage form

manufacturer, batch

releaser (packager -

Enestia Belgium NV,

Klocknerstraat 13930

Hamont-Achel,

Limburg B-3930,

Belgium)

Belgium G03BA03 1304525.11.2013

25.11.2018PoM

Besins Healthcare SA,

Avenue Louise 287,

1050 Brussels,

Belgium

63

313 Anesteran isofluranesolution for

inhalation

100ml,

100ml glass bottle (1)

S.C. Rompharm

Company S.R.L.,

Ilfov, 75100 Otopeni,

Str. Eroilor, Nr. 1A

Romania N01AB06 1219501.02.2013

01.02.2018PoM

S.C. Rompharm

Company S.R.L.,


Str. Eroilor, Nr. 1A,

ROMANIA

314 ANGAL

chlorhexidine

(chlorhexidine

dihydrochloride),


hydrochloride)

pastilles5mg+1mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,

Laboratoria Qualiphar

NV, Rijksweg 9,

Bornem, B-2880,

Belgium-bulk

manufacturer,

packager

Slovenia R02A 1641610.02.2017

10.02.2022OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

315 ANGAL LEMON

chlorhexidine

(chlorhexidine

dihydrochloride),


hydrochloride)

pastilles with lemon

flavour

5mg+1mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,


NV, Rijksweg 9,

Bornem, B-2880,

Belgium-bulk

manufacturer,

packager

Slovenia R02A 1641510.02.2017

10.02.2022OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

316

ANGAL LEMON

spray for local

application

chlorhexidine

(chlorhexidine

digluconate),


hydrochloride)

spray for local

application with

lemon flavour

2mg/ml+0.5mg/ml, 30ml

glass bottle with

mechanical spray device

and spray nozzle

Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,


NV, Rijksweg 9,

Bornem, B-2880,

Belgium-bulk

manufacturer,

packager

Slovenia R02A 1626219.12.2016

19.12.2021OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

64

317ANGAL S spray for

local application

chlorhexidine

(chlorhexidine

digluconate),


hydrochloride)

spray for local

application

2mg/ml+0.5mg/ml, 30ml

glass bottle with

mechanical spray device

and spray nozzle

Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,


NV, Rijksweg 9,

Bornem, B-2880,

Belgium-bulk

manufacturer,

packager

Slovenia R02A 1626119.12.2016

19.12.2021OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

318 Anginovag

dequalinium

(dequalinium

chloride),

tyrothricin,

enoxolone,

hydrocortisone

(hydrocortisone

acetate),

tyrothricin,


hydrochloride)

spray

1mg/ml+


/ml+1mg/ml, 20ml (200

doses) pastic container

and pump dispenser

Ferrer Internacional,

S.A., Joan Buscalla, 1-

9 08173 Sant Cugat

del Valles, Barcelona

Spain R02A 1473403.08.2015

03.08.2020OTC

Laboratorios Novag,

S.A.,Gran Via Carlos

III, 94, 08028

Barcelona, Spain

319 Angiovit-AV

folic acid,

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin

tablets film-coated5mg+4mg+ 0,006mg,

blisters (60/6x10/)

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.

Russia A11BA 13067/115.01.2016

09.12.2018OTC

Altayvitamini CJSC,

659325, The Altay


Zavodskaya Str.,

Russia

320 Anoro Ellipta

umeclidinium

(umeclidinium

bromide), vilanterol

(vilanterol

trifenatate)

powder for

inhalation

62.5mcg/dose+


strip (60/2x30/ dose) in

plastic inhaler

Glaxo Operations UK

Ltd, Priory Street,

Ware, Hertfordshire

SG12 0DJ

UK R03AL03 1529604.02.2016

04.02.2021PoM

Glaxo Group Limited,



TW8 9GS, UK

321 Antaxone

naltrexone

(naltrexone

hydrochloride)

capsules50mg,


Zambon S.P.A., Via

Della Chimica, 9,

Vicenza, 36100

Italy N07BB04 1459408.06.2015

08.06.2020PoM

Zambon S.P.A., Via

Lillo Del Duca, 10,

Bresso, 20091, Italy

65

322 Anti-Acnesalicylic acid, sulfur,

zinc oxidesuspension topical

20mg/ml+ 50mg/ml+

150mg/ml,

30ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD02AF 12419

11.08.2013

11.08.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

323Anti-Angin

Formula

chlorhexidine

(chlorhexidine

bigluconate),

tetracaine

(tetracaine

hydrochloride)

dosed spray for

topical use

0,24mg/dose (1,2mg/g) +

0,12mg/dose (0,6mg/g),


(100 doses)

Natur Produkt

Europe

B.V.,Tweeberg 17,

5246XL Rosmalen

(bulk manufacturer -

Herkel

B.V.,Nobelweg 6,3899

BN Zeewold, the

Netherlands)

the Netherlands R02AA20 13568/125.12.2014

10.06.2019OTC

Valeant LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

324Anti-Angin

Formula

chlorhexidine

(chlorhexidine

diacetate),

tetracaine

(tetracaine

hydrochloride),

ascorbic acid

lozenges2mg+0,2mg+50mg, in

blister (20/2x10/)

Herkel

B.V.,Nobelweg 6,3899

BN Zeewold

the Netherlands R02AA20 1636930.12.2016

30.12.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

325 Anticol disulfiram tablets500mg,


Warsaw

Pharmaceutical

Works "Polfa" S.A.,

Karolkowa 22/24 str.,

01-207 Warsaw

Poland P03AA04 1420406.02.2015

06.02.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

326 Anti-Cold

acetaminophen,

chlorpheniramine

(chlorpheniramine

maleate),

phenylpropanol-

amine

hydrochloride

syrup with orange

flavour

160mg+1mg+5mg, 60ml

plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaR05X 12192

01.02.2013

01.02.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

66

327 Anti-Cold

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

chlorpheniramine

(chlorpheniramine

maleate)

tablets325mg+5mg+2mg, in

blister (20/2x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN02BE51 17191

28.11.2017

28.11.2022OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

328 Anti-Cold

paracetamol,

chlorpheniramine

(chlorpheniramine

maleate),

phenylpropanolami

ne

(phenylpropanolam

ine hydrochloride)

syrup with orange

flavour

32mg/ml+

0,2mg/ml+1mg/ml, 60ml

glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


12.12.2017

12.12.2022OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

329 Antiflu

acetaminophen,

phenylephrine

(phenylephrine

hydrochloride),

chlorpheniramine

(chlorpheniramine

maleate)

tablets film-coated325mg+5mg+2mg, in

blister (12/1x12/)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer

USA N02BE51 1615323.11.2016

23.11.2021OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

67

330 Antiflu

acetaminophen,

phenylephrine

(phenylephrine

hydrochloride),

chlorpheniramine

(chlorpheniramine

maleate)

powder for oral

solution with lemon

flavour

650mg+10mg+4mg

sachets (5)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer

USA N02BE51 1615423.11.2016

23.11.2021OTC

for Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

331 Antiflu Kids

paracetamol,

ascorbic acid,

chlorpheniramine

(chlorpheniramine

maleate)

powder for oral

solution with

raspberry flavour

160mg+50mg+ 1mg,

sachets (5)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer

USA N02BE51 1615523.11.2016

23.11.2021OTC

AO BAYER, 3rd

Rybinskaya St., 18,

build. 2, 107113

Moscow, Russia

332 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid

tablets effervescent

500mg+10mg+ 200mg,

in plastic container (10),

in strip (30/5x6/)

Natur Produkt

Pharma Sp. z o.o., ul.

Podstoczysko 30, 07-

300 Ostrow

Mazowiecka

Poland N02BE51 1495422.10.2015

22.10.2020OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

333 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid


250mg+3mg+ 50mg,


in strip (30/5x6/)

Natur Produkt



300 Ostrow

Mazowiecka

Poland N02BE51 1495522.10.2015

22.10.2020OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

68

334 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid

powder for oral

solution with

chamomile flavour

500mg+10mg+ 200mg,

5g sachets (6, 10)

Natur Produkt



300 Ostrow

Mazowiecka

Poland N02BE51 1532304.02.2016

04.02.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

335 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid

powder for oral

solution with honey

and lemon flavour

500mg+10mg+ 200mg,

5g sachets (6, 10)

Natur Produkt



300 Ostrow

Mazowiecka

Poland N02BE51 1532404.02.2016

04.02.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

336 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid


250mg+3mg+ 50mg, in

plastic container (10),

(30/5x6/) in strip

Natur Produkt

Europe

B.V.,Tweeberg 17,

5246 XL Rosmalen-

batch releaser, Natur

Produkt Pharma Sp. z

o.o., ul. Podstoczysko

30, 07-300 Ostrow

Mazowiecka, Poland-

bulk manufacturer,

packager

the Netherlands N02BE51 1547002.04.2016

02.04.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

337 Antigrippin

paracetamol,

chlorphenamine

(chlorphenamine

maleate), ascorbic

acid


500mg+10mg+ 200mg,


in strip (30/5x6/)

Natur Produkt

Europe

B.V.,Tweeberg 17,

5246 XL Rosmalen-

batch releaser, Natur

Produkt Pharma Sp. z

o.o., ul. Podstoczysko

30, 07-300 Ostrow

Mazowiecka, Poland-

bulk manufacturer,

packager

the Netherlands N02BE51 1550419.04.2016

19.04.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

69

338 Antilice

pyrethrins

(permethrin+

tetramethrin),

piperonyl butoxide

shampoo1,65mg/ml+ 16,5mg/ml,

100ml plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP03AC54 13763

14.08.2014

14.08.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

339 Antimyk-Neu clotrimazole cream10mg/g,

20g aluminium tube

"NOKI" JV LTD Co.,


region

Republic of

ArmeniaD01AC01 16142

10.11.2016

10.11.2021OTC

"NOKI" JV LTD Co.,


region, Republic of

Armenia

340 Anusol

xeroform,

belladonna extract,

zinc (zinc sulfate)

suppositories rectal100mg+20mg+ 50mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia C05AX03 1695105.09.2017

05.09.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

341 AnviRem

paracetamol,

ascorbic acid,

calcium gluconate

(calcium gluconate

monohydrate),

rimantadine

(rimantadine

hydrochloride),

rutoside (rutin),

loratadine

powder for oral

solution with lemon

flavour

360mg+300mg+

100mg+50mg+

20mg+3mg,

sachets (3, 6, 12 and 24)

Pharmproject JSC,

bld. 14, lit. A,

Sofiyskaya str., Saint

Petersburg, 192236

Russia R05X 1708623.10.2017

23.10.2022OTC

"AnviLab" LLC,

141302 Sergiev Posad,

Festival street, 10,

Sergiev Posad

municipal district,

urban settlement

Sergiev Posad,

Moscow region,

Russia

342 AnviRem

paracetamol,

ascorbic acid,

calcium gluconate

(calcium gluconate

monohydrate),

rimantadine

(rimantadine

hydrochloride),

rutoside (rutin),

loratadine

powder for oral

solution with lemon

and honey flavour

360mg+300mg+

100mg+50mg+

20mg+3mg,

sachets (3, 6, 12)

Pharmproject JSC,

bld. 14, lit. A,


Petersburg, 192236

Russia R05X 1708723.10.2017

23.10.2022OTC

"AnviLab" LLC,



Sergiev Posad

municipal district,

urban settlement

Sergiev Posad,

Moscow region,

Russia

70

343 AnviRem

paracetamol,

ascorbic acid,

calcium gluconate

(calcium gluconate

monohydrate),

rimantadine

(rimantadine

hydrochloride),

rutoside (rutin),

loratadine

powder for oral

solution with

raspberry flavour

360mg+300mg+

100mg+50mg+

20mg+3mg,

sachets (3, 6, 12, 24)

Pharmproject JSC,

bld. 14, lit. A,


Petersburg, 192236

Russia R05X 1708823.10.2017

23.10.2022OTC

"AnviLab" LLC,



Sergiev Posad

municipal district,

urban settlement

Sergiev Posad,

Moscow region,

Russia

344 AnviRem

paracetamol,

ascorbic acid,

calcium gluconate

(calcium gluconate

monohydrate),

rimantadine

(rimantadine

hydrochloride),

rutoside (rutin),

loratadine

powder for oral

solution with

blackcurrant flavour

360mg+300mg+

100mg+50mg+

20mg+3mg,

sachets (3, 6, 12, 24)

Pharmproject JSC,

bld. 14, lit. A,


Petersburg, 192236

Russia R05X 1708923.10.2017

23.10.2022OTC

"AnviLab" LLC,



Sergiev Posad

municipal district,

urban settlement

Sergiev Posad,

Moscow region,

Russia

345 Apaurin diazepamsolution for i/v and

i/m injection

5mg/ml,

2ml ampoule,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N05BA01 1669223.05.2017

23.05.2022PoM/UC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

346 Apaurin diazepam tablets coated5mg,


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 N05BA01 1683810.07.2017

10.07.2022PoM/UC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

71

347

Apidra solution for

injection in a pre-

filled pen

insulin glulisinesolution for s/c

injection

100U/ml,

3ml Solostar pre-filled

pens (5)

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,


65926 Frankfurt am

Main

Germany A10AB06 1376014.08.2014

14.08.2019PoM

Sanofi-Aventis

Deutschland GmbH,

Industriepark

Hoechst,


65926 Frankfurt am

Main, Germany

348 Apilac royal jelly tablets sublingual

10mg,


30/3x10/)

VIFITEH CJSC,

SCRAM, Obolensk v.,

corp. 84, corp. 87,

build. 90, Serpukhov

district, Moscow

region,142279

Russia A13A 1537126.02.2016

26.02.2021OTC

VIFITEH CJSC,

SCRAM, Obolensk v.,

Serpukhov district,

Moscow

region,142279, Russia

349 Apilac Grindeks royal jellyointment for

external use

10mg/g,

50g aluminium tube

Tallinn


JSC, Tondi 33, 11316

Tallinn

Estonia D11AX 1640510.02.2017

10.02.2022OTC

Grindeks JSC,

Krustpils street 53,

LV-1057, Riga, Latvia

350 Apilac Grindeks royal jelly tablets sublingual

10mg,


50/2x25/)

Grindeks JSC,

Krustpils street 53, LV-

1057, Riga

Latvia A13A 1640610.02.2017

10.02.2022OTC

Grindeks JSC,



351 Apisarthron

bee venom

standardized, allyl

isothiocyanate,

methyl salicylate

ointment

0,03mg/g+10mg/g+100mg

/g,

20g aluminium tube

Esparma GmbH,

Werner-von-Siemens-

Ring 8, 39116

Magdeburg Saxony-

Anhalt - batch

releaser (Lichtenheldt

GmbH, Werk I -

Industriestraasse 7-

1123812 Wahlstedt,

Germany, bulk

manufacturer,

packager)

Germany M02AC 1369624.07.2014

24.07.2019OTC

Esparma GmbH,

Seepark 7 339116

Magdeburg, Germany

72

352 Apo-Amoxi Clav

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets875mg+125mg,


Apotex Inc., 3701

Weston Road,

Weston, Ontario,

M9L 2S8-batch

releaser, Apotex Inc.,

20 Kenhar Drive,

Weston, Ontario,

M9L 1N1, Canada-

bulk manufacturer,

packager

Canada J01CR02 1454909.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

353 Apo-Amoxi Clav

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets250mg+125mg,


Apotex Inc., 3701

Weston Road,

Weston, Ontario,

M9L 2S8-batch


20 Kenhar Drive,

Weston, Ontario,

M9L 1N1, Canada-

bulk manufacturer,

packager

Canada J01CR02 1455009.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

354 Apo-Amoxi Clav

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

tablets500mg+125mg,


Apotex Inc., 3701

Weston Road,

Weston, Ontario,

M9L 2S8-batch


20 Kenhar Drive,

Weston, Ontario,

M9L 1N1, Canada-

bulk manufacturer,

packager

Canada J01CR02 1455109.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

73

355 Apo-Atenol atenolol tablets

50mg,



Apotex Inc., 150

Signet Drive, Toronto,

Ontario, M9L 1T9-

batch releaser, bulk

manufacturer, Apotex

Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada C07AB03 1672205.06.2017

05.06.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

356 Apo-Atenol atenolol tablets

100mg,



Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada C07AB03 1672305.06.2017

05.06.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

357 Apo-Celecoxib celecoxib capsules100mg,


Apotex Inc., 150


Ontario, M9L 1T9 -

batch releaser, Apotex

Research Private

Limited, Plot no.1

and 2, Bommasandra

lndustrial area, 4th

Phase, Jigani Link

Road, Bangalore - 560

099, India -bulk

manufacturer,

packager

Canada M01AH01 1721008.12.2017

08.12.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

74

358 Apo-Celecoxib celecoxib capsules200mg,


Apotex Inc., 150


Ontario, M9L 1T9 -


Research Private

Limited, Plot no.1

and 2, Bommasandra

lndustrial area, 4th

Phase, Jigani Link

Road, Bangalore - 560

099, India -bulk

manufacturer,

packager

Canada M01AH01 1721108.12.2017

08.12.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

359 Apo-Cephalex cefalexin tablets250mg,

plastic container (100)

Apotex Inc., 400

Ormont Drive

Weston, Ontario,

M9L 1N9

Canada J01DB01 1440916.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

360 Apo-Cephalex cefalexin tablets500mg, plastic container

(100)

Apotex Inc., 400

Ormont Drive

Weston, Ontario,

M9L 1N9

Canada J01DB01 1441016.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

361 Apo-Clopidogrel

clopidogrel

(clopidogrel

bisulfate)

tablets75mg,


Apotex Inc., 150


Ontario, M9L 1T9 -


Inc., 50 Steinway

Blvd., Etobicoke,

Ontario, M9W 6Y3,

Canada-bulk


Inc., 4100 Weston

Road, Weston,

Ontario, M9L 2Y6,

Canada-packager

Canada B01AC04 1435825.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

75

362 Apo-Desmopressin

desmopressin

(desmopressin

acetate)

tablets0,1mg,


Apotex Inc., 150


Ontario, M9L 1T9 -


Inc., 50 Steinway

Blvd., Etobicoke,

Ontario, M9W 6Y3,

Canada-bulk


Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada-packager

Canada H01BA02 1677722.06.2017

22.06.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

363 Apo-Desmopressin

desmopressin

(desmopressin

acetate)

tablets0,2mg,


Apotex Inc., 150


Ontario, M9L 1T9 -


Inc., 50 Steinway

Blvd., Etobicoke,

Ontario, M9W 6Y3,

Canada-bulk


Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada-packager

Canada H01BA02 1677822.06.2017

22.06.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

364 Apo-Esomeprazole

esomeprazole

(esomeprazole

magnesium)

tablets delayed-

release

40mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC05 1438516.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

76

365 Apo-Esomeprazole

esomeprazole

(esomeprazole

magnesium)

tablets delayed-

release

20mg,


Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC05 1458609.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

366 Apo-Lansoprazole lansoprazolecapsules delayed-

release

30mg,


Apotex Inc., 50

Steinway Blvd.,

Etobicoke, Ontario,

M9W 6Y3

Canada A02BC03 1438616.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

367 Apo-Lansoprazole lansoprazolecapsules delayed-

release

15mg,


Apotex Inc., 50

Steinway Blvd.,

Etobicoke, Ontario,

M9W 6Y3

Canada A02BC03 1438716.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

368 Apo-Letrozole letrozole tablets2,5mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada-packager

Canada L02BG04 1700926.09.2017

26.09.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

77

369 Apo-Levocarb carbidopa, levodopa tablets25mg+100mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada-packager

Canada N04BA02 1709723.10.2017

23.10.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

370 Apo-Levocarb carbidopa, levodopa tablets25mg+250mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada-packager

Canada N04BA02 1709823.10.2017

23.10.2022PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

371 Apo-Omeprazole omeprazolecapsules delayed-

release

20mg,


Apotex Inc., 50

Steinway Blvd.,

Etobicoke, Ontario,

M9W 6Y3-batch

releaser, bulk


Inc., 4100 Weston

Road, Weston,

Ontario, M9L 2Y6,

Canada- packager

Canada A02BC01 1438416.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

372 Apo-Omeprazole omeprazolecapsules delayed-

release

20mg,


Apotex Inc., 50

Steinway Blvd.,

Etobicoke, Ontario,

M9W 6Y3

Canada A02BC01 1488124.09.2015

24.09.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

78

373 Apo-Pantoprazole

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets enteric-

coated

40mg,


Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC02 1435425.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

374 Apo-Pantoprazole

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets enteric coated20mg,


Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC02 1435525.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

375 Apo-Rabeprazole

rabeprazole

(rabeprazole

sodium)

tablets enteric-

coated

10mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC04 1437816.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

79

376 Apo-Rabeprazole

rabeprazole

(rabeprazole

sodium)

tablets enteric-

coated

20mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BC04 1437916.04.2015

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

377 Apo-Salventsalbutamol

(salbutamol sulfate)tablets

2mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Weston,

Ontario, M9L 2Y6,

Canada -packager

Canada R03AC02 1473603.08.2015

03.08.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

378 Apo-Salventsalbutamol

(salbutamol sulfate)tablets

4mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Weston,

Ontario, M9L 2Y6,

Canada -packager

Canada R03AC02 1473703.08.2015

03.08.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

80

379 Apo-Sildenafilsildenafil (sildenafil

citrate)tablets

50mg,

in blister (4/1x4/)

Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada G04BE03 1435625.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

380 Apo-Sildenafilsildenafil (sildenafil

citrate)tablets

25mg,

in blister (4/1x4/)

Apotex Inc., 150


Ontario, M9L 1T9-



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada G04BE03 1435725.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

381 Apo-Sucralfate sucralfate tablets1000mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada A02BX02 1455209.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

81

382 Apo-Sulfatrim-DSsulfamethoxazole,

trimethoprimtablets

800mg+160mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Weston,

Ontario, M9L 2Y6,

Canada -packager

Canada J01EE01 1454809.06.2015

09.06.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

383 Apo-Tamoxtamoxifen

(tamoxifen citrate)tablets

10mg,


Apotex Inc., 3701

Weston Road,

Weston, Ontario,

M9L 2S8-batch

releaser (Apotex Inc.,

285 Gary Ray Drive,

Weston, Ontario,

M9L 1P3, Canada-

bulk manufacturer,

packager)

Canada L02BA 1451315.05.2015

15.05.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

384 Apo-Tamoxtamoxifen

(tamoxifen citrate)tablets

20mg,


Apotex Inc., 3701

Weston Road,

Weston, Ontario,

M9L 2S8-batch

releaser (Apotex Inc.,

285 Gary Ray Drive,

Weston, Ontario,

M9L 1P3, Canada-

bulk manufacturer,

packager)

Canada L02BA 1451415.05.2015

15.05.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

82

385 Apo-Valacyclovir

valacyclovir

(valacyclovir

hydrochloride

monohydrate)

tablets (caplet)1000mg,


Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada J05AB11 1435225.03.2015

25.03.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

386 Apo-Valacyclovir

valacyclovir

(valacyclovir

hydrochloride

monohydrate)

tablets (caplet)

500mg,

in blister (8/1x8/,

30/3x10)

Apotex Inc., 150


Ontario, M9L 1T9 -



Inc., 4100 Weston

Road, Toronto,

Ontario, M9L 2Y6,

Canada -packager

Canada J05AB11 14395/102.08.2016

16.04.2020PoM

Apotex Inc., 150

Signet Drive,

Toronto, Ontario,

M9L 1T9, Canada

387 Aqua Maris adriatic sea water spray throat30ml/100ml,

30ml glass bottle

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b.

Croatia R02A 1321131.01.2014

31.01.2019OTC

Jadran Galenski

Laboratorij d.d.,

51000 Rijeka, Pulac

b.b., Croatia

388 Aquadetrim plusvitamin A, vitamin

D3drops oral

20000IU/ml+

10000IU/ml,

10ml glass bottle

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch


manufacturer,

packager - Medana

Pharma JSC, str.

Polskiej Organizacji

Wojskowej 57,98-200

Sieradz, Poland)

Poland A11CB 1328104.03.2014

04.03.2019PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

83

389

Aquadetrim

Vitamin D3

Medana

cholecalciferol drops oral15000IU/ml,

10ml glass bottle

Medana Pharma S.A.,

98-200 Sieradz, W.

Lokietka 10- batch

releaser, Medana

Pharma S.A., str.


Wojskowej 57, 98-200

Sieradz, Poland- bulk

manufacturer,

packager

Poland A11CC05 1667111.05.2017

11.05.2022PoM

Medana Pharma S.A.,

98-200 Sieradz, W.

Lokietka 10, Poland

390 Aquavit-D3 cholecalciferol solution oral

375 mkg/ml(15000

IU/ml),

10ml glass vial-dropper

PJSC "Technolog",

Manuilskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine AC11CC05 1479704.09.2015

04.09.2020PoM

PJSC "Technolog",

Manuilskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

391 Arbidol

umifenovir

(umifenovir

hydrochloride)

capsules

100mg,

blister (10/1x10/,

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

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia J05AX 14281/121.04.2016

19.03.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

392 Arbidol

umifenovir

(umifenovir

hydrochloride)

tablets film-coated

50mg,

blisters (10/1x10/,

20/2x10/)

Pharmstandard-

Tomskchimpharm


R.Luxemburg str. 89-

batch releaser,

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia-bulk

manufacturer,

packager

Russia J05AX 14608/102.02.2017

03.07.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

84

393 Arcoxia etoricoxib tablets film-coated120mg,

in blister (7/1x7/, 28/4x7/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,

Frosst Iberica S.A.,

Via Complutense 140,

28805 Alcala de

Henares, Madrid,

Spain- bulk

manufacturer

the Netherlands M01AH05 1549919.04.2016

19.04.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


in blister (7/1x7/, 28/4x7/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,



28805 Alcala de

Henares, Madrid,

Spain- bulk

manufacturer


19.04.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland


in blister (7/1x7/, 28/4x7/)

Merck Sharp &

Dohme B.V.

Waarderweg 39, 2031

BN Haarlem-batch

releaser, packager,



28805 Alcala de

Henares, Madrid,

Spain- bulk

manufacturer


19.04.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

85

396 Arduanpipecuronium

bromide

powder lyophilized

and solvent for


4mg, 10ml glass vial, in

blister (25/5x5/) and 2ml

solvent in ampoules, in

blister (25/5x5/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M03AC06 1450115.05.2015

15.05.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

397 Aremed anastrozole tablets film-coated1mg,

in blisters (28/2x14/)

Remedica Ltd,

Aharnon street,

Limassol Industrial

Estate, 3056 Limassol

Cyprus L02BG03 14684/113.03.2017

29.06.2020PoM

Remedica Ltd,

Aharnon street,

Limassol Industrial

Estate, 3056 Limassol,

Cyprus

398 Arginine-Liqvoarginine (arginine

hydrochloride)

concentrate for


210,7mg/ml,

20ml glass vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaB05XB01 14938

20.10.2015

20.10.2020PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

399 Argosulfan silver sulfathiazole cream for external

use

20mg/g,

15g, 40g aluminium tube,


Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D06BA02 1611410.11.2016

10.11.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

400 Aricardesmolol (esmolol

hydrochloride)

solution for i/v

injection

10mg/ml,

10ml glass vial (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaC07AB09 15378

26.02.2016

26.02.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

401Arifam

1.5mg/10mg

indapamide,

amlodipine

(amlodipine

besilate)

tablets modified-

release

1,5mg+10mg,


Les Laboratoires

Servier Industrie, 905,

route de Saran, 45520

Gidy

France C08GA02 1383018.09.2014

18.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

402 Arifam 1.5mg/5mg

indapamide,

amlodipine

(amlodipine

besilate)

tablets modified-

release

1,5mg+5mg,


Les Laboratoires



Gidy

France C08GA02 1382918.09.2014

18.09.2019PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

86

403 ARIFON Retard indapamidetablets prolonged-

release film-coated

1,5mg,


Les Laboratoires

Servier Industrie (905,


Gidy)

France C03BA11 1295928.10.2013

28.10.2018PoM

Les Laboratoires

Servier (50, rue

Carnot, 92284

Suresnes cedex,

France)

404 Aripegis aripiprazole tablets

10mg,


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

Nobelfarma Ilac

Sanayii Ve Tic. A.S.,

81100 Sancaklar,

Duzce

Turkey N05AX12 1393029.10.2014

29.10.2019PoM


PLC, 1106 Budapest,


Hungary


15mg,


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

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N05AX12 1393129.10.2014

29.10.2019PoM


PLC, 1106 Budapest,


Hungary


30mg,


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

Nobelfarma Ilac


81100 Sancaklar,

Duzce

Turkey N05AX12 1393229.10.2014

29.10.2019PoM


PLC, 1106 Budapest,


Hungary


10mg,


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


PLC, 1165 Budapest,


120

Hungary N05AX12 1484704.09.2015

04.09.2020PoM


PLC, 1106 Budapest,


Hungary


15mg,


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


PLC, 1165 Budapest,


120

Hungary N05AX12 1484804.09.2015

04.09.2020PoM


PLC, 1106 Budapest,


Hungary

409 Arixtra

fondaparinux

(fondaparinux

sodium)


5մգ/մլ,

0.5մլ նախալցված

ներարկիչ(10)

Aspen Notre Dame de

Bondeville, 1 rue de

l’Abbaye, 76960

Notre Dame de

Bondeville, France

France B01AX05 14272/131.07.2015

26.02.2020PoM

Aspen Pharma

Trading Limited,

3016 Lake Drive,

Citywest Business

Campus, Dublin 24,

Ireland

87

410 Arlevertcinnarizine,

dimenhydrinatetablets

20mg+40mg,


50/2x25/)

Hennig Arzneimittel

GmbH & Co. KG,

Liebigstrasse 1 - 2,

65439 Floersheim-am-

Main

Germany N07CA52 1576304.07.2016

04.07.2021PoM

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

411 Armalgon methyl salicylate ointment300mg/g,

25g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaM02AC 14351

25.03.2015

25.03.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

412 Armenicum

iodine, potassium

iodide, lithium

chloride, polyvinyl

alcohol, dextrin,

sodium chloride

capsules

28,76mg+

43,14mg+0,72mg+10,79m

g+ 359,53mg+ 32,36mg,



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ05AX 13877

23.09.2014

23.09.2019PoM

"Armenicum+" CJSC,

37 Nalbandayan,

Yerevan 0001,

Republic of Armenia

413 Armenicum

iodine, potassium

iodide, lithium

chloride, polyvinyl

alcohol, dextrin,

sodium chloride

paste

13,6mg/g+ 20,4mg/g+

0,3mg/g+ 5,1mg/g+

170,3mg/g+ 15,3mg/g,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

Armenia- 14822

04.09.2015

04.09.2020PoM

Armenicum+' CJSC,

37 Nalbandayan,

Yerevan 0001,

Republic of Armenia

414 Armenicum

iodine, potassium

iodide, lithium

chloride, polyvinyl

alcohol, dextrin,

sodium chloride

concentrate for


0,16g/20ml+ 0,24g/20ml+

0,004g/20ml+

0,06g/20ml+ 2g/20ml+

0,18g/20ml,

20ml glass vial (1)

"Armenicum+" CJSC,

37 Nalbandyan,

Yerevan, 0001

Republic of

ArmeniaJ05AX 14911

02.10.2015

02.10.2020PoM

"Armenicum+" CJSC,

37 Nalbandyan,

Yerevan, 0001,

Republic of Armenia

415 Aromasin exemestane tablets coated25mg,


Pfizer Italia S.R.L.,

Localita Marino del

Tronto 63100 Ascoli

Piceno, Italy

Italy L02BG06 1218901.02.2013

01.02.2018PoM

Pfizer Italia S.R.L.,

Localita Marino del

Tronto 63100 Ascoli

Piceno, Italy

88

416 Arthrinal 20 tenoxicam tablets film-coated20mg,


Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus M01AC02 1375705.08.2014

05.08.2019PoM

Remedica Ltd.,

Limassol Industrial

Estate,Aharnon

street,P.O. Box

51706, 3508 Limassol,

Cyprus

417 Articaine 1:100000

articaine (articaine

hydrochloride),

epinephrine

(epinephrine

hydrotartrate)

solution for injection40mg/ml+ 10mcg/ml,

1.8ml cartridges (50)

DFL Industria e

Comercio S.A.,

Estrada do

Guerengue, 2059,

Jacarepagua, Rio de

Janeiro-RJ

Brazil N01BB58 1495923.10.2015

23.10.2020PoM

DFL Industria e

Comercio S.A.,

Estrada do

Guerengue, 2059,

Jacarepagua, Rio de

Janeiro-RJ, Brazil

418 Articaine-Liqvo


hydrochloride),

epinephrine

(epinephrine

hydrotartrate)

solution for injection40mg/ml+ 0.01mg/ml,

20ml glass vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


19.04.2016

19.04.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

419 Articaine-Liqvo


hydrochloride),

epinephrine

(epinephrine

hydrotartrate)


20ml glass vial

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


19.04.2016

19.04.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

420 Artinibsa


hydrochloride),

epinephrine

(epinephrine

tartrate)


1.8ml cartridges (50)

Laboratories Inibsa

S.A., Ctra. Sabadell a

Granollers, km 14.5,

08185 Llica de Vall,

Barcelona

Spain N01BB58 1459808.06.2015

08.06.2020PoM

Inibsa Dental S.L.U.,

Ctra. Sabadell a

Granollers, km 14.5,

08185 Llica de Vall,

Barcelona, Spain

421 Artmeloc meloxicam tablets15mg,


Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus M01AC06 1671723.05.2017

23.05.2022PoM

Giga Pharm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

89

422 Artra

chondroitin sulfate

(chondroitin sulfate

sodium),

glucosamine

(glucosamine

hydrochloride)

tablets film-coated

500mg+500mg,

in plastic container (30,

60, 100, 120)

Unipharm, Inc., 200

Hick str., Westbury,

New York 11590

USAM01AX05,

M01AX25 13175

10.01.2014

10.01.2019OTC

Unipharm, Inc., 350,

5th avenue, suite

6701, New York,

10118, USA

423 Artra MSM Forte

chondroitin sulfate


sodium),

glucosamine

hydrochloride,

methyl sulfonyl

methane,

hyaluronic acid

tablets film-coated

400mg+500mg+

300mg+10mg,


Unipharm Inc., 75

Progress Lane,

Waterbury,

Connecticut(CT),

06705

USA M09AX 1399826.11.2014

26.11.2019OTC


5th avenue, suite

6701, New York,

10118, USA

424 Artrozan meloxicam tablets15mg,

in blister (20)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia M01AC06 1272923.07.2013

23.07.2018PoM

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

425 Artrozan meloxicam solution for injection

6mg/ml,

2,5ml ampoules (10/2x5/,

3/1x3/)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia M01AC06 1354230.05.2014

30.05.2019PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28,

Russia

426 Artrum ketoprofensolution for i/v and

i/m injection

50mg/ml,

2ml ampoules, in blister

(10/2x5/)

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia M01AE03 1484304.09.2015

04.09.2020PoM

Biosintez OJSC,

Druzhby st. 4,

440033, Penza, Russia

427 Artrum ketoprofen suppositories rectal100mg,

(10/2x5/)

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia M01AE03 1484404.09.2015

04.09.2020PoM

Biosintez OJSC,

Druzhby st. 4,


90

428 Artrum ketoprofen gel for external use25mg/g,

30g aluminium tube

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia M02AA10 1484504.09.2015

04.09.2020PoM

Biosintez OJSC,

Druzhby st. 4,


429 Artrum ketoprofen gel for external use50mg/g,

30g aluminium tube

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia M02AA10 1484604.09.2015

04.09.2020PoM

Biosintez OJSC,

Druzhby st. 4,


430 Ascophen-Arpi


paracetamol,

caffeine

tablets

200mg+200mg+ 40mg,

in blister (6/1x6/,

10/1x10/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


21.11.2014

21.11.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

431 Ascophen-Darnitsa


paracetamol,

caffeine

tablets

200mg+200mg+ 40mg,

in blister (6 and 10),

(6/1x6/ and 10/1x10/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kyiv,

Boryspilska Str.,13

Ukraine N02BA51 1706405.10.2017

05.10.2022OTC

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kyiv,

Boryspilska Str.,13,

Ukraine

432 Ascophen-P

paracetamol,


caffeine

tablets

200mg+200mg+ 40mg,

blister (10/1x10/,

20/2x10/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia N02BA71 12612/206.09.2016

21.06.2018OTC

OTCPharm PJSC,

123317, Moscow,


Russia

433 Ascorbic acid ascorbic acid tablets chewable25mg,

in parafine paper (10)

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia A11GA01 1276314.08.2013

14.08.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia



Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia A11GA01 1276414.08.2013

14.08.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

91



Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia A11GA01 1276514.08.2013

14.08.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

436 Ascorbic acid ascorbic acid solution for injection

50mg/ml,

1ml ampoules (10), 1ml

ampoules, label banderol

(10), 1ml ampoules,

dividella (10)

Open Joint Stock

Company

"Borisovskiy zavod

Medicinskikh

Preparatov" (64/27,


222120, Minsk oblast)

Belarus A11GA01 1297528.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast, Belarus)


50mg/ml,


ampoules, label banderol

(10), 2ml ampoules,

dividella (10)

Open Joint Stock

Company

"Borisovskiy zavod

Medicinskikh

Preparatov" (64/27,



Belarus A11GA01 1297628.10.2013

28.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,


438 Ascorbic acid ascorbic acid dragee50mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A11GA 1368725.07.2014

25.07.2019OTC

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia


100mg/ml,

2ml ampoules (10) and


(10/2x5/)

Lekhim-Kharkiv JSC,

36, 17-go Partsyezda

str., 61115 Kharkov

Ukraine A11GA01 1460703.07.2015

03.07.2020PoM

Lekhim-Kharkiv JSC,


str., 61115 Kharkov,

Ukraine


50mg/ml, 2ml ampoules

(10) and (2ml ampoules,

in blister 10/2x5/)

Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine A11GA01 1462803.07.2015

03.07.2020PoM

Lekhim-Kharkiv JSC,



Ukraine

92

441 Ascorbic acid ascorbic acid solution for injection50mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaA11GA01 16681

31.05.2017

31.05.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

442 Ascorbic acid ascorbic acid solution for injection50mg/ml,

2ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaA11GA01 16682

31.05.2017

31.05.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

443Ascorbic acid with

glucose

ascorbic acid,

dextrose (dextrose

monohydrate)

tablets

100mg+877mg,



Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia A11GB 1218801.02.2013

01.02.2018OTC

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28,

RUSSIA

444Ascorbic acid with

glucose

ascorbic acid,

glucose (glucose

monohydrate)

tablets100mg+ 877mg,

in blister (10)

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,



Belarus A11GB 1244002.10.2013

02.10.2018OTC

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,


445 Ascorutin

ascorbic acid,

rutoside ( rutoside

trihydrate)

tablets50mg+50mg,


Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia C05CA51 1302925.11.2013

25.11.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

446 Ascorutinascorbic acid,

rutosidetablets

50mg+50mg,

in container (50)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia C05CA51 1360620.06.2014

20.06.2019OTC

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

93

447 Ascorutin

ascorbic acid,

rutoside (rutoside

trihydrate)

tablets50mg+50mg,


PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region

Ukraine C05CA51 1727613.12.2017

13.12.2022OTC

PJSC "Technolog",

Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine

448 Ascovet clotrimazole solution

32mg/ml,

0.5ml ampoules (50), 1ml

ampoules (50)

Agrobioprom CJSC,

143985, Moscow,

Balashikhinski

district, Novo-Milet

r/d, Poltevskoe shosse,

4

Russia

QJ02AB90;

veterinary

drug

1676602.06.2017

02.06.2022OTC

Agrobioprom CJSC,

107139, Moscow,

pereulok

Orlikov,house 3,

Russia

449 Asentrasertraline (sertraline

hydrochloride)tablets film-coated

50mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia N06AB06 1563924.05.2016

24.05.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

450 Askophen-Extra


paracetamol,

caffeine

tablets300mg+100mg+ 50mg,

blister (10, 10/1x10/)

Lubnypharm' PJSC,

37500, Poltava obl.,

Lubny, Petrovskogo

str., 16

Ukraine N02BA51 13637/217.08.2016

27.06.2019OTC

Lubnypharm' PJSC,

37500, Poltava obl.,

Lubny, Petrovskogo

str., 16, Ukraine

451 Asomex-2,5

amlodipine

(amlodipine

besilate)

tablets2,5mg,


Emcure

Pharmaceuticals Ltd.,

Lane No. 3, Phase II,

SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India C08CA01 1327604.03.2014

04.03.2019PoM

Emcure


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

Bhosari, Pune-

411026, Maharashtra,

India

452 Asomex-5

amlodipine

(amlodipine

besilate)

tablets5mg,


Emcure



SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India C08CA01 1327704.03.2014

04.03.2019PoM

Emcure


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

Bhosari, Pune-


India

94

453 Asomex-D

amlodipine

(amlodipine

besilate),

hydrochloro-

thiazide

tablets2,5mg+12,5mg,


Emcure



SIDCO Industrial

Complex, Bari-

Brahmana, Jammu

(J&K)-181 133

India C08CA01 1363327.06.2014

27.06.2019PoM

Emcure


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

Bhosari, Pune-


India

454Asparaginase

medacl-asparaginase

powder lyophilized

for solution for

injection

10000U,

glass vial

Medac GmbH,

Theaterstrasse 6,

22880 Wedel-

secondary packager,


manufacturer,

primary packager -

Kyowa Hakko Kirin

Co., Ltd, Fuji Plant

1188 Shimotogari,

Nagaizumi-cho Sunto-

gun, Shizuoka, Japan)

Germany L01XX02 13007/106.12.2016

13.11.2018PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

455Asparaginase

medacl-asparaginase

powder lyophilized

for solution for

injection

5000U,

glass vial

Medac GmbH,

Theaterstrasse 6,

22880 Wedel-

secondary packager,


manufacturer,

primary packager -

Kyowa Hakko Kirin

Co., Ltd, Fuji Plant

1188 Shimotogari,

Nagaizumi-cho Sunto-

gun, Shizuoka, Japan)

Germany L01XX02 13104/106.12.2016

02.12.2018PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

456Asparkam-

Zdorovye

magnesium

asparaginate

tetrahydrate,

potassium

asparaginate

hemihydrate

tablets

175mg+175mg,


50/1x50/)

Zdorovye

Pharmaceutical

Company LLC, str.

Shevchenko 22,

Kharkov

Ukraine A12CX 1305425.11.2013

25.11.2018OTC

Zdorovye

Pharmaceutical

Company LLC, str.

Shevchenko 22,

Kharkov, Ukraine

95

457 Aspicor 100 acetylsalicylic acidtablets gastro-

resistant

100mg,


Coral Laboratories

Ltd., Plot No. 57/1

(16), Bhenslore,

Dunetha, Nani

Daman 396 210

India B01AC06 1638710.02.2017

10.02.2022OTC

Coral Laboratories

Ltd., 503, Dalamal

House, 5th floor, J.B.

Marg, Nariman Point,

Mumbai 400 021,

India

458 Aspicor 300 acetylsalicylic acidtablets gastro-

resistant

300mg,


Coral Laboratories

Ltd., Plot No. 57/1

(16), Bhenslore,

Dunetha, Nani

Daman 396 210

India B01AC06 1483804.09.2015

04.09.2020OTC

Coral Laboratories

Ltd., 503, Dalamal

House, 5th floor, J.B.

Marg, Nariman Point,

Mumbai 400 021,

India

459 Aspirin Cacetylsalicylic acid,

ascorbic acidtablets effervescent

400mg+240mg,

in strip (10/5x2/)

Bayer Bitterfeld

GmbH, Ortsteil

Greppin Salegaster

Chaussee 1, 06803

Bitterfeld-Wolfen

Germany N02BA51 1499316.11.2015

16.11.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

460 Aspirin cardio acetylsalicylic acidtablets enteric-

coated

100mg,


Bayer Bitterfeld

GmbH, Ortsteil

Greppin Salegaster

Chaussee 1, 06803

Bitterfeld-Wolfen -

batch releaser,

primary and

secondary packager

(dosage form

manufacturer - Bayer

Bitterfeld GmbH,

Ortsteil Greppin

Salegaster Chaussee 1,

06803 Bitterfeld-

Wolfen)

Germany N02BA01 1219301.02.2013

01.02.2018OTC

Bayer Vital GmbH,

51368 Leverkusen,

Germany

96

461 Aspirin cardio acetylsalicylic acidtablets enteric-

coated

300mg,


Bayer Bitterfeld

GmbH, Ortsteil

Greppin Salegaster

Chaussee 1, 06803

Bitterfeld-Wolfen -

batch releaser,

primary and

secondary packager

(dosage form

manufacturer - Bayer

Bitterfeld GmbH,

Ortsteil Greppin

Salegaster Chaussee 1,

06803 Bitterfeld-

Wolfen)

Germany N02BA01 1219401.02.2013

01.02.2018OTC

Bayer Vital GmbH,

51368 Leverkusen,

Germany

462 Aspirin Cardio acetylsalicylic acidtablets gastro-

resistant

100mg,


Bayer Bitterfeld

GmbH, Ortsteil

Greppin, Salegaster

Chaussee 1, 06803

Bitterfeld-Wolfen-

batch releaser,

packager, Bayer

Pharma AG, Kaiser-

Wilhelm-Allee, 51368

Leverkusen, Germany-

bulk manufacturer

Germany B01AC06 1701426.09.2017

26.09.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

463 Astradez-Light

N,N-bis(3-

aminopropyl)dodec

ylamine, N,N-

didecyl-N,N-

dimethyl amonium

chloride

solution

7,1+/-0,1%+

3,5+/-0,3%,

1l in plastic container

Gigiena-Med JSC

Prophylaxis Centre,

241004, Karachevskoe

road, 4th km, Bryansk

Russia 1244707.05.2013

07.05.2018OTC

Gigiena-Med JSC

Prophylaxis

Centre,119361,

Ozernaya str., 42,

Moscow, Russia

464 Asvitol ascorbic acid tablets chewable200mg,


Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia A11GA01 1705205.10.2017

05.10.2022OTC

OTCPharm PJSC,

123317, Moscow,


Russia

97

465 Atarax

hydroxyzine

(hydroxyzine

hyrochloride)



UCB Pharma S.A.,

Chemin du Foriest, B-

1420 Braine

Belgium N05BB01 15024/113.03.2017

02.12.2020PoM

l'Alleud

GlaxoSmithKline

Export Ltd., 980

Great West Road,


TW8 9GS, UK

466 Atenolol atenolol tablets film-coated25mg,

in blister (28)

CP Pharmaceuticals

Ltd., Ash Road North,

Wrexham LL13 9UF -

batch releaser ( dosage

form manufacturer,

packager - Wockhardt

Limited, H-14/2

MIDC, Waluj,

Aurangabad,

Maharashtra, IN-

431136, India)

UK C07AB03 1232703.04.2013

03.04.2018PoM

Wockhardt UK Ltd.,

Ash Road North,

Wrexham Industrial

Estate, LL13 9 UF,

UK


in blister (28)

CP Pharmaceuticals


Wrexham LL13 9UF -


form manufacturer,


Limited, H-14/2

MIDC, Waluj,

Aurangabad,

Maharashtra, IN-

431136, India)

UK C07AB03 1232803.04.2013

03.04.2018PoM

Wockhardt UK Ltd.,

Ash Road North,

Wrexham Industrial

Estate, LL13 9 UF,

UK

98


in blister (28)

CP Pharmaceuticals


Wrexham LL13 9UF -


form manufacturer,


Limited, H-14/2

MIDC, Waluj,

Aurangabad,

Maharashtra, IN-

431136, India)

UK C07AB03 1232903.04.2013

03.04.2018PoM

Wockhardt UK Ltd.,

Ash Road North,

Wrexham Industrial

Estate, LL13 9 UF,

UK

469 Atenolol atenolol tablets50mg,

in blisters (30/2x15/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia C07AB03 14276/103.04.2017

19.03.2020PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

470 Atenolol atenolol tablets50mg,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus C07AB03 1558512.05.2016

12.05.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

471 Atenolol atenolol tablets100mg, (30/3x10/), in

blister

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus C07AB03 1558612.05.2016

12.05.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

99

472Atenolol 100mg

Tabletsatenolol tablets

100mg,


Accord Healthcare


Pinner Road, North




Plot No 5/6/7, Pharmez,

Near Village Matoda,

Sarkhej-Bavla Highway,

NH-8A, Matoda, District-

Ahmedabad, 382 210,








packager

UK C07AB03 1525613.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

473Atenolol 100mg


100mg,


Accord Healthcare

Limited, Sage House, 319

Pinner Road, North


4HF - batch releaser, Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C07AB03 1525813.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

100

474Atenolol 25mg


25mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK C07AB03 1525513.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

475Atenolol 25mg


25mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C07AB03 1525913.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

101

476Atenolol 50mg


50mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK C07AB03 1525713.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

477Atenolol 50mg


50mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C07AB03 1526013.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

478

Atenolol Sopharma

25mg film-coated

tablets

atenolol tablets film-coated25mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C07AB03 1537326.02.2016

26.02.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,


479

Atenolol Sopharma

50mg film-coated

tablets

atenolol tablets film-coated50mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C07AB03 1537426.02.2016

26.02.2021PoM

Sopharma JSC, str.

Iliensko shosse 16,


102

480 Atoris

atorvastatin

(atorvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA05 1465203.07.2015

03.07.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

481 Atoris

atorvastatin

(atorvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA05 1478203.08.2015

03.08.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

482 Atoris

atorvastatin

(atorvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA05 1478303.08.2015

03.08.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

483 Atoris

atorvastatin

(atorvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA05 1561724.05.2016

24.05.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

484 Atoris

atorvastatin

(atorvastatin

calcium)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C10AA05 1561824.05.2016

24.05.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

485 Atortonus

atorvastatin

(atorvastatin

calcium trihydrate)



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC10AA05 15720

22.06.2016

22.06.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

103

486 Atorvastatin

atorvastatin

(atorvastatin

calcium

hemihydrate)


in blister (28)

Dexcel-Pharma Ltd., 7

Sopwith Way, Drayton

Fields Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer - Dexcel

Pharma Technologies

Limited, 10 Hakidma

Street, Northern Hi-

tech City Park,

Yokneam, Israel)

(packager - Dexcel Ltd.,

1 Dexcel St., Or-Akiva

30600, Israel)

UK C10AA05 1253222.05.2013

22.05.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

487 Atorvastatin

atorvastatin

(atorvastatin

calcium

hemihydrate)


in blister (28)




Daventry,

Northamptonshire,

NN11 8PB - batch



Pharma Technologies

Limited, 10 Hakidma


tech City Park,

Yokneam, Israel)



30600, Israel)

UK C10AA05 1253322.05.2013

22.05.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

104

488 Atorvastatin

atorvastatin

(atorvastatin

calcium

hemihydrate)


in blister (28)




Daventry,

Northamptonshire,

NN11 8PB - batch



Pharma Technologies

Limited, 10 Hakidma


tech City Park,

Yokneam, Israel)



30600, Israel)

UK C10AA05 1253422.05.2013

22.05.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

489 Atorvastatin

atorvastatin

(atorvastatin

calcium)

tablets film-coated

20mg,


30/3x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C10AA05 1314310.01.2014

10.01.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

490 Atorvastatin

atorvastatin

(atorvastatin

calcium)

tablets coated

10mg,


30/3x10/)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus C10AA05 1322524.02.2014

24.02.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

491 Atorvastatin

atorvastatin

(atorvastatin

calcium trihydrate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C10AA05 1329104.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

492 Atorvastatin

atorvastatin

(atorvastatin

calcium trihydrate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C10AA05 1329204.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

493 Atorvastatin

atorvastatin

(atorvastatin

calcium trihydrate)


in blister(30/3x10/)

Replek Farm Ltd.-


1000 Skopje

Macedonia C10AA05 1329304.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

105

494 Atorvastatin

atorvastatin

(atorvastatin

calcium trihydrate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C10AA05 1329404.03.2014

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

495Atracurium

Besylate Injection

atracurium

(atracurium

besylate)


5ml ampoules (5)

Swiss Parenterals Pvt.

Ltd., 809 Kerala

Industrial Estate ,

G.I.D.C, Near Bavla,

Dist. Ahmedabad-382

220,Gujarat

India M03AC04 1701126.09.2017

26.09.2022PoM


Ltd., 809 Kerala

Industrial Estate ,


Dist. Ahmedabad-382

220,Gujarat, India

496

Atracurium

Besylate Injection

10mg/ml

atracurium

(atracurium

besylate)


2,5ml ampoules (5)


Ltd., 809 Kerala

Industrial Estate ,


Dist. Ahmedabad-382

220,Gujarat

India M03AC04 1342714.04.2014

14.04.2019PoM


Ltd., 809 Kerala

Industrial Estate ,


Dist. Ahmedabad-382

220,Gujarat, India

497 Atrican 250 tenonitrozolecapsules gastro-

resistant

250mg,

in blister (8/1x8/)

Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France P01AX08 1354923.05.2014

23.05.2019PoM

Laboratoire Innotech

International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

498 Atropine sulfateatropine (atropine

sulfate)drops eye

10mg/ml,

5ml glass vial and dropper

Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8

Ukraine S01FA01 1301025.11.2013

25.11.2018PoM

Experimental plant

GNCLS LLC, 61057,

Kharkov, Vorobeva

str., 8, Ukraine


sulfate)

solution for i/m, i/v

and s/c injection

1mg/ml,

1ml ampoules (10)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine A03BA01 1589623.08.2016

23.08.2021PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

106


sulfate)drops eye

10mg/ml,

5ml glass vial and dropper

"PHARMEX GROUP"

LLC, 100, Shevchenka

str.,08300, Kyiv

region, Boryspil

Ukraine S01FA01 1709023.10.2017

23.10.2022PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

501 Atrovent N

ipratropium

bromide

(ipratropium

bromide

monohydrate)

aerosol for

inhalation, dosed

20mcg/dose,

10ml (200doses)

aluminium container

with measuring pump

Boehringer Ingelheim

Pharma GmbH & Co.

KG, Binger Strasse

173, 55216 Ingelheim

am Rhein

Germany R03BB01 1641710.02.2017

10.02.2022PoM


International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

502 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)



SmithKline Beecham

Limited, Clarendon

road, Worthing, West

Sussex, BN14 8QH

UK J01CR02 12472/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

503 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)



SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12473/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

504 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)



SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12474/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

505 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

125mg/5ml+

31,25mg/5ml, 100ml glass

bottle

SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12475/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

107

506 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

200mg/5ml+ 28,5mg/5ml,

70ml glass bottle

SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12476/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

507 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

250mg/5ml+ 62,5mg/5ml,

100ml glass bottle

SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12477/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

508 Augmentin

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension

400mg/5ml+ 57mg/5ml,

70ml glass bottle

SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12478/121.03.2014

13.05.2018PoM

Beecham Group PLC,



TW8 9GS, UK

509 Augmentin ES

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)

powder for oral

suspension with

strawberry flavour

600mg/5ml+ 42.9mg/5ml,


5ml measuring spoon

Glaxo Wellcome

Production, Z.I. de la

Peyenniere, 53100

Mayenne

France J01C R02 1480204.09.2015

04.09.2020PoM

Laboratoire

GlaxoSmithKline,

100, route de

Versailles, 78163

Marly-Le-Roi cedex,

France

510Augmentin

intravenous

amoxicillin

(amoxicillin

sodium), clavulanic

acid (potassium

clavulanate)

powder for solution

for injection

1000mg+200mg, glass

vials (10)

SmithKline Beecham

Limited, Clarendon


Sussex, BN14 8QH

UK J01CR02 12802/121.03.2014

23.08.2018PoM

Beecham Group PLC,



TW8 9GS, UK

108

511 Avamigran

propyphenazone,

caffeine, camylofin

(camylofin

hydrochloride),

mecloxamine

(mecloxamine

citrate), ergotamine

(ergotamine

tartrate)

tablets film-coated

200mg+80mg+

25mg+20mg+ 0,75mg,


Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaN02CA52 17201

08.12.2017

08.12.2022PoM

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo, Bosnia And

Herzegovina

512 Avamysfluticasone

(fluticasone furoate)

spray nasal

(suspension)

27,5mcg/dose, plastic

bottle

Glaxo Operations UK

Limited, Harmire


Co Durham DL12

8DT

UK R01AD12 1442614.04.2015

14.04.2020PoM

Glaxo Group Ltd, 980

Great West Road,


TW8 9GS, UK

513 Avastin bevacizumabconcentrate for


25mg/ml,

4ml glass vial (1)

Roche Diagnostics

GmbH, Sandhofer

Strasse 116, D-68305

Mannheim-batch

releaser, bulk

manufacturer,

primary packager, F.

Hoffmann-La Roche

Ltd. Wurmisweg CH-

4303 Kaiseraugst,

Switzerland-

secondary packager

Germany

L01XC07;

new

indication

14359/125.03.2015

25.03.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

514 Avastin bevacizumabconcentrate for


25mg/ml,

16ml glass vial (1)

Roche Diagnostics

GmbH, Sandhofer


Mannheim-batch

releaser, bulk

manufacturer,

primary packager, F.

Hoffmann-La Roche

Ltd. Wurmisweg CH-

4303 Kaiseraugst,

Switzerland-

secondary packager

Germany

L01XC07;

new

indication

14360/125.03.2015

25.03.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

109

515 Avecor 10-Aversi

bisoprolol

(bisoprolol

fumarate)



Aversi-Rational Ltd,

0198 Tbilisi,

Chirnakhuli str. 14

Georgia C07AB07 1313710.01.2014

10.01.2019PoM


0198 Tbilisi,

Chirnakhuli str. 14,

Georgia

516 Avelox

moxifloxacin

(moxifloxacin

hydrochloride)

solution for infusion1.6mg/ml,

250ml glass vial

Bayer Pharma AG, D-

51368 , LeverkusenGermany J01MA14 14948

20.10.2015

20.10.2020PoM

Bayer Pharma AG, D-

51368 , Leverkusen,

Germany

517 Avelox moxifloxacin tablets coated400mg,

in blister (5/1x5/)

Bayer Pharma AG, D-

51368 LeverkusenGermany J01MA14 16379

30.12.2016

30.12.2021PoM

Bayer Pharma AG, D-

51368 Leverkusen,

Germany

518 Avexon-Rational

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial



0198 Tbilisi-

secondary packager,


manufacturer,

primary packager-

Reyoung

Pharmaceutical Co.

Ltd., No 6 Erlangshan

Road, Yiyuan County,

Shandong Province,

China)

Georgia J01DD04 1579720.07.2016

20.07.2021PoM



0198 Tbilisi, Georgia

519 Avia-More

veratrum album ,

anamirta cocculus

(Cocculus), natrium

tetraboracicum

(Borax)

tablets

C200+C200+ C200,


40/2x20/)

NPF Materia Medica

Holding Ltd., 54,


Chelyabinsk 454139

Russiahomeopathic

drug12510

01.06.2013

01.06.2018OTC

NPF Materia Medica

Holding Ltd., 9 bld.,

3rd Samotyochny


Russia

520 Avodart dutasteride capsules0,5mg,


GlaxoSmithKline

Pharmaceuticals

S.A.,189 Grunwaldzka

street, 60-322 Poznan

Poland G04CB02 1224607.03.2013

07.03.2018PoM

GlaxoSmithKline

Export Ltd, 980 Great

West Road,


TW8 9GS, UK

110

521 Axetine

cefuroxime

(cefuroxime

sodium)

powder for solution

for injection/infusion

750mg,

glass vial (10)

Medochemie Ltd., 2

Michael Eracleous

Street, Agios

Athanasios Industrial

Area, 4101, Agios


Cyprus J01DC02 1221407.03.2013

07.03.2018PoM

Medochemie Ltd.,

P.O. Box 51409, 3505

Limassol, Cyprus

522 Axetine

cefuroxime

(cefuroxime

sodium)

powder for solution


1500mg,

glass vial (10)

Medochemie Ltd., 2

Michael Eracleous

Street, Agios

Athanasios Industrial

Area, 4101, Agios


Cyprus J01DC02 1221507.03.2013

07.03.2018PoM

Medochemie Ltd.,

P.O. Box 51409, 3505

Limassol, Cyprus

523Axol Liquid

3mg/ml

ambroxol

(ambroxol

hydrochloride)

liquid3mg/ml,


Y.S.P. Industries (M)

SDN. BHD., Lot 3,5 &

7, Jalan P/7, Section

13, Kawasan

Perindustrian Bandar

Baru Bangi, 43000

Kajang, Selangor

Darul Ehsan

Malaysia R05CB06 1315210.01.2014

10.01.2019OTC

Y.S.P. Industries (M)

SDN. BHD., 16th

Floor, Plaza VADS,

No.1, Jalan Tun

Mohd. Fuad, Taman

Tun Dr. Ismail, 60000

Kuala Lumpur,

Malaysia

524 Azaleptine clozapine tablets25mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AH02 12847

17.09.2013

17.09.2018PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

525 Azaleptine 100mg clozapine tablets100mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN05AH02 13867

18.09.2014

18.09.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

111

526 Azaleptol clozapine tablets100mg,


PJSC "Technolog"

(Manuylskogo str. 8,

20300

Uman,Cherkassy

region)

Ukraine N05AH02 1295328.10.2013

28.10.2018PoM/UC

PJSC "Technolog"

(Manuylskogo str. 8,

20300

Uman,Cherkassy

region, Ukraine)

527 Azarga

brinzolamide,

timolol (timolol

maleate)

drops eye

(suspension)

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

vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01ED51 1360220.06.2014

20.06.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

528 Azastrole anastrozole tablets film-coated1mg,


Douglas

Manufacturing Ltd,

Corner Te Pai Place

and Central Park

Drive, Lincoln

Auckland

New Zealand L02BG03 1393329.10.2014

29.10.2019PoM

Eris Pharmaceuticals

Pty LTD, 6 Eastern

road South

Melbourne, Victoria,

3205, Australia

529 Azatril 100mg/5ml

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

100mg/5ml,

20ml glass bottle, double-

ended measuring spoon

and an oral dosing syringe

Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad

Bulgaria J01FA10 1229922.03.2013

22.03.2018PoM

Balkanpharma-

Razgrad

AD(ACTAVIS

GROUP), 68 Aprilsko

Vastanie Blvd, 7200

Razgrad, Bulgaria

530 Azatril 200mg/5ml

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

200mg/5ml,

20ml glass bottle, double-

ended measuring spoon

and an oral dosing syringe

Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad

Bulgaria J01FA10 1230022.03.2013

22.03.2018PoM

Balkanpharma-

Razgrad

AD(ACTAVIS

GROUP), 68 Aprilsko

Vastanie Blvd, 7200

Razgrad, Bulgaria

531 Azibiot

azithromycin

(azithromycin

dihydrate)


in blister (3/1x3/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01FA10 1489224.09.2015

24.09.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

112

532 Aziflam D.S.

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

40mg/ml,


and 5ml measuring

syringe

Flamingo


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

Area, Rabale, Navi

Mumbai 400 701

India J01FA10 1238319.04.2013

19.04.2018PoM

Flamingo


P.O. Box No

27257,Mumbai 400

071, India

533 Azimac azithromycin capsules250mg,

in blister (6/2x3/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia J01FA10 1374524.07.2014

24.07.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


534 Azimac azithromycin capsules500mg,

in blister (3/1x3/)

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia J01FA10 1374624.07.2014

24.07.2019PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


535 Azimac 200mg/5ml

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

40mg/ml,

15ml glass bottle, and

measuring syringe

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi (dosage

form manufacturer -

Arafarma Group, S.A.,

C/Fray Gabriel de San

Antonio, 6-10, Pol.

Ind. Del Henares,

19180, Marchamalo,

Guadalajara, Spain)

Georgia J01FA10 1218201.02.2013

01.02.2018PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


536 Azimed

azithromycin

(azithromycin

dihydrate)

capsules250mg,

in blister (6/1x6/)

Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine J01FA10 1337904.04.2014

04.04.2019PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

537 Azirex azithromycin tablets film-coated500mg,


Pharmtechnology

LLC, Korzhenevskogo

str., 22, 220024,

Minsk

Belarus J01FA10 1677922.06.2017

22.06.2022PoM

Giga Farm LLC,

Gogunca str.3/5,

Gyumri, Republic of

Armenia

113

538 Azithromycin azithromycin tablets film-coated500mg,

in blister (3/1x3/)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01FA10 1576804.07.2016

04.07.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

539 Azithromycin azithromycin capsules250mg,

in blister (6/1x6/)

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus J01FA10 1621708.12.2016

08.12.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

540Azithromycin

500mg

azithromycin

(azithromycin

monohydrate)


in blister (3)

Sandoz S.R.L., str.

Livezeni nr. 7A,

540472, Targu Mures

Romania J01FA10 1227222.03.2013

22.03.2018PoM


57, Ljubljana,

Slovenia

541 Azithromycin ABR

azithromycin

(azithromycin

dihydrate)

capsules hard500mg,

in blister (3/1x3/)

Balkanpharma-

Razgrad AD, 68

Aprilsko Vastanie

Blvd, 7200 Razgrad

Bulgaria J01FA10 1724608.12.2017

08.12.2022PoM

Antibiotic-Razgrad

AD, 68, Aprilsko

vastanie Blvd,

Razgrad, 7200,

Bulgaria, Bulgaria

542AZITHROMYCIN-

ASTRAPHARMazithromycin capsules

500mg,

in blister (3)

'ASTRAPHARM' Ltd,

6, Kievskaya Str.,

Vishnevoye, Kiev-

Svyatoshinskiyy

district, Kiev region,

08132

Ukraine J01FA10 1469616.07.2015

16.07.2020PoM

ASTRAPHARM' Ltd,

6, Kievskaya Str.,

Vishnevoye, Kiev-

Svyatoshinskiyy

district, Kiev region,

08132, Ukraine

543 Azitrom-Replek

azithromycin

(azithromycin

dihydrate)


blister (3)

Replek Farm Ltd.-


1000 Skopje

Macedonia J01FA10 13290/111.07.2016

04.03.2019PoM

Replek Farm Ltd.-


1000 Skopje

114

544 Azitrox

azithromycin

(azithromycin

dihydrate)

capsules250mg,

blister (6/1x6/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia J01FA10 14180/103.10.2016

21.01.2020PoM

OTCPharm PJSC,

123317, Moscow,


Russia

545 Azitrox

azithromycin

(azithromycin

dihydrate)

capsules500mg,

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

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia J01FA10 14215/103.10.2016

12.02.2020PoM

OTCPharm PJSC,

123317, Moscow,


Russia

546 Azitrox

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

100mg/5ml,

50ml glass bottle with

15.9g powder (for 20ml

prepared suspension),

measuring spoon and

dropper

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia J01FA10 14935/125.07.2016

20.10.2020PoM

OTCPharm PJSC,

123317, Moscow,


Russia

547 Azitrox

azithromycin

(azithromycin

dihydrate)

powder for oral

suspension

200mg/5ml,

50ml glass bottle with

15.9g powder (for 20ml

prepared suspension),

measuring spoon and

dropper

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia J01FA10 14936/125.07.2016

20.10.2020PoM

OTCPharm PJSC,

123317, Moscow,


Russia

548 Azopt brinzolamide drops eye10mg/ml,

5ml plastic vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14,

2870 Puurs

Belgium S01EC04 1280423.08.2013

23.08.2018PoM

Alcon


Route des Arsenaux

41 Case Postale 1701

Fribourg, Switzerland

549 BC Benzogel benzocaine gel200mg/g,

6g syringe

“Bio-Chem” LTD,

Manandyan, 33, 1/1,

Yerevan

Republic of

ArmeniaC05AD03 14149

29.12.2014

29.12.2019OTC

“Bio-Chem” LTD,

Manandyan, 33, 1/1,


Armenia

115

550 Bactox 250mg/5ml

amoxicillin

(amoxicillin

trihydrate)

powder for oral

suspension

250mg/5ml,


measuring spoon

Innothera Chouzy,

Rue Rene Chantereau

L` lsle Vert 41150,

Chouzy sur Cisse

France J01CA04 1416124.12.2014

24.12.2019PoM


International, 22

Avenue Aristide

Brand 94110 Arcueil,

France

551 Bactrimsulfamethoxazole,

trimethoprimsuspension


100ml bottle

Cenexi SAS, Rue

Marcel et Jacques

Gaucher, 52,

Fontenay sous Bois,

94120

France J01EE01 1241802.06.2013

02.06.2018PoM

F. Hoffmann-La

Roche Ltd,

Greenzacherstrasse

124, 4070 Basel,

Switzerland

552 Bactrim fortesulfamethoxazole,

trimethoprimtablets

800mg+160mg,


F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel -

batch releaser,

Productos Roche S.A.

de C.V., Via Isidro

Fabela Norte N 1536-

B, Parque Industrial

Toluca (Estado de

Mexico) 50030,

Mexico, Mexico-bulk

manufacturer, F.

Hoffmann-La Roche

Ltd, Betriebsstandort

Kaiseraugst, 4303

Kaiseraugst,

Switzerland-primary

and secondary

packager

Switzerland J01EE01 1538822.02.2016

22.02.2021PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

553Bactroban 2%

creammupirocin cream

20mg/g,

15g aluminium tube

Glaxo Operations UK

Limited (trading as:

Glaxo Wellcome

Operations) Harmire


Durham, DL12 8DT

UK D06AX09 13207/131.07.2015

21.01.2019PoM

Beecham Group PLC,

Stockley Park West,

Uxbridge, Middlesex

UB11 1BT, UK

116

554Bactroban 2%

ointmentmupirocin ointment

20mg/g,

15g aluminium tube

Glaxo Operations UK

Limited (trading as:

Glaxo Wellcome

Operations) Harmire


Durham, DL12 8DT

UK D06AX09 13208/111.12.2014

21.01.2019PoM

Beecham Group PLC,

Stockley Park West,

Uxbridge, Middlesex

UB11 1BT, UK

555 BacTRONNsulfamethoxazole,

trimethoprimsuspension oral


50ml, 55ml, 60ml, 80ml,

100ml, 120ml glass bottle

and measuring cup

Medicon


Industral Plot

No.17/A-1, Block-D,

Section-10, Mirpur,

Dhaka

Bangladesh J01EE01 1236309.04.2013

09.04.2018PoM

Medicon


Industral Plot

No.17/A-1, Block-D,

Section-10, Mirpur,

Dhaka, Bangladesh

556 Bagodilol 12,5 carvedilol tablets12,5mg,


Laboratorios Bago

S.A.,1429 4th str.,La

Plata,Buenos Aires

Argentina C07AG02 12700/126.03.2014

23.07.2018PoM

Laboratorios Bago

S.A.,248 Bernardo de

Irigoyen str.,Buenos

Aires,Argentina

557 Bagodilol 25 carvedilol tablets25mg,


Laboratorios Bago


Plata,Buenos Aires

Argentina C07AG02 12701/126.03.2014

23.07.2018PoM

Laboratorios Bago



Aires,Argentina

558 Bagodilol 6,25 carvedilol tablets6,25mg,


Laboratorios Bago


Plata,Buenos Aires

Argentina C07AG02 12699/126.03.2014

23.07.2018PoM

Laboratorios Bago



Aires,Argentina

559 Bagomet 500

metformin

(metformin

hydrochloride)

tablets film-coated

500mg,


60/6x10/, 100/10x10/)

Quimica Montpellier

S.A., Virrey Liniers

673, Ciudad

Autonoma de Buenos

Aires

Argentina A10BD02 1319510.01.2014

10.01.2019PoM

Quimica Montpellier

S.A., Virrey Liniers

673, Ciudad

Autonoma de Buenos

Aires, Argentina

117

560Bagomet Plus

500/2,5

metformin

(metformin

hydrochloride),

glibenclamide

tablets film-coated

500mg+2,5mg,


60/6x10/)

Quimica Montpellier

S.A. (Virrey Liniers

673, Ciudad

Autonoma de Buenos

Aires)

Argentina A10BD02 1289207.10.2013

07.10.2018PoM

Quimica Montpellier


673, Ciudad

Autonoma de Buenos

Aires, Argentina)

561Bagomet Plus

500/5

metformin

(metformin

hydrochloride),

glibenclamide

tablets film-coated

500mg+5mg,


60/6x10/)

Quimica Montpellier


673, Ciudad

Autonoma de Buenos

Aires)

Argentina A10BD02 1289307.10.2013

07.10.2018PoM

Quimica Montpellier


673, Ciudad

Autonoma de Buenos

Aires, Argentina)

562Balzamic liniment

of Vishnevskybirch tar, xeroform liniment

30mg/g+30mg/g, 40g

aluminium tube

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus D08AX 1389306.10.2014

06.10.2019OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

563 Baneocin

bacitracin zinc,

neomycin

(neomycine sulfate)

powder for external

use

250IU/g+5000IU/g, 10g in

plastic container

Sandoz GmbH,


A-6250 Kundl-batch

releaser;

(Pharmazeutische

Fabrik Montavit

GmbH, Salzbergstr.

96, 6067Absam Tirol,

Austria- bulk

manufacturer,

packager)

Austria D06AX 1335104.04.2014

04.04.2019OTC

Sandoz GmbH,


A-6250 Kundl,

Austria

118

564 Baneocin

bacitracin zinc,

neomycin

(neomycine sulfate)

ointment250IU/g+5000IU/g, 20g

aluminum tube

Sandoz GmbH,


A-6250 Kundl - batch

releaser; (Merck

KGaA & Co., Plant

Spittal, Hosslgasse 20,

9800 Spittal/Drau,

Austria - bulk

manufacturer,

packager)

Austria D06AX 1335204.04.2014

04.04.2019OTC

Sandoz GmbH,


A-6250 Kundl,

Austria

565

Bars

Insectoacaricide for

dogs

fipronil drops50mg/ml; (4) container-

dropper 1,4ml

NVTS

Agrovetzashchita S-P,

OOO, oblast

Moskovskaya,

Sergiyev Posad, ulitsa

Tsentralnaya

Russia

QP53AX65

veterinary

drug

1214301.02.2013

01.02.2018PoM

NVTS

Agrovetzashchita S-P,

OOO, oblast

Moskovskaya,

Sergiyev Posad, ulitsa

Tsentralnaya, RUSSIA

566BC Dentahex

Solution

chlorhexidine

(chlorhexidine

gluconate)

solution20mg/ml,


Bio-Chem Ltd., 0046,

Erevan, Manandyan

str. 33, 1/1

Republic of

ArmeniaA01AB03 13438

14.04.2014

14.04.2019OTC

Bio-Chem Ltd., 0046,

Erevan, Manandyan

str. 33, 1/1, Republic

of Armenia

567 BCG vaccine

BCG

vaccine(Bacillus

Calmette Guerin

Strain)

powder lyophilized

for solution for

injection

between 2x10^5 and

8x10^5 CFU/0,1ml; (50)

10/20 dose glass vial/

(50/5x10/) sodium

chloride 0.9% 1ml

ampoules with solvent in

blister, (300/6 box/)(50)

10/20 dose glass vial/

(50/5x10/) sodium

chloride 0.9% 1ml

ampoules with solvent in

blister

Serum Institute of

India Pvt. Ltd., 212/2,

Hadapsar, Pune

411028

IndiaJ07AN01;

vaccine17092

23.10.2017

23.10.2022PoM

Serum Institute of

India Pvt. Ltd., 212/2,

Hadapsar, Pune

411028, India

568 Be-Bo benzyl benzoate emulsion

200mg/ml,


bottle


Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaP03AX01 12529

01.06.2013

01.06.2018OTC


Norq, Mikoyan 13,

Yerevan, Armenia

119

569Befungin-

Tatpharm

chaga, cobalt

chloride

hexahydrate

solution oral1000mg/ml+ 1,76mg/ml,

100ml glass bottle

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia A13A 15542/108.02.2017

19.04.2021PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

570 Belara

chlormadinone

(chlormadinone

acetate),

ethinylestradiol

tablets film-coated

2mg+0,03mg,


63/3x21/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA 1425820.02.2015

20.02.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

571

Bendamustine

Moosmann

2,5mg/ml

bendamustine

(bendamustine

hydrochloride)

powder for

concentrate for


25mg,

glass vial (1)

Thymoorgan

Pharmazie GmbH,

Schiffgraben 23,

38690 Goslar

Germany L01AA09 1677222.06.2017

22.06.2022PoM

Moosmann


Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

572

Bendamustine

Moosmann

2,5mg/ml

bendamustine

(bendamustine

hydrochloride)

powder for

concentrate for


100mg,

glass vial (1)

Thymoorgan

Pharmazie GmbH,

Schiffgraben 23,

38690 Goslar

Germany L01AA09 1677322.06.2017

22.06.2022PoM

Moosmann


Vanahovit 8,

Proshyan v., Ashtarak

Ave., Kotayk Marz

2413, Republic of

Armenia

573 Bendaz 300 albendazole bolus (tablets)300mg,


Agio Pharmaceuticals

Limited, T-82,

M.I.D.C., Bhosari,

Pune 411026

Maharashtra State

India

QP52AC11;

veterinary

drug

1438916.04.2015

16.04.2020PoM


Limited, A-38,

Nandjyot Industrial

Estate, Kurla -

Andheri Road,

Safedpool, Mumbai -

400 072, India

120

574 Bendaz 600 albendazole bolus (tablets)600mg,



Limited, T-82,

M.I.D.C., Bhosari,

Pune 411026

Maharashtra State

India

QP52AC11;

veterinary

drug

1438816.04.2015

16.04.2020PoM


Limited, A-38,

Nandjyot Industrial

Estate, Kurla -

Andheri Road,

Safedpool, Mumbai -

400 072, India

575 BeneFix nonacog alfapowder for solution

for injection

250IU,

glass vial, 5ml solvent in

pre-filled syringe, vial

adapter, sterile infusion

set, (2) alcohol swabs,

plaster, gauze pad

Wyeth Farma S.A.,

Autovia del Norte A-

1 Km 23, Desvio

Algete Km 1, 28700

San Sebastian de los

Reyes, Madrid

Spain B02BD09 1330204.03.2014

04.03.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK


for injection

500IU,





plaster, gauze pad

Wyeth Farma S.A.,


1 Km 23, Desvio

Algete Km 1, 28700


Reyes, Madrid

Spain B02BD09 1330304.03.2014

04.03.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK


for injection

1000IU,





plaster, gauze pad

Wyeth Farma S.A.,


1 Km 23, Desvio

Algete Km 1, 28700


Reyes, Madrid

Spain B02BD09 1330404.03.2014

04.03.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK


for injection

2000IU,





plaster, gauze pad

Wyeth Farma S.A.,


1 Km 23, Desvio

Algete Km 1, 28700


Reyes, Madrid

Spain B02BD09 1330504.03.2014

04.03.2019PoM

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13

9NJ, UK

121

579 Bengaymethyl salicylate,

racementholcream

150mg/g+ 100mg/g,

50g aluminium tube

Janssen-Cilag,

Domaine de

Maigremont, 27100

Val De Reuil

France M02AC 1306609.12.2013

09.12.2018OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya

str., 17, building 2,

Russia

580 Benzonal benzobarbital tablets100mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AA 13965

04.11.2014

04.11.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

581Benzonal-

Tatpharmbenzobarbital tablets

100mg,

blisters (50/5x10/)

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 261

Russia N03AA 12931/108.02.2017

07.10.2018PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

582 Benzyl benzoate benzyl benzoate emulsion topical250mg/ml,

120ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaP03AX01 12483

02.10.2013

02.10.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

583Benzylbenzoate

Grindeksbenzylbenzoate

ointment for

external use

200mg/g,

30g aluminium tube

Tallinn



Tallinn

Estonia P03AX01 1629730.12.2016

30.12.2021OTC

Grindeks JSC,



584 Benzylpenicillin

benzylpenicillin

(benzylpenicillin

sodium)

powder for solution

for injection

1000000IU,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CE01 1596015.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

122

585Benzylpenicillin

sodium

benzylpenicillin

(benzylpenicillin

sodium)

powder for solution

for injection

1000000IU,

glass vial (50),

(1000/20box /50/)

Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical

Factory,No 388 Hahei

Road, Hulan District.,

Harbin

China J01CE01 1695405.09.2017

05.09.2022PoM

Harbin

Pharmaceutical

Group Co., Ltd.,

General

Pharmaceutical

Factory, No 109

Xuefu Road, Nangang

District., Harbin,

China

586Benzylpenicillin

sodium salt

benzylpenicillin

(benzylpenicillin

sodium)

powder for solution

for i/m injection

1000000IU,

10ml glass vials (50)

"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CE01 1557412.05.2016

12.05.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

587 Bepanthen cream dexpanthenol cream50mg/g,

30g aluminium tube

GP Grenzach

Produktions GmbH,

Emil-Barell-Strasse 7,

D-79639 Grenzach-

Wyhlen

Germany D03AX03 1389830.09.2014

30.09.2019OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

588Bepanthen

ointmentdexpanthenol ointment

50mg/g,

30g aluminium tube

GP Grenzach

Produktions GmbH,


D-79639 Grenzach-

Wyhlen

Germany D03AX03 1389730.09.2014

30.09.2019OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

589 Bepanthen Plus

dexpanthenol,

chlorhexidine

(chlorhexidine

dihydrochloride)

cream50mg/g+5mg/g, 30g

aluminium tube

GP Grenzach

Produktions GmbH,


D-79639 Grenzach-

Wyhlen

Germany D08AC52 1271323.07.2013

23.07.2018OTC

Bayer Consumer

Care AG, Peter

Merian-Strasse 84,

4052 Basel,

Switzerland

590 Bepanthen Plus

dexpanthenol,

chlorhexidine

(chlorhexidine

digluconate)

spray


plastic container with

pump dispenser

Lichtenheldt GmbH

Pharmazeutische

Fabrik,

Industriestrasse 7-11,

Schleswig-Holstein,

Wahlstedt, 23812

Germany D08AC02 1481604.09.2015

04.09.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

123

591 Beriate 1000

human blood

coagulation factor

VIII

powder and solvent

for solution for

injection/ infusion

1000IU,

glass vial (1), 10ml glass

vial with solvent,

transfer/filter set (1)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany B02BD02 1483104.09.2015

04.09.2020PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

592 Beriate 500

human blood

coagulation factor

VIII

powder and solvent

for solution for

injection/ infusion

500IU,

glass vial (1), 5ml glass

vial with solvent,

transfer/filter set (1)

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg

Germany B02BD02 1483004.09.2015

04.09.2020PoM

CSL Behring GmbH,

Emil-von-Behring-

Strasse 76, 35041

Marburg, Germany

593 Berlipril 10enalapril (enalapril

maleate)tablets

10mg,


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 C09AA02 1655703.04.2017

03.04.2022PoM

Berlin-Chemie A.G.,

Glienicker Weg 125,

12489 Berlin,

Germany

594 Berlipril 20enalapril (enalapril

maleate)tablets

20mg,


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 C09AA02 1655603.04.2017

03.04.2022PoM

Berlin-Chemie A.G.,

Glienicker Weg 125,

12489 Berlin,

Germany

124

595 Berlipril plus

enalapril (enalapril

maleate),

hydrochlorothia-

zide

tablets10mg+25mg,


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 C09BA02 1530104.02.2016

04.02.2021PoM

Berlin-Chemie A.G.,

Glienicker Weg 125,

D-12489 Berlin,

Germany

596Berlithion 600

capsulesthioctic acid capsules soft

600mg,


30/2x15/)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin-batch

releaser, Catalent

Germany Eberbach

GmbH,

Gammelsbacherstrass

e 2, D-69412

Eberbach, Germany-

bulk manufacturer,

Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf,

Germany-packager

Germany A16AX01 1597215.09.2016

15.09.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

597 Berlithion 600 ED thioctic acid

concentrate for

solution for i/v

infusion

25mg/ml,

25ml ampoules (24ml

concentrate) (5, 10)

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin - batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln, 31789,

Germany- bulk

manufacturer,

packager

Germany A16AX01 1597315.09.2016

15.09.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

125

598 Berodual

fenoterol (fenoterol

hydrobromide),

ipratropium

bromide

(ipratropium

bromide

monohydrate)

solution inhalation500mcg/ml+ 261mcg/ml,

20ml glass container

Istituto de Angeli

S.R.L. Loc. Prulli,

103/C 50066 Reggello,

Firenze

Italy R03AL01 1643606.03.2017

06.03.2022PoM


International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

599 Berodual N

ipratropium

bromide

(ipratropium

bromide

monohydrate),

fenoterol (fenoterol

hydrobromide)

aerosol for

inhalation, dosed

20mcg/dose+ 50mcg/dose,

10ml (200doses)

aluminium container

with measuring pump


Pharma GmbH & Co.

KG, Binger Strasse

173, 55216 Ingelheim

am Rhein

Germany R03AL01 1641810.02.2017

10.02.2022PoM


International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

600 Berotec Nfenoterol (fenoterol

hydrobromide)aerosol for inhalation

100mcg/dose,

10ml aluminium bottle


Pharma GmbH & Co.

KG, Binger Strasse

173, D-55216

Ingelheim am Rhein

Germany R03AC04 12208/131.03.2017

07.03.2018PoM


International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

601 Betacid

betamethasone

(betamethasone

dipropionat),

salicylic acid

lotion0,5mg/ml+ 20mg/ml,

30ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD07XC01 12468

11.08.2013

11.08.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

602 Betacid

betamethasone

(betamethasone

dipropionat),

salicylic acid

ointment for topical

use

0,5mg/g+30mg/g, 15g

aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD07XC01 12469

11.11.2013

11.11.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

126

603 Betaderm

betamethasone

(betamethasone

dipropionate),

gentamicin

(gentamicin sulfate)

ointment for

external use

0,5mg/g+1mg/g, 15g

aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07CC01 1491820.10.2015

20.10.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

604 Betadina povidone-iodinesolution for external

use

100mg/ml,

20ml, 30ml and 50ml

plastic vial

Pharmaceutical

Company "NOKA"

Ltd, Davtashen 2nd

block 21/1, Yerevan

Republic of

ArmeniaD08AG02 16613

10.04.2017

10.04.2022OTC

Pharmaceutical

Company "NOKA"

Ltd, Davtashen 2nd

block 21/1, Yerevan,

Republic of Armenia

605 Betadine povidone-iodine ointment100mg/g,

20g aluminium tube


PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary D08AG02 12757/122.06.2015

14.08.2018OTC


PLC, 1106 Budapest,


Hungary

606 Betadine povidone-iodine suppositories vaginal200mg,



PLC, 9900, Kormend,

Matyas kiraly st. 65

Hungary G01AX11 12852/122.06.2015

17.09.2018OTC


PLC, 1106 Budapest,


Hungary

607 Betadine povidone-iodine suppositories vaginal200mg,

(14/2x7/)

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia G01AX11 1559624.05.2016

24.05.2021OTC

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

608 Betadine povidone-iodinesolution for external

use

100mg/ml,

100ml plastic bottle-

dropper

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia D08AG02 1559724.05.2016

24.05.2021OTC

Alkaloid AD-Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

127

609 Betadine povidone-iodinesolution for external

use

100mg/ml,

30ml, 120ml, 1000ml

plastic bottle-dropper


PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary D08AG02 1595415.09.2016

15.09.2021OTC


PLC, 1106 Budapest,

Kereszturi ut 30-38,

Hungary

610 Betadinok povidone-iodinesolution for external

use

100mg/ml,

20ml, 30ml, 75ml plastic

vial

"NOKI" JV LTD Co.,


region

Republic of


19.12.2014

19.12.2019OTC

"NOKI" JV LTD Co.,


region, Republic of

Armenia

611 Betafucin

fusidic acid,

betamethasone

(betamethasone

valerate)

cream20mg/g+1mg/g, 15g

aluminium tube

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city

Egypt D07BC01 1425120.02.2015

20.02.2020PoM

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city, Egypt

612

Betahistine

dihydrochloride

16mg Tablets

betahistine

(betahistine

dihydrochloride)

tablets16mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK N07CA01 1526113.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

128

613

Betahistine

dihydrochloride

16mg Tablets

betahistine

(betahistine

dihydrochloride)

tablets16mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK N07CA01 1526213.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

614

Betahistine

dihydrochloride

8mg Tablets

betahistine

(betahistine

dihydrochloride)

tablets8mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK N07CA01 1526313.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

129

615

Betahistine

dihydrochloride

8mg Tablets

betahistine

(betahistine

dihydrochloride)

tablets8mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK N07CA01 1526413.01.2016

13.01.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

616 Betaiodine povidone-iodine solution mouthwash10mg/ml,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


09.12.2013

09.12.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

617 Betaiodine povidone-iodinesolution for external

use

100mg/ml,

30ml, 60ml, 100ml, 1l,

3,6l, 4l plastic bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaD08AG02 12518/2

22.02.2016

01.06.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

618 Betaiodine povidone-iodine soap liquid

75mg/ml,

80ml, 140ml plastic

bottle, 1l, 3l plastic

container

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


30.12.2016

29.05.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

619 Betaiodine povidone-iodine cream100mg/g,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


14.04.2015

16.12.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

130

620 Betamaks sulpiride tablets film-coated50mg,


Grindeks JSC,


1057, Riga

Latvia N05AL01 1484904.09.2015

04.09.2020PoM

Grindeks JSC,





Grindeks JSC,


1057, Riga

Latvia N05AL01 1485004.09.2015

04.09.2020PoM

Grindeks JSC,





Grindeks JSC,


1057, Riga

Latvia N05AL01 1485104.09.2015

04.09.2020PoM

Grindeks JSC,



623 Betamed-N Cream

betamethasone

(betamethasone

valerate), neomycin

(neomycin

sulphate)

cream0.1%+0.5%,

30g aluminium tube

Medpharma Pharm.

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD07CC01 15003

02.12.2015

02.12.2020PoM

Medpharma Pharm.

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

624Betamed-N

Ointment

betamethasone

(betamethasone

valerate), neomycin

(neomycin

sulphate)

ointment0,1%+0,5%,

30g aluminium tube

Medpharma Pharm.

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD07CC01 15004

02.12.2015

02.12.2020PoM

Medpharma Pharm.

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

625 Betamethasone

betamethasone

(betamethasone

valerate)


use

1mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


26.12.2013

26.12.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

626Betamethasone

cream

betamethasone

(betamethasone

valerate)

cream1mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


16.12.2014

16.12.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

131

627

Betamox LA

150mg/ml

suspension for

injection

amoxicillin

(amoxicillin

trihydrate)

suspension for

injection

150mg/ml,


Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

QJ01CA04

veterinary

drug

1281417.09.2013

17.09.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

628 Betasalic

betamethasone

(betamethasone

dipropionate),

salicylic acid

ointment0,64mg/g+30mg/g, 15g

aluminum tube

Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine D07XC01 1337804.04.2014

04.04.2019PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

629 Betaserc

betahistine

(betahistine

dihydrochloride)

tablets8mg,


ABBOTT Healthcare

SAS, Route de

Belleville, Lieu-dit

Maillard, 01400

Chatillon Sur

Chalaronne

France N07CA01 1250023.06.2013

23.06.2018PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

630 Betaserc

betahistine

(betahistine

dihydrochloride)

tablets16mg,


ABBOTT Healthcare

SAS, Route de


Maillard, 01400

Chatillon Sur

Chalaronne

France N07CA01 1250123.06.2013

23.06.2018PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

631 Betaserc

betahistine

(betahistine

dihydrochloride)

tablets

24mg,


60/3x20/)

ABBOTT Healthcare

SAS, Route de


Maillard, 01400

Chatillon Sur

Chalaronne

France N07CA01 1250223.07.2013

23.07.2018PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

1381 CP Weesp, the

Netherlands

632 Betastin

betahistine

(betahistine

dihydrochloride)

tablets

24mg,


30/3x10/, 100/10x10/)

Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine N07CA01 1597415.09.2016

15.09.2021PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

132

633 Betastin

betahistine

(betahistine

dihydrochloride)

tablets16mg,


Pharmacare PLC,

Ramallah, Betunia,

Industrial Zone

Palestine N07CA01 1597515.09.2016

15.09.2021PoM

Pharmacare Int.

Co./German

Palestinian Joint

Venture, Jerusalem,

P.O. box 51621,

Palestine

634 Betmiga mirabegrontablets film-coated

prolonged-release

25mg,


30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel - packager,

batch releaser (Avara

Pharmaceutical

Tecnologies Inc., 3300

Marshall Avenue,

Norman, OK 73072,

USA - bulk

manufacturer)

the Netherlands G04BD12 13571/211.09.2017

10.06.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

635 Betmiga mirabegrontablets film-coated

prolonged-release

50mg,

in blister (10/1x10/

30/3x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel - packager,

batch releaser (Avara

Pharmaceutical

Tecnologies Inc., 3300

Marshall Avenue,

Norman, OK 73072,

USA - bulk

manufacturer)

the Netherlands G04BD12 13572/211.09.2017

10.06.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

636 Betoptic Sbetaxolol (betaxolol

hydrochloride)

drops eye

(suspension)

2,5mg/ml,

5ml vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01ED02 1359906.06.2014

06.06.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

133

637 Bicalox bicalutamide tablets film-coated50mg,


Douglas

Manufacturing Ltd,

Corner Te Pai Place

and Central Park

Drive, Lincoln

Auckland

New Zealand L02BB03 1427719.03.2015

19.03.2020PoM

Eris Pharmaceuticals

Pty LTD, 6 Eastern

road South

Melbourne, Victoria,

3205, Australia

638Bicalutamide 50mg

film-coated tabletsbicalutamide tablets film-coated

50mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 Sarkhej-

Bavla Highway, Matoda

Village, Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L02BB03 1443216.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

639Bicalutamide

Grindeksbicalutamide tablets film-coated

50mg,


Grindeks JSC,


1057, Riga- batch

releaser, Kocak Farma

Ilac ve Kimya Sanayi

A.S., Cerkezkoy

Organize Sanayi

Bolgesi, Karagac Mah.

11, Sok. No 5,

Kapakli/Tekirdag,

Turkey-bulk

manufacturer,

packager

Latvia L02BB03 1587411.08.2016

11.08.2021PoM

Grindeks JSC,



134

640Bicalutamide-

TEVAbicalutamide tablets film-coated

150mg,


30/3x10/)

Teva Pharmaceutical

Industries Ltd., 18 Eli

Hurvitz Street,

Industrial Zone, Kfar

Saba 44102

Israel L02BB03 1422320.02.2015

20.02.2020PoM

Teva Pharmaceutical

Industries Ltd. 5,

Basel Street, P.O. Box

3190, 49131 Petach

Tikva, Israel

641Bicalutamide-

TEVAbicalutamide tablets film-coated

50mg,


30/3x10/)

Teva Pharmaceutical


Hurvitz Street,


Saba 44102 for

Israel L02BB03 1422420.02.2015

20.02.2020PoM

Teva Pharmaceutical

Industries Ltd. 5,

Basel Street, P.O. Box

3190, 49131 Petach

Tikva, Israel

642 Bicillin-3

benzathine

benzylpenicillin,

benzylpenicillin

sodium,

benzylpenicillin

procaine

powder for

suspension for i/m

injection

200000IU+ 200000IU+

200000IU,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CE30 1560924.05.2016

24.05.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

643 Bicillin-3

benzylpenicillin

benzathine,

benzylpenicillin

sodium,

benzylpenicillin

procaine

powder for

suspension for i/m

injection

400000IU+ 400000IU+

400000IU,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CE30 1561024.05.2016

24.05.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

644 Bicillin-3

benzathine

benzylpenicillin,

benzylpenicillin

sodium,

benzylpenicillin

procaine

powder for i/m

suspension for

injection

200000IU+ 200000IU+

200000IU,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CE30 1611610.11.2016

10.11.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

645 Bicillin-5

benzathine

benzylpenicillin,

benzylpenicillin

procaine

powder for

suspension for i/m

injection

1200000IU+ 300000IU,


"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01CE30 1553119.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

135

646 Bicillin-5

benzathine

benzylpenicillin,

benzylpenicillin

procaine

powder for i/m

suspension for

injection

1200000IU+ 300000IU,

glass vial (40)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01CE30 1611710.11.2016

10.11.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

647 Bidop 10mg

bisoprolol

(bisoprolol

fumarate)

tablets

10mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Niche

Generics Limited,

Unit 5, 151 Baldoyle

Industrial Estate,

Dublin 13, Ireland-

bulk manufacturer,

JSC GEDEON

RICHTER- RUS,

Lesnaya St. 40.,

Shuvoye, Moscow

region, Yegoriyevsky

district, 140342,

Russia-packager

Hungary C07AB07 1628719.12.2016

19.12.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

648 Bidop 2,5mg

bisoprolol

(bisoprolol

fumarate)

tablets

2,5mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Niche

Generics Limited,


Industrial Estate,

Dublin 13, Ireland-

bulk manufacturer,

JSC GEDEON

RICHTER- RUS,

Lesnaya St. 40.,

Shuvoye, Moscow


district, 140342,

Russia-packager

Hungary C07AB07 1628519.12.2016

19.12.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

136

649 Bidop 5mg

bisoprolol

(bisoprolol

fumarate)

tablets

5mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Niche

Generics Limited,


Industrial Estate,

Dublin 13, Ireland-

bulk manufacturer,

JSC GEDEON

RICHTER- RUS,

Lesnaya St. 40.,

Shuvoye, Moscow


district, 140342,

Russia-packager

Hungary C07AB07 1628619.12.2016

19.12.2021PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

650 Bifidumbacterin bifidobacteriumpowder lyophilized

for oral solution

107, glass vials (5 dose)

(10/2x5/)

Ecopolis CJSC

(601900

Vladimirskaya oblast,

Kovrov, Kuznechnaya

str. 143, korp. 1)

Russia A07FA 1298528.10.2013

28.10.2018OTC

Ecopolis CJSC

(601900

Vladimirskaya oblast,

Kovrov, Kuznechnaya

str. 143, korp. 1,

Russia)

651 Bifiform

bifidobacterium

longum,

enterococcus

faecium

capsules gastro-

resistant

1x10^7CFU + 1x10^7

CFU,

in aluminium container

(30)

Ferrosan A/S,

Sydmarken 5,

Soeborg,DK- 2860

Denmark A07FA 1573022.06.2016

22.06.2021OTC

Ferrosan A/S,

Sydmarken 5,

Soeborg,DK- 2860,

Denmark

652 Bilobilginkgo biloba folies

dry extractcapsules

40mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

SloveniaC04AX

herbal drug12789

14.08.2013

14.08.2018OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

653 Bilobil forteginkgo biloba dry

extractcapsules

80mg,


60/6x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

SloveniaN06DX02;

herbal drug15631

24.05.2016

24.05.2021OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

137

654 Bilobil intenseginkgo biloba folies

dry extractcapsules

120mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia herbal drug 1231522.03.2013

22.03.2018OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

655 Biogenta

amoxicillin

(amoxicillin

trihydrate),

gentamicin

(gentamicin

sulphate)

suspension for i/m

injection

150mg/ml+ 40mg/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

QJ01RA01;

veterinary

drug

1605617.10.2016

17.10.2021PoM

Interchemie werken

"De Adelaar" B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

656 Biokson

ceftriaxone

(ceftriaxone sodium

triseskvihydrate)

powder for solution

for i/v and i/m

injection

1000mg,

glass vial (1)

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia J01DD04 1410629.12.2014

29.12.2019PoM

Biosintez OJSC,

Druzhby st. 4,


657Biolectra

Magnesium forte

magnesium

(magnesium oxide)


with lemon flavour

243mg,


Hermes Arzneimittel

GmbH, Hans-

Urmiller-Ring 52,

82515 Wolfratshausen

Germany A12CC10 1633930.12.2016

30.12.2021OTC

Alpen Pharma AG,

Cazinoplatz 2, 3011

Bern, Switzerland

658

Biolectra

Magnesium

fortissimum

magnesium

(magnesium oxide,

magnesium

carbonate)


with lemon flavour

365mg (342mg-

369.4mg+670mg), in


Hermes Arzneimittel

GmbH, Hans-

Urmiller-Ring 52,

82515 Wolfratshausen

Germany A12CC10 1633830.12.2016

30.12.2021OTC

Alpen Pharma AG,

Cazinoplatz 2, 3011

Bern, Switzerland

138

659 Biopassit Syrup

tinospora cordifolia,

withania somnifera,

terminalia arjuna,

celastrus

paniculatus,

nardostachys

jatamansi, centella

asiatica, glycyrrhiza

glabra, adhatoda

vasica

syrup

77,5mg/ml+ 77,5mg/ml+

77,5mg/ml+ 77,5mg/ml+

77,5mg/ml+ 77,5mg/ml+

40mg/ml+40mg/ml,

100ml glass bottle

Multani


C-100, Okhla

Industrial Area, Phase-

I, New Delhi-110020

India 1217301.02.2013

01.02.2018OTC

Multani


C-100, Okhla

Industrial Area, Phase-

I, New Delhi-110020,

INDIA

660 Biosanitoleum rusci,

florfenicol


use

125mg/ml+ 43mg/ml,

100ml, 170ml and 350ml

aerosol container

Firma

"BioChimPharm

LLC", 600910,

Vladimirskaya region,

Raduzhny city, block

16, build.23, SP-16,

placement 1-23

Russia

QJ01BA99;

veterinary

drug

1707205.10.2017

05.10.2022PoM

Firma

"BioChimPharm

LLC", 600910,

Vladimirskaya region,

Raduzhny city, block

16, build.23, SP-16,

placement 1-23,

Russia

661 Biotaksim

cefotaxime

(cefotaxime

sodium)

powder for solution

for i/v and i/m

injection

1000mg,

10ml glass vial (1)

Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia J01DD01 1385718.09.2014

18.09.2019PoM

Biosintez OJSC,

Druzhby st. 4,


662 Biovetalgin

metamizole

(metamizole

sodium)


500mg/ml,


bottle

Bioveterinarian

Industry Plant in

Drwalew JSC, 6

Grojecka str., 05-651,

Drwalew

Poland

QN02BB02;

veterinary

drug

1723808.12.2017

08.12.2022PoM

Bioveterinarian

Industry Plant in

Drwalew JSC, 6

Grojecka str., 05-651,

Drwalew, Poland

663 Bipin-T amitrasesolution for external

use

12,5%,

0,5ml ampoule (1), 1ml

ampoule (1), 1ml glass

vials (5)

Agrobioprom CJSC,

143980, Moscow,

Balashikhinski

district,,Novo-Milet

r/d , Poltevskoe shosse

, 4

Russia

QP53AD01

veterinary

drug

12267/114.04.2015

22.02.2018PoM

Agrobioprom CJSC,

107139, Moscow,

pereulok

Orlikov,house 3,

Russia

139

664 Biprol

bisoprolol

(bisoprolol

fumarate)


blisters (30/3x10/)

Makiz-Pharma LLC,

109029, Moscow, 6-5

Avtomobilny proezd

Russia C07AB07 12923/115.06.2016

07.10.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

665 Biprol

bisoprolol

(bisoprolol

fumarate)


blisters (30/3x10/)

Makiz-Pharma LLC,

109029, Moscow, 6-5

Avtomobilny proezd

Russia C07AB07 12924/115.06.2016

07.10.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

666 Biprol

bisoprolol

(bisoprolol

fumarate)


blisters (30/3x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse St.

Russia C07AB07 13092/115.06.2016

09.12.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

667 Biprol

bisoprolol

(bisoprolol

fumarate)


blisters (30/3x10/)

Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62


Russia C07AB07 13093/115.06.2016

09.12.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

668 Biprol

bisoprolol

(bisoprolol

fumarate)

tablets film-coated2,5mg,


Hemofarm LLC,

249030, Obninsk,

Kaluga Region, 62

Kievskoye shosse

Russia C07AB07 1625019.12.2016

19.12.2021PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

669 Bisacodyl bisacodyl suppositories rectal10mg

(10/2x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829

Moldova A06AB02 1250801.06.2013

01.06.2018OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829,

Moldova

140

670 Bisacodyl bisacodyl

tablets gastro-

resistant enteric-

coated

5mg,


Open Joint Stock

Company, Borisovskiy

zavod Medicinskikh

Preparatov, 64/27,



Belarus A06AB02 1323624.02.2014

24.02.2019OTC

Open Joint Stock

Company,

Borisovskiy zavod

Medicinskikh

Preparatov, 64/27,

Chapayev str.,

Borisov 222120,


671 Bisacodyl bisacodyltablets gastro-

resistant

5mg,


Balkanpharma-

Razgrad AD, 68,

Aprilsko vastanie

Blvd, 7200 Razgrad

Bulgaria A06AB02 1682810.07.2017

10.07.2022OTC

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko

Shosse" N3, Dupnitsa

2600, Bulgaria

672 Bisacodyl bisacodyl suppositories rectal10mg,


Lekhim-Kharkiv JSC,

36,Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv

Ukraine A06AB02 1704526.09.2017

26.09.2022OTC

Lekhim-Kharkiv JSC,

36,Severyna

Pototskoho str.,

61115, Kharkiv

region, Kharkiv,

Ukraine

673 Bisacodyl Grindeks bisacodyltablets enteric-

coated

5mg,


Grindeks JSC,


1057, Riga

Latvia A06AB02 1507707.12.2015

07.12.2020OTC

Grindeks JSC,



674Bisacodyl-

Hemofarmbisacodyl

tablets gastro-

resistant

5mg,


Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb

Serbia A06AB02 1627519.12.2016

19.12.2021OTC

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

675Bisacodyl-

Nizhpharmbisacodyl suppositories rectal

10mg

(10/2x5/)

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia A06AB02 1343214.04.2014

14.04.2019OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

141

676 Biseptolsulfamethoxazole,

trimethoprimtablets

100mg+20mg,

in blister (20)

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland J01EE01 1302725.11.2013

25.11.2018PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.




trimethoprimtablets

400mg+80mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland J01EE01 13028/126.09.2014

25.11.2018PoM

Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.






glass bottle and measuring

cup

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch


manufacturer,

packager - Medana

Pharma JSC, str.


Wojskowej 57,98-200

Sieradz, Poland)

Poland J01EE01 1327904.03.2014

04.03.2019PoM

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

679 Bisoprolol

bisoprolol

(bisoprolol

fumarate)

tablets coated5mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC07AB07 12294

22.03.2013

22.03.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

680 Bisoprolol

bisoprolol

(bisoprolol

fumarate)

tablets coated2,5mg,


Open joint stock

company, Borisovskiy

zavod medicinskikh

preparatov, 64/27,



Belarus C07AB07 1330704.03.2014

04.03.2019PoM

Open joint stock


zavod medicinskikh

preparatov, 64/27,


222120, Minsk

region, Belarus

142

681 Bisoprolol

bisoprolol

(bisoprolol

fumarate)

tablets coated5mg,


Open joint stock


zavod medicinskikh

preparatov, 64/27,



Belarus C07AB07 1330804.03.2014

04.03.2019PoM

Open joint stock


zavod medicinskikh

preparatov, 64/27,


222120, Minsk

region, Belarus

682 Bisoprolol

bisoprolol

(bisoprolol

fumarate)

tablets coated10mg,


Open joint stock


zavod medicinskikh

preparatov, 64/27,



Belarus C07AB07 1330904.03.2014

04.03.2019PoM

Open joint stock


zavod medicinskikh

preparatov, 64/27,


222120, Minsk

region, Belarus

683 Bisoprolol

bisoprolol

(bisoprolol

fumarate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C07AB07 1371624.07.2014

24.07.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

684 Bisoprolol

bisoprolol

(bisoprolol

fumarate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C07AB07 1371724.07.2014

24.07.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

685 Bisoprolol

bisoprolol

(bisoprolol

fumarate)



Replek Farm Ltd.-


1000 Skopje

Macedonia C07AB07 1371824.07.2014

24.07.2019PoM

Replek Farm Ltd.-


1000 Skopje,

Macedonia

686Bisoprolol 10mg

film-coated tablets

bisoprolol

(bisoprolol

fumarate)



Lek S.A.,16 Podlipie

Str., 95-010 Strykow Poland C07AB07 16756

05.06.2017

05.06.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

143

687Bisoprolol 2,5mg

film-coated tablets

bisoprolol

(bisoprolol

fumarate)



Lek S.A.,16 Podlipie

Str., 95-010 StrykowPoland C07AB07 16754

05.06.2017

05.06.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

688Bisoprolol 5mg

film-coated tablets

bisoprolol

(bisoprolol

fumarate)



Lek S.A., ul.

Domaniewska 50C,

Warszawa, 02-672-

batch releaser, Lek

S.A.,16 Podlipie Str.,

95-010 Strykow,

Poland-bulk

manufacturer,

packager

Poland C07AB07 1675505.06.2017

05.06.2022PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

689Bisoprolol

Fumarate

bisoprolol

(bisoprolol

fumarate)

tablets2,5mg,


Chanelle Medical,

Loughrea, Co. Galway Ireland C07AB07 12720

23.07.2013

23.07.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,


Armenia

690Bisoprolol

Fumarate

bisoprolol

(bisoprolol

fumarate)

tablets

5mg,


100/10x10/)

Chanelle Medical,


23.07.2013

23.07.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,


Armenia

691Bisoprolol

Fumarate

bisoprolol

(bisoprolol

fumarate)

tablets

10mg,


100/10x10/)

Chanelle Medical,


23.07.2013

23.07.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,


Armenia

144

692 Blemaren

citric acid,

potassium

hydrogencarbo-

nate, sodium citrate


1197mg+ 967,5mg+

835,5mg,

in plastic container

(80/4x20/)

Esparma GmbH,

Seepark 7, 39116

Magdeburg - batch

releaser (Allphamed

Pharbil Arzneimittel

GmbH Hildebrandstr.

12, 37081 Gottingen,

Germany - bulk

manufacturer,

packager)

Germany G04BC 1387423.09.2014

23.09.2019PoM

Esparma GmbH,

Seepark 7, 39116

Magdeburg, Germany

693 Blestar 24

betahistine

(betahistine

hydrochloride)

tablets24mg,

in strip (20/2x10/)


0198 Tbilisi,

Chirnakhuli str. 14 -

secondary packager,


form manufacturer,

primary packager -

Omega

Pharmaceuticals, Plot

No 119 to 123, 149 to

151, G.I.D.C.,

Wadhwan city

363035, Dist.

Surendranagar,

Gujarat, India)

Georgia N07CA01 1266904.07.2013

04.07.2018PoM


0198 Tbilisi,


Georgia

694 Bobotic simethicone drops oral66,66mg/ml,

30ml glass bottle

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10-batch

releaser; (Medana

Pharma JSC, str.


Wojskowej 57,98-200

Sieradz, Poland-bulk

manufacturer,

packager)

Poland A03AX13 1336104.04.2014

04.04.2019OTC

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

145

695 Boncur zoledronic acidconcentrate for


4mg/5ml,

5ml glass vial (1)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaM05BA08 15452

02.04.2016

02.04.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

696 Bonjigar

eclipta

alba,picrorrhiza

kurrooa,solanum

nigrum,cichorium

intybus,glycyrrhiza

glabra,tamarix

gallica,raphanus

sativus,berberis

aristata,silbyum

marianum,spherant

us indica,boerhavia

diffusa

capsules

250mg+100mg+

50mg+175mg+

200mg+100mg+

50mg+150mg+

200mg+50mg+ 100mg,


60)



Industrial

Area,Karachi-74900

PakistanA05C;

herbal drug12678

12.07.2013

12.07.2018OTC



Industrial

Area,Karachi-74900,

Pakistan

697 Bonjigar

eclipta

alba,picrorrhiza

kurrooa,solanum

nigrum,cichorium

intybus,glycyrrhiza

glabra,tamarix

gallica,raphanus

sativus,berberis

aristata,silbyum

marianum,spherant

us indica,boerhavia

diffusa

syrup

8,3mg/ml+ 3,3mg/ml+

1,7mg/ml+ 5,8mg/ml+

6,7mg/ml+ 3,3mg/ml+

1,7mg/ml+ 5mg/ml+

6,7mg/ml+ 1,7mg/ml+

3,3mg/ml,

in glass container (90,

120, 150)



Industrial area,

Karachi-74900

PakistanHA05BA

herbal drug 14030

26.11.2014

26.11.2019PoM



Industrial area,

Karachi-74900,

Pakistan

698 Bonviva

ibandronic acid

(ibandronic acid

monosodium

monohydrate)


in blister (1, 3)

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel -


manufacturer, F.

Hoffmann-La Roche

Ltd., Wurmisweg, CH-

4303, Kaiseraugst,

Switzerland-packager

Switzerland M05BA06 1517517.12.2015

17.12.2020PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse,

124, CH-4070, Basel,

Switzerland

146

699 Bonviva ibandronic acidsolution for i/v

injection

1mg/ml,

3ml pre-filled glass

syringe (1) and needle (1)

Roche Diagnostics

GmbH, Sandhofer


Mannheim - batch

releaser, secondary

packager, Vetter

Pharma-Fertigung

GmbH & Co. KG,

Eisenbahn strasse 2-4,

88085 Langenargen,

Germany- bulk

manufacturer,

primary packager

Germany M05BA06 1599716.09.2016

16.09.2021PoM

F. Hoffmann La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070,

Switzerland

700Boric acid

ointment 5%boric acid ointment

50mg/g,

25g in aluminium tube


Norq, Mikoyan 13,

Yerevan

Republic of

ArmeniaD08AD 12522

01.06.2013

01.06.2018OTC


Norq, Mikoyan 13,

Yerevan, Armenia

701 BoriVit

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,


hydrochloride)


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

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

2ml ampoules, blister

(10/1x10/), 2ml ampoules

(10)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus A11DB 12160/123.03.2016

01.02.2018PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

702 BoriVit

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,


hydrochloride)

solution for i/m

injection

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

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

2ml ampoules

(10, 10/1x10/ )

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus A11DB 1697805.09.2017

05.09.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

147

703 Borizol riluzole tablets film-coated50mg,


SIC Borshchahivskiy

Chemical-


PJSC, 17, Mira St,

Kiev 03134

Ukraine N07XX02 1410929.12.2014

29.12.2019PoM

SIC Borshchahivskiy

Chemical-


PJSC, 17, Mira St,

Kiev 03134, Ukraine

704 Bovaclox DC

cloxacillin

(cloxacillin

benzathine),

ampicillin

(ampicillin

trihydrate)

suspension for

administration into

the milk duct

500mg/4,5g+ 250mg/4,5g,

4,5g plastic syringes (24,

120)

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP

UK

J01CA51

veterinary

drug

1271623.07.2013

23.07.2018PoM

Norbrook


Station Works

Camlough Road,

Newry, Co. Down,

BT35 6JP, UK

705 Bravadin

ivabradine

(ivabradine

hydrobromide)



Krka-RUS LLC, 50

Moskovskaya str.,

Istra, Moscow region

143500

Russia C01EB17 1598515.09.2016

15.09.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,


143500, Russia

706 Bravadin

ivabradine

(ivabradine

hydrobromide)



Krka-RUS LLC, 50

Moskovskaya str.,


143500

Russia C01EB17 1598615.09.2016

15.09.2021PoM

Krka-RUS LLC, 50

Moskovskaya str.,


143500, Russia

707Bretaris Genuair

322mcg

aclidinium

(aclidinium

bromide)

powder for

inhalation

322mcg/dose; (1) inhaler

(30 unit doses), (1) inhaler

(60 unit doses), (3) inhaler

(180/3x60/ unit doses)

Industrias

Farmaceuticas

Almirall S.A., Ctra.


08740 Sant Andreu de

la Barca, Barcelona

Spain R03BB05 13779/116.02.2016

05.09.2019PoM

Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin,

Germany

708 Breviprost travoprost drops eye0,04mg/ml,

2.5ml plastic vial (1, 10)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01EE04 16786

22.06.2017

22.06.2022PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

148

709 Bridion

sugammadex

(sugammadex

sodium)

solution for i/v

injection

100mg/ml,

2ml glass vial (10)

N.V. Organon,

Molenstraat 110, 5342

CC Oss

the Netherlands V03AB35 1452215.05.2015

15.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

710 Bridion

sugammadex

(sugammadex

sodium)

solution for i/v

injection

100mg/ml,

5ml glass vial (10)

N.V. Organon,

Molenstraat 110, 5342

CC Oss

the Netherlands V03AB35 1452315.05.2015

15.05.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

711 Brilliant green brilliant greensolution for external

use

10mg/ml,

10ml glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaD08AX 13477

06.05.2014

06.05.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

712 Brimica Genuair

aclidinium

(aclidinium

bromide),

formoterol

fumarate dihydrate

powder for

inhalation

340mcg/dose+

12mcg/dose, (1) inhaler

with 60 unit doses, (3)

inhalers with 180(3x60)

unit doses

Industrias

Farmaceuticas

Almirall S.A., Ctra.


08740 Sant Andreu de

la Barca, Barcelona

Spain R03AL05 1572222.06.2016

22.06.2021PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

713 Brimoptic

brimonidine

(brimonidine

tartrate), timolol

(timolol maleate)

drops eye2mg/ml+6,8mg/ml, 10ml

vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01EX 13643

27.06.2014

27.06.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

714 Britomar torasemidetablets prolonged-

release

5mg,


Ferrer International,

S.A., Joan Buscalla,1-9

08173 Sant Cugat del

Valles, Barcelona

Spain C03CA04 1639910.02.2017

10.02.2022PoM


S.A., Gran Via Carlos

III, 94, 08028,

Barcelona, Spain

149

715 Britomar torasemidetablets prolonged-

release

10mg,




9 08173 Sant Cugat


Spain C03CA04 1640010.02.2017

10.02.2022PoM



III, 94, 08028,

Barcelona, Spain

716 Bromhexin

bromhexine

(bromhexine

hydrochloride)

syrup with apricot

flavour

4mg/5ml,


measuring spoon

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia R05CB02 1269423.07.2013

23.07.2018OTC

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

717 Bromhexin

bromhexine

(bromhexine

hydrochloride)

syrup with pear

flavour

4mg/5ml,


measuring spoon

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R05CB02 1322624.02.2014

24.02.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

718 Bromhexin

bromhexine

(bromhexine

hydrochloride)

syrup with cherry

flavour

4mg/5ml,


measuring spoon or

measuring syringe

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R05CB02 1322724.02.2014

24.02.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

719 Bromhexin

bromhexine

(bromhexine

hydrochloride)

tablets8mg,


Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R05CB02 1703026.09.2017

26.09.2022OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

720Bromhexin 4

Berlin-Chemie

bromhexine

(bromhexine

hydrochloride)

solution oral

0,8mg/ml,


measuring spoon

Berlin-Chemie A.G.,

Glienicker Weg 125 D-

12489 Berlin

Germany R05CB02 1377605.09.2014

05.09.2019OTC

Berlin-Chemie A.G.,

Glienicker Weg 125

D-12489 Berlin,

Germany

150

721Bromhexin 8

Berlin-Chemie

bromhexine

(bromhexine

hydrochloride)

tablets8mg,


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 R05CB02 1377505.09.2014

05.09.2019OTC

Berlin-Chemie A.G.

Glienicker Weg 125

D-12489 Berlin,

Germany

722Bromhexin 8

Berlin-Chemie

bromhexine

(bromhexine

hydrochloride)

tablets coated8mg,


Berlin-Chemie

A.G.,Glienicker Weg

125 D-12489 Berlin-

batch releaser, SWISS

CAPS GmbH,

Grassingerstrasse 9,

83043 Bad Aibling,

Germany-packager,

Dragenopharm

Apotheker Puschl

GmbH, Gollstrasse 1,

84529 Tittmoning,

Germany- bulk

manufacturer

Germany R05CB02 1429219.03.2015

19.03.2020OTC

Berlin-Chemie

A.G.,Glienicker Weg

125 D-12489 Berlin,

Germany

723 Bromhexine

bromhexine

(bromhexine

hydrochloride)

tablets8mg,


Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus R05CB02 1661925.04.2017

25.04.2022OTC

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

724Bromocriptin-

Richter

bromcriptine

(bromocriptine

mesylate)

tablets2,5mg,

in glass bottle (30)

Gedeon Richter OJSC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G02CB01 1414729.12.2014

29.12.2019PoM

Gedeon Richter

OJSC, Gyomroi ut 19-

21, 1103 Budapest,

Hungary

151

725 Bronchicum Sthyme liquid

extractsyrup

150mg/ml,


measuring cup

A. Nattermann & Cie.

GmbH,

Nattermannallee 1, D-

50829 Kolne

GermanyR05CA

herbal drug 13915

29.10.2014

29.10.2019OTC


GmbH,


50829 Kolne,

Germany

726 Bronchicum TP

thyme liquid

extract, primula

root liquid extract

elixir50mg/g+25mg/g, 130g

(100ml) glass bottle


GmbH,


50829 Kolne

GermanyR05CA10;

herbal drug13697

24.07.2014

24.07.2019OTC


GmbH,


50829 Kolne,

Germany

727 Bronchobos carbocisteine syrup

250mg/5ml,

250ml glass bottle (200ml

syrup) and measuring

spoon

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And

HerzegovinaR05CB03 15944

30.08.2016

30.08.2021OTC

Bosnalijek d.d.,

Jukiceva 53, 71000


Herzegovina

728 Bronchobos carbocisteine syrup

125mg/5ml,

250ml glass bottle (200ml

syrup) and measuring

spoon

Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And


30.08.2016

30.08.2021OTC

Bosnalijek d.d.,

Jukiceva 53, 71000


Herzegovina

729 Bronchobos carbocisteine capsules375mg,


Bosnalijek d.d.,

Jukiceva 53, 71000

Sarajevo

Bosnia And


30.08.2016

30.08.2021OTC

Bosnalijek d.d.,

Jukiceva 53, 71000


Herzegovina

730Bronchobru Dextro

syrup

guaifenesin,

dextromethorphan

hydrobromide

syrup10mg/ml+ 1,5mg/ml,

125ml glass bottle

Bruphamexport

SPRL, Rue de la

Grotte, 14, Bruxelles,

1020 - batch releaser

(dosage form

manufacturer,

packager -

Laboratoires Sterop

NV, Scheutlaan 46-

50, Anderlecht, B-

1070, Belgium)

Belgium R05FB 1273223.07.2013

23.07.2018OTC

Bruphamexport

SPRL, Rue de la


1020, Belgium

152

731 Broncholytin

glaucine (glaucine

hydrobromide),

ephedrine

(ephedrine

hydrochloride)

syrup

5,75mg/5ml+ 4,6mg/5ml,


bottle and measuring cup

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia-batch

releaser, Sopharma

JSC, Vrabevo vlg.

5660, district of

Lovetch, Bulgaria-

bulk manufacturer,

packager

Bulgaria R05DB20 1723208.12.2017

08.12.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,


732 Broncho-munallyophilized

bacterial lysatecapsules hard

7mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,

primary and

secondary packager,

OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin

2/Geneva,

Switzerland-bulk

manufacturer

Slovenia R07AX 1466103.07.2015

03.07.2020PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

733 Broncho-munal Plyophilized

bacterial lysatecapsules hard

3,5mg,


Lek Pharmaceuticals


57, 1526 Ljubljana-

batch releaser,

primary and

secondary packager,

OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin

2/Geneva,

Switzerland-bulk

manufacturer

Slovenia R07AX 1466203.07.2015

03.07.2020PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

734 Brovanol-plus

praziquantel,

ivermectin,

levamisole

(levamisole

hydrochloride)

tablets50mg+2mg+38mg, in

blister (10/1x10/)

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kyiv

region, 07400

Ukraine

QP52AA51;

veterinary

drug

1418106.02.2015

06.02.2020PoM

"Brovafarma" Ltd,18-

a, Nezalezhnosti

blvd., Brovary, Kyiv

region, 07400,

Ukraine

153

735 Brovin syrup levodropropizine syrup

6mg/ml,

60ml and 120ml glass or

plastic bottle

Osoth Inter

Laboratories Co. Ltd.,

600/9 Moo 11,

Sukhaphiban 8 Road,

Nong Kham, Si Racha,

Chonburi 20230

Thailand R05DB27 15286/107.02.2017

04.02.2021PoM

Eurodrug

Laboratories S.A.,

Assesteenweg 117/7,

B-1740 Ternat,

Belgium

736 Brucor 20mg simvastatin tablets film-coated20mg,


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 C10AA01 1341714.04.2014

14.04.2019PoM



B-1020, Brussels,

Belgium

737 Brucor 40mg simvastatin tablets film-coated40mg,




B-1020, Brussels -

batch releaser


Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal - bulk

manufacturer,

packager)

Belgium C10AA01 1341814.04.2014

14.04.2019PoM



B-1020, Brussels,

Belgium

738 Brufen ibuprofen syrup

20mg/ml,


and 5ml measuring

syringe

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover

Germany M01AE01 13922/113.05.2015

29.10.2019OTC

Abbott Laboratories

GmbH, Freundallee

9A, 30173 Hannover,

Germany

154

739 Brulium domperidone suspension oral

1mg/ml,

100ml, 200ml glass bottle,

measuring spoon and

measuring dropper



B-1020, Brussels -

batch releaser


Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal - bulk

manufacturer,

packager)

Belgium A03FA03 1341614.04.2014

14.04.2019PoM



B-1020, Brussels,

Belgium

740Brulium

Linguatabsdomperidone tablets orodispersible

10mg,




B-1020, Brussels

Belgium A03FA03 1446922.04.2015

22.04.2020PoM



B-1020, Brussels,

Belgium

741Brumipril 10mg

capsulesramipril capsules

10mg,

in blister (56/8x7)

Brupharmexport

SPRL, Rue de la

Grotte, 14, Brussels,


(dosage form

manufacturer,

packager -

Laboratoires Sterop

NV, Scheutlaan 46-

50, Anderlecht, B-

1070, Belgium)

Belgium C09AA05 1283217.09.2013

17.09.2018PoM

Brupharmexport

SPRL, Rue de la


1020, Belgium

742Brumipril 2,5mg


2,5mg,

in blister (56/8x7)

Brupharmexport

SPRL, Rue de la



(dosage form

manufacturer,

packager -

Laboratoires Sterop

NV, Scheutlaan 46-

50, Anderlecht, B-

1070, Belgium)

Belgium C09AA05 1283017.09.2013

17.09.2018PoM

Brupharmexport

SPRL, Rue de la


1020, Belgium

155

743Brumipril 5mg


5mg,

in blister (56/8x7)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch

releaser (doage form

manufacturer,

packager - Farmalabor

Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium C09AA05 1283117.09.2013

17.09.2018PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

744 Brusartan 100mglosartan (losartan

potassium)tablets film-coated

100mg,



14 Rue De la Grotte,

B-1020 Brussels -

batch releaser


Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal - bulk

manufacturer,

packager)

Belgium C09CA01 1350230.05.2014

30.05.2019PoM



B-1020 Brussels,

Belgium

745 Brusartan 50mglosartan (losartan

potassium)tablets film-coated

50mg,


56/8x7/)



B-1020 Brussels -

batch releaser


Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal - bulk

manufacturer,

packager)

Belgium C09CA01 1350130.05.2014

30.05.2019PoM



B-1020 Brussels,

Belgium

156

746 Brusartan HTZ

losartan (losartan

potassium),

hydrochlorothia-

zide

tablets film-coated

50mg+12,5mg,


56/8x7/)

Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium C09DA01 1313510.01.2014

10.01.2019PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

747 Brustin

betahistine

(betahistine

dihydrochloride)

tablets16mg,




B-1020, Brussels -

batch releaser


Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal - bulk

manufacturer,

packager)

Belgium N07CA01 1361527.06.2014

27.06.2019PoM



B-1020, Brussels,

Belgium

748 Bruzepam diazepam solution for injection

10mg/2ml,

2ml ampoules

(100/10x10/)

Brupharmexport

SPRL, Rue de la


1020

Belgium N05BA01 1311124.12.2013

24.12.2018PoM/UC

Brupharmexport

SPRL, Rue de la


1020, Belgium

749

Bupivacaine

hydrochloride

0,5%

bupivacaine

(bupivacaine

hydrochloride)


10ml ampoules (10)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw

Poland N01BB01 1663625.04.2017

25.04.2022PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

157

750Bupivacaine WPW

Spinal 0,5% Heavy

bupivacaine

(bupivacaine

hydrochloride)


4ml ampoules (5)

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw

Poland N01BB01 1456109.06.2015

09.06.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

751 Buscopanhyoscine

butylbromidetablets coated

10mg,


Delpharm Reims, 10

rue Colonel

Charbonneaux,

Reims, 51100

France A03BB01 1699305.09.2017

05.09.2022PoM


International GmbH,

Binger Strasse 173,

55216 Ingelheim am

Rhein, Germany

752 Butadion phenylbutazone ointment50mg/g,

20g aluminium tube

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary M02AA01 1531604.02.2016

04.02.2021OTC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

753 Butasal-100butafosfan, vitamin

B12solution for injection

100mg/ml+ 50mcg/ml,

100ml glass bottle

Interchemie werken


Vanapere tee 14,


bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QA13A;

veterinary

drug

1458109.06.2015

09.06.2020PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

754 Caduet

amlodipine

(amlodipine

besilate),

atorvastatin

(atorvastatin

calcium)



Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany C10AA55 1526922.01.2016

22.01.2021PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street New

York 10017, USA

158

755 Caduet

amlodipine

(amlodipine

besilate),

atorvastatin

(atorvastatin

calcium)



Pfizer Manufacturing

Deutschland GmbH,

Betriebsstatte

Freiburg,

Mooswaldallee 1,

79090 Frieburg

Germany C10AA55 1527022.01.2016

22.01.2021PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

756Caffeine Citrate

Injection, USPcaffeine

solution for i/v

injection

20mg/ml,

3ml glass vial (1)

Cadila Healthcare

Ltd., Sarkhej-Bavla

National Highway No

8A, Moraiya, Tal.

Sanand, Dist.

Ahmedabad 382 210

India N06BC01 1453120.05.2015

20.05.2020PoM

Sagent

Pharmaceuticals Inc.,

1901 N. Roselle Road,

Suite 700,

Schaumburg, Illinois

60195, USA

757Caffeine-benzoate

sodium

caffeine (caffeine-

benzoate sodium)tablets

100mg,

strip (6, 10), blister (10,

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

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 262

Russia N06BC01 14027/108.06.2017

26.11.2019PoM

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

758 Caffetin

paracetamol,

propyphenazone,

caffeine, codeine

(codeine phosphate)

tablets

250mg+210mg+

50mg+7,1mg,

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

10/1x10/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N02BE51 1638410.02.2017

10.02.2022PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

759 Caffetin Cold

paracetamol,

pseudoephedrine

(pseudoephedrine

hydrochloride),

dextromethorphan

(dextromethorphan

hydrobromide),

ascorbic acid

tablets film-coated

500mg+30mg+

15mg+60mg,

in blister (10)

Alkaloid-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia )

Slovenia N02BE51 1253122.05.2013

22.05.2018OTC

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

159

760 Caffetin COLD

paracetamol,

pseudoephedrine

(pseudoephedrine

hydrochloride),

dextromethorphan

(dextromethorphan

hydrobromide),

ascorbic acid

tablets film-coated

500mg+30mg+

15mg+60mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N02BE51 1721808.12.2017

08.12.2022OTC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

761 Caffetin COLDmax

paracetamol,

phenylephrine

(phenylephrine

hydrochloride)

powder for oral

solution

1000mg+12,2mg, 5,15g

sachets (10)


Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Hermes

Pharma Ges.m.b.H,

Allgau 36 9400

Wolfsberg, Austria)

Slovenia N02BE51 1258811.06.2013

11.06.2018OTC


Slandrova ulica 4,

1231 Ljubljana-

Crnuce, Slovenia

762 Caffetin COLDmax

paracetamol,

phenylephrine

hydrochloride

powder for oral

solution

1000mg+12,2mg, sachets

(10)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje-batch releaser,

Hermes Pharma

Ges.m.b.H., Allgau

36, 9400 Wolfsberg,

Austria - bulk

manufacturer,

packager

Macedonia N02BE51 1721608.12.2017

08.12.2022OTC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

763 Caffetin Ladyibuprofen

(ibuprofen lysinate)tablets film-coated

200mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia M01AE01 1645806.03.2017

06.03.2022OTC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

160

764 Caffetin SC

paracetamol,

propyphenazone,

caffeine

tablets

250mg+210mg+ 50mg,

in strip

(6/1x6/, 12/2x6/)


Slandrova ulica 4,

1231 Ljubljana-

Crnuce - batch


manufacturer,

packager - Alkaloid

AD-Skopje, bul.

Aleksandar

Makedonski 12, 1000,

Skopje, Macedonia )

Slovenia N02BE51 1253022.05.2013

22.05.2018OTC

Alkaloid Ltd,

Motopista 2, 2

"Ricardo Vakarini"

str., fl. 3, ap. 10 Sofia

1404, Bulgaria

765 Caffetin SC

paracetamol,

propyphenazone,

caffeine

tablets250mg+210mg+ 50mg,

in strip (6/1x6/, 12/2x6/)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N02BE51 1721708.12.2017

08.12.2022OTC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

766 Cafin caffeine tablets chewable55mg,

in blister (10)

IBN AL-Haytham

Pharma Industries

Co., P.O.Box 16232,

Al Mansoura-Aleppo

Syria N06BC01 1402826.11.2014

26.11.2019PoM

IBN AL-Haytham

Pharma Industries

Co., P.O.Box 16232,

Al Mansoura-Aleppo,

Syria

767 Calcemin

calcium, vitamin

D3, zinc(zinc

oxide), copper

(copper oxide),

manganese

(manganese sulfate),

boron (sodium

borate)

tablets coated

250mg+50IU+

2mg+0,5mg+

0,5mg+50mcg,


60, 120)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 150

&160 Commerce

Drive Hauppauge,

New York 11788,

USA -bulk

manufacturer

USA A12AX 1501402.12.2015

02.12.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

161

768 Calcemin Advance

calcium, vitamin

D3, magnesium,

zinc, copper,

manganese, boron

tablets film-coated

500mg+200IU+

40mg+7,5mg+

1mg+1,8mg+ 250mcg,


60, 120)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer

USA A12AX 1703126.09.2017

26.09.2022OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

769 Calcemin Silver

calcium, vitamin

D3, magnesium,

zinc, copper,

manganese, boron

tablets film-coated

500mg+400IU+

40mg+7,5mg+

1mg+1,8mg+ 250mcg,


60)

Contract Pharmacal

Corporation, 135

Adams avenue,

Hauppauge, New

York 11788-batch

releaser, packager,

Contract Pharmacal

Corporation, 160

Commerce Drive

Hauppauge, New

York 11788, USA-

bulk manufacturer for

Bayer Consumer Care

AG, Peter Merian-


Switzerland

USA A12AX 1684310.07.2017

10.07.2022OTC

770 CalciD-Denk

calcium (calcium

carbonate),

cholecalciferol

tablets effervescent1000mg+22mcg(880IU),


Losan Pharma GmbH,

Otto- Hahn-Strasse

13,15, 79395

Neuenburg

Germany A12AX 1683110.07.2017

10.07.2022PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

771 Calcium chloride calcium chloride solution for injection100mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaB05XA07 16684

31.05.2017

31.05.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

162

772Calcium chloride-

Darnitsa

calcium chloride

(calcium chloride

hexahydrate)


100mg/ml,

10ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine B05XA07 1235109.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

773Calcium chloride-

Darnitsa

calcium chloride

(calcium chloride

hexahydrate)


100mg/ml,

5ml ampoules,

in blister (10)(10/2x5/)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine B05XA07 1235209.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

774Calcium D3

Nycomed

calcium (calcium

carbonate),

cholecalciferol

tablets chewable

with orange flavour

500mg+5mcg (200IU),


50, 100)

Takeda AS,

Drammensveien 852

No-1383 Asker

Norway A12AX 15983/2 30.08.2017

15.09.2021OTC

Takeda AS,

Drammensveien 852

No-1383 Asker,

Norway

775Calcium D3

Nycomed Forte

calcium (calcium

carbonate),

cholecalciferol

tablets chewable

with lemon flavour

500mg+10mcg (400IU),


60, 120)

Takeda AS,

Drammensveien 852

No-1383 Asker

Norway A12AX 15984/2 30.08.2017

15.09.2021OTC

Takeda AS,

Drammensveien 852

No-1383 Asker,

Norway

776 Calcium gluconate

calcium gluconate

(calcium gluconate

monohydrate)

tablets

500mg,


20/2x10/), in strip (10)

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia A12AA03 12880/121.11.2013

25.09.2018OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

777Calcium gluconate

stabilizedcalcium gluconate solution for injection

100mg/ml,

5ml ampoules (5, 10)

PJSC "Farmak",

04080, Kiev, Frunze

str. 74

Ukraine A12AA03 1236519.04.2013

19.04.2018PoM

PJSC "Farmak",

04080, Kiev, Frunze

str. 63, Ukraine


stabilizedcalcium gluconate solution for injection

100mg/ml,


PJSC "Farmak",

04080, Kiev, Frunze

str. 74

Ukraine A12AA03 1236619.04.2013

19.04.2018PoM

PJSC "Farmak",

04080, Kiev, Frunze

str. 63, Ukraine

163


Tatpharmcalcium gluconate tablets

500mg,

strip (10/1x10/), blisters

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

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260

Russia A12AA03 14295/108.02.2017

19.03.2020OTC

Tatchempharmpre-

paraty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

780

Calcium gluconate-

Darnitsa

(stabilized)

calcium gluconate solution for injection

100mg/ml,

5ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine A12AA03 1235909.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

781

Calcium gluconate-

Darnitsa

(stabilized)

calcium gluconate solution for injection

100mg/ml,

10ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine A12AA03 1236009.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

782Calcium+Vitamin

D3 Vitrum

calcium, vitamin

D3tablets film-coated

500mg+200IU,


60, 100)

Unipharm, Inc., 200

Hick str., Westbury,

New York 11590

USA A12AX 1317910.01.2014

10.01.2019OTC


5th avenue, suite

6701, New York,

10118, USA

783

Calciumfolinate

"EBEWE"

100mg/10ml

calcium folinatesolution for

injection/infusion

10mg/ml,

10ml ampoules (5)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,

Mondseestrasse 11, At-

4866 Unterach am

Attersee

Austria V03AF03 1223607.03.2013

07.03.2018PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

784

Calciumfolinate

"EBEWE"

30mg/3ml

calcium folinatesolution for

injection/infusion

10mg/ml,

3ml ampoules (5)

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria V03AF03 1223507.03.2013

07.03.2018PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

164

785 Calciveyxol 38

calcium gluconate

(calcium gluconate

monohydrate),

magnesium

chloride

(magnesium

chloride

hexahydrate), boric

acid


380mg/ml+

60mg/ml+50mg/ml,

500ml plastic bottle (1,

12)

Veyx-Pharma GmbH,

Sohreweg 6, 34639

Schwarzenborn-

batch releaser,

secondary packager,

Bela-Pharma GmbH

& Co.KG, Lohner Str.

19, Vechta,

Niedersachsen, 49377,

Germany- bulk

manufacturer,

primary packager

Germany

QA12;

veterinary

drug

1651217.03.2017

17.03.2022PoM

Veyx-Pharma

GmbH, Sohreweg 6,

34639

Schwarzenborn,

Germany

786 Calendulatinctura calendulae

D1suppositories rectal

57mg,


Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow

Russiahomeopathic

drug12201

07.03.2013

07.03.2018OTC

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow,

RUSSIA

787 Calendulatinctura calendulae

D1ointment

100mg/g,

30g aluminium tube

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow

Russiahomeopathic

drug12202

07.03.2013

07.03.2018OTC

Moscow

Pharmaceutical

Works CJSC, 125239,

Pharmaceutical

driveway 1, Moscow,

RUSSIA

788 Calgel


hydrochloride),

cetylpyridinum

(cetylpyridinum

chloride)

gel3,3mg/g+1mg/g, 10g

aluminium tube

GlaxoSmithKline


189 Grunwaldzka


Poland N01BB52 1274723.07.2013

23.07.2018PoM

Glaxo Wellcome UK

Limited, Stockley

Park, Middlesex, UB

11 1BT, UK

789 Calumid bicalutamide tablets film-coated50mg,



Gyomroi ut 19-21,

1103 Budapest

Hungary L02BB03 1231122.03.2013

22.03.2018PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

165

790 Calypsolketamine (ketamine

hydrochloride)solution for injection

500mg/10ml,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N01AX03 1408716.12.2014

16.12.2019PoM/UC

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

791 Camphor oil camphorsolution for external

use

100mg/ml,

30ml glass bottle

ESCO-PHARM LLC

(Nor-Norq V block,

Mikoyan 13, Yerevan

0079)

Republic of

ArmeniaM01AX10 12991

28.10.2013

28.10.2018OTC

ESCO-PHARM LLC

(Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia)

792 Campto

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for i/v

infusion

20mg/ml vial,

2ml plastic vial

Pfizer (Perth) Pty

Limited, 15 Brodie

Hall Drive

Technology Park

Bentley WA 6102

Australia L01XX19 1333617.03.2014

17.03.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd Street, New

York 10017, USA

793 Campto

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for i/v

infusion

20mg/ml vial,

5ml plastic vial

Pfizer (Perth) Pty

Limited, 15 Brodie

Hall Drive

Technology Park

Bentley WA 6102

Australia L01XX19 1333717.03.2014

17.03.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

794 Campto

irinotecan

(irinotecan

hydrochloride

trihydrate)

concentrate for

solution for i/v

infusion

20mg/ml vial,

15ml plastic vial

Pfizer (Perth) Pty

Limited, 15 Brodie

Hall Drive

Technology Park

Bentley WA 6103

Australia L01XX19 1333817.03.2014

17.03.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

795 Candida candida albicans tablets6C,


A Nelson and Co

Limited, 5 Endeavour

Way, Wimbledon,

London SW19 8UH

UK

J02AX

homeopathic

drug

1351430.05.2014

30.05.2019PoM

A Nelson and Co


Way, Wimbledon,

London SW19 8UH,

UK

166

796 Canephron N

centauri herba,

levistici radix,

rosmarini folia

tablets coated18mg+18mg+ 18mg,


Bionorica SE,

Kerschensteinerstr. 11-

15, 92318 Neumarkt

GermanyG04BX;

herbal drug14576

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

797 Canephron N

centauri herba,

levistici radix,

rosmarini folia

drops oral

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

100ml glass container-

dropper

Bionorica SE,

Kerschensteinerstr. 11-

15, 92318 Neumarkt

GermanyG04BX;

herbal drug14577

09.06.2015

09.06.2020PoM

Bionorica SE,

Kerschensteinerstr.

11-15, 92318

Neumarkt, Germany

798 Caniverm tablets

fenbendazole,

praziquantel,

pyrantel (pyrantel

embonate)

tablets

150mg+50mg+ 144mg,

in blister (6/1x6/), sachets

(100)

Bioveta a.s.,

Komenskeho 212,

68323 Ivanovice na

Hane

Czech Republic

QP52AC30;

veterinary

drug

1530204.02.2016

04.02.2021PoM

Bioveta a.s.,

Komenskeho 212,

68323 Ivanovice na

Hane, Czech

Republic

799

Capecitabine

Accord 150mg film-

coated tablets

capecitabine tablets film-coated150mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK L01BC06 1512911.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

167

800

Capecitabine

Accord 150mg film-

coated tablets



Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK L01BC06 1513011.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

801

Capecitabine

Accord 150mg film-

coated tablets



Pharmacare Premium

Limited, HHF 003, Hal

Far Industrial Estate,

Birzebbugia BBg 3000-

batch releaser, Intas

Pharmaceuticals

Limited, Plot No 457 &

458 &191/218P, Sarkhej-



Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,

Unit C & D, Homefield

Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513211.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

168

802

Capecitabine

Accord 150mg film-

coated tablets



Pharmacare Premium





Pharmaceuticals

Limited, Plot No 5/6/7,

Pharmez, Near Village

Matoda, Sarkhej-Bavla

Highway, NH-8A,

Matoda, District-

Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,


Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513411.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

803

Capecitabine

Accord 300mg film-

coated tablets



Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK L01BC06 1512811.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

169

804

Capecitabine

Accord 300mg film-

coated tablets

capecitabine tablets film-coated300mg, (60/1x60/), in

blister

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK L01BC06 1513111.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

805

Capecitabine

Accord 300mg film-

coated tablets



Pharmacare Premium





Pharmaceuticals


458 &191/218P, Sarkhej-



Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,


Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513611.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

170

806

Capecitabine

Accord 300mg film-

coated tablets



Pharmacare Premium





Pharmaceuticals




Highway, NH-8A,

Matoda, District-

Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,


Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513711.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

807

Capecitabine

Accord 500mg film-

coated tablets



Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK L01BC06 1512611.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

171

808

Capecitabine

Accord 500mg film-

coated tablets



Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK L01BC06 1512711.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

809

Capecitabine

Accord 500mg film-

coated tablets



Pharmacare Premium





Pharmaceuticals




Highway, NH-8A,

Matoda, District-

Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,


Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513311.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

172

810

Capecitabine

Accord 500mg film-

coated tablets



Pharmacare Premium





Pharmaceuticals


458 &191/218P, Sarkhej-



Ahmedabad, 382 210,

Gujarat- bulk


Healthcare Limited,


Business Park,

Homefield Road,

Haverhill, CB9 8QP-


packager

Malta L01BC06 1513511.12.2015

11.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

811 Capotril captopril tablets25mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


10.01.2014

10.01.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

812 Capotril 50mg captopril tablets50mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


03.08.2016

03.08.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

173

813 Caproferr

ferric chloride (III),

epsilon-

aminocaproic acid

solution947mg/ml+ 24mg/ml,

20ml, 30ml plastic vial

The Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry, A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Erevan, Azatutyun

avenue 26

Republic of

ArmeniaB02BC 13317

04.03.2014

04.03.2019OTC

The Scientific

Technological Center

of Organic and

Pharmaceutical

Chemistry, A.L.

Mndjoyan Institute of

Fine Organic

Chemistry NAS RA ,

Erevan, Azatutyun

avenue 26, Republic

of Armenia

814 Capsicam

dimethyl sulfoxide,

camphor racemic,

turpentine oil,

benzyl nicotinate,

nonivamide

ointment for

external use

50mg/g+30mg/g+

30mg/g+20mg/g+ 2mg/g,


and applicator

Grindex JSC, Krustpils

street 53, LV-1057,

Riga

Latvia M02AX 1384818.09.2014

18.09.2019OTC

Grindex JSC,



815 Capsicam

dimethyl sulfoxide,

camphor racemic,

turpentine oil,

benzyl nicotinate,

nonivamide

ointment for

external use

50mg/g+30mg/g+

30mg/g+20mg/g+ 2mg/g,

30g and 50g aluminium

tube and applicator

Tallinn



Tallinn

Estonia M02AX92 1568108.06.2016

08.06.2021OTC

Grindeks JSC,



816 Captopril captopril tablets25mg,


Open Joint Stock

Company , 64/27,



Belarus C09AA01 1283617.09.2013

17.09.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,


817 Captopril captopril tablets25mg,


Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine C09AA01 1402226.11.2014

26.11.2019PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

174

818Captopril 12.5mg

Tabletscaptopril tablets

12,5mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK C09AA01 1514717.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

819Captopril 12.5mg


12,5mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C09AA01 1514817.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

175

820Captopril 25mg


25mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C09AA01 1514617.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

821Captopril 25mg


25mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK C09AA01 1514917.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

176

822Captopril 50mg


50mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK C09AA01 1514517.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

823Captopril 50mg


50mg,


Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK C09AA01 1515017.12.2015

17.12.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

824 Captopril Denk 25 captopril tablets

25mg,


100/10x10)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C09AA01 12731/120.05.2014

23.07.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

177

825Captopril+HCT

Denk 50/25

captopril,

hydrochloro-

thiazide

tablets

50mg+25mg,


100/10x10/)

Denk Pharma GmbH

& Co. KG, Gollstr. 1,

84529 Tittmoning

Germany C09BA01 12249/120.05.2014

07.03.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

826 Carbalex 200mg carbamazepine tablets

200mg,


100/10x10/)

G.L. Pharma GmbH,

Schlossplatz 1, 8502

Lannach -batch

releaser, G.L. Pharma

GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria N03AF01 1575404.07.2016

04.07.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

827Carbalex 300mg

retardcarbamazepine

tablets prolonged-

release

300mg,


100/10x10/)

G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria N03AF01 1575504.07.2016

04.07.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

828Carbalex 600mg

retardcarbamazepine

tablets prolonged-

release

600mg,


100/10x10/)

G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria N03AF01 1575604.07.2016

04.07.2021PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

178

829 Carbamazepine carbamazepine tablets200mg,


Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia N03AF01 1346906.05.2014

06.05.2019PoM

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

830 Carbamazepine carbamazepine tablets200mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AF01 13960

28.10.2014

28.10.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

831Carbamazepine-

Zdorovyecarbamazepine tablets

200mg,


20/2x10/)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine N03AF01 1674205.06.2017

05.06.2022PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

832Carbidopa and

Levodopa-TEVAcarbidopa, levodopa tablets

25mg+250mg,


100/10x10/)

TEVA

Pharmaceutical


Hurvitz str.,


Saba 44102

Israel N04BA02 1388506.10.2014

06.10.2019PoM

TEVA

Pharmaceutical

Industries Ltd., 5

Basel str., P.O. Box

3190, 49131 Petach

Tikva, Israel

833 Carbo activatus activated charcoal tablets250mg,

in blister (10), strip (10)

SIC Borshchahivskiy

chemical-

pharmaceutical plant

PJSC 17, Mira St, Kiev

03134

Ukraine A07BA01 1285817.09.2013

17.09.2018OTC

SIC Borshchahivskiy

chemical-

pharmaceutical plant

PJSC 17, Mira St, Kiev

03134, Ukraine

834Carbocisteine 2%

syrup for childrencarbocisteine syrup

100mg/5ml,

120ml bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


14.08.2014

14.08.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

179

835Carbocisteine 5%

syrup for adultscarbocisteine syrup

250mg/5ml,

120ml bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


14.08.2014

14.08.2019OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

836

Carboplatin

10mg/ml

concentrate for

solution for

infusion

carboplatinconcentrate for


10mg/ml,

45ml glass vial

Accord Healthcare


Pinner Road, North







Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443316.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

837

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

15ml glass vial

Accord Healthcare


Pinner Road, North







Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443416.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

180

838

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

60ml glass vial

Accord Healthcare


Pinner Road, North







Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443516.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

839

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

15ml glass vial

Accord Healthcare


Pinner Road, North


4HF -batch releaser, Intas






Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443616.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

181

840

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

45ml glass vial

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443716.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

841

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

5ml glass vial

Accord Healthcare


Pinner Road, North







Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443816.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

182

842

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

60ml glass vial

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1443916.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

843

Carboplatin

10mg/ml

concentrate for

solution for

infusion



10mg/ml,

5ml glass vial

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk







packager

UK L01XA02 1444016.04.2015

16.04.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

844

Carboplatin-

Asteria Inj.

450mg/45ml

carboplatin solution for injection10mg/ml,

45ml glass bottle

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth L01XA02 12654/120.08.2015

04.07.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

183

845

Carboplatin-

Asteria Inj.

450mg/45ml

carboplatinsolution for i/v

injection

10mg/ml,

45ml glass vial

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South L01XA02 1679022.06.2017

22.06.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, Korea South

846 Carbosin carboplatinconcentrate for


10mg/ml,

15ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands L01XA02 12291/104.04.2014

22.03.2018PoM

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem,

the Netherlands

847 Carbosin carboplatinconcentrate for


10mg/ml,

45ml glass vial

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem

the Netherlands L01XA02 12292/104.04.2014

22.03.2018PoM

Pharmachemie

B.V.,Swensweg 5, NL

2031 GA Haarlem,

the Netherlands

848Cardibru 25mg

tabletscarvedilol tablets

25mg,


Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium C07AG02 1283417.09.2013

17.09.2018PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

184

849Cardibru 6,25mg

tabletscarvedilol tablets

6,25mg,


Brupharmexport

SPRL, 14 Rue De la

Grotte, B-1020

Brussels - batch


manufacturer,


Produtos

Farmaceuticos, S.A,

Zona Industrial de

Condeixa-a-Nova,

Sebal Grande 3150-


Portugal)

Belgium C07AG02 1283317.09.2013

17.09.2018PoM

Brupharmexport

SPRL, Rue de la

Grotte, 14, B-1020,

Brussels, Belgium

850 Cardilopin

amlodipine

(amlodipine

besilate)

tablets10mg,



PLC, 1165 Budapest,


120

Hungary C08CA01 1700405.09.2017

05.09.2022PoM


PLC, 1106 Budapest,


Hungary

851 Cardilopin

amlodipine

(amlodipine

besilate)

tablets5mg,



PLC, 1165 Budapest,


120

Hungary C08CA01 1700505.09.2017

05.09.2022PoM


PLC, 1106 Budapest,


Hungary

852 Cardilopin

amlodipine

(amlodipine

besilate)

tablets2,5mg,



PLC, 1165 Budapest,


120

Hungary C08CA01 1700605.09.2017

05.09.2022PoM


PLC, 1106 Budapest,


Hungary

853 Cardio-AS acetylsalicylic acid tablets100mg,


NOKI JV LTD Co.,


region

Republic of

ArmeniaB01AC06 15315

04.02.2016

04.02.2021OTC

NOKI JV LTD Co.,


region, Republic of

Armenia

185

854 Cardiolife


magnesium

hydroxide

tablets coated75mg+15,2mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


17.12.2015

17.12.2020OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

855 Cardiomagnyl


magnesium

hydroxide

tablets film-coated

75mg+15.2mg,

in glass container (30,

100)

Takeda GmbH,

Production Site

Oranienburg, Lehnitz

str. 70-98, 16515

Oranienburg

Germany B01AC30 12251/118.08.2015

07.03.2018OTC

Takeda



Moscow 119048,

Russia

856 Cardiomagnyl


magnesium

hydroxide

tablets film-coated150mg+30,39mg, in glass

container (30, 100)

Takeda GmbH,

Production Site

Oranienburg, Lehnitz

str. 70-98, 16515

Oranienburg

Germany B01AC30 12252/118.08.2015

07.03.2018OTC

Takeda



Moscow 119048,

Russia

857 Cardionat

meldonium

(meldonuim

dihydrate)


100mg/ml,

5ml ampoules, blisters

(10/2x5/)

Moscow Endocrine

Plant FSUE, 25, bld 1,

bld 2,

Novokhokhlovskaya

st., Moscow, 109052

Russia C01EB 14182/127.01.2017

06.02.2020PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

858 Carditon levocarnitine solution oral100mg/ml,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi-batch

releaser, secondary

packager, Anfarm

Hellas S.A., Sximatari

Viotias, 32009, Greece-

bulk manufacturer,

primary packager

Georgia A16AA01 1474203.08.2015

03.08.2020PoM

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


186

859 Caripazimlatex exsicco

papayaeae

powder lyophilized

for solution for

external use

350PU/ml,

10ml glass vial

LEPL Tbilisi State

Medical University

Iovel Kutateladze

Institute of

Pharmacochemistry,

P.Sarajishvili St. 36,

0159, Tbilisi

GeorgiaG03B;

herbal drug14036/1

22.01.2015

19.12.2019PoM

LEPL Tbilisi State

Medical University

Iovel Kutateladze

Institute of

Pharmacochemistry,

P.Sarajishvili St. 36,

0159, Tbilisi, Georgia

860

Carminativum

Babynos colic

drops

fennel (foeniculi

amari fructus),

coriander (coriandri

fructus), chamomile

(matricariae flos)

drops oral

320mg/g+ 200mg/g+

200mg/g,

30ml glass bottle

Dentinox Company Germany A03AX 1253801.06.2013

01.06.2018OTC

Pharmaceutical

Products Lenk &

Schuppan KG,

Nunsdorfer Ring

1912277, Berlin,

Germany

861Carsil 22,5mg

coated tabletssilymarin tablets coated

22,5mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

BulgariaA05BA03;

herbal drug16728

05.06.2017

05.06.2022OTC

Sopharma JSC, str.

Iliensko shosse 16,


862 Carsil Forte silymarin capsules hard90mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia-batch

releaser, Sopharma

JSC, 110, 23rd

Pehoten Shipchenski

Polk Blvd., 6100

Kazanlak, Bulgaria-

bulk manufacturer,

primary and

secondary packager

Bulgaria

A05BA03;

բուսական

ծագման դեղ

1494120.10.2015

20.10.2020PoM

Sopharma JSC, str.

Iliensko shosse 16,


863 Carvedi-Denk 25 carvedilol tablets25mg,


Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luechow

Germany C07AG02 1269623.07.2013

23.07.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

187

864 Carvedi-Denk 6,25 carvedilol tablets6,25mg,


Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luechow

Germany C07AG02 1269523.07.2013

23.07.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

865 Carvedigamma carvedilol tablets film-coated

12,5mg,


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

Woerwag Pharma

GmbH & Co. KG,

Calwer Str. 7, 71034

Boblingen-batch

releaser, S.C. Magistra

C & C S.R.L., 82A

Aurel Vlaicu Blvd.,

900055 Constanta,

Romania-bulk

manufacturer,

packager

Germany C07AG02 1493920.10.2015

20.10.2020PoM

Woerwag Pharma

GmbH & Co. KG,


Boblingen, Germany

866 Carvedigamma carvedilol tablets film-coated

25mg,


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

Woerwag Pharma

GmbH & Co. KG,


Boblingen-batch

releaser, S.C. Magistra

C & C S.R.L., 82A

Aurel Vlaicu Blvd.,

900055 Constanta,

Romania-bulk

manufacturer,

packager

Germany C07AG02 1494420.10.2015

20.10.2020PoM

Woerwag Pharma

GmbH & Co. KG,


Boblingen, Germany

867 Carvedilol carvedilol tablets6,25mg,

in blister (40)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaC07AG02 12165

01.02.2013

01.02.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

188

868 Carvedilol carvedilol tablets25mg,

in blister (40)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


01.02.2013

01.02.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


08.06.2016

08.06.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

870 Carvedilol carvedilol tablets25mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


26.12.2017

26.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia



Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


26.12.2017

26.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

872Carvedilol Sandoz

12,5mgcarvedilol tablets

12,5mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany C07AG02 1447330.04.2015

30.04.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia


25mgcarvedilol tablets

25mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany C07AG02 1447430.04.2015

30.04.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

189


6,25mgcarvedilol tablets

6,25mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany C07AG02 1447230.04.2015

30.04.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

875 Carvedilol-Mic carvedilol capsules6,25mg,


Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.113

Belarus C07AG02 1304025.11.2013

25.11.2018PoM

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112, Belarus

876 Carvedilol-Mic carvedilol capsules12,5mg,


Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.114

Belarus C07AG02 1304125.11.2013

25.11.2018PoM

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112, Belarus

877 Carvedilol-Mic carvedilol capsules25mg,


Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112

Belarus C07AG02 1304225.11.2013

25.11.2018PoM

Minskintercaps UE,

220075-Minsk, 26

Inzhenernaya St,

P.B.112, Belarus

878 Carvilex 12,5mg carvedilol tablets12,5mg,


Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria

Bulgaria C07AG02 1699005.09.2017

05.09.2022PoM

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria,

Bulgaria

879 Carvilex 25mg carvedilol tablets25mg,


Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria

Bulgaria C07AG02 1698805.09.2017

05.09.2022PoM

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria,

Bulgaria

190

880 Carvilex 6,25mg carvedilol tablets6,25mg,


Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria

Bulgaria C07AG02 1698905.09.2017

05.09.2022PoM

Balkanpharma-

Dupnitsa AD,

(ACTAVIS GROUP),

str."Samokovsko


2600, Bulgaria,

Bulgaria

881 Catafast

diclofenac

(diclofenac

potassium)

powder for oral

solution

50mg,

sachets (3, 9, 21)

Mipharm S.p.A., VIA

Bernardo Quaranta,

12, 20141 Milano (MI)

Italy M01AB05 1332110.03.2014

10.03.2019PoM

Novartis Pharma AG,

Lichstrasse 35, 4056

Basel, Switzerland

882 Cavinton vinpocetine solution for injection

5mg/ml,

2ml ampoules, in plastic

tray (10/2x5/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N06BX18 1511415.12.2015

15.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

883 Cavinton vinpocetine solution for injection

5mg/ml,

5ml ampoules in plastic

tray (10/2x5/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N06BX18 1511515.12.2015

15.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

884 Cavinton vinpocetine tablets5mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N06BX18 1511715.12.2015

15.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

885 Cavinton Forte vinpocetine tablets

10mg,


90/6x15/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary N06BX18 1511615.12.2015

15.12.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

191

886 Cedax ceftibuten capsules hard400mg,

sachets (5/5x1/)

Merck Sharp &

Dohme Corp.13900

North West 57th

Court, Miami Lakes

FL 33014

USA J01DD14 13342/128.04.2014

17.03.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

887 Cedax ceftibutenpowder for oral

suspension

36mg/ml,


measuring cup

Merck Sharp &

Dohme Corp.13900

North West 57th

Court, Miami Lakes

FL 33014

USA J01DD14 1349730.05.2014

30.05.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

888 Cefalexincefalexin (cefalexin

monohydrate)

granules for oral

suspension

250mg/5ml,


measuring spoon

Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemomont D.O.O.,

Montenegro 81000,

Podgorica, 8 marta

55a, Montenegro-

bulk manufacturer,

packager

Serbia J01DB01 1557312.05.2016

12.05.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

889 Cefalexincefalexin (cefalexin

monohydrate)capsules

500mg,


Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemomont D.O.O.,

Montenegro 81000,

Podgorica, 8 marta

55a, Montenegro-

bulk manufacturer,

packager

Serbia J01DB01 1566208.06.2016

08.06.2021PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia

192

890 Cefamezincefazolin (cefazolin

sodium)

powder for solution

for injection

1000mg,

glass vial (1)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto-batch releaser,

Labesfal-Laboratorios

Almiro, S.A, Santiago

de Besteiros, 3465-

157, Portugal-bulk

manufacturer,

packager

Slovenia J01DB04 1619708.12.2016

08.12.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

891 Cefazim-100cefixime (cefixime

trihydrate)tablets film-coated

100mg,


Zim Laboratories Ltd.,

B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India J01DD08 1476703.08.2015

03.08.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

892 Cefazim-200cefixime (cefixime

trihydrate)tablets film-coated

200mg,



B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.)

India J01DD08 1476603.08.2015

03.08.2020PoM

Zim Laboratories

Ltd., Ground Floor,

Sadoday Gyan,

Nelson Square,

Chhindwara Road,

Nagpur-440 013,

India

893 Cefazolincefazolin (cefazolin

sodium)

powder for solution

for i/v and i/m

injection

1000mg,


Biosintez OJSC,

Druzhby st. 4,

440033, Penza

Russia J01DB04 1385918.09.2014

18.09.2019PoM

Biosintez OJSC,

Druzhby st. 4,


894 Cefazolin cefazolinpowder for solution

for injection

500mg,

glass vials (10)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01DB04 1596215.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

193

895 Cefazolin cefazolinpowder for solution

for injection

1000mg,

glass vials (10)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J01DB04 1596315.09.2016

15.09.2021PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

896 Cefazolincefazolin (cefazolin

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1, 5, 10, 50)

"Biohimik " PJSC,

Republic of Mordovia,

430030, Saransk,

Vasenko str., 15A

Russia J01DB04 1685010.07.2017

10.07.2022PoM

"PROMOMED RUS "

LLC, 101000,

Moscow, Arkhangelsk

pereulok,1, build.1,

Russia

897 Cefazolin cefazolin (cefazolin

sodium)

powder for solution

for injection

1000mg,

in glass vials

(1, 10, 50, 270)

Open joint stock


zavod medicinskikh

preparatov", 64/3,ul.

Chapaeva, Borisov


Belarus J01DB04 1689208.08.2017

08.08.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

898Cefazolin-Asteria

Inj. 0,5g

cefazolin (cefazolin

sodium)

powder for solution

for i/m and i/v

injection

500mg,

vials (10)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do Seoul, South Korea

Korea Sourth J01DB04 13488/106.07.2015

15.05.2019PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

899Cefazolin-Asteria

Inj. 1g

cefazolin (cefazolin

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

vials (10)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth J01DB04 13489/106.07.2015

15.05.2019PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

900 Cefazolin-Belmedcefazolin (cefazolin

sodium)

powder for solution

for i/m and i/v

injection

500mg,

glass vial (1, 20)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus J01DB04 14809/121.12.2016

04.09.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

194

901 Cefazolin-Belmedcefazolin (cefazolin

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1, 20)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus J01DB04 14810/121.12.2016

04.09.2020PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

902 Cefecon D paracetamol suppositories rectal250mg,

(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia N02BE01 1670023.05.2017

23.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia


(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia N02BE01 1670123.05.2017

23.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia


(10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7

Russia N02BE01 1670223.05.2017

23.05.2022OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod,

Salganskaya st., 7,

Russia

905 Cefepimcefepime (cefepime

hydrochloride)

powder for solution

for injection

1000mg,

glass vial (1, 10), glass vial

(dividella) (10/1x10/)

Open Joint Stock

Company , 64/27,



Belarus J01DE01 1285117.09.2013

17.09.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,


906 Cefepime cefepimepowder for solution

for injection

1000mg,

glass vial (1, 10), glass

vial dividella (10)

Open joint stock


zavod medicinskikh

preparatov", 64/3, ul.

Chapaeva,Borisov,

Minsk region

Belarus J01DE01 1621108.12.2016

08.12.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

195

907Cefepime-Asteria

Inj. 1g

cefepime (cefepime

hydrochloride)

powder for solution

for injection

1000mg,

glass vial (1, 10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South J01DE01 1612610.11.2016

10.11.2021PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

908 Cefichewcefixime (cefixime

trihydrate)tablets chewable

200mg,


SRS Pharmaceuticals

Pvt. Ltd., Plot No.11

& 12 Kumar

Industrial Estate, Gat

No. 1251-1261,

Alandi-Markal Road,

Markal, Pune 412 105

India J01DD08 1421720.02.2015

20.02.2020PoM

SRS Pharmaceuticals

Pvt. Ltd., 602, 6th

Floor, Marathon Max

Bldg. No 2, Mulund

Goreagon Link Road

L.B.S. Marg, Mulund,

Mumbai,400 080,

India

909 Cefichewcefixime (cefixime

trihydrate)tablets chewable

400mg,


SRS Pharmaceuticals

Pvt. Ltd., Plot No.11

& 12 Kumar

Industrial Estate, Gat

No. 1251-1261,

Alandi-Markal Road,

Markal, Pune 412 105

India J01DD08 1421820.02.2015

20.02.2020PoM

SRS Pharmaceuticals

Pvt. Ltd., 602, 6th

Floor, Marathon Max

Bldg. No 2, Mulund

Goreagon Link Road

L.B.S. Marg, Mulund,

Mumbai,400 080,

India

196

910 Cefort

ceftriaxone

(ceftriaxone

sodium)

powder for solution


1000mg,

glass vials (10)

Antibiotice S.A., 1

Valea Lupului str.,

707410 lasi-secondary

packager, batch

releaser (bulk

manufacturer,

primary packager-

Sinopharm Zhijun

(Shenzhen)

Pharmaceutical Co.,

Ltd, No. 16, Lanqing

Yilu, Hi-tech zone,

Guanlan, Longhua

New District,

Shenzhen,

Guangdong, 518110,

China)

Romania J01DD04 1580520.07.2016

20.07.2021PoM

Antibiotice S.A., 1

Valea Lupului str.,

707410 lasi, Romania

911 Cefotaxime

cefotaxime

(cefotaxime

sodium)

powder for solution

for injection

500mg,

glass vial (10)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01DD01 1561224.05.2016

24.05.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

912 Cefotaxime

cefotaxime

(cefotaxime

sodium)

powder for solution

for injection

1000mg,

glass vials (10)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01DD01 1561324.05.2016

24.05.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

197

913 Cefotaxime Atb 1g

cefotaxime

(cefotaxime

sodium)

powder for solution


1000mg,

glass vial (1, 10, 50)

Antibiotice S.A., 1

Valea Lupului str.,

707410 lasi-batch

releaser, Facta

Farmaceutici S.p.A.,

Nucleo Industriale S.

Atto, 64100

TERAMO (TE), Italy-

bulk manufacturer,

packager

Romania J01DD01 1590223.08.2016

23.08.2021PoM

Antibiotice S.A., 1

Valea Lupului str.,


914 Cefotaxime Atb 1g

cefotaxime

(cefotaxime

sodium)

powder for solution


1000mg,


Antibiotice S.A., 1

Valea Lupului str.,

707410 lasi - batch

releaser, secondary

packager, Facta

Farmaceutici S.p.A.,

Nucleo Industriale S.

Atto, 64100

TERAMO (TE), Italy-

bulk manufacturer,

primary packager

Romania J01DD01 1596115.09.2016

15.09.2021PoM

Antibiotice S.A., 1

Valea Lupului str.,


915Cefotaxime sodium

for injection 1,0g

cefotaxime

(cefotaxime

sodium)

powder for solution

for injection

1000mg,

glass vial and 5ml solvent

in ampoule

Harbin

Pharmaceutical

Group Co., Ltd.,

(General

Pharmaceutical

Factory, No 109

Xuefu Road,Nangang

District., Harbin)

China J01DD10 1289807.10.2013

07.10.2018PoM

Harbin

Pharmaceutical

Group Co., Ltd.,

(General

Pharmaceutical

Factory, No 109

Xuefu Road,Nangang

District., Harbin,

China)

916 Cefrobactum

cefoperazone

(cefoperazone

sodium), sulbactam

(sulbactam sodium)

powder for solution

for injection

1000mg+1000mg, 20ml

glass vial (1)


Limited R-40, T.T.C.

Rabale, Thane-

Belapur Road, Navi

Mumbai 400 701

India J01DD62 1618823.11.2016

23.11.2021PoM

S.P. Incomed Pvt.

Ltd., H-680, Palam

Extn.-1, New Delhi

110 045, India

198

917 Ceftionel-50ceftiofur (ceftiofur

hydrochloride)

suspension for

injection

50mg/ml,

100ml glass bottle

Interchemie werken


Vanapere tee 14,


bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QJ01DD90;

veterinary

drug

1528904.02.2016

04.02.2021PoM

Interchemie werken

De Adelaar B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

918 Ceftonus

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vials (25)

Panpharma Z.I., du

Clairay-Luitre 35133,

Fougeres

France J01DD04 1217201.02.2013

01.02.2018PoM

Panpharma Z.I., du

Clairay-Luitre 35133,

Fougeres, France

919 Ceftriaxon

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

500mg,

glass vials (10)

Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine J01DD04 1233109.04.2013

09.04.2018PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

920 Ceftriaxon

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vials (10)

Kievmedpreparat

OJSC, 01032, Kiev,


139

Ukraine J01DD04 1233209.04.2013

09.04.2018PoM

Kievmedpreparat

OJSC, 01032, Kiev,


139, Ukraine

921 Ceftriaxone

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1g,

glass vial (1, 10, 270)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01DD04 15409/105.04.2017

09.03.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

199

922 Ceftriaxone

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

500mg,

glass vial (1, 10, 270)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01DD04 15416/105.04.2017

09.03.2021PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

923 Ceftriaxone

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1)

"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01DD04 1554419.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

924 Ceftriaxone

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

500mg,

glass vial (1)

"Sintez" OJSC, Pr.


Kurgan, 640008

Russia J01DD04 1554519.04.2016

19.04.2021PoM

"Sintez" OJSC, Pr.


Kurgan, 640008,

Russia

925Ceftriaxone

1000mg

ceftriaxone

(ceftriaxone

sodium)

powder for solution


1000mg,

glass vial (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01DD04 16294

26.12.2016

26.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

926

Ceftriaxone 1g

powder for

solution for

injection

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for injection

1000mg,

glass vials (1, 10)

CP Pharmaceuticals


Wrexham, LL13 9UF

UK J01DD04 1396329.10.2014

29.10.2019PoM

Wockhardt UK Ltd

Ash Road North,

Wrexham, LL13 9UF,

UK

927 Ceftriaxone 500mg

ceftriaxone

(ceftriaxone

sodium)

powder for solution


500mg,

glass vial (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01DD04 16295

26.12.2016

26.12.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

200

928Ceftriaxone

ALPHAceftriaxone

powder for solution

for injection

1g/vial,

10ml glass vial

ALPHA_Aleppo

Pharmaceutical

Industries, Mansoura,

Aleppo

Syria J01DD04 1279514.08.2013

14.08.2018PoM

ALPHA-Aleppo

Pharmaceutical

Industries, Baron

Street, Aleppo, Syria

929Ceftriaxone for

injection

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (10)

Reyoung

Pharmaceutical Co.


Road, Yiyuan County,

Shandong Province

China J01DD04 1714307.11.2017

07.11.2022PoM

Reyoung

Pharmaceutical Co.


Road, Yiyuan

County, Shandong

Province, China

930Ceftriaxone

sodium

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,


Belmedpreparaty

RUE, Grodninsky

region, Lida, str.

Kachana,19/8

Belarus J01DD04 1663525.04.2017

25.04.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

931Ceftriaxone-

Asteria

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m injection

1000mg,

3,5ml glass vial and (1)

solvent in ampoule

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth J01DD04 1517717.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

932Ceftriaxone-

Asteria Inj. 0,5g

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m/i/v injection

500mg,

glass vials (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth J01DD04 12825/120.08.2015

17.09.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

933Ceftriaxone-

Asteria Inj. 0,5g

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for solution for i/m/

and i/v injection

500mg,

glass vial (1) and (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South J01DD04 1674605.06.2017

05.06.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, Korea South

201

934Ceftriaxone-

Asteria Inj. 1g

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m/i/v injection

1000mg,

glass vials (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth J01DD04 12826/120.08.2015

17.09.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

935Ceftriaxone-

Asteria Inj. 1g

ceftriaxone

(ceftriaxone

sodium)

powder for solution

for i/m and i/v

injection

1000mg,

glass vial (1) and (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South J01DD04 1674705.06.2017

05.06.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

936 Ceftrimo-S

ceftriaxone

(ceftriaxone

sodium), sulbactam

(sulbactam sodium)

powder for solution

for injection1000mg+500mg, glass vial

Klintoz


Ltd., Nalagarh Road

Baddi, 173205, Distt.

Solan, H.P.

India J01DD54 1267104.07.2013

04.07.2018PoM

Klintoz


Ltd., 405, Madhuban

bilding,55,Nehru

Place, New Delhi-

110019, India

937 Celebrex celecoxib capsules100mg,

blisters (20/2x10/)

R-Pharm Germany

GmbH, Heinrich-

Mack-Str. 35, 89257,

Illertissen-batch

releaser, packager,

Neolpharma Inc.,

Caguas 99 Jardines

str., Caguas, Puerto

Rico 00725, USA-bulk

manufacturer

Germany M01AH01 14685/106.09.2016

29.06.2020PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd street, New

York 10017, USA

938 Celebrex celecoxib capsules200mg,

blisters (20/2x10/)

R-Pharm Germany

GmbH, Heinrich-

Mack-Str. 35, 89257,

Illertissen-batch

releaser, packager,

Neolpharma Inc.,

Caguas 99 Jardines

str., Caguas, Puerto

Rico 00725, USA-bulk

manufacturer

Germany M01AH01 14686/106.09.2016

29.06.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

202

939 Celecoxib celecoxib capsules100mg,


Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30

Belarus M01AH01 1394429.10.2014

29.10.2019PoM

Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30,

Belarus

940 Celecoxib celecoxib capsules200mg,


Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30

Belarus M01AH01 1394529.10.2014

29.10.2019PoM

Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30,

Belarus

941 Celestoderm-V

betamethasone

(betamethasone 17-

valerate)

ointment1mg/g,

30g aluminum tube


N.V., Industriepark


den-Berg

Belgium D07AC01 1336404.04.2014

04.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

942

Celestoderm-V

cream with

Garamycin

betamethasone

(betamethasone 17-

valerate),

gentamicin


cream1mg/g+1mg/g,

30g aluminium tube


N.V., Industriepark


den-Berg

Belgium D07CC01 1350030.05.2014

30.05.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

943Celestoderm-V

with Garamycin

betamethasone

(betamethasone

valerate),

gentamicin


ointment1mg/g+1mg/g,

30g aluminium tube


N.V., Industriepark


den-Berg

Belgium D07CC01 1433225.03.2015

25.03.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

944 Celex celecoxib capsules200mg


Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of

ArmeniaM01AH01 16642

25.04.2017

25.04.2022PoM

Tufenkji Group LLC,

Kochinyan 13/16,


Armenia

203

945 CellCeptmycophenolate

mofetilcapsules

250mg,


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 L04AA06 1448918.05.2015

18.05.2020PoM

F. Hoffmann-La

Roche Ltd.,

Greenzacher-strasse,

124, CH-4070, Basel,

Switzerland

946 Cenipres


maleate),

nitrendipine

tablets10mg+20mg,




9 08173 Sant Cugat


Spain C09BB06 1274623.07.2013

23.07.2018PoM



III, 94, 08028,

Barcelona, Spain

947

Ceraxon 1000mg

solution for

injection

citicolinesolution for i/v and

i/m injection

1000mg/4ml,

4ml ampoules (5)




Valles, Barcelona

Spain N06BX06 13269/102.06.2015

10.03.2019PoM


S.A., Joan Gran Via

Carlos III, 94 08028,

Barcelona, Spain

948Ceraxon 100mg/ml

oral solution

citicoline (citicoline

sodium)solution oral

100mg/ml,

30ml glass bottle,

10ml sachets (6, 10)



III, 94, 08028,

Barcelona

Spain N06BX06 13267/123.06.2014

10.03.2019PoM



III, 94, 08028,

Barcelona, Spain

949

Ceraxon 500mg

solution for

injection

citicoline (citicoline

sodium)


i/m injection

500mg/4ml,

4ml ampoules (5)




Valles, Barcelona

Spain N06BX06 13268/102.06.2015

10.03.2019PoM


S.A., Joan Gran Via

Carlos III, 94 08028,

Barcelona, Spain

204

950 Cerebrolysatecattle or porcine

brain hydrolysatesolution for injection

47-77mg/ml; (10)

ampoules1ml, (10/2x5/)

ampoules 1ml in blister,

(5/1x5/) ampoules 1ml in

blister

Belmedpreparaty

RUE, 220006, Minsk,

Mayakovskogo st. 1

Belarus N06BX 1704026.09.2017

26.09.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

951 Cerebrolysinporcine brain

peptidessolution for injection

215,2mg/ml,

1ml ampoules,


EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee-, bulk

manufacturer, batch

releaser, Ever Pharma

Jena GmbH, Otto-

Schott-Strasse 15,

07745

Jena,Thueringen,

Germany -packager

Austria N06BX 1423720.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,

2ml ampoules,


EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee-, bulk

manufacturer, batch


Jena GmbH, Otto-

Schott-Strasse 15,

07745

Jena,Thueringen,

Germany -packager

Austria N06BX 1423820.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria

205



215,2mg/ml,

5ml ampoules,

in blister (5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee-, bulk

manufacturer, batch


Jena GmbH, Otto-

Schott-Strasse 15,

07745

Jena,Thueringen,

Germany -packager

Austria N06BX 1423920.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,

10ml ampoules,

in blister (5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee-, bulk

manufacturer, batch


Jena GmbH, Otto-

Schott-Strasse 15,

07745

Jena,Thueringen,

Germany -packager

Austria N06BX 1424020.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,

1ml ampoules,


EVER Neuro Pharma

GmbH,


4866 Unterach am

Attresee - bulk

manufacturer, batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,


Germany- packager

Austria N06BX 1424120.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria

206



215,2mg/ml,

2ml ampoules,


EVER Neuro Pharma

GmbH,


4866 Unterach am

Attresee - bulk

manufacturer, batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,


Germany- packager

Austria N06BX 1424220.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,

5ml ampoules,

in blister (5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attresee - bulk

manufacturer, batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,


Germany- packager

Austria N06BX 1424320.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,

10ml ampoules,

in blister (5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attresee - bulk

manufacturer, batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,


Germany- packager

Austria N06BX 1424420.02.2015

20.02.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria

207



215,2mg/ml,

20ml ampoules,

in blister (5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attresee - bulk

manufacturer, batch

releaser, Hameln

Pharmaceuticals

GmbH, Langes Feld

13, Hameln,


Germany- packager

Austria N06BX 1451715.05.2015

15.05.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria



215,2mg/ml,


(5/1x5/)

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee-, bulk

manufacturer, batch


Jena GmbH, Otto-

Schott-Strasse 15,

07745

Jena,Thueringen,

Germany -packager

Austria N06BX 1451815.05.2015

15.05.2020PoM

EVER Neuro Pharma

GmbH,


4866 Unterach am

Attersee, Austria

208

961 Cerotex choline alfoscerate capsules

400mg,


28/2x14/), (42/3x14/,

56/4x14/)

"Sotex"PharmFirm"

CJSC, Bld. 11, village

Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345- batch

releaser, primary and

secondarypackager,

"Artlife" Ltd, bld. 8/2

Nahimova str.,

Tomsk, 634034,

Russia- bulk

manufacturer

Russia N07AX02 16409/110.10.2017

10.02.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

962 Cerotexcholine alfoscerate

polyhydrate

solution for i/m and

i/v injection

250mg/ml,

4ml ampoules (3, 5)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,

village Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia N07AX02 1648024.02.2017

24.02.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

963 Certican everolimus tablets0,25mg,


Novartis Pharma

Stein AG,


4332 Stein


16.01.2020PoM

Novartis Pharma AG,


Basel, Switzerland

964 Certican everolimus tablets0,75mg,


Novartis Pharma

Stein AG,


4332 Stein


16.01.2020PoM

Novartis Pharma AG,


Basel, Switzerland

209

965 Cerucal

metoclopramide

(metoclopramide

hydrochloride

monohydrate)

tablets10mg,


Pliva Hrvatska d.o.o.,

Prilaz baruna

Filipovica 25, Zagreb

10000

Croatia A03FA01 1239519.04.2013

19.04.2018PoM

Teva Pharmaceutical

Industries Ltd, 5 Basel

str., P.O. Box 3190,

Petah Tikva, 49131,

Israel

966 Cerucal

metoclopramide

(metoclopramide

hydrochloride

monohydrate)


2ml ampoules (10)

Teva Pharmaceutical

Works Private

Limited Company, H-

2100 Godollo,

Tancsics Mihaly ut 82

Hungary A03FA01 12496/126.03.2014

01.06.2018PoM

Teva Pharmaceutical

Industries Ltd., 5


3190, Petach Tikva,

49131, Israel

967 Cervarix

human

papillomavirus type

16 L1 protein,

human

papillomavirus type

18 L1 protein

suspension for

injection


0.5ml pre-filled syringe (1

dose) (1) and needle (1)

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 1300

Wavre, Belgium-bulk

manufacturer,

packager

BelgiumJ07BM02;

vaccine15382

26.02.2016

26.02.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

210

968 Cervarix

human

papillomavirus type

16 L1 protein,

human

papillomavirus type

18 L1 protein

suspension for

injection


0.5ml pre-filled syringe

(1dose) (1) and needle (1)

GlaxoSmithKline



1330 Rixensart- batch

releaser,

GlaxoSmithKline

Biologicals SA, Parc

de la Noire Epine Rue

Fleming, 20 1300

Wavre, Belgium-bulk

manufacturer,

primary packager,

GlaxoSmithKline

Biologicals SA, Rue

des Aulnois, 637

59230 Saint Amand

Les Eaux, France-

secondary packager

BelgiumJ07BM02;

vaccine15383

26.02.2016

26.02.2021PoM

GlaxoSmithKline



1330 Rixensart,

Belgium

969 Cetamol paracetamol suppositories rectal80mg,

(10/2x5/)

Medical Horizon Ltd,

Ararat province,

Masis city, Masis

station, Gortsaranain

22

Republic of


09.12.2013

09.12.2018OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

970 Cetamol paracetamol suppositories rectal150mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of


09.12.2013

09.12.2018OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

971 Cetamol paracetamol suppositories rectal325mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of


09.12.2013

09.12.2018OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

211

972 Cetamol paracetamoldrops oral (solution

with cherry flavour)

100mg/ml,

30ml plastic bottle


Ararat province,

Masis city, Masis


22

Republic of


10.01.2014

10.01.2019OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

973 Cetamol paracetamolsyrup (with cherry

flavour)

24mg/ml,

100ml glass bottle


Ararat province,

Masis city, Masis


22

Republic of


10.01.2014

10.01.2019OTC


Ararat province,

Masis city, Masis


22, Republic of

Armenia

974Cetirizine-Asteria

Tab. 10mg

cetirizine (cetirizine

hydrochloride)tablets film-coated

10mg,


Hankook Korus

Pharm Co., Ltd, 30,


Si, Chungcheongbuk-

do

Korea South R06AE07 1679322.06.2017

22.06.2022OTC

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

975 Cetrotidecetrorelix

(cetrorelix acetate)

powder lyophilized

for solution for s/c

injection

0,25mg,

glass vials with powder

(7), 1ml prefilled syringes

with solvent (7), needles

(14), alcohol swabs (14)

Baxter Oncology

GmbH, Kantstrasse 2,

Halle/Westfalen,

33790

Germany H01CC02 1578220.07.2016

20.07.2021PoM

Merck Serono Europe

Ltd., Marsh Wall 56,

London E14 9TP, UK

976 Cevikap ascorbic acid drops oral

100mg/ml,

10ml, 30ml glass bottle-

dropper

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10 - batch

releaser, Medana

Pharma JSC, str.


Wojskowej 57, 98-200

Sieradz, Poland-bulk

manufacturer,

packager

Poland A11GA01 1552819.04.2016

19.04.2021OTC

Medana Pharma JSC,

98-200 Sieradz, W.

Lokietka 10, Poland

212

977 Cezera

levocetirizine

(levocetirizine

dihydrochloride)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia R06AE09 1538526.02.2016

26.02.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

978 Champix

varenicline

(varenicline

tartrate)

tablets film-coated

0,5mg/1mg,

(11/1x11/)(0,5mg) in

blister, (14/1x14/)(1mg)

in blister

R-Pharm Germany

GmbH, Heinrich-

Mack-Str. 35, 89257,

Illertissen, Bavaria

Germany N07BA03 12129/114.08.2015

01.02.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

979 Champix

varenicline

(varenicline

tartrate)

tablets film-coated

1mg,


56/2x28/)

R-Pharm Germany

GmbH, Heinrich-

Mack-Str. 35, 89257,

Illertissen, Bavaria

Germany N07BA03 12130/114.08.2015

01.02.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

980 Charcoal activated charcoal activated tablets

250mg,


30(/3x10, 50/5x10/),

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia A07BA01 1409318.12.2014

18.12.2019OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

981 Chemi Spray

chlortetracycline

(chlortetracycline

hydrochloride),

gentian violet

aerosol for external

use


container

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QD06AA02;

veterinary

drug

1523723.12.2015

23.12.2020PoM

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

213

982 Chicktonic

vitamin A, vitamin

D3, vitamin E,

vitamin B1, vitamin

B2, vitamin B6,

vitamin B12,

vitaminK3, sodium

pantotenat, choline

chloride, D,L-

methionine, L-lysine,

L-triptophane, L-

threonine, inositol,

arginine, valine,

serine, aspartic acid,

glutamic acid,

proline, glycine,

alanine, cystine,

leucine, isoleucine,

phenylalanine,

tyrosine, histidine,

biotin

solution oral

2500000IU/l+

500000IU/l+ 3750mg/l+

3500mg/l+ 4000mg/l+

2000mg/l+

10mg/l+250mg/l+

15000mg/l+ 400mg/l+

5000mg/l+

2500mg/l+75mg/l+

500mg/l+2.5mg/l+

490mg/l+ 1100mg/l+

680mg/l+ 1450mg/l+

1160mg/l+

510mg/l+575mg/l+

975mg/l+150mg/l+

1500mg/l+ 125mg/l+

810mg/l+ 340mg/l+

900mg/l+2mg/l,

1l plastic container

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19

Spain

QA11JC

veterinary

drug

1275414.08.2013

14.08.2018OTC

Invesa Industrial

Veterinaria, S.A.,

08950 Esplugues de


Esmeralda 19, Spain

983 Chirocaine

levobupivacaine

(levobupivacaine

hydrochloride)

solution for

injection/infusion

5mg/ml,

10ml ampoules (10)

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

Pontina KM 52, SNC -

Campoverde di

Aprilia 04011 Aprilia

(LT) -batch releaser,

secondary packager,

Curida AS,

Solbaervegen 5,

Elverum, NO-2409,

Norway- bulk

manufacturer,

primary packager

Italy N01BB10 1613710.11.2016

10.11.2021PoM

AbbVie

Biopharmaceuticals

GmbH, Neuhofstrasse

23, Postfach 6341

Baar, Switzerland

984Chlophazolin 150

micrograms tablets

clonidine (clonidine

hydrochloride)tablets

150mcg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria C02AC01 1541509.03.2016

09.03.2021PoM/UC

Sopharma JSC, str.

Iliensko shosse 16,


985 Chocolaxcalcium sennosides

A,Btablets chewable

12mg,

chocolate squares

(12/2x6/, 24/4x6/)

Mentholatum

Australasia Pty Ltd,

12-16 Janine

Street,Scoresby Vic

3179

Australia A06AB 1214801.02.2013

01.02.2018OTC

FW Medical LLP, 31

Milndavie Road,

Strathblane, Glasgow

G63 9EW, Scotland,

United Kingdom

214

986Choline

alphoscerate

choline

alphosceratesolution for injection

250mg/ml,

4ml ampoules (5)

Open joint stock


zavod medicinskikh

preparatov" 64/27,



Belarus N07AX02 1342414.04.2014

14.04.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64/27,


222120, Minsk

region, Belarus

987 Cholisal

choline salicylate,

cetalkonium

chloride

gel dental87,1mg/g+ 0,1mg/g,

10g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland A01AD 1627419.12.2016

19.12.2021OTC

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

988 Chondro-Ritz

chondroitin sulfate


sodium),

glucosamine

(glucosamine

sulfate)

capsules200mg+250mg,


GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala

str., Tbilisi

Georgia M09A 1518530.12.2015

30.12.2020OTC

GM Pharmaceuticals

Ltd, PSP group 65,

Qvemo Phonichala


989 Chondroxid

chondroitin sulfate


sodium)

gel for external use

50mg/g,

30g aluminium or plastic

tube

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia M01AX25 12875/109.09.2016

19.09.2018OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

990 Chondroxid

chondroitin sulfate


sodium)

tablets250mg,


Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia M01AX25 1319310.01.2014

10.01.2019OTC

Nizhpharm OJSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

215

991 Chophytolextractum cynara

scolymustablets coated

200mg,


180/6x30/)

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 A05AX 1239719.04.2013

19.04.2018OTC

ABBOTT Products

GmbH, Hans-Bockler-

Allee 20, 30173

Hannover, Germany

992 Chophytolcynara scolymus

extractsolution oral

200mg/ml,

120ml glass bottle

Laboratoires Rosa-

Phytopharma, 2

avenue du Traite de

Rome, 78400-Chatou-

batch releaser,

Laboratoires Mayoly

Spindler, 6 avenue de

l`Europe,78400

Chatou Cedex, France-

bulk manufacturer,

packager

FranceA05AX;

herbal drug16751

05.06.2017

05.06.2022OTC

Laboratoires Rosa-

Phytopharma 68, rue

Jean-Jacques

Rousseau 75001

Paris,France

216

993 Choragongonadotrophin

chorionic

powder for solution

for injection

1500IU,

powder, in ampoules (3)

and 1ml solvent, in

ampoules (3)

Ferring GmbH,

Wittland 11, Postfach

21 45, D-24109 Kiel, -

bulk manufacturer,

primary packager,

batch releaser (Haupt

PharmaWulfing

GmbH, Bethelner

Landstr. 18, 31028

Gronau/Leine,

Germany - solvent

manufacturer,

primary packager);

(Ferring International

Center SA, Chemin

de la Vergognausaz

50, 1162 Saint-Prex,

Switzerland -

secondary packager)

Germany G03GA01 1345306.05.2014

06.05.2019PoM

Ferring GmbH,


21 45, D-24109 Kiel,

Germany

994 Choragongonadotrophin

chorionic

powder for solution

for injection

5000IU,

powder, in ampoules (3)

and 1ml solvent, in

ampoules (3)

Ferring GmbH,


21 45, D-24109 Kiel, -

bulk manufacturer,

primary packager,

batch releaser (Haupt

PharmaWulfing

GmbH, Bethelner

Landstr. 18, 31028

Gronau/Leine,

Germany - solvent

manufacturer,

primary packager);

(Ferring International

Center SA, Chemin

de la Vergognausaz


Switzerland -

secondary packager)

Germany G03GA01 1345406.05.2014

06.05.2019PoM

Ferring GmbH,


21 45, D-24109 Kiel,

Germany

217

995 Chymotrypsin chymotrypsin

powder lyophilized

for solution for

injection, local and

external use

10mg,

glass vial (10)

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158

Russia B06AA04 1573823.06.2016

23.06.2021PoM

"Samson-Med" LLC,

Moscow highway, 13,

Saint Petersburg,

196158, Russia

996Chymotrypsin

Crystallinechymotrypsin

lyophilisate for


10mg,

glass vial (10)

"BIOFARMA" "PP"

LLC, 37, Kyivska Str.,

Bila Tserkva, 09100,

Kyiv region

Ukraine D03B 1657803.04.2017

03.04.2022PoM

"BIOFARMA" "PP"



Kyiv region, Ukraine

997Chymotrypsin

crystallizedchymotrypsin

powder lyophilized

for solution for

injection and for

external use

10mg,

ampoules (10)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine D03B 1367908.07.2014

08.07.2019PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

998 Cialis tadalafil tablets film-coated

20mg,

in blister (1/1x1/, 2/1x2/,

4/2x2/, 8/4x2/)

Lilly S.A., Avda de la

Industria 30, 28108

Alcobendas-Madrid-

primary, secondary

packager, batch


manufacturer - Lilly

del Caribe, Inc.,

Puerto Rico 00985

Industrial Park, 12,6

km 65th Infantry

Road, Carolina, Spain)

Spain G04BE08 1224807.03.2013

07.03.2018PoM

Eli Lilly Nederland


NL-3991 RA, Houten,

the Netherlands

999 Cialis tadalafil tablets film-coated

20mg,

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

8/4x2)


Industria 30, 28108

Alcobendas-Madrid-

batch releaser,

packager, Lilly del

Caribe, Inc., Puerto

Rico 00985, 12,6 km

65th Infantry Road,

Carolina, USA- bulk

manufacturer

Spain G04BE08 1707705.10.2017

05.10.2022PoM

Eli Lilly Nederland

B.V.,Grootslag 1-5,

NL-3991

RA,Houten,the

Netherlands

218

1000 Ciazil

epirubicin

(epirubicin

hydrochloride)


5ml glass vial

Genepharm S.A., 18th

km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L01DB03 1372524.07.2014

24.07.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51

Pallini Attiki, Greece

1001 Ciazil

epirubicin

(epirubicin

hydrochloride)


25ml glass vial


km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L01DB03 1372624.07.2014

24.07.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51


1002 Cilapenem

imipenem

(imipenem

monohydrate),

cilastatin (cilastatin

sodium)

powder for solution

for infusion

500mg+500mg, glass

bottle (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus J01DH51 1544802.04.2016

02.04.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1003 Cilozek cilostazol tablets100mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland B01AC23 1537926.02.2016

26.02.2021PoM

Adamed Limited

Liability Company,

Pienkow 149, 05-152

Czosnow, Poland

1004 Cinnabsin

cinnabaris trit. D3,

hydrastis trit. D3,

kalium

bichromicum trit.

D3, echinacea

trit.D1

tablets

25mg+25mg+

25mg+25mg,


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

Germanyhomeopathic

drug14331

25.03.2015

25.03.2020OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,

Ottostrasse 24, 76227

Karlsruhe, Germany

219

1005 Cinnarizine cinnarizine tablets25mg,

in blister (50)

Farma AD, 2600

Dupnitsa, Str. "Neofit

Rilski" 13

Bulgaria N07CA02 1262021.06.2013

21.06.2018PoM

Farma AD, 2600

Dupnitsa, Str. "Neofit

Rilski" 13, Bulgaria

1006Cinnarizine

Sopharmacinnarizine tablets

25mg,


Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia

Bulgaria N07CA02 1651317.03.2017

17.03.2022PoM

Sopharma JSC, str.

Iliensko shosse 16,


1007 CinnoVex interferon beta-1a

powder lyophilized

for solution for i/m

injection

30mcg (6MIU),

(4 /1 glass vial with

powder +1pre-filled

syringe with 1ml solvent+

2 needles/)

CinnaGen Co., West

6th St., 3rd Sq.,

Simindasht Industrial

Area, Karaj, Alborz

Iran L03AB07 1657403.04.2017

03.04.2022PoM

CinnaGen Co., West

6th St., 3rd Sq.,

Simindasht Industrial

Area, Karaj, Alborz,

Iran

1008 Ciprinol ciprofloxacin solution for infusion2mg/ml,

100ml glass vial

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1612010.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1009 Ciprinol

ciprofloxacin

(ciprofloxacin

hydrochloride

monohydrate)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1614623.11.2016

23.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1010 Ciprinol ciprofloxacinconcentrate for


10mg/ml,

10ml ampoules (5)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1640110.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1011 Ciprinol

ciprofloxacin

(ciprofloxacin

hydrochloride

monohydrate)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1640210.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1012 Ciprinol

ciprofloxacin

(ciprofloxacin

hydrochloride

monohydrate)



KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01MA02 1640310.02.2017

10.02.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

220

1013 Ciprobay

ciprofloxacin

(ciprofloxacin

hydrochloride

monohydrate)



Bayer Pharma AG, D-

51368 Leverkusen Germany J01MA02 16381

30.12.2016

30.12.2021PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353, Berlin,

Germany

1014 Cipro-Denk 500

ciprofloxacin

(ciprofloxacin

hydrochloride)



Allphamed PHARBIL

Arzneimittel GmbH,

Hildebrandstr. 12,

37081 Gottingen

Germany J01MA02 1613810.11.2016

10.11.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1015 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)


in blister (10)

Borisov Medical

Preparations Plant

OJSC, 64/27,



Belarus J01MA02 1221607.03.2013

07.03.2018PoM

Borisov Medical

Preparations Plant

OJSC, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast,

BELARUS

1016 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)


in blister (10)

Borisov Medical

Preparations Plant

OJSC, 64/27,



Belarus J01MA02 1221707.03.2013

07.03.2018PoM

Borisov Medical

Preparations Plant

OJSC, 64/27,

Chapayev str.,

Borisov 222120,

Minsk oblast,

BELARUS

1017 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)

drops eye/ear3mg/ml,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01AE03 1603217.10.2016

17.10.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1018 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)

drops eye3mg/ml,


Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01AE03 16148

23.11.2016

23.11.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

221

1019 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)

solution for infusion2mg/ml,

200ml plastic pack

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaJ01MA02 16264

19.12.2016

19.12.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1020 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)



Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus J01MA02 1717630.11.2017

30.11.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

1021 Ciprofloxacin

ciprofloxacin

(ciprofloxacin

hydrochloride)



Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus J01MA02 1717730.11.2017

30.11.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

1022Ciprofloxacin

Alkaloidciprofloxacin

concentrate for


10mg/ml,

10ml ampoules,

in blister (5)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000


secondary packager,

Mefar Ilac Sanayii

A.S., Ramazanoglu,

Mah. Ensar-Cad.

No:20, 34906 Kurtkoy-

Pendik, Istanbul,

Turkey- bulk

manufacturer,

primary packager

Macedonia J01MA02 1634330.12.2016

30.12.2021PoM

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

222

1023Ciprofloxacin-

Asteria Tab. 500mg

ciprofloxacin

(ciprofloxacin

hydrochloride)

tablets film-coated

500mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth J01MA02 13669/209.10.2015

08.07.2019PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

1024Ciprofloxacin-

Asteria Tab. 500mg

ciprofloxacin

(ciprofloxacin

hydrochloride)

tablets film-coated

500mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


Si, Chungcheongbuk-

do

Korea South J01MA02 1719208.12.2017

08.12.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, South Korea

1025 Cipro-Tech 0,2%

ciprofloxacin

(ciprofloxacin

hydrochloride)

solution for infusion2mg/ml; 100ml and

200ml plastic pack

PharmaTech CJSC,


str. 111

Republic of

ArmeniaJ01MA02 15431

02.04.2016

02.04.2021PoM

PharmaTech CJSC,



Armenia

1026CIPRO-TRO

500mg

ciprofloxacin

(ciprofloxacin

hydrochloride)



S Kant Healthcare

LTD, Plot 1802-1805,

GIDC Phase III, Vapi -

396 195

India J01MA02 1717830.11.2017

30.11.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

1027

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion

cisplatinconcentrate for


1mg/1ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North


4HF - batch releaser (bulk

manufacturer, primary

packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,

Gujarat, India) (secondary

packager- Accord




Haverhill, CB9 8QP, UK)

UK L01XA01 14664/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

223

1028

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14665/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1029

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14666/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

224

1030

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14667/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1031

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14668/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

225

1032

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,


Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14669/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1033

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14670/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

226

1034

Cisplatin 1mg/ml

Concentrate for

Solution for

Infusion



1mg/1ml,


Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01XA01 14671/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1035 Cisplatin Ebewe cisplatinconcentrate for


0,5mg/ml,


EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01XA01 1391429.10.2014

29.10.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

1036Cisplatin-Asteria

Inj. 50mg/50mlcisplatin solution for injection

1mg/ml,

50ml glass bottle

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth L01XA01 12655/120.08.2015

04.07.2018PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

1037Cisplatin-Asteria

Inj. 50mg/50mlcisplatin

solution for i/v

injection

1mg/ml,

50ml glass vial

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South L01XA01 1680422.06.2017

22.06.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

YoungDeungPo-Ku,

Seoul, Korea South

227

1038 Cisplatin-Teva cisplatinconcentrate for


0,5mg/ml,

20ml, 50ml and 100ml

glass bottle

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem

the Netherlands L01XA01 1356910.06.2014

10.06.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

1039 Cisplatin-Teva cisplatinconcentrate for


1mg/ml,

100ml glass bottle

Pharmachemie B.V.

Swensweg 5, NL 2031

GA Haarlem

the Netherlands L01XA01 1357010.06.2014

10.06.2019PoM

TEVA

Pharmaceutical

Industries LTD, 5


3190, 49131 Petach

Tikva, Israel

1040 CITOLEPTciticoline (citicoline

sodium)


i/m injection

250mg/ml,

4ml ampoules,

in blister (5/1x5/)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,


settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia N06BX06 1644906.03.2017

06.03.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

1041 CITOLEPTciticoline (citicoline

sodium)


i/m injection

125mg/ml,

4ml ampoules,

in blister (5/1x5/)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,


settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia N06BX06 1645006.03.2017

06.03.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

1042 Citramon P


paracetamol,

caffeine (caffeine

monohydrate)

tablets240mg+180mg+ 30mg, in

strip (6, 10)

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.


str., 124

Russia N02BA71 1500702.12.2015

02.12.2020OTC

Irbitskiy

himfarmzavod JSC,

643 RU, Irbit, St.

Sverdlovsk, Kirova

str., 172, Russia

228

1043 Citramon-P


paracetamol,

caffeine (caffeine

monohydrate)

tablets

240mg+180mg+ 30mg,


20/2x10/)

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18

Russia N02BA71 12357/104.09.2013

09.04.2018OTC

Pharmstandard-

Leksredstva OJSC,

305022, Kursk,


1a/18, Russia

1044 Clacin-Asteria clarithromycin tablets

500mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth J01FA09 1525329.12.2015

29.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

1045 Clafendiclofenac

(diclofenac sodium)gel

50mg/g,

45g aluminium tube

Antibiotice S.A., 1,

Valea Lupului,

707410 lasi

Romania M02AA15 1687031.07.2017

31.07.2022OTC


Valea Lupului,


1046 Claforan

cefotaxime

(cefotaxime

sodium)

powder and solvent

for solution for

injection

1000mg,


in ampoule

Zentiva Saglik

Urunleri San.ve Tic.

A.S., Kucukkaristiran

Mahalessi, Merkez

Sokak No:223/A,

39780

Buyukkaristiran,

Luleburgaz, Kirklareli

Turkey J01DD01 1592423.08.2016

23.08.2021PoM

Sanofi Aventis Ilaclari

Ltd. Sti., Buyukdere

Cad. No:193 Levent

34394 Sisli-Istanbul,

Turkey

1047 Clarazole Cream ketoconazole cream20mg/g,

30g aluminium tube

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD01AC08 13668

08.07.2014

08.07.2019OTC

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

1048 Clarem 250 clarithromycin tablets film-coated250mg,


Remedica Ltd,

Aharnon street,

Limassol Industrial


Cyprus J01FA09 1586127.07.2016

27.07.2021PoM

Remedica Ltd,

Aharnon street,

Limassol Industrial


Cyprus

229

1049 Clarem 500 clarithromycin tablets film-coated500mg,


Remedica Ltd,

Aharnon street,

Limassol Industrial


Cyprus J01FA09 1586227.07.2016

27.07.2021PoM

Remedica Ltd,

Aharnon street,

Limassol Industrial


Cyprus

1050 Clarithromycin clarithromycin tablets coated250mg,

in blister (10)

Open joint stock


zavod medicinskikh

preparatov, 64/27,



Belarus J01FA09 1328404.03.2014

04.03.2019PoM

Open joint stock


zavod medicinskikh

preparatov, 64/27,


222120, Minsk

region, Belarus

1051

Clarithromycin

250mg Film-coated

Tablets

clarithromycin tablets film-coated250mg,


Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK J01FA09 1541822.03.2016

22.03.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

230

1052

Clarithromycin

250mg Film-coated

Tablets

clarithromycin tablets film-coated250mg; (14/1x14/), in

blister

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK J01FA09 1541922.03.2016

22.03.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1053

Clarithromycin

500mg Film-coated

Tablets



Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,








packager

UK J01FA09 1542022.03.2016

22.03.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

231

1054

Clarithromycin

500mg Film-coated

Tablets



Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,








packager

UK J01FA09 1542122.03.2016

22.03.2021PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1055Clarithromycin

Grindeksclarithromycin tablets film-coated

250mg,


Bluepharma -

Industria

Farmaceutica, S.A., S.

Martinho do Bispo,

Coimbra, 3045-016

Portugal J01FA09 1401626.11.2014

26.11.2019PoM

Grindeks JSC,


1057, Riga, Latvia

1056Clarithromycin

Grindeksclarithromycin tablets film-coated

500mg,


Bluepharma -

Industria

Farmaceutica, S.A., S.

Martinho do Bispo,

Coimbra, 3045-016

Portugal J01FA09 1401726.11.2014

26.11.2019PoM

Grindeks JSC,


1057, Riga, Latvia

1057 Claritine loratadine syrup

1mg/ml,



spoon


N.V., Industriepark


den-Berg

Belgium R06AX13 13614/107.12.2015

27.06.2019OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

1058 Claritine loratadine tablets10mg,

blister (10/1x10/)


N.V Industriepark 30,

B-2220 Heist op-den-

Berg

Belgium R06AX13 13707/101.09.2016

24.07.2019OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

232

1059 ClariTRONN clarithromycin tablets film-coated

500mg,


100/10x10/)

Protech Biosystems

Pvt. Ltd., Plot No 145-

146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001

India J01FA09 13123/104.06.2014

10.01.2019PoM

Protech Biosystems

Pvt. Ltd., Plot No 145-

146, Pace City-1,

Sector-37, Gurgaon,

Haryana-122001,

India

1060 ClariXyz desloratadine tablets film-coated5mg,


Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208

Bangladesh R06AX27 13674/126.09.2014

08.07.2019OTC

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

1061 ClariXyz desloratadine syrup

0,5mg/ml,


double-ended measuring

spoon (2,5ml/5ml)

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208

Bangladesh R06AX27 13675/126.09.2014

08.07.2019OTC

Orion Pharma Ltd.,


Tejgaon Industrial

Area, Dhaka-1208,

Bangladesh

1062 Clavoton 1g

amoxicillin

(amoxicillin

trihydrate),

clavulanic acid

(potassium

clavulanate)



Medochemie Ltd-

Factory B, 48 Iapetou

street, Agios


Area, 4101 Agios


Cyprus J01CR02 1498718.11.2015

18.11.2020PoM

Medochemie Ltd., 1-

10

Constantinoupoleos


Cyprus

1063 Clemastin

clemastine

(clemastine

fumarate)


1mg/ml,


ampoules, dividella (10)

Open Joint Stock

Company , 64/27,



Belarus R06AA04 1303625.11.2013

25.11.2018PoM

Open Joint Stock

Company , 64/27,

Chapayev str.,

Borisov 222120,


1064 Clexane

enoxaparin

(enoxaparin

sodium)


20mg/0,2ml,

0,2ml pre-filled syringes

(2)

Sanofi Winthrop

Industrie, 180, rue

Jean Jaures, 94702

Maisons-Alfort Cedex

France B01AB05 12650/127.06.2017

04.07.2018PoM

Sanofi-Aventis

France, 82 avenue

Raspail, 94250

Gentilly, France

233

1065 Clexane

enoxaparin

(enoxaparin

sodium)


40mg/0,4ml,


(10/2x5/)

Sanofi Winthrop

Industrie, 180, rue

Jean Jaures, 94702


France B01AB05 12651/127.06.2017

04.07.2018PoM

Sanofi-Aventis

France, 82 avenue

Raspail, 94250

Gentilly, France

1066 Clexane

enoxaparin

(enoxaparin

sodium)


60mg/0,6ml,


(2)

Sanofi Winthrop

Industrie, 180, rue

Jean Jaures, 94702


France B01AB05 12652/127.06.2017

04.07.2018PoM

Sanofi-Aventis

France, 82 avenue

Raspail, 94250

Gentilly, France

1067 Clexane

enoxaparin

(enoxaparin

sodium)


80mg/0,8ml,


(10/2x5/)

Sanofi Winthrop

Industrie, 180, rue

Jean Jaures, 94702


France B01AB05 12653/127.06.2017

04.07.2018PoM

Sanofi-Aventis

France, 82 avenue

Raspail, 94250

Gentilly, France

1068 Clexepar

enoxaparin

(enoxaparin

sodium)


20mg/0,2ml,


(6)

Gland Pharma Ltd,

Survey No: 143 - 148,

150&151, D.P. Pally,

Dundigal Post,

Qutbullapur Mandal,

Ranga Reddy District,

Hyderabad, 500 043,

Telangana State

India B01AB05 1693428.08.2017

28.08.2022PoM

APC Pharmaceuticals

& Chemicals (Europe)

Ltd., 9TH Floor, C P

House, 97-107

Uxbridge Road,

Ealing, London W5

5TL, UK

1069 Clexepar

enoxaparin

(enoxaparin

sodium)


40mg/0,4ml,


(6)

Gland Pharma Ltd,

Survey No: 143 - 148,

150&151, D.P. Pally,

Dundigal Post,

Qutbullapur Mandal,

Ranga Reddy District,

Hyderabad, 500 043,

Telangana State

India B01AB05 1693528.08.2017

28.08.2022PoM

APC Pharmaceuticals

& Chemicals (Europe)

Ltd., 9TH Floor, C P

House, 97-107

Uxbridge Road,

Ealing, London W5

5TL, UK

234

1070Climaxan

homeopatic

cimicifuga racemosa

C200, lachesis

mutus C50, apis

mellifica C200

tabletsin blister (20/1x20/,

40/2x20/)

NPF Materia Medica

Holding LLC, 54,


Chelyabinsk 454139

Russiahomeopathic

drug14296/1

31.07.2015

19.03.2020OTC

NPF Materia Medica


3rd Samotyochny


Russia

1071 Clindabiox

clindamycin

(clindamycin

phosphate)

suppositories vaginal100mg

(3/1x3/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AA10 1346306.05.2014

06.05.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

1072 Clindamycin

clindamycin

(clindamycin

hydrochloride)

capsules150mg,

in blister (16)

Chanelle Medical,

Loughrea, Co. Galway Ireland J01FF01 12544

06.06.2013

06.06.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Armenia

1073 Clindamycin

clindamycin

(clindamycin

hydrochloride)

capsules300mg,

in blister (16)

Chanelle Medical,

Loughrea, Co. Galway Ireland J01FF01 12545

06.06.2013

06.06.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Armenia

1074 Clobetasol

clobetasol

(clobetasol

propionate)

cream for topical use0,5mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


05.10.2013

05.10.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1075 Clobetasol

clobetasol

(clobetasol

propionate)


use

0,5mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


05.10.2013

05.10.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

235

1076 Clogrel

clopidogrel

(clopidogrel

besilate)



Specifar SA, 1, 28

Octovriou str., Agia

Varvara, 12351

Greece B01AC04 1666011.05.2017

11.05.2022PoM

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska

19, 83-200 Starogard

Gdanski, Poland

1077 Clomentin

escitalopram

(escitalopram

oxalate)



Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia

Cyprus N06AB10 13609/102.12.2014

20.06.2019PoM

Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

1078 Clomezole

metronidazole,

neomycin

(neomycin sulfate),

clotrimazole

suppositories vaginal500mg+200mg+ 150mg,

(10/2x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF20 1362427.06.2014

27.06.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

1079 Clonazepam clonazepam tablets2mg,

in blister (24)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AE01 12723

23.07.2013

23.07.2018PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Armenia

1080 Clonazepam clonazepam tablets2mg,


Tarchomin

Pharmaceutical

Works "Polfa" S.A.,

2,A. Fleminga str.,03-

176 Warsaw

Poland N03AE01 1581520.07.2016

20.07.2021PoM/UC

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw, Poland

1081 Clopacin 75mg

clopidogrel

(clopidogrel

besilate)

tablets film-coated

75mg,


84/6x14/)

Acino Pharma AG,

Birsweg 2, CH-4253

Liesberg

Switzerland B01AC04 13449/130.06.2015

06.05.2019PoM

Acino Pharma AG,

Birsweg 2, CH-4253


236

1082 Clopi-Denk 75

clopidogrel

(clopidogrel

besylate)



Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luechow

Germany B01AC04 1405319.12.2014

19.12.2019PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1083 Clopidogrel

clopidogrel

(clopidogrel

bisulfate)

tablets coated75mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus B01AC04 1410429.12.2014

29.12.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1084 Clopidol

clopidogrel

(clopidogrel

bisulfate)



Tufenkji Group LLC,

Kochinyan 13/16,

Yerevan- batch

releaser, packager,


B-21/22, MIDC Area,

Kalmeshwar-441 501,

Dist. Nagpur (M.S.),

India- bulk

manufacturer

Republic of


25.04.2017

25.04.2022PoM

Tufenkji Group LLC,

Kochinyan 13/16,


Armenia

1085Clopiton 75mg film-

coated tablets

clopidogrel

(clopidogrel

bisulfate)



Medopharm, No 34-

B,Industrial Area,

Malur-563 130,

Karnataka for Troge

Medical GmbH,

Milchstrasse 19, D-

20148 Hamburg,

Germany

India B01AC04 12335/128.09.2013

09.04.2018PoM

Troge Medical

GmbH, Milchstrasse

19, D-20148

Hamburg, Germany

237

1086 Closan-50 closantelsolution for s/c

injection

50mg/ml,

100ml glass bottle

Interchemie werken


Vanapere tee 14,


bulk manufacturer,

primary packager,

batch releaser,

Interchemie werken

"De Adelaar" B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands-

secondary packager

Estonia

QP52AG09;

veterinary

drug

1606417.10.2016

17.10.2021PoM

Interchemie werken

"De Adelaar" B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

1087 Clostilbegytclomifene

(clomifene citrate)tablets

50mg,

in glass vial (10)


PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary G03GB02 1610310.11.2016

10.11.2021PoM


PLC, 1106 Budapest,


Hungary

1088Clotri-Denk100

Vaginalclotrimazole tablets vaginal

100mg,

in blister (6), applicator

Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luchow

Germany G01AF02 1285917.09.2013

17.09.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

1089 Clotrimazol clotrimazole spray

10mg/ml,

20g plastic container with

pump dispenser

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania D01AC01 1678022.06.2017

22.06.2022OTC

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1090 Clotrimazole clotrimazole cream for topical use10mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


11.08.2013

11.08.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

238

1091 Clotrimazole clotrimazole cream vaginal20mg/g,

50g aluminium tube

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


11.08.2013

11.08.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1092 Clotrimazole clotrimazole solution topical10mg/ml,

30ml glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


11.08.2013

11.08.2018OTC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1093 Clotrimazole clotrimazole suppositories vaginal100mg

(6)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova G01AF02 1316010.01.2014

10.01.2019PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

1094 Clotrimazole clotrimazole cream10mg/g,

15g aluminium tube

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829

Moldova D01AC01 1325524.02.2014

24.02.2019OTC

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis., MD-4829,

Moldova

1095 Clotrimazole clotrimazolecream for external

use

10mg/g,

20g aluminium tube

GlaxoSmithKline

Pharmaceuticals



Poland D01AC01 1489924.09.2015

24.09.2020OTC

GlaxoSmithKline

Pharmaceuticals

S.A.,189

Grunwaldzka street,

60-322 Poznan,

Poland

1096 Clotrimazole clotrimazole tablets vaginal100mg,

in blister (6/1x6/)

GlaxoSmithKline

Pharmaceuticals



Poland G01AF02 1505102.12.2015

02.12.2020PoM

GlaxoSmithKline

Pharmaceuticals

S.A.,189

Grunwaldzka street,

60-322 Poznan,

Poland

239

1097 Clovate

clobetasol

(clobetasol

propionate)

ointment for

external use

0,5mg/g,

25g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AD01 1492720.10.2015

20.10.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1098 Clovate

clobetasol

(clobetasol

propionate)

cream for external

use

0,5mg/g,

25g aluminium tube

Pharmaceutical

Company Jelfa S.A.,

ul. Wincentego Pola

21, 58-500 Jelenia

Gora

Poland D07AD01 1492820.10.2015

20.10.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1099 Coal Tar coal tar shampoo20mg/ml,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


29.10.2014

29.10.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1100 Co-Amlessa

perindopril

(perindopril tert-

butylamine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets2mg+0,625mg+ 5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BX01 1585420.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1101 Co-Amlessa

perindopril

(perindopril tert-

butylamine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets4mg+1,25mg+5mg, in

blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BX01 1585520.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1102 Co-Amlessa

perindopril

(perindopril tert-

butylamine),

indapamide,

amlodipine

(amlodipine

besilate)

tablets4mg+1,25mg+ 10mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BX01 1585620.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

240

1103 Co-Amlessa

perindopril

(perindopril tert-

butylamine),

indapamide,

amlodipine

(amlodipine

besilate)


blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BX01 1585720.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1104 Co-Amlessa

perindopril

(perindopril tert-

butylamine),

indapamide,

amlodipine

(amlodipine

besilate)


blister (30/3x10/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BX01 1585820.07.2016

20.07.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1105 Coaxil tianeptine tablets coated12,5mg,


Les Laboratoires



Gidy

France N06AX14 1356710.06.2014

10.06.2019PoM/UC

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1106 CocarBevit

disodium adenosine

triphosphate

trihydrate,

cocarboxylase,

cyanocobalamin,

nicotinamide

powder lyophilized

for solution for

injection

10mg+50mg+

500mcg+20mg, 2ml

ampoules (3) and 2ml

ampoules with solvent (3)

Biopharm JSC,

380060, 3 Gotua str.,

Tbilisi

Georgia C01EB 1462003.07.2015

03.07.2020PoM

GPC JSC, 6, Sanapiro

str., 0108, Tbilisi,

Georgia

1107Cocarboxylase

hydrochloride

cocarboxylase

(cocarboxylase

hydrochloride)

powder lyophilized

for solution for i/v &

i/m injection

50mg,

ampoules (5), 2ml

solvent in ampoules (5)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia A11DA 1224107.03.2013

07.03.2018PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28,

RUSSIA

1108Cocarboxylase

hydrochloride

cocarboxylase

(cocarboxylase

hydrochloride)

powder lyophilized

for solution for

injection

50mg,

ampoules (10) and 2ml

solvent in ampoule(10)

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9

Ukraine A11DA 1257606.06.2013

06.06.2018PoM

Biopharma PJSC,

03680, Kiev, N.

Amosova str. 9,

Ukraine

241

1109Cocarboxylase

hydrochloride

cocarboxylase

(cocarboxylase

hydrochloride)

powder lyophilized

for solution for

injection

50mg,

glass vial, in blister

(10/2x5/), glass vial

(10/1x10//(5)+ 2ml

solvent in ampoule/(5)),

in blister, glass vial

(20/2x10//(10)+ 2ml

solvent in ampoule/(10))

in blister

"BIOFARMA" "PP"



Kyiv region

Ukraine A11DA 1602517.10.2016

17.10.2021PoM

"BIOFARMA" "PP"



Kyiv region, Ukraine

1110 Codelac Broncho

ambroxol

(ambroxol

hydrochloride),

glycyrrhizinic acid

trisodium (sodium

glycyrrhizinate),

thermopsis extract,

sodium

hydrocarbonate

tablets

20mg+30mg+

10mg+200mg, blister

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

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R05CA10 14363/115.09.2016

25.03.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1111Codelac Broncho

with thyme

ambroxol

(ambroxol

hydrochloride),

glycyrrhizic acid

trisodium (sodium

glycyrrhizinate),

thyme extract

elixir

10mg/5ml+30mg/5ml+50

0mg/5ml; 100ml glass


spoon

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia R05CA10 1729026.12.2017

26.12.2021OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1112 Codelac Neobutamirate

(butamirate citrate)

tablets modified-

release film-coated

50mg,


Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia R05DB13 14833/129.01.2016

04.09.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1113 Co-Diovan

valsartan,

hydrochlorothia-

zide



Novartis Farma S.p.A.,

Via Provinciale Schito

131, 80058 Torre

Annunziata, (NA)

Italy C09DA03 1472615.07.2015

15.07.2020PoM

Novartis Pharma AG,


Basel, Switzerland

242

1114 Co-Diovan

valsartan,

hydrochlorothia-

zide

tablets film-coated

80mg+12,5mg,


28/2x14/)



131, 80058 Torre

Annunziata, (NA)

Italy C09DA03 1472715.07.2015

15.07.2020PoM

Novartis Pharma AG,


Basel, Switzerland

1115 Co-Diovan

valsartan,

hydrochlorothia-

zide





131, 80058 Torre

Annunziata, (NA)-


manufacturer,

Mipharm S.p.A., Via

Bernardo Quaranta,

12, IT-20141 Milano

(MI), Italy- packager

Italy C09DA03 1547102.04.2016

02.04.2021PoM

Novartis Pharma AG,


Basel, Switzerland

1116 Co-Diovan

valsartan,

hydrochlorothia-

zide





131, 80058 Torre

Annunziata, (NA)-


manufacturer,

Mipharm S.p.A., Via

Bernardo Quaranta,

12, IT-20141 Milano

(MI), Italy- packager

Italy C09DA03 1547202.04.2016

02.04.2021PoM

Novartis Pharma AG,


Basel, Switzerland

1117 Co-Diroton

lisinopril (lisinopril

dihydrate),

hydrochlorothia-

zide

tablets

10mg+12,5mg,


30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BA03 1440116.04.2015

16.04.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

243

1118 Co-Diroton


dihydrate),

hydrochlorothia-

zide

tablets

20mg+12,5mg,


30/3x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser, Gedeon

Richter Poland Sp.z

o.o., ul.Graniczna

35,Grodzisk

Mazowiecki, 05-825,

Poland - bulk

manufacturer,

packager

Hungary C09BA03 1440316.04.2015

16.04.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1119Coffein-natrium

benzoate

caffeine-sodium

benzoatesolution for injection

100mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaN06BC01 13169

10.01.2014

10.01.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1120Coffein-natrium

benzoate

caffeine- sodium

benzoatesolution for injection

200mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaN06BC01 13170

10.01.2014

10.01.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1121 Colchicine colchicine tablets0,5mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaM04AC01 14730

30.07.2015

30.07.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1122 Colchicine colchicine tablets1mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaM04AC01 16021

30.09.2016

30.09.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

244

1123 Colchicine colchicine tablets1mg,


S.C. Biofarm S.A., str.

Logofatul Tautu No

99, sector 3,

Bucharest, 031212

Romania M04AC01 1681322.06.2017

22.06.2022PoM

S.C. Biofarm S.A., str.

Logofatul Tautu No

99, sector 3,

Bucharest, 031212,

Romania

1124Colchicine

Opocalciumcolchicine tablets

1mg,


S.C Zentiva S.A,

Theodor Pallady Blvd

nr. 50, sector 3,

Bucuresti, cod 032266

Romania M04AC01 1612910.11.2016

10.11.2021PoM

Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l` Europe, 78400

Chatou, France

1125Colchicine 500

Microgram Tabletscolchicine tablets

0,5mg,


CP Pharmaceuticals


Wrexham LL 13 9UF -


form manufacturer -

Wockhardt Limited,

Survey No. 106/4-5-7,

Kadaiya, Nani Daman,

IN-396210, India)

UK M04AC01 1240518.04.2013

18.04.2018PoM

Wockhardt UK

Limited, Ash Road

North, Wrexham

Industrial Estate, LL

13 9 UF, UK

1126 Colchicum-Dispert colchicine tablets coated0,5mg,


Pharmaselect

International

Beteiligungs GmbH,


20, 1020 Vienna -

batch releaser, Haupt

Pharma Wulfing

GmbH, Bethelner

Landstrasse 18,

Gronau/Leine,


Germany- bulk

manufacturer,

packager

Austria M04AC01 1678222.06.2017

22.06.2022PoM

Pharmaselect

International

Beteiligungs GmbH,


20, 1020 Vienna,

Austria

245

1127 Coldenzagelsemium

sempervirenstablets

6C,


A Nelson and Co


Way, Wimbledon,

London SW19 8UH

UK

R05X

homeopathic

drug

1352030.05.2014

30.05.2019PoM

A Nelson and Co


Way, Wimbledon,

London SW19 8UH,

UK

1128 Coldrex

paracetamol,

caffeine,

phenylephrine

(phenylephrine

hydrochloride),

terpin hydrate,

ascorbic acid

tablets

500mg+25mg+

5mg+20mg+30mg, in

blister (12/1x12/)

S.C. Europharm S.A.,

2 Panselelor str.,

Brasov, county of

Brasov, 500419 -

packager, batch

releaser

(GlaxoSmithKline

Dungarvan Ltd.,

Knockbrack,

Dungarvan, County

Waterford, Ireland -

bulk manufacturer)

Romania N02BE51 1384018.09.2014

18.09.2019OTC

GlaxoSmithKline

Consumer

HealthCare, 980

Great West Road,


TW8 9GS, UK

1129 Coldrex HotRem

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

ascorbic acid

powder for oral

solution with honey

and lemon flavour

750mg+10mg+ 60mg,

5g sachets (10)

SmithKline Beecham

S.A. Ctra. de Ajalvir,

KM-2500-28806,

Alcala de Henares,

Madrid

Spain N02BE51 15357/127.06.2017

26.02.2021OTC

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

1130 Coldrex HotRem

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

ascorbic acid

powder for oral

solution with lemon

flavour

750mg+10mg+ 60mg,

5g sachets (10)

SmithKline Beecham


KM-2500-28806,

Alcala de Henares,

Madrid

Spain N02BE51 15358/104.05.2017

26.02.2021OTC

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

246

1131 Coldrex MaxGrip

paracetamol,

phenylephrine

(phenylephrine

hydrochloride),

ascorbic acid

powder for oral

solution with lemon

flavour

1000mg+10mg+ 40mg,

6,427g sachets (10)

SmithKline Beecham


KM-2500-28806,

Alcala de Henares,

Madrid

Spain N02BE51 13973/125.12.2017

21.11.2019OTC

GlaxoSmithKline

Consumer Healhtcare

(UK) Trading

Limited, 980 Great

West Road,


TW8 9GS, UK

1132Coldrex Menthol

Active

paracetamol,

phenylephrine

(phenylephrine

hydrochloride)

powder for oral

solution with honey

and lemon flavour

600mg+10mg,

6g sachets (10)

SmithKline Beecham

S.A. (Carretera de

Ajalvir, km 2500,

Alcala de Henares,

Madrid, E-28806)

Spain N02BE51 12756/121.10.2013

14.08.2018OTC

GlaxoSmithKline

Consumer

HealthCare (980

Great West Road,


TW8 9GS, UK)

1133 Colexil Oral

colistin (colistin

sulfate),

enrofloxacin

solution oral

1200000IU/ml+

100mg/ml,


Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QJ01RA95;

veterinary

drug

1497218.11.2015

18.11.2020PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray, the

Netherlands

1134 Colokit

sodium phosphate

(sodium phosphate

monohydrate),

disodium phosphate

(disodium

phosphate

anhydrous)

tablets1102mg+398mg,


Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l'Europe-BP 51,

78400 Chatou Cedex -


form manufacturer,

packager - Wellspring

Pharmaceuticals

Canada Corp., 400

Iroquois Shore Road,

Oakville, ON, L6H

1M5, Canada)

France A06AD 12546/120.11.2013

06.06.2018PoM

Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l,Europe-BP 51,

78400 Chatou Cedex,

France

247

1135 Colokit

sodium phosphate

(sodium phosphate

monohydrate),

disodium phosphate

(disodium

phosphate

anhydrous)



Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l'Europe, 78400

Chatou -batch

releaser, Laboratoires

STRADIS, 29 rue

Leon Faucher 51100

Reims, France-

packager, Laboratoires

GALENIQUES

VERNIN, 20 rue

Louis-Charles Vernin,

77190 Dammarie-Les-

Lys, France -bulk

manufacurer

France A06AD 1502802.12.2015

02.12.2020PoM

Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l'Europe, 78400

Chatou, France

1136 Colokit

sodium phosphate

(sodium phosphate

monohydrate),

disodium phosphate

(disodium

phosphate

anhydrous)



Laboratoires

GALENIQUES

VERNIN, 20 rue

Louis-Charles Vernin,

77190 Dammarie-Les-

Lys-bulk

manufacturer, batch

releaser, Laboratoires

STRADIS, 29 rue

Leon Faucher 51100

Reims, France-

packager

France A06AD 1502902.12.2015

02.12.2020PoM

Laboratoires

MAYOLY

SPINDLER, 6 avenue

de l'Europe, 78400

Chatou, France

1137CoLosar-Denk

100/12,5

losartan (losartan

potassium),

hydrochloro-

thiazide



Denk Pharma GmbH


84529 Tittmoning

Germany C09DA01 1335904.04.2014

04.04.2019PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

248

1138CoLosar-Denk

50/12,5

losartan (losartan

potassium),

hydrochloro-

thiazide



Denk Pharma GmbH


84529 Tittmoning

Germany C09DA01 1607626.10.2016

26.10.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

1139 Combilipen

thiamine (thiamine

hydrochloride),

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin,


hydrochloride)

solution for i/m

injection

50mg/ml+ 50mg/ml+

0.5mg/ml+ 10mg/ml,


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

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A11DB 1465103.07.2015

03.07.2020PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28,

Russia

1140 Combilipen Tabs

benfotiamine,

pyridoxine

(pyridoxine

hydrochloride),

cyanocobalamin

tablets film-coated

100mg+100mg+ 2mcg,


30/2x15/, 60/4x15/)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia A11АB 1359010.06.2014

10.06.2019PoM

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28,

Russia

1141Complivit Calcium

D3

cholecalciferol,

calcium

tablets chewable

with orange flavour

0,005mg+500mg, in

plastic container (30, 100)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A12AX 13808/114.12.2015

05.09.2019OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1142Complivit Calcium

D3 Forte

cholecalciferol,

calcium (calcium

carbonate)

tablets

chewablewith mint

flavour

500mg+0.01mg,


and (100)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A12AX 14744/121.04.2016

03.08.2020OTC

OTCPharm PJSC,

123317, Moscow,


Russia

249

1143 Complivit Mamma

vitamin A, vitamin

E, vitamin B1,

vitamin B2, vitamin

B6, vitamin C,

nicotinamide, folic

acid, calcium

pantothenat,

vitamin B12,

ergocalciferol,

phosphor (calcium

hydrophosphate

dihydrate), ferrum

(ferrum fumarate),

manganese

(manganese sulfate

monohydrat

tablets film-coated

0,5675mg

(1650IU)+20mg+

2mg+2mg+5mg+

100mg+20mg+

0,4mg+10mg+ 0,005mg+

0,00625mg

(250IU)+19mg+

10mg+2,5mg+1mg+10mg

+25mg+ 25mg,

plastic container (30, 60)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia A11AA04 12310/109.02.2016

22.03.2018OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1144Complivit

Ophthalmo

vitamin A, vitamin

E, vitamin B1,

vitamin B2, vitamin

B6, vitamin C, folic

acid, rutoside,

vitamin B12, lutein,

zeaxanthin, selen

(sodium selenite),

copper (copper

sulfate

pentahydrate), zinc

(zinc oxide)

tablets film-coated

1mg(2907IU)+

15mg+5mg+2mg+

5mg+50mg+

400mcg+25mg+

3mcg+2,5mg+

1mg+25mcg+ 1mg+5mg,


60)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudaiberdina 28

Russia A11AA04 1539426.02.2016

26.02.2021OTC

Otcpharm PJSC,

123317, Moscow,


Russia

250

1145 Complivit-Active

vitamin A, vitamin E,

vitamin B1, vitamin B2,

vitamin B6, vitamin C,

nicotinamide, folic acid,

rutin (rutoside), calcium

pantotenat, vitamin B12,

ergocalciferol, phosphor

(calcium

hydrophosphate

dihydrate), ferrum

(ferrum fumarate),

manganese (manganese

sulfate monohydrate),

copper (copper sulfate

pentahydrate), zinc

(zinc sulfate

heptahydrate),

magnesium (magnesium

oxide), potassium

(potassium

hydrophosphate

dihydrate), selenate

(sodium selenate),

iodine(sodium iodine),

fluoride (sodium

fluoride)

tablets film-coated

0,7912mg+10mg+1mg+1

mg+1,5mg+50mg+7,5mg+

0,2mg+10mg+

5mg+0,003mg+

0,0025mg(100IU)+27mg+

10mg+1mg+1mg+5mg+22

mg+35mg+0,01mg+

0,1mg+0,5mg, plastic

container (30, 60)

Pharmstandard-

UfaVITA OJSC,

450077, Ufa, str.

Khudajberdina 28

Russia A11AA04 12219/125.07.2016

07.03.2018OTC

OTCPharm PJSC,

123317, Moscow,


Russia

1146 Concor 10mg

bisoprolol

(bisoprolol

fumarate)

tablets film-coated

10mg,


30/1x30/, 50/5x10/,

50/2x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany C07AB07 1339909.04.2014

09.04.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1147 Concor 5mg

bisoprolol

(bisoprolol

fumarate)

tablets film-coated

5mg,


30/1x30/, 50/5x10/,

50/2x25/, 90/3x30/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany C07AB07 1375225.07.2014

25.07.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

1148 Concor COR 2,5mg

bisoprolol

(bisoprolol

fumarate)

tablets film-coated

2,5mg,


30/3x10/, 30/1x30/,

50/5x10/, 50/2x25/)

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt

Germany C07AB07 1375125.07.2014

25.07.2019PoM

Merck KGaA

Frankfurter Strasse

250, 64 293

Darmstadt, Germany

251

1149 Condyline podophyllotoxinsolution for external

use

5mg/ml,

3,5ml glass vial and

plastic applicators (30)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the NetherlandsD06BB04;

herbal drug14042

19.12.2014

19.12.2019PoM

Astellas Pharma

Europe B.

V.,Sylviusweg 62,

2333 BE Leiden, the

Netherlands

1150 Condyline podophyllotoxinsolution for external

use

5mg/ml,

3,5ml glass vial and

plastic applicators (30)

Famar Nederland

B.V., Industrieweg 1,

5531 AD Bladel

the Netherlands D06BB04 1664811.05.2017

11.05.2022PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1151 Contractubex

extract cepae,

heparin (heparin

sodium), allantoin

gel for external use

100mg/g+50IU/g+

10mg/g,

20g aluminium tube

Merz Pharma GmbH

& Co. KGaA,

Ludwigstrasse 22,

Reinheim, Hessen,

64354

Germany C05BA53 1656803.04.2017

03.04.2022OTC

Merz

Pharmaceuticals

GmbH, Eckenheimer

Landstrasse 100,

60318

Frankfurt/Main,

Germany

1152 Contrahist

levocetirizine

(levocetirizine

dihydrochloride)



Pharmaceutical

Works Adamed

Pharma Joint Stock

Company, 95-054

Ksawerow, Szkolna

St. 33

Poland R06AE09 1542902.04.2016

02.04.2021OTC

Adamed Limited

Liability Company,

Pienkow 149, 05-152

Czosnow, Poland

1153 Controloc

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

20mg,

in blister (7/1x7/,

14/1x14/)

Takeda GmbH,

Lehnitz str. 70-98,

16515 Oranienburg

Germany A02BC02 13952/120.07.2015

28.10.2019PoM

Takeda GmbH, Byk-

Gulden str. 2, D-

78467, Konstanz,

Germany

1154 Controloc

pantoprazole

(pantoprazole

sodium

sesquihydrate)

tablets gastro-

resistant

40mg,


28/2x14/)

Takeda GmbH,

Lehnitz str. 70-98,

16515 Oranienburg

Germany A02BC02 13953/120.07.2015

28.10.2019PoM

Takeda GmbH, Byk-

Gulden str. 2, D-

78467, Konstanz,

Germany

252

1155 Controloc

pantoprazole

(pantoprazole

sodium

sesquihydrate)

powder for solution

for injection

40mg,

glass vial (1)

Takeda GmbH,

Robert-Bosch-Str. 8,

78224 Singen

Germany A02BC02 13954/308.11.2017

28.10.2019PoM

Takeda GmbH, Byk-

Gulden str. 2, D-

78467, Konstanz,

Germany

1156 Convulex valproic acidtablets prolonged-

release film-coated

300mg,

in glass or plastic

container (50)

G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria N03AG01 1434325.03.2015

25.03.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1157 Convulex valproic acidtablets prolonged-

release film-coated

500mg,

in glass or plastic

container (50)

G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria N03AG01 1434425.03.2015

25.03.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1158 Convulex valproic acid solution oral

300mg/ml,


measuringe syringe

G.L. Pharma GmbH,


Lannach-batch


GmbH, Arnethgasse

3, 1160 Vienna,

Austria -bulk

manufacturer,

packager

Austria N03AG01 1444804.05.2015

04.05.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

253

1159 Convulex valproic acid syrup

50mg/ml,


measuring syringe

G.L. Pharma GmbH,


Lannach-batch


GmbH, Arnethgasse

3, 1160 Vienna,

Austria -bulk

manufacturer,

packager

Austria N03AG01 1444904.05.2015

04.05.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1160 Convulsofin

calcium valproate

(calcium valproate

dihydrate)

tablets300mg,


Merckle GmbH,

Ludwig-Merckle-

Strasse 3, 89143

Blaubeuren - batch

releaser (Klocke

Pharma-Service

GmbH, Strassburger

Str. 77, Appenweier,

77767, Germany -

bulk manufacturer,

packager)

Germany N03AG01 1399426.11.2014

26.11.2019PoM

TEVA

Pharmaceutical

Industries Ltd., 5


3190, 49131 Petach

Tikva, Israel

1161 Copegus ribavirin tablets film-coated200mg; (42), (168), in

plastic container

F. Hoffmann-La

Roche Ltd.

Wurmisweg CH-4303

Kaiseraugust-batch

releaser, secondary

packager,Patheon

Inc., 2100 Syntex

Court, Mississauga,

Ontario, L5N 7K9,

Canada-bulk

manufacturer,

primary packager

Switzerland J05AB04 1420606.02.2015

06.02.2020PoM

F. Hoffmann La

Roche Ltd.,

Grenzacherstrasse 124

Basel, CH-4070,

Switzerland

1162 CoPlavixclopidogrel,

acetylsalicylic acidtablets film-coated

75mg+100mg,


Sanofi Winthrop

Industrie, 1, rue de la

Vierge, Ambares et

Lagrave, 33565

Carbon Blanc cedex

France B01AC30 1719508.12.2017

08.12.2022PoM

Sanofi Pharma Bristol-

Myers Squibb SNC,

174 Avenue de

France-F-75013 Paris,

France

254

1163 Co-Prenessa

perindopril

(perindopril

erbumine),

indapamide

tablets8mg+2,5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA04 1449615.05.2015

15.05.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1164 Co-Prenessa

perindopril

(perindopril

erbumine),

indapamide

tablets4mg+1,25mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA04 1609110.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1165 Co-Prenessa

perindopril

(perindopril

erbumine),

indapamide

tablets2mg+0,625mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C09BA04 1609210.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1166 Coraxan 5mg ivabradine tablets film-coated

5mg,

in blister 28/2x14/,

56/4x14/)

Les Laboratoires

Servier Industrie 905,


Gidy

France C01EB17 1641310.02.2017

10.02.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1167 Coraxan 7,5mg ivabradine tablets film-coated

7,5mg,


56/4x14/)

Les Laboratoires



Gidy

France C01EB17 1641410.02.2017

10.02.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1168 Cordarone

amiodarone

(amiodarone

hydrochloride)


3ml ampoules (6)

Sanofi Winthrop


Vierge, Ambares et

Lagrave, 33565

Carbon Blanc cedex

France C01BD01 1251301.06.2013

01.06.2018PoM

Sanofi-Aventis

France, 1-13

boulevard Romain

Rolland, 75014 Paris,

France

255

1169 Cordarone

amiodarone

(amiodarone

hydrochloride)

tablets scored200mg,


Chinoin

Pharmaceutical and

Chemical Works

Private Co. Ltd., 2112

Veresegyhaz, Levai u.

5

Hungary C01BD01 15080/103.04.2017

07.12.2020PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

1170Cordiamin-

Darnitsanikethamide solution for injection

250mg/ml,

2ml ampoules,


Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine R07AB02 1234709.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

1171 Cordipin XL nifedipinetablets modified-

release

40mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C08CA05 1508115.12.2015

15.12.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1172 Cordix clopidogrel tablets film-coated75mg,


Pharmaceutical

Works Polfa in

Pabianice JSC, 5

Marszalka J.


200 Pabianice

Poland B01AC04 1705805.10.2017

05.10.2022PoM

Pharmaceutical

Works Adamed

Pharma Joint Stock

Company, 95-054

Ksawerow, Szkolna

St. 33, Poland

1173 Coripren

lercanidipine

(lercanidipine

hydrochloride),


maleate)


(28/2x14/)

Recordati Industria

Chimica e

Farmaceutica S.p.A.,

Via Civitali, 1-20148

Milano

Italy C09BB02 1578020.07.2016

20.07.2021PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

1174 Coripren

lercanidipine

(lercanidipine

hydrochloride),


maleate)


(28/2x14/)

Recordati Industria

Chimica e

Farmaceutica S.p.A.,

Via Civitali, 1-20148

Milano

Italy C09BB02 1578120.07.2016

20.07.2021PoM

Recordati Ireland

Ltd., Raheens East,

Ringaskiddy, Co

Cork, Ireland

1175 Coronal 10

bisoprolol

(bisoprolol

fumarate)



Zentiva a.s.

(Nitrianska 100, 920

27 Hlohovec)

Slovakia C07AB07 1292207.10.2013

07.10.2018PoM

Zentiva a.s.


27 Hlohovec, Slovak

Republic)

256

1176 Coronal 5

bisoprolol

(bisoprolol

fumarate)



Zentiva a.s.


27 Hlohovec)

Slovakia C07AB07 1292107.10.2013

07.10.2018PoM

Zentiva a.s.


27 Hlohovec, Slovak

Republic)

1177 Corsiz

alfa-bromisovaleric

acid ethyl ester,

phenobarbital,

peppermint oil

tablets8,2mg+7,5mg+ 0,58mg,



0198 Tbilisi,

Chirnakhuli str. 14

Georgia N05CB02 1286317.09.2013

17.09.2018OTC


0198 Tbilisi,


Georgia

1178 Cortexincattle or pig brain

cortex polypeptides

powder lyophilized


injection

10mg,

5ml glass vials (10/2x5)

"Geropharm" Ltd,

196158 Saint

Petersburg,

Moskovskoe shosse,

13, lit. VL.

Russia N06BX 12550/130.12.2016

06.06.2018PoM

"Geropharm" Ltd,

191119 Saint

Petersburg,

Zvenigorodskaya ul.

9, Russia

1179 Cortexincattle brain cortex

polypeptides

powder lyophilized


injection

10mg,


(10/2x5/)

"Geropharm" Ltd,

building 83, lit. AAN,

Obolensk, Serpukhov

district, Moscow

region, 142279

Russia N06BX 1555012.05.2016

12.05.2021PoM

"Geropharm" Ltd, 9

Zvenigorodskaya st.,

191119 Saint

Petersburg, Russia

1180 Cortexincattle brain cortex

polypeptides

powder lyophilized


injection

5mg,


(10/2x5/)

"Geropharm" Ltd,

building 83, lit. AAN,

Obolensk, Serpukhov

district, Moscow

region, 142279

Russia N06BX 1555112.05.2016

12.05.2021PoM

"Geropharm" Ltd, 9

Zvenigorodskaya st.,

191119 Saint

Petersburg, Russia

1181 Corvalol

alfa-

bromisovalerianic

acid ethyl ether ,

phenobarbital,

peppermint oil

solution

20mg/ml+ 18,26mg/ml+

1,42mg/ml,

30ml glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaN05CM 13381

04.04.2014

04.04.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

257

1182 Corvalol Farmak

alfa-bromisovaleric

acid ethyl ester,

phenobarbital,

peppermint oil

tablets

12.42mg+11.34mg+0.88m

g,


30/3x10/, 50/5x10/)

PJSC "Farmak", 74

Frunze str., Kiev,

04080

UkraineN05CM;

herbal drug15576/1

27.10.2016

12.05.2021OTC

PJSC "Farmak", 74

Frunze str., Kiev,

04080, Ukraine

1183 Corvalol-MFF

alfa-

bromisovalerianic

acid ethyl ether,

phenobarbital

drops oral

20mg/ml+8,26mg/ml,

15ml, 25ml and 50ml

glass vial-dropper

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow

Russia N05CM 1354130.05.2014

30.05.2019OTC

Moscow

Pharmaceutical

factory JSC, 125239,

Pharmaceutical

passage 1, Moscow,

Russia

1184Corvalol-

Pharmstandard

alfa-bromisovaleric

acid ethyl ester,

phenobarbital,

peppermint oil

drops oral

20mg/ml+ 18,26mg/ml+

1,42mg/ml,

25ml glass bottle-dropper

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18

Russia N05CM 1711123.10.2017

23.10.2022OTC

Pharmstandard-

Leksredstva JSC,

305022, Kursk,


1a/18, Russia

1185 Coryol carvedilol tablets12,5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AG02 1334317.03.2014

17.03.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1186 Coryol carvedilol tablets25mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AG02 1552119.04.2016

19.04.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1187 Coryol carvedilol tablets6,25mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia C07AG02 1552219.04.2016

19.04.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

258

1188 Co-Sentor

losartan (losartan

potassium),

hydrochlorothi-

azide



Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser (Gedeon

Richter Polska Sp.z

o.o., Graniczna str.

N35 , Grodzisk

Mazowiecki 05-825,

Poland - bulk

manufacturer,

packager)

Hungary C09DA01 1392529.10.2014

29.10.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1189 Co-Sentor

losartan (losartan

potassium),

hydrochloro-

thiazide



Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser (Gedeon

Richter Polska Sp.z

o.o., Graniczna str.

N35 , Grodzisk

Mazowiecki 05-825,

Poland - bulk

manufacturer,

packager)

Hungary C09DA02 1392629.10.2014

29.10.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1190 Co-Sentor

losartan (losartan

potassium),

hydrochlorothia-

zide



Gedeon Richter

Polska Sp. z o.o., ul.

Ks. J. Poniatowskiego

5, Grodzisk

Mazowiecki, 05-825-

batch releaser,

Gedeon Richter

Polska Sp. z o.o., ul.

Graniczna 35,

Grodzisk Mazowiecki,

05-825, Poland-bulk

manufacturer,

primary and

secondary packager

Poland C09DA01 1489724.09.2015

24.09.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

259

1191 Co-trimoxazolesulfamethoxazole,

trimethoprimtablets

400mg+80mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01EE01 12849

17.09.2013

17.09.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia




glass bottle

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ01EE01 13295

04.03.2014

04.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia


trimethoprimtablets

400mg+80mg,


Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01EE01 1444104.05.2015

04.05.2020PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222120, Minsk

region, Belarus

1194CoValsar-Denk

160/12.5

valsartan,

hydrochlorothia-

zide



Denk Pharma GmbH


84529 Tittmoning

Germany C09DA03 1534026.02.2016

26.02.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1195CoValsar-Denk

320/12.5

valsartan,

hydrochlorothia-

zide



Denk Pharma GmbH


84529 Tittmoning

Germany C09DA03 1534126.02.2016

26.02.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1196CoValsar-Denk

80/12.5

valsartan,

hydrochlorothi-

azide



Denk Pharma GmbH


84529 Tittmoning

Germany C09DA03 1533926.02.2016

26.02.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

260

1197 Coverex

perindopril

(perindopril

erbumine)

tablets4mg,

in blister (30)


PLC, 1165 Budapest,


120

Hungary C09AA04 1285317.09.2013

17.09.2018PoM


PLC, 1106 Budapest,


Hungary

1198 Credanil 25/250 carbidopa, levodopa tablets25mg+250mg,


Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus N04BA02 1459708.06.2015

08.06.2020PoM

Remedica Ltd,

Limassol Industrial

Estate, Aharnon


Cyprus

1199 Crinone progesterone gel vaginal

80mg/g,

1,125g pre-filled plastic

applicators (6) and

1,125g pre-filled plastic

applicators (15)

Central Pharma

(Contract Packing)

Limited, Caxton

Road, Bedford,

Bedfordshire, MK41

OXZ - secondary

packager, batch

releaser (Fleet


94 Rickmansworth

Road, Watford,

Hertfordshire, WD18

7JJ, UK - bulk

manufacturer);

(Maropack AG,

Industriestrasse

Briseck 4, CH 6144

Zell, Switzerland -

primary packager)

UK G03DA04 1344706.05.2014

06.05.2019PoM

Serono Limited,

Bedfont Cross,

Stanwell Road,

Feltham, Middlesex,

TW14 8NX, UK

1200 Crurovit cilostazol tablets

50mg,


56/4x14/)


PLC, 1165 Budapest,


120

Hungary B01AC23 1449215.05.2015

15.05.2020PoM


PLC, 1106 Budapest,


Hungary

1201 Crurovit cilostazol tablets

100mg,


56/4x14/)


PLC, 1165 Budapest,


121

Hungary B01AC23 1449315.05.2015

15.05.2020PoM


PLC, 1106 Budapest,


Hungary

261

1202 CTC-Oblets

chlortetracycline

(chlortetracycline

hydrochloride)

tablets vaginal1000mg,


Sogeval, Zone

Autoroutiere (53950,

Louverne)

France

QJ01AA03

veterinary

drug

1292507.10.2013

07.10.2018PoM

V.M.D. n.v. (Hoge

Mauw 900, B-2370

Arendonk, Belgium)

1203 Curiosin zinc hyaluronate gel1,027mg/g,

15g aluminium tube


Gyomroi ut 19-21,

1103 Budapest

Hungary D10A 1284117.09.2013

17.09.2018OTC

Gedeon Richter


21, 1103 Budapest,

Hungary

1204 Curosurf poractant alfasuspension

endotracheal

80mg/ml,

1.5ml glass vial

Chiesi

Pharmaceuticals

GmbH, Gonzagagasse

16/16, Wien, 1010-

batch releaser, Chiesi

Farmaceutici S.p.A,

Via Palermo 26/A-

43122 Parma(PR),

Italy-bulk

manufacturer,

primary packager,

G.L. Pharma GmbH,

Arnethgasse 3, 1160

Wien, Austria-

secondary packager

Austria R07AA02 1618223.11.2016

23.11.2021PoM

Chiesi

Pharmaceuticals

GmbH, Gonzagagasse

16/16, Wien, 1010,

Austria

1205Cutiderm

Ointment

fluticasone

(fluticasone

propionate)

ointment0,05mg/g,

10g aluminum tube

Incepta

Pharmaceuticals

Limited, Dewan Idris

Road, Zirabo, Savar,

Dhaka

Bangladesh D07AC17 13580/105.09.2014

10.06.2019PoM

Incepta

Pharmaceuticals



Dhaka, Bangladesh

1206 Cyanocobalamin cyanocobalaminsolution for i/m or

s/c injection

0,2mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaB03B A01 13593

10.06.2014

10.06.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

262

1207 Cyanocobalamin cyanocobalaminsolution for i/m or

s/c injection

0,5mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaB03B A01 13594

10.06.2014

10.06.2019PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1208 Cyclodol

trihexyphenidyl

(trihexyphenidyl

hydrochloride)

tablets

2mg,


48/2x24/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN04AA01 13894

06.10.2014

06.10.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1209 Cyclodol Grindeks

trihexyphenidyl

(trihexyphenidyl

hydrochloride)

tablets2mg,


Grindeks JSC,


1057, Riga

Latvia N04AA01 1621808.12.2016

08.12.2021PoM/UC

Grindeks JSC,



1210 Cyclodol-AM

trihexyphenidyl

(trihexyphenidyl

hydrochloride)

tablets2mg,


SIC Borshchahivskiy

Chemical-


PJSC, 17, Mira St,

Kiev 03134

Ukraine N04AA01 1382110.09.2014

10.09.2019PoM/UC

SIC Borshchahivskiy

Chemical-


PJSC, 17, Mira St,

Kiev 03134, Ukraine

1211 Cycloferon

acridonacetic acid,

N-methyl glucamin

(meglumin)


i/v injection

125mg/ml+ 96,3mg/ml,

2ml ampoules,

in blister (5)

Scientific

Technological

Pharmaceutical Firm

"POLISAN" Ltd,

192102, Saint

Petersburg, Salova st.

72, building 2, lit. A

Russia L03AX 1664125.04.2017

25.04.2022PoM

Scientific

Technological

Pharmaceutical Firm

"POLISAN" Ltd,

192102, Saint

Petersburg, Salova st.

72, building 2, lit. A,

Russia

1212Cyclophospha-

mide-Asteriacyclophosphamide

powder for solution

for injection

500mg,

glass vial (10)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth L01AA01 1517417.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

263

1213 Cyclophosphan cyclophosphamidepowder for solution

for injection

200mg,

glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01AA01 1342514.04.2014

14.04.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1214 Cycloserine cycloserine capsules250mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus J04AB01 1561624.05.2016

24.05.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1215 Cymbalta

duloxetine

(duloxetine

hydrochloride)

capsules hard gastro-

resistant

60mg,


28/2x14/)


Industria 30, 28108

Alcobendas-Madrid,

Spain - batch releaser,

packager (dosage form

manufacturer - Eli

Lilly and Company,

Lilly Technology

Center ,Indianapolis,

Indiana 46285, USA)

Spain N06AX21 1242729.04.2013

29.04.2018PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

1216 Cymbalta

duloxetine

(duloxetine

hydrochloride)

capsules gastro-

resistant

30mg,

in blister (7/1x7/,

14/2x7/, 14/1x14/,

28/4x7/, 28/2x14/)


Industria 30, 28108

Alcobendas-Madrid,




del Caribe Inc.,

Puerto Rico Industrial

Park, 12,6km 65th

Infantry Road,

Carolina, 00985

Puerto Rico)

Spain N06AX21 14135/129.05.2015

29.12.2019PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

264

1217 Cymbalta

duloxetine

(duloxetine

hydrochloride)

capsules gastro-

resistant

60mg,

in blister (7/1x7/,

14/2x7/, 14/1x14/,

28/4x7/, 28/2x14/)


Industria 30, 28108

Alcobendas-Madrid,




del Caribe Inc.,

Puerto Rico Industrial

Park, 12,6km 65th

Infantry Road,

Carolina, 00985

Puerto Rico)

Spain N06AX21 14136/129.05.2015

29.12.2019PoM

Eli Lilly Nederland


NL-3991 RA Houten,

the Netherlands

1218 Cystone

didymocarpus

pedicellata,

saxifraga ligulata,

rubia cordifolia,

cyperus scariosus,

achyranthes aspera,

onosma bracteatum,

vernonia cinerea,

mumie purified,

lime silicate calx

tablets

65mg+49mg+

16mg+16mg+

16mg+16mg+

16mg+13mg+ 16mg,


Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123

India G04BX 1261921.06.2013

21.06.2018PoM

Himalaya Drug

Company, N11,

Makali Grama

Dasanapura Hobli,

Nelamangala Taluk,

Bangalore 562 123,

India

1219 Cytarabine cytarabine

powder lyophilized

for solution for

injection

100mg,

ampoules (5)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BC01 1260221.06.2013

21.06.2018PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1220 Cytarabine cytarabine

powder lyophilized

for solution for

injection

100mg,

glass vial (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01BC01 1529004.02.2016

04.02.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

265

1221 Cyteal

hexamidine

(hexamidine

diisetionate),

chlorhexidine

(chlorhexidine

digluconate),

chlorocresol


use

100mg/100ml+

0.5ml/100ml+

300mg/100ml, 250ml

plastic container

Pierre Fabre

Medicament

Production, site

Progipharm, Rue du

Lycee, 45500 Gien

France D08AC52 1566108.06.2016

08.06.2021OTC

Pierre Fabre

Medicament

Production, 45, place

Abel Gance, 92100

Boulogne, France

1222 Cytosar cytarabine

powder lyophilized

for solution for

injection

500mg,

glass vial and 10ml

solvent in ampoule

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01BC01 1460118.06.2015

18.06.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1223 Cytosar cytarabine

powder lyophilized

for solution for

injection

100mg,


in ampoule

Actavis Italy S.p.A.,

Viale Pasteur, 10,

20014 Nerviano,

Milan

Italy L01BC01 1460218.06.2015

18.06.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1224 Cytotec misoprostol tablets

200mcg,


60/6x10/)

Piramal Healthcare

UK Limited, Whalton

Road Morpeth,

Northumberland,

NE61 3YA

UK A02BB01 1391629.10.2014

29.10.2019PoM

Pfizer H.C.P.

Corporation, 235,

East 42nd str. New

York 10017, USA

1225 Dacarbazine medac dacarbazine

powder lyophilized

for solution for

injection

100mg,

glass vial (10)

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

secondary packager,

batch releaser

(Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany -

bulk manufacturer,

primary packager)

Germany L01AX04 13770/106.12.2016

05.09.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

266

1226 Dacarbazine medac dacarbazine

powder for solution

for injection or

infusion

200mg,

glass vial (10)

Medac GmbH,

Theaterstrasse 6,

22880 Wedel -

secondary packager,

batch releaser

(Oncotec Pharma

Production GmbH,

Am Pharmapark,

06861 Dessau-

Rosslau, Germany -

bulk manufacturer,

primary packager)

Germany L01AX04 13771/231.03.2017

05.09.2019PoM

Medac GmbH,

Theaterstrasse 6,

22880 Wedel,

Germany

1227 Dafneginciclopirox

(ciclopirox olamine)cream vaginal

10mg/g,

78g aluminium tube and

(14) applicator

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1, 29016

Cortemaggiore (PC)

Italy G01AX12 1613010.11.2016

10.11.2021PoM

Polichem S.r.l., Via G.

Marcora, 11, 20121

Milan (MI), Italy

1228 Dafneginciclopirox

(ciclopirox olamine)suppositories vaginal

100mg,

(6/1x6/) and applicator (6)

Doppel Farmaceutici

S.R.L., Via Martiri

delle Foibe, 1, 29016

Cortemaggiore (PC)

Italy G01AX12 1613110.11.2016

10.11.2021PoM

Polichem S.r.l., Via G.

Marcora, 11, 20121

Milan (MI), Italy

1229 Daivobet

betamethasone

(betamethasone

dipropionate),

calcipotriol

(calcipotriol

monohydrate)

ointment for

external use

0,5mg/g+ 0,05mg/g,

15g, 30galuminium or

plastic tube

LEO Laboratories

Limited, 285 Cashel

Road, Dublin 12

Ireland D05AX52 12750/122.11.2016

06.08.2018PoM

LEO Pharmaceutical

Products Ltd A/S

(LEO Pharma

A/S),Industriparken

55, DK-2750

Ballerup, Denmark

267

1230 D-AL prick-test

I-pollen - 1000JSK/1000PNU (1-

grass pollen mixture

I(1000JSK/ml) -

Arrhenatherum elatius,

Dactylis glomerata, Festuca sp.,

Lolium sp., Phleum pratense,

Secale cereale, 2-Spring trees

(1000 JSK /ml) - Alnus

glutinosa, Betula pendula,

Carpinus betulus, Corylus

avellana, 3-Autumn pollen

mixture (1000PNU/ml) -

Artemisia absinthium,

Artemisia vulgaris, Solidago

canadensis, 4-ambrosia

(1000JSK/ml) - Ambrosia

artemisiifolia, 5-ambrosia

(1000PNU/ml) - Ambrosia

artemisiifolia), II-mites -

1000PNU (mixture of mites

(1000PNU/ml) - Acarus siro,

Dermatophagoides farinae,

Dermatophagoides

pteronyssinus), III-moulds -

1000PNU(1-outdoor mould

mixture (1000PNU/ml) -

Alternaria sp.. Botrytis cinerea,

Cladosporium sp., Fusarium

sp., Chrysonilia sitophila, 2-

indoor mould mixture

(1000PNU/ml) - Aspergillus

fumigatus, Aspergillus niger,

Penicillium sp., Mucor sp.,

Rhizopus sp)

solution for skin-

prick test

I-pollen - 1000JSK/ml,

1000PNU/ml+II-mites -

1000PNU/ml+III-moulds -

1000PNU/ml, (1) glass vial

3ml and control solution

in I or III glass vial 3ml

Sevapharma a.s.,

Vitavska 53, 252 63

Roztoky, building 101

and 102

Czech Republic V04CL 1398326.11.2014

26.11.2019PoM

Sevapharma a.s.,

Prumyslova 1472/11,

102 19 Praha 10,

Czech Republic

1231 Dalacin

clindamycin

(clindamycin

hydrochloride)

capsules150mg,

blisters (16/2x8/)

Fareva Amboise, Zone

Industrielle, 29 route

des Industries, 37530

Poce-sur-Cisse

France G01AA10 13411/109.09.2016

14.04.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1232 Dalacin

clindamycin

(clindamycin

hydrochloride)

capsules300mg,

blisters (16/2x8/)




Poce-sur-Cisse

France J01FF01 13412/109.09.2016

14.04.2019PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1233 Dalacin

clindamycin

(clindamycin

phosphate)

cream vaginal

20mg/g,

20g plastic or aluminium

tube and applicators (3)

Pharmacia and

Upjohn Company,

7000 Portage road,

Kalamazoo MI 49001

USA J01FF01 1450915.05.2015

15.05.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

268

1234 Dapsone dapsone tablets100mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaJ04BA02 16759

31.05.2017

31.05.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1235 Dareq desloratadine tablets film-coated5mg,


Delorbis


17 Athinon Street,

Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia - packager,

batch releaser (Iberfar-

Industria

Farmaceutica, S.A.,

Rua Consiglieri

Pedroso, No 121-123-

Queluz de Baixo,

Barcarena- 2745-557,

Portugal - bulk

manufacturer)

Cyprus R06AX27 13445/118.12.2014

16.04.2019PoM

Delorbis

Pharmaceuticals

Ltd.,17 Athinon

str.,Ergates Industrial

Area, 2643 Ergates,

P.O. Box 28629, 2081

Lefkosia, Cyprus

1236 Decapeptiltriptorelin

(triptorelin acetate)solution for injection

0,1mg/ml,

1ml pre-filled syringes (7)

Ferring GmbH,


21 45, D-24109 Kiel -

dosage form

manufacturer,

primary packager,

batch releaser

(secondary packager -

Ferring International

Center SA, Chemin

de la Vergognausaz


Switzerland)

Germany L02AE04 1263425.06.2013

25.06.2018PoM


Center SA, Chemin

de la Vergognausaz


Switzerland

269

1237 Decapeptil Depotriptorelin

(triptorelin acetate)

microcapsules for

suspension for

injection

3,75mg,

pre-filled syringe, 1ml

solvent in pre-filled

syringe, needle

Ferring GmbH,


21 45, D-24109 Kiel -

dosage form

manufacturer,

primary packager,

batch releaser

(secondary packager -


Center SA, Chemin

de la Vergognausaz


Switzerland)

Germany L02AE04 1263525.06.2013

25.06.2018PoM


Center SA, Chemin

de la Vergognausaz


Switzerland

1238 Decaris

levamisole

(levamisole

hydrochloride)

tablets50mg,

in blister (2/1x2/)

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser (S.C. Gedeon

Richter Romania S.A.,

99-105 Guza Voda

str., 540306, Targu-

Mures, Romania -

bulk manufacturer,

packager)

Hungary P02CE01 1401426.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1239 Decaris

levamisole

(levamisole

hydrochloride)

tablets150mg,

in blister (1)

Gedeon Richter PLC,

Gyomroi ut 19-21,


releaser (S.C. Gedeon

Richter Romania S.A.,

99-105 Guza Voda

str., 540306, Targu-

Mures, Romania -

bulk manufacturer,

packager)

Hungary P02CE01 1401526.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

270

1240 Deep Heat

methyl salicylate,

menthol (racemic),

eucalyptus oil,

terpentine oil

cream for external

use

128mg/g+ 59,1mg/g+

19,7mg/g+ 14,7mg/g,


The Mentholatum

Company Limited, 1

Redwood Avenue,

Peel Park Campus,

East Kilbride, G74

5PE, Scotland

UK M02AC 1478614.08.2015

14.08.2020OTC

The Mentholatum

Company Limited, 1

Redwood Avenue,

Peel Park Campus,

East Kilbride, G74

5PE, Scotland, UK

1241 Deep Relief

ibuprofen,

levomenthol

(menthol)

gel for external use50mg/g+30mg/g, 15g, 50g,

100g aluminium tube

The Mentholatum

Company Limited, 1

Redwood Avenue,

Peel Park Campus,

East Kilbride, G74

5PE, Scotland

UK M02AX10 1478714.08.2015

14.08.2020OTC

The Mentholatum

Company Limited, 1

Redwood Avenue,

Peel Park Campus,

East Kilbride, G74

5PE, Scotland, UK

1242 Delufen

sinapis nigra D2,

euphorbium D6,

pulsatilla pratensis

D6, luffa operculata

D12, hydrargyrum

biiodatum D12

spray nasal

0,01ml+0,1ml+

0,1ml+0,1ml+ 0,1ml,

20ml plastic bottle

Richard Bittner AG,


9560 Feldkirchen

Austria

R01AX

homeopathic

drug

1259221.06.2013

21.06.2018OTC

Richard Bittner AG,



1243 Denk-Air 10mg

montelukast

(montelukast

sodium)



Denk Pharma GmbH


84529 Tittmoning

Germany R03DC03 1680022.06.2017

22.06.2022PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1244Denk-Air Junior

4mg

montelukast

(montelukast

sodium)

tablets chewable4mg,


Denk Pharma GmbH


84529 Tittmoning

Germany R03DC03 1679922.06.2017

22.06.2022PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1245Denk-Air Junior

5mg

montelukast

(montelukast

sodium)

tablets chewable5mg,


Denk Pharma GmbH


84529 Tittmoning

Germany R03DC03 1679822.06.2017

22.06.2022PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

271

1246 De-Nol

bismuth

tripotassium

dicitrate

tablets coated

120mg,


112/14x8/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel

the Netherlands A02BX05 1436125.03.2015

25.03.2020PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1247 De-Nol

bismuth

tripotassium

dicitrate

tablets film-coated

120mg,


56/8x7/, 112/8x14/)

"ORTAT" JSC,

Kostromskaya distr.,

Susaninsky region, vil.

Severnoe, microdistr.

Kharitonovo, 157092-

batch releaser,

packager, "R-Pharm"

JSC, Gromova str.,15,

150061, Yaroslavl,

Russia - bulk

manufacturer

Russia A02BX05 17007/108.11.2017

05.09.2022PoM

Astellas Pharma

Europe B. V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1248 Dentinox-Gel N

tincture

chamomille,


hydrochloride),

polidocanol 600

gel

150mg/g+

3,4mg/g+3,2mg/g, 10g

aluminium tube

Dentinox Company Germany G03GA07 1253901.06.2013

01.06.2018OTC

Pharmaceutical

Products Lenk &

Schuppan KG,

Nunsdorfer Ring

1912277, Berlin,

Germany

1249 Dentokind

belladonna D6,

chamomilla D6,

ferrum

phosphoricum D6,

hepar sulfuris D12,

pulsatilla D6

tablets

15mg+15mg+

15mg+15mg+ 15mg,


Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,


Karlsruhe

Germany

A01A;

homeopathic

drug

1678722.06.2017

22.06.2022OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,


Karlsruhe, Germany

1250 DepaChronvalproic acid

(valproate sodium)

tablets controlled-

release coated

300mg,


Incepta

Pharmaceuticals



Dhaka

Bangladesh N03AG01 1309109.12.2013

09.12.2018PoM

Incepta

Pharmaceuticals

Limited, 40, Shahid

Taijuddin Ahmed

Sarani,Tejgaon I/A,

Dhaka -1208,

Bangladesh

272

1251 Depakinevalproate sodium

(valproic acid)syrup

57,64mg/ml,

150ml glass vial and

measuring syringe

Unither Liquid

Manufacturing, 1-3

Allee de la Neste Z.I.

d'En Sigal, 31770,

Colomiers

France N03AG01 1539709.03.2016

09.03.2021PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

1252 Depakine Chronovalproic acid

(valproate sodium)

tablets prolonged-

release film-coated

300mg,

in plastic container

(100/2x50/)

Sanofi Winthrop

Industrie 1, rue de la

Vierge 33565 Carbon

Blanc cedex

France N03AG01 1273323.07.2013

23.07.2018PoM

Sanofi-Aventis

(Suisse) SA, 11, rue de

Veyrot 1217 Meyrin,

Switzerland

1253 Depakine Chronovalproic acid

(valproate sodium)

tablets prolonged-

release film-coated

500mg,


Sanofi Winthrop


Vierge, Ambares et

Lagrave, 33565

Carbon Blanc cedex

France N03AG01 1273423.07.2013

23.07.2018PoM

Sanofi-Aventis

France, 1-13

boulevard Romain


France

1254Depakine enteric

300

valproate sodium

(valproic acid)

tablets gastro-

resistant

300mg,


Sanofi-Aventis S.A.,

Ctra. C35 La Batlloria

a Hostalric, km

63.09,17404 Riells I

Viabrea (Girona)

Spain N03AG01 1591023.08.2016

23.08.2021PoM

Sanofi Winthrop


Vierge-Ambares et

Lagreve, 33565

Carbon Blanc-Cedex,

France

1255 Depanthol

dexpanthenol,

chlorhexidine

(chlorhexidine

bigluconate)

suppositories vaginal 100mg+16mg, (10/2x5/)

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia G01AX 13544/103.02.2016

30.05.2019OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

1256 Depanthol

dexpanthenol,

chlorhexidine

(chlorhexidine

bigluconate)

cream for external

use

52,5mg/g+8mg/g, 30g

aluminium tube

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7

Russia D08AC52 13860/122.01.2016

18.09.2019OTC

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia

273

1257 Deprexor

venlafaxine

(venlafaxine

hydrochloride)

tablets

37,5mg,


60/6x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia - batch

releaser (Unipharm

JSC, 3 Traiko Stanoev

Str., Sofia 1797,

Bulgaria - bulk

manufacturer,

packager)

Bulgaria N06AX16 1346706.05.2014

06.05.2019PoM

Sopharma JSC, str.

Iliensko shosse 16,


1258 Deprexor

venlafaxine

(venlafaxine

hydrochloride)

tablets

75mg,


60/6x10/)

Sopharma JSC, str.

Iliensko shosse 16,

1220 Sofia - batch

releaser (Unipharm

JSC, 3 Traiko Stanoev

Str., Sofia 1797,

Bulgaria - bulk

manufacturer,

packager)

Bulgaria N06AX16 1346806.05.2014

06.05.2019PoM

Sopharma JSC, str.

Iliensko shosse 16,


1259 Deprimsulfamethoxazole,

trimethoprimtablets

400mg+80mg,

in bliater (20/2x10/)

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon


Cyprus J01EE01 1249017.05.2013

17.05.2018PoM

Remedica Ltd.,

Limassol Industrial

Estate, Aharnon

street, P.O. Box

51706, 3508 Limassol,

Cyprus

1260 Dercin

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

infusion

1000mg,

glass vial (1)


PLC, 1165 Budapest,


120 -batch releaser,

SUN Pharmaceutical

Industries Ltd.,Baroda

Highway, Halol,

Gujarat, 389350, India-

bulk manufacturer,

packager

Hungary L01BC05 1424620.02.2015

20.02.2020PoM


PLC, 1106 Budapest,


Hungary

274

1261 Dercin

gemcitabine

(gemcitabine

hydrochloride)

powder lyophilized

for solution for

infusion

200mg,

glass vial (1)


PLC, 1165 Budapest,


120 -batch releaser,

SUN Pharmaceutical

Industries Ltd.,Baroda

Highway, Halol,

Gujarat, 389350, India-

bulk manufacturer,

packager

Hungary L01BC05 1424720.02.2015

20.02.2020PoM


PLC, 1106 Budapest,


Hungary

1262 Dermamed Cream

clobetasol

(clobetasol

propionate)

cream0,5mg/g,

30g aluminium tube

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD07A D01 13471

06.05.2014

06.05.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

1263Dermamed

Ointment

clobetasol

(clobetasol

propionate)

ointment0,5mg/g,

30g aluminium tube

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235

United Arab

EmiratesD07A D01 13470

06.05.2014

06.05.2019PoM

Medpharma Pharm .

& Chem. Inds LLC,

Sharjah, Industrial

Area 13, P.O. Box:

25235, United Arab

Emirates

1264 Dermatril

betamethasone

(betamethasone

dipropionate),

clotrimazole,

gentamicin


cream0,5mg/g+10mg/g+ 1mg/g,

15g aluminium tube

Arpimed LLC, Kotayk

Marz (Abovyan, 2nd

Micro-District, 19

Building)

Republic of

ArmeniaD07CC01 12902

07.10.2013

07.10.2018PoM

Arpimed LLC,

Kotayk Marz

(Abovyan, 2nd Micro-


Republic of Armenia)

1265 Dermazin silver sulfadiazine cream10mg/g,

50g aluminium tube

Salutas Pharma

GmbH, Lange

Goehren 3, 39171

Osterweddingen

Germany D06BA01 1495015.10.2015

15.10.2020OTC

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

275

1266 Dermobacter

benzalkonium

chloride,

chlorhexidine

(chlorhexidine

digluconate)


application

500mg/100ml+

200mg/100ml, 125ml,


Innothera Chouzy,

Rue Rene Chantereau

"Lisle Vert", 41150

Chouzy-Sur-Cisse

France D08AX 1409418.12.2014

18.12.2019OTC


International, 22,

Avenue Aristide

Briand, 94110

Arcueil, France

1267 Dermovate

clobetasol

(clobetasol

propionate)

cream0,5mg/g,

25g in aluminium tube

GlaxoSmithKline

Pharmaceuticals S.A.

(189 Grunwaldzka

street, 60-322

Poznan)

Poland D07AD01 1294421.10.2013

21.10.2018PoM

GlaxoSmithKline

Export Ltd (980 Great

West Road,


TW8 9GS, UK)

1268 Dermovate

clobetasol

(clobetasol

propionate)

ointment0,5mg/g,

25g aluminium tube

GlaxoSmithKline

Pharmaceuticals S.A.

(189 Grunwaldzka

street, 60-322

Poznan)

Poland D07AD01 1294521.10.2013

21.10.2018PoM

GlaxoSmithKline

Export Ltd (980 Great

West Road,


TW8 9GS, UK)

1269Desa 5mg F.C

tabletsdesloratadine tablets film-coated

5mg,

in strip (20/2x10/)

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city

Egypt R06AX27 1424820.02.2015

20.02.2020PoM

Delta Pharma,

Industrial Zone

B4,10th of Ramadan

city, Egypt

1270 Deslora-Denk 5 desloratadine tablets film-coated5mg,


Denk Pharma GmbH


84529 Tittmoning

Germany R06AX27 1450315.05.2015

15.05.2020PoM

Denk Pharma GmbH

& Co. KG,


81675 Muenchen,

Germany

1271 Desmopressin

desmopressin

(desmopressin

acetate)

drops nasal0,1mg/ml,

5ml glass vial-dropper

Biopharm JSC, 0160,

Gotua str. 3, TbilisiGeorgia H01BA02 14105

29.12.2014

29.12.2019PoM

Biopharm JSC, 0160,

Gotua str. 3, Tbilisi,

Georgia

276

1272 Detralex diosmin, hesperidin tablets film-coated

450mg+50mg,


36/3x12/, 60/4x15/)

Les Laboratoires



Gidy

France C05CA53 12745/202.05.2016

23.07.2018OTC

Les Laboratoires

Servier, 50,rue

Carnot, 92284

Suresnes cedex,

France

1273 Detralex diosmin, hesperidin tablets film-coated

450mg+50mg,


36/3x12/, 60/4x15/)

Les Laboratoires



Gidy

France C05CA53 1719408.12.2017

08.12.2022OTC

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1274 Detrimed cholecalciferol drops oral

15000IU/ml,

10ml and 15ml glass

bottle and dropper


Ararat province,

Masis city, Masis


22

Republic of

ArmeniaA11CC05 14901

24.09.2015

24.09.2020PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia

1275 Devit 50000 cholecalciferol tablets film-coated

1,25mg (50 000IU),


8/1x8/)

Quest Vitamins

Middle East Fze,Jebel-

Ali Free Zone, P.O.

Box 17836, Dubai

United Arab

EmiratesA11CC05 16794

22.06.2017

22.06.2022PoM

Lamyra LLP, 3rd

floor, 49 Farringdon

Road, London

EC1M3JP, UK

1276 Dexalfen

dexketoprofen

(dexketoprofen

trometamol)


i/v injection

25mg/ml,

2ml ampoules,

in blister (5/1x5/)

"Sotex"PharmFirm"

CJSC, Bld. 10, 11, 12,


settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345

Russia M01AE17 1660010.04.2017

10.04.2022PoM

"Sotex"PharmFirm"


Belikovo, rural

settlement

Bereznjakovskoe,

Sergiev-Posad

municipal district,

Moscow Region,

141345, Russia

277

1277 Dexalgin

dexketoprofen

(dexketoprofen

trometamol)

tablets film-coated

25mg,


30/3x10/, 50/5x10/)

Laboratorios Menarini

S.A., str. Alfonso XII,

587 08918 Badalona

(Barcelona)

Spain M01AE17 1635830.12.2016

30.12.2021OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

1278 Dexalgin

dexketoprofen

(dexketoprofen

trometamol)

tablets film-coated

25mg,


30/3x10/, 50/5x10/)

A.Menarini

Manufacturing

Logistics and Services

S.r.l.,Via Campo Di

Pile, 67100 L` Aquila

Italy M01AE17 1706005.10.2017

05.10.2022OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

1279 Dexalgin inject

dexketoprofen

(dexketoprofen

trometamol)


i/m injection

25mg/ml,

2ml ampoules

(1, 5)

A. Menarini

Manufacturing

Logistic and Services

Srl Via Sette Santi 3,

50131 Firenze

Italy M01AE17 1392129.10.2014

29.10.2019PoM

Menarini

International O. L.

S.A., Luxembourg 1,

Avenue de la Gare, L-

1611 Luxembourg

1280 Dexalgin sachet

dexketoprofen

(dexketoprofen

trometamol)

granules for oral

solution

25mg,

sachets (10, 20, 30)

Laboratorios Menarini

S.A., str. Alfonso XII,

587 08918 Badalona

(Barcelona)

Spain M01AE17 1676302.06.2017

02.06.2022OTC

Menarini

International

Operations

Luxembourg S.A.,1,

avenue de la Gare,

1611, Luxembourg

1281 Dexamethason

dexamethasone

(dexamethasone

sodium phosphate)


1ml ampoules (25/5x5/)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia H02AB02 1671323.05.2017

23.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1282 Dexamethason dexamethasone tablets0,5mg,


KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia H02AB02 1672020.05.2017

20.05.2022PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

278

1283Dexamethason

0,1%dexamethasone

drops eye

(suspension)

1mg/ml,

5ml plastic vial

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw

Poland S01BA01 1307309.12.2013

09.12.2018PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

1284 Dexamethasone

dexamethasone

(dexamethasone

sodium phosphate)


4mg/ml,


ampoules, in blister

(5/1x5/)

Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine H02AB02 1301425.11.2013

25.11.2018PoM

Lekhim-Kharkiv JSC,



Ukraine

1285 Dexamethasone

dexamethasone

(dexamethasone

sodium phosphate)


4mg/ml,


(10/2x5/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaH02AB02 13313

04.03.2014

04.03.2019PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1286 Dexamethasone

dexamethasone

(dexamethasone

sodium phosphate)


4mg/ml,

1ml ampoules (10, 25,

100)

S.C. Rompharm

Company S.R.L.,



Romania H02AB02 1426820.02.2015

20.02.2020PoM

S.C. Rompharm

Company S.R.L.,



Romania

1287 Dexamethasone

dexamethasone

(dexamethasone

sodium phosphate)


i/v injection

4mg/ml,


(10/2x5/)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaH02AB02 15304

04.02.2016

04.02.2021PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1288 Dexamethasone dexamethasonedrops eye,

suspension

1mg/ml,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01BA01 1603817.10.2016

17.10.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

279

1289

Dexamethasone

sodium phosphate

4mg/ml injection

dexamethasone

(dexamethasone

sodium phosphate)

solution for injection 4mg/ml,

1ml ampoules (10)

Cisen Pharmaceutical

Co., Ltd, Tongji Tech

Industry garden,

Jining High & New

Technology Industries

Development Zone,

Haichuan Road,

Jining,Shandong

Province

China H02AB02 1689108.08.2017

08.08.2022PoM

Troge Medical

GmbH, Milchstrasse

19, 20148 Hamburg,

Germany

1290Dexamethasone-

Asteria Inj. 5mg/ml

dexamethasone

(dexamethasone

disodium

phosphate)


5mg/ml,


(50/5x10/)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea Sourth H02AB02 13728/116.07.2015

24.07.2019PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

1291 Dexarom

dexketoprofen

(dexketoprofen

trometamol)


i/m injection

25mg/ml,

2ml ampoules (5/1x5/)

and 2ml ampoules, in

blister (10/2x5/)

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania M01AE17 1462203.07.2015

03.07.2020PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1292 Dexatobromtobramycin,

dexamethasone

drops eye

(suspension)

3mg/ml+1mg/ml,

5ml plastic vial

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01CA01 1663325.04.2017

25.04.2022PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1293 Dexdor

dexmedetomidine

(dexmedetomidine

hydrochloride)

concentrate for


100mcg/ml,


Orion Corporation,

Orionintie 1, 02200

Espoo

Finland N05CM18 1479404.09.2015

04.09.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

280

1294Deximune 100mg

soft capsulesciclosporin capsules soft

100mg,


Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB (Swiss

Caps AG,

Husenstrasse 35,

Kirchberg, CH-9533,

Switzerland - bulk

manufacturer)

(Klocke Verpackungs-

Service GmbH, Max-

Becker-Strasse 6,

Weingarten, D-76356,

Germany - packager)

UK L04AD01 1339804.04.2014

04.04.2019PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

1295Dexpanthenol-

Hemofarmdexpanthenol

ointment for

external use

50mg/g,

30g aluminium tube

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant



No: bb, Serbia-bulk

manufacturer,

packager

Serbia D03AX03 1621208.12.2016

08.12.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

1296 Diabeton MR gliclazidetablets modified-

release

60mg,


Les Laboratoires



Gidy

France A10BB09 1495115.10.2015

15.10.2020PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1297 Diabeton MR gliclazidetablets modified-

release

60mg,


Servier (Ireland)

Industries Ltd, Gorey

Road, Arklow-Co

Wicklow

Ireland A10BB09 1495215.10.2015

15.10.2020PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

281

1298 Diacarb acetazolamide tablets250mg,


Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska 19,

83-200 Starogard

Gdanski

Poland S01EC01 1587823.08.2016

23.08.2021PoM

Pharmaceutical

Works Polpharma

S.A., ul. Pelplinska

19, 83-200 Starogard

Gdanski, Poland

1299 Dialipon thioctic acid capsules

300mg,


60/6x10/)

PJSC "Farmak", 74

Frunze str., Kiev,

04080

Ukraine A16AX01 1597815.09.2016

15.09.2021PoM

PJSC "Farmak", 74

Frunze str., Kiev,

04080, Ukraine

1300 Dialipon thioctic acid solution for infusion

30mg/ml,

20ml ampoules

(5, 10),

20ml ampoules,

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

PJSC "Farmak", 74

Frunze str., Kiev,

04080

Ukraine A16AX01 1634530.12.2016

30.12.2021PoM

PJSC "Farmak", 63

Frunze str., Kiev,

04080, Ukraine

1301 DiaMar-M

metformin

(metformin

hydrochloride),

glimepiride

tablets500mg+2mg,


Perdaman


Ltd., G/5 & G/6

Gorwa B.I.D.C., City

Vadodara-390 016,

dist. Vadodara

India A10BD02 1725412.12.2017

12.12.2022PoM

Perdaman


Ltd., Level-11, A-111,

Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

1302 DiaMet F

metformin

(metformin

hydrochloride)



Perdaman


Ltd. (G/5 & G/6


Vadodara-390 016,

dist. Vadodara)

India A10BA02 1292807.10.2013

07.10.2018PoM

Perdaman


Ltd. (Level-11, A-111,

Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India)

282

1303 DiaMet F

metformin

(metformin

hydrochloride)



Perdaman


Ltd., G/5 & G/6


Vadodara-390 016,

dist. Vadodara

India A10BA02 1374424.07.2014

24.07.2019PoM

Perdaman



Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

1304 DiaMet F

metformin

(metformin

hydrochloride)

tablets film-coated

1000mg,


150/15x10/)

Perdaman


Ltd., G/5 & G/6


Vadodara-390 016,

dist. Vadodara

India A10BA02 1725512.12.2017

12.12.2022PoM

Perdaman



Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

1305 Diane 35

cyproterone

(cyproterone

acetate),

ethinylestradiol

dragee2mg+0,035mg,


Bayer Pharma AG,

Mullerstrasse 178,

13353 Berlin -

packager, batch

releaser (Bayer

Weimar GmbH & Co.

KG,

Doebereinerstrasse

20, 99427 Weimar,

Germany - bulk

manufacturer)

Germany G03HB01 1377705.09.2014

05.09.2019PoM

Bayer Pharma AG,

Mullerstrasse 178,

13353 Berlin,

Germany

283

1306 Diaxelmet 1000mg

metformin

(metformin

hydrochloride)



Centre Specialites

Pharmaceutiques,

Z.A.C. des Suzots, 35

rue de la Chapelle,

63450, Saint Amant

Tallende- batch

releaser, Micro Labs

Limited, Plot No.

S155- S159, Verna

Industrial Estate,

Phase III, Verna

Salcette, 403722 Goa,

India - bulk

manufacturer,

packager

France A10BA02 1650917.03.2017

17.03.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France


metformin

(metformin

hydrochloride)



Centre Specialites

Pharmaceutiques,


rue de la Chapelle,

63450, Saint Amant

Tallende- batch


Limited, Plot No.

S155- S159, Verna

Industrial Estate,

Phase III, Verna


India - bulk

manufacturer,

packager

France A10BA02 1651017.03.2017

17.03.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

284


metformin

(metformin

hydrochloride)



Centre Specialites

Pharmaceutiques,


rue de la Chapelle,

63450, Saint Amant

Tallende- batch


Limited, Plot No.

S155- S159, Verna

Industrial Estate,

Phase III, Verna


India - bulk

manufacturer,

packager

France A10BA02 1650817.03.2017

17.03.2022PoM

Les Laboratoires

Servier, 50, rue

Carnot, 92284

Suresnes cedex,

France

1309 Diazepam 10mg diazepam tablets10mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


30.04.2014

30.04.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1310 Diazepam 5mg diazepam tablets5mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


30.04.2014

30.04.2019PoM/UC

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

285

1311 Diazepam Alkaloid diazepam solution for injection10mg/2ml,

2ml ampoules (10)

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000


secondary packager,

Mefar Ilac Sanayii

A.S., Ramazanoglu,

Mah. Ensar-Cad.

No:20, 34906 Kurtkoy-

Pendik, Istanbul,

Turkey- bulk

manufacturer,

primary packager

Macedonia N05BA01 1637430.12.2016

30.12.2021PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

1312 Diazepam Alkaloid diazepam tablets coated5mg,


Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje

Macedonia N05BA01 1637530.12.2016

30.12.2021PoM/UC

Alkaloid AD Skopje,

Blvd. Aleksandar

Makedonski 12, 1000

Skopje, Macedonia

1313 Diazolin

mebhydrolin

(mebhydrolin

napadisylate)

dragee100mg,


Marbiopharm JSC,


of Mari El,Yoshkar-


Russia R06AX15 1439616.04.2015

16.04.2020OTC

Marbiopharm JSC,


of Mari El,Yoshkar-

Ola, st. Karl Marx

121, Russia

1314 Diazoline-Farmak mebhydrolin tablets coated50mg,


PJSC "Farmak", 74

Frunze str., Kiev,

04080

Ukraine R06AX15 1577204.07.2016

04.07.2021OTC

PJSC "Farmak", 63

Frunze str., Kiev,

04080, Ukraine

1315 DiaZone-MR 60mg gliclazidetablets modified-

release

60mg,


Perdaman


Ltd., G/5 & G/6


Vadodara-390 016,

dist. Vadodara

India A10BB09 1725612.12.2017

12.12.2022PoM

Perdaman



Himalaya House, KG

Marg, Cannaught

Place, New Delhi-

110001, India

286

1316 Dibazol bendazolsolution for i/m

injection

10mg/ml,

1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaC04AX 15674

08.06.2016

08.06.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1317 Dibazol bendazolsolution for i/m

injection

10mg/ml,

5ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaC04AX 15675

08.06.2016

08.06.2021PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1318 Dicetel

pinaverium

(pinaverium

bromide)



Abbott Healthcare

SAS, Route de

Belleville, Lieu dit

Maillard, 01400

Chatillon sur

Chalaronne

France A03AX04 1501202.12.2015

02.12.2020PoM

Abbott Products SAS,

42 rue Rouget de

Lisle, 92150 Suresnes,

France

1319 Dicetel

pinaverium

(pinaverium

bromide)



Abbott Healthcare

SAS, Route de


Maillard, 01400

Chatillon sur

Chalaronne

France A03AX04 1501302.12.2015

02.12.2020PoM

Abbott Products SAS,

42 rue Rouget de

Lisle, 92150 Suresnes,

France

1320 Diclac 75mg/3mldiclofenac

(diclofenac sodium)solution for injection

75mg/3ml,


Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia M01AB05 1583420.07.2016

20.07.2021PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

287

1321 Diclac gel 5%diclofenac

(diclofenac sodium)gel for external use

50mg/g,

50g aluminium tube

Salutas Pharma

GmbH,

Betriebsstaette

Osterweddingen,

Lange Goehren

3,Suelzetal, OT

Osterweddingen,Sach

sen-Anhalt, 39171

Germany M02AA15 1618323.11.2016

23.11.2021OTC

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1322 Diclac ID 150diclofenac

(diclofenac sodium)

tablets modified-

release

150mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany M01AB05 1446822.04.2015

22.04.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1323 Diclac ID 75diclofenac

(diclofenac sodium)

tablets modified-

release

75mg,


Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben

Germany M01AB05 1446722.04.2015

22.04.2020PoM

Sandoz


Verovskova Str. 57,

1000 Ljubljana,

Slovenia

1324 Diclarendiclofenac


10mg/g,

100g aluminium tube

Laboratorios Basi-

Industria

Farmaceutica, S.A.,

Parque Industrial

Manuel Lourenco

Ferreira, lote 15, 3450-

232 Mortagua

Portugal M02AA15 1653617.03.2017

17.03.2022OTC

GM Pharmaceuticals

Ltd, 65,Phonichala


1325 Dicloberl N 75diclofenac


25mg/ml,

3ml ampoules (5)

A. Menarini

Manufacturing


S.r.l. (Via Sette Santi,

3-50131 Florence)

Italy M01AB05 1297828.10.2013

28.10.2018PoM

Berlin-Chemie AG

(Glienicker Weg 125,

12489 Berlin,

Germany)

288

1326 Dicloberl N 75diclofenac


25mg/ml,

3ml ampoules (5)

Berlin-Chemie AG


12489 Berlin) - batch


manufacturer,

packager - A.

Menarini

Manufacturing


S.r.l. /Via Sette Santi,

3-50131 Firenze,

Italy/)

Germany M01AB05 1297928.10.2013

28.10.2018PoM

Berlin-Chemie AG


12489 Berlin,

Germany)

1327 Dicloberl retarddiclofenac

(diclofenac sodium)

capsules prolonged-

release

100mg,


Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin -

packager, batch

releaser (bulk

manufacturer -

Riemser Speciality

Production GmbH,

Gartenstrasse 6,

88471, Laupheim,

Baden-Wurttemberg,

Germany)

Germany M01AB05 1302025.11.2013

25.11.2018PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany


(diclofenac sodium)

capsules prolonged-

release

100mg,


Menarini-Von

Heyden GmbH,

Germany Leipziger

Strasse 7-13, 01097

Dresden- packager,

Riemser Speciality

Production GmbH,

88471 Laupheim,

Mittelstrasee 18,

Germany-bulk

manufacturer, Berlin-

Chemie AG,

Glienicker Weg 125,

12489 Berlin-batch

releaser

Germany M01AB05 1416224.12.2014

24.12.2019PoM

Berlin-Chemie AG

(Menarini Group),

Glienicker Weg 125,

12489 Berlin,

Germany

289


(diclofenac sodium)

capsules prolonged-

release

100mg,


Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin-batch

releaser (Hennig

Arzneimittel GmbH

& Co. KG,

Liebigstrasse 1 - 2,

65439 Floersheim-am-

Main, Hessen,

Germany-bulk

manufacturer,

Menarini-Von

Heyden

GmbH,Leipziger

Strasse 7-13, 01097

Dresden, Germany-

packager)

Germany M01AB05 1450815.05.2015

15.05.2020PoM

Berlin-Chemie AG,

Glienicker Weg 125,

12489 Berlin,

Germany

1330 Diclobrudiclofenac

(diclofenac sodium)


i/v injection

25mg/ml,

3ml ampoules in blister

(5)

Brupharmexport

SPRL, Rue de la



(dosage form

manufacturer,

packager -

Laboratoires Sterop

NV, Scheutlaan 46-

50, Anderlecht, B-

1070, Belgium)

Belgium M01AB05 1277814.08.2013

14.08.2018PoM

Brupharmexport

SPRL, Rue de la


1020, Belgium

1331Diclo-Denk 100

Rectal

diclofenac

(diclofenac sodium)suppositories rectal

100mg,

in blister (10)

Haupt Pharma

Wulfing GmbH

Bethelner Landstr. 18,

31028 Gronau

Germany M01AB05 12146/125.02.2013

01.02.2018PoM

Denk Pharma GmbH

& Co. KG :


81675 Munchen,

Germany

1332Diclo-Denk 100

Retard

diclofenac

(diclofenac sodium)

tablets delayed-

release

100mg,


(100/10x10/)

Denk Pharma GmbH


84529 Tittmoning

Germany M01AB05 1607828.10.2016

28.10.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

290

1333 Diclo-Denk 50diclofenac

(diclofenac sodium)

tablets enteric-

coated

50mg,


100/10x10/)

Denk Pharma GmbH


84529 Tittmoning

Germany M01AB05 1607928.10.2016

28.10.2021PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

1334Diclo-Denk 75

injection

diclofenac


25mg/ml,

3ml ampoules (10)

Haupt Pharma

Wulfing GmbH

Bethelner Landstr. 18,

31028 Gronau

Germany M01AB0 1214501.02.2013

01.02.2018PoM

Denk Pharma GmbH

& Co. KG :


81675 Munchen,

Germany

1335 Diclofenacdiclofenac

(diclofenac sodium)

tablets film-coated

prolonged-release

100mg,

blisters (20/2x10/)

Hemofarm Ltd,

249030, Obninsk,

Kaluga Region, 62


Russia M01AB05 12205/115.06.2016

07.03.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia



50mg,

(6)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829

Moldova M01AB05 1245607.05.2013

07.05.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829,

Moldova



100mg,

(6, 10/2x5/)

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829

Moldova M01AB05 1245707.05.2013

07.05.2018PoM

Farmaprim SRL,

Crinilor str., 5,

Porumbeni, Criuleni

dis.,MD-4829,

Moldova


(diclofenac sodium)

tablets enteric film-

coated

50mg,

blisters (20/2x10/)

Hemofarm Ltd,

249030, Obninsk,

Kaluga Region, 62


Russia M01AB05 12584/106.04.2016

06.06.2018PoM

Nizhpharm JSC,

603950, Nizhny

Novgorod, GSP-459,

Salganskaya st., 7,

Russia



10mg/g,

40g aluminium tube

Hemofarm D.O.O.



No: bb

Serbia M02AA15 1287719.09.2013

19.09.2018OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

291


(diclofenac sodium)

tablets gastro-

resistant film-coated

50mg,


Hemofarm A.D.

26300, Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm D.O.O.,

Bosnia and

Herzegovina-bulk

manufacturer,

packager

Serbia M01AB05 1360420.06.2014

20.06.2019PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia


(diclofenac sodium)

tablets prolonged-

release film-coated

100mg,


Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb

Serbia M01AB05 1360520.06.2014

20.06.2019PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia


(diclofenac sodium)

solution for i/m

injection

25mg/ml,

3ml ampoules (5)

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb

Serbia M01AB05 1411629.12.2014

29.12.2019PoM

Hemofarm A.D.,

26300, Vrsac,

Beogradskii put bb,

Serbia



10mg/g,

40g aluminium tube

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb-

batch releaser,

Hemofarm A.D.

Vrsac, branch plant



No: bb, Serbia-bulk

manufacturer,

packager

Serbia M02AA15 1627819.12.2016

19.12.2021OTC

Hemofarm A.D.,

26300 Vrsac,

Beogradskii put bb,

Serbia

1344Diclofenac

Ophthalmic

diclofenac

(diclofenac sodium)drops eye

1mg/ml,

10ml vial-dropper

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of

ArmeniaS01BC03 15796

20.07.2016

20.07.2021PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

292

1345 Diclofenac sodiumdiclofenac

(diclofenac sodium)

ointment for

external use

10mg/g,

30g aluminium tube

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus M01AB05 13853/122.01.2015

18.09.2019OTC

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

1346 Diclofenac sodiumdiclofenac

(diclofenac sodium)


i/v injection

25mg/ml,


(5, 5/1x5/)

Lekhim-Kharkiv JSC,


str., 61115 Kharkov

Ukraine M01AB05 1602417.10.2016

17.10.2021PoM

Lekhim-Kharkiv JSC,



Ukraine

1347 Diclofenac-Asteriadiclofenac

(diclofenac sodium)tablets

100mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth M01AB05 1517117.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea


(diclofenac sodium)tablets

50mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth M01AB05 1517217.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea



75mg/3ml,

3ml ampoules (5)

Hankook Korus

Pharm Co., Ltd, 78

Daepungsandan-ro,

Daeso-myeon,

Eumseong-gun,

Chungcheongbuk-do

Korea South M01AB05 1647706.03.2017

06.03.2022PoM

GL Corporation,

Woori Venture

Tower 201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, Korea South

1350Diclofenac-

Zdorovye

diclofenac


10mg/g,


Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine M01AB55 1631530.12.2016

30.12.2021OTC

Pharmaceutical

Company "Zdorovye"



Ukraine

293

1351 Dicloflex 75mg SRdiclofenac

(diclofenac sodium)

tablets prolonged-

release

75mg,


56/4x14/)

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer,

packager - Dexcel

Ltd., 1 Dexcel St., Or-

Akiva 30600, Israel)

UK M01AB05 1269017.07.2013

17.07.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

1352Dicloflex Retard

100mg

diclofenac

(diclofenac sodium)

tablets prolonged-

release

100mg,


Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB - batch


manufacturer,

packager - Dexcel

Ltd., 1 Dexcel St., Or-

Akiva 30600, Israel)

UK M01AB05 1269117.07.2013

17.07.2018PoM

Dexcel-Pharma Ltd.,

7 Sopwith Way,

Drayton Fields

Industrial Estate,

Daventry,

Northamptonshire,

NN11 8PB, UK

1353 Diclondiclofenac


12,5mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of

ArmeniaM01AB05 13595

10.06.2014

10.06.2019PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia



25mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of


10.06.2014

10.06.2019PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia

294



50mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of


10.06.2014

10.06.2019PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia



100mg

(10/2x5/)


Ararat province,

Masis city, Masis


22

Republic of


10.06.2014

10.06.2019PoM


Ararat province,

Masis city, Masis


22, Republic of

Armenia

1357 Dicloton 75mg/3mldiclofenac

(diclofenac sodium)

solution for

injection/infusion

25mg/ml,

3ml ampoules (5)

Medochemie Ltd., 48

Iapetou street, Agios


Area, 4101 Agios


Cyprus M01AB05 1462103.07.2015

03.07.2020PoM

Medochemie Ltd., 1-

10 Constantinoupo-

leos street, 3011

Limassol, Cyprus

1358 Dicynone etamsylate solution for injection250mg/2ml,

2ml ampoules (50)

Lek Pharmaceuticals

d.d. Verovskova Str.

57, 1526 Ljubljana

Slovenia B02BX01 1409018.12.2014

18.12.2019PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

1359 Dicynone etamsylate tablets250mg,


Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia B02BX01 1409118.12.2014

18.12.2019PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

1360 Dicynone etamsylate tablets250mg,


Lek Pharmaceuticals

d.d.,Trimlini 2D,


releaser, packager,

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia-bulk

manufacturer

Slovenia B02BX01 1727513.12.2017

13.12.2022PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

295

1361 Dicynone 250 etamsylatesolution for i/v and

i/m injection

125mg/ml,

2ml ampoules (4)

OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin

2/Geneva - secondary

packager, batch

releaser (Sanofi

Winthrop Industrie, 6

boulevard de l-

Europe-21800

Quetigny, France -

bulk manufacturer,

primary packager)

Switzerland B02BX01 1398226.11.2014

26.11.2019PoM

OM Pharma SA, 22,

rue du Bois-du-Lan,

1217 Meyrin

2/Geneva,

Switzerland

1362 Dieverm 600 albendazole bolus600mg,

blisters (50/5x10/)

Zagros Pharmed Pars

Pharma. Co., Malayer

Ring Way, Borujerd

Iran

QP52AC11;

veterinary

drug

14710/224.10.2016

16.07.2020PoM

Zagros Pharmed Pars

Pharma. Co., No 26,

Nader Alley, Parvin

st., West Dr. Fatemi

ave., Tehran, Iran

1363 Dificlir fidaxomicin tablets film-coated

200mg,


100/10x10/)

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel, (packager,

batch releaser),

Patheon Inc., 2100

Syntex Court,

Mississauga, Ontario,

L5N 7K9, Canada

(dosage form

manufacturer)

the Netherlands A07AA12 1412429.12.2014

29.12.2019PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1364 Diflazon fluconazole capsules150mg,

in blister (1)

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J02AC01 1337304.04.2014

04.04.2019PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1365 Diflucan fluconazolesolution for i/v

infusion

2mg/ml,

50ml glass vial




Poce-sur-Cisse

France J02AC01 13112/124.07.2017

24.12.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

296

1366 Diflucan fluconazole capsules50mg,

in blister (7)




Poce-sur-Cisse

France J02AC01 13113/124.07.2017

24.12.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1367 Diflucan fluconazole capsules150mg,

in blister (1)




Poce-sur-Cisse

France J02AC01 13114/124.07.2017

24.12.2018PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1368 Diflukonazol fluconazole capsules150mg,

in blister (1)

Replek Farm Ltd,


1000 Skopje

Macedonia J02AC01 1357610.06.2014

10.06.2019PoM

Esculap Ltd., 17/2, 1

block, Davidashen,

0054, Yerevan,

Republic of Armenia

1369 Difluzol fluconazole capsules150mg,

in blister (1)

Kievmedpreparat

PJSC, 01032, Kiev,


139

Ukraine J02AC01 1358610.06.2014

10.06.2019PoM

Kievmedpreparat

PJSC, 01032, Kiev,


139, Ukraine

1370 Digoxin digoxin tablets250mcg,


Pharmstandard-

Tomskchimpharm


avenue Lenina, 211

Russia C01AA05 1221807.03.2013

07.03.2018PoM

Pharmstandard-

Tomskchimpharm


avenue Lenina, 211,

Russia

1371 Digoxin digoxin tablets0,25mg,


Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw

Poland C01AA05 1464503.07.2015

03.07.2020PoM

Warsaw

Pharmaceutical

Works "Polfa" S.A.,


01-207 Warsaw,

Poland

1372 Digoxin digoxin tablets0,25mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of


24.09.2015

24.09.2020PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

297

1373 Digoxin digoxin solution for injection

0,25mg/ml,

1ml ampoules,

in blister

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

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C01AA05 1701626.09.2017

26.09.2022PoM

Experimental Plant

"GNCLS" LLC, 61057,

Kharkov, Vorobyova

str., 8, Ukraine

1374 Digoxin Grindeks digoxin tablets0,25mg,


Grindeks JSC,


1057, Riga

Latvia C01AA05 1624919.12.2016

19.12.2021PoM

Grindeks JSC,



1375 Digoxin-Zdorovye digoxin tablets

0,25mg,


50/1x50, 50)

Pharmaceutical

Company "Zdorovye"


Shevchenko str., 22

Ukraine C01AA05 1636230.12.2016

30.12.2021PoM

Pharmaceutical

Company "Zdorovye"



Ukraine

1376 Diklofendiclofenac

(diclofenac sodium)


i/m injection

25mg/ml,

3ml ampoules (5)

Galenika a.d.

Batajnicki drum bb,

11080 Belgrade-batch

releaser, secondary

packager, Mefar Ilac

Sanayii A.S.,

Ramazanoglu Mah.

Ensar Cad. No. 20,

Kurtkoy-Pendik, TR-

34906 Istanbul,

Turkey-bulk

manufacturer,

primary packager

Serbia M01AB05 1418806.02.2015

06.02.2020PoM

Galenika a.d., 11080

Belgrade, Batajnicki

drum b.b.,Serbia

298

1377 Dilatrend carvedilol tablets6,25mg,


F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel -


S.p.A, Via Morelli 2,

20090, Segrate, Italy -

bulk manufacturer)

(F.Hoffmann-La

Roche Ltd.,

Wurmisweg, 4303

Kaiseraugust,

Switzerland -

packager)

Switzerland C07AG02 1382218.09.2014

18.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

1378 Dilatrend carvedilol tablets12,5mg,


F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel -




bulk manufacturer)

(F.Hoffmann-La

Roche Ltd.,

Wurmisweg, 4303

Kaiseraugust,

Switzerland -

packager)


18.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

1379 Dilatrend carvedilol tablets25mg,


F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel -




bulk manufacturer)

(F.Hoffmann-La

Roche Ltd.,

Wurmisweg, 4303

Kaiseraugust,

Switzerland -

packager)


18.09.2019PoM

F. Hoffmann-La

Roche Ltd.,

Grenzacherstrasse

124, 4070 Basel,

Switzerland

299

1380 Diltiazemdiltiazem (diltiazem

hydrochloride)tablets

60mg,


30/3x10/)

'Lubnypharm' PJSC,

37500, Poltava region,

Lubny, Petrovskogo

str. 16

Ukraine C08DB01 1551519.04.2016

19.04.2021PoM

Lubnypharm' PJSC,

37500, Poltava region,

Lubny, Petrovskogo

str. 16, Ukraine

1381Diltiazem

Lannacher 180mg

diltiazem (diltiazem

hydrochloride)

tablets film-coated

prolonged-release

180mg,


G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria C08DB01 1432825.03.2015

25.03.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1382Diltiazem

Lannacher 90mg

diltiazem (diltiazem

hydrochloride)

tablets film-coated

prolonged-release

90mg,


G.L. Pharma GmbH,


Lannach -batch


GmbH,

Industriestrasse 1,

8502 Lannach,

Austria -bulk

manufacturer,

packager

Austria C08DB01 1432725.03.2015

25.03.2020PoM

VALEANT LLC,

Shabolovka st. 31,

building 5, 115162,

Moscow, Russia

1383 Diltiazem Retarddiltiazem (diltiazem

hydrochloride)

capsules prolonged-

release

90mg,


S.C. Rompharm

Company S.R.L.,



Romania C08DB01 1317110.01.2014

10.01.2019PoM

S.C. Rompharm

Company S.R.L.,



Romania

1384 Diltiazem Retarddiltiazem (diltiazem

hydrochloride)

capsules prolonged-

release

180mg,


S.C. Rompharm

Company S.R.L.,



Romania C08DB01 1317210.01.2014

10.01.2019PoM

S.C. Rompharm

Company S.R.L.,



Romania

300

1385 Dilvecor 25mg carvedilol tablets25mg,



Valea Lupului,

707410 lasi

Romania C07AG02 1402026.11.2014

26.11.2019PoM


Valea Lupului,


1386 Dilvecor 6,25mg carvedilol tablets6,25mg,



Valea Lupului,

707410 lasi

Romania C07AG02 1401926.11.2014

26.11.2019PoM


Valea Lupului,


1387 Dimedrol

diphenhydramine

(diphenhydramine

hydrochloride)


10mg/ml; (10) ampoules

1ml, (10) ampoules 1ml

label banderol, (10)

ampoules 1ml dividella

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,



Belarus R06AA02 1249201.06.2013

01.06.2018PoM

Open Joint Stock

Company

<Borisovskiy zavod

Medicinckikh

Preparatov>, 64/27,

Chapayev str.,

Borisov 222120,


1388 Dimedrol

diphenhydramine

(diphenhydramine

hydrochloride)


1ml ampoules (10)

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,


No6

Republic of

ArmeniaR06AA02 16762

02.06.2017

02.06.2022PoM

Yerevan Chemical-

Pharmaceutical firm

OJSC, Yerevan,

Ajaryan street, 2

Line, No6, Republic

of Armenia

1389 Dimedrol

diphenhydramine

(diphenhydramine

hydrochloride)

solution for i/m

injection

10mg/ml,


ampoules label banderol

(10), 1ml ampoules, in

blister (10/1x10/)

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus R06AA02 1720508.12.2017

08.12.2022PoM

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

1390 Dimedrol-Belmed

diphenhydramine

(diphenhydramine

hydrochloride)

tablets

50mg,


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

Belmedpreparaty

RUE, Grodninsky

region, Skidzyel,

Kizevich str., 50

Belarus R06AA02 1638810.02.2017

10.02.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

301

1391 Dimedrol-Darnitsa

diphenhydramine

(diphenhydramine

hydrochloride)

tablets50mg,

in blister (10)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,


Ukraine R06AA02 1235009.04.2013

09.04.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borisopolskaya

Str.,13, Ukraine

1392 Dimedrol-Darnitsa

diphenhydramine

(diphenhydramine

hydrochloride)


10mg/ml,

1ml ampoules,

in blister (10/2x5), 1ml

ampoules (10)

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13

Ukraine R06AA02 1259121.06.2013

21.06.2018PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Borispolskaya Str.,13,

Ukraine

1393 Dimex

diphenhydramine

(diphenhydramine

hydrochloride),

ammonium

chloride

syrup

1.992mg/ml+

19.92mg/ml,



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

Bulgaria R06AA52 1488324.09.2015

24.09.2020OTC

Sopharma JSC, str.

Iliensko shosse 16,


1394 Dimexid dimethylsulfoxide

concentrate for


use

100ml,

glass bottle

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-


Russia M02AX03 1222007.03.2013

07.03.2018OTC

Marbiopharm JSC,

424006,The Republic

of Mari El,Yoshkar-

Ola, st. Karl Marx

121, RUSSIA

1395 Dimexid dimethylsulfoxide

concentrate for


use

100ml,

100ml glass bottle

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079

Republic of

ArmeniaM02AX03 13131

10.01.2014

10.01.2019OTC

ESCO-PHARM LLC,

Nor-Norq V block,

Mikoyan 13, Yerevan

0079, Republic of

Armenia

1396 Dimiadrospirenone,

ethinylestradioltablets film-coated

3mg+0,02mg,


84/3x28/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary G03AA12 1720208.12.2017

08.12.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

302

1397 Diminaveto

diminazene

(diminazene

diaceturate),

antipyrine

(phenazone)

granules

445mg/g+ 555mg/g,

2.36g sachets (10) 23.6g

sachets (10)

Laboratoria Smeets

NV, Fotografielaan

42, 2610 Wilrijk

Belgium

QP51AX07;

veterinary

drug

1479304.09.2015

04.09.2020PoM

V.M.D. NV, Hoge

Mauw 900,B- 2370

Arendonk, Belgium

1398 Dinga

glimepiride,

metformin

(metformin

hydrochloride)

tablets2mg+500mg,


Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaA10BD02 13103

09.12.2013

09.12.2018PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

1399 Diovan valsartan tablets film-coated

80mg,


28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain C09CA03 1459508.06.2015

08.06.2020PoM

Novartis Pharma AG,


Basel, Switzerland

1400 Diovan valsartan tablets film-coated

160mg,


28/2x14/)

Novartis Farmaceutica

S.A., Ronda de Santa

Maria 158, 08210

Barbera del Valles,

Barcelona

Spain C09CA03 1459608.06.2015

08.06.2020PoM

Novartis Pharma AG,


Basel, Switzerland

1401 Dipal Conc. 1+4 iodinesolution for external

use

7,5mg/ml,

1l, 5l, 10l, 20l, 60l and

200l in plastic container

DeLaval N.V.,

Industriepark-

Drongen 10, B-9031,

Gent

Belgium

QD08AG

veterinary

drug

1388006.10.2014

06.10.2019OTC

DeLaval N.V.,

Industriepark-

Drongen 10, B-9031,

Gent, Belgium

1402 Diphenin phenytoin tablets117mg,

in blister (10)

Arpimed LLC, Kotayk

Marz, Abovyan, 2nd

Micro-District, 19

Building

Republic of

ArmeniaN03AB02 16874

31.07.2017

31.07.2022PoM

Arpimed LLC,

Kotayk Marz,

Abovyan, 2nd Micro-


Republic of Armenia

303

1403 Diphereline 0,1mgtriptorelin


powder lyophilized


injection

0,1mg,

0,1mg glass vial (7) and

1ml solvent in ampoules

(7)

Ipsen Pharma

Biotech, Parc

d'Activites du Plateau

de Signes, Chemin

departemental No

402, SIGNES, 83870

France L02AE04 1672405.06.2017

05.06.2022PoM

Ipsen Pharma, 65

quai Georges

Gorse,92100

Boulogne-Billancourt,

France

1404Diphereline

3,75mg

triptorelin


powder lyophilized

for prolonged-release

suspension for i/m

injection

3,75mg,

3,75mg glass vial, 2ml

solvent in ampoule, 3ml

syringe and needles (2)

Ipsen Pharma

Biotech, Parc

d'Activites du Plateau

de Signes, Chemin

departemental No

402, SIGNES, 83870

France L02AE04 1672505.06.2017

05.06.2022PoM

Ipsen Pharma, 65

quai Georges

Gorse,92100


France

1405 Diprosalic

betamethasone

(betamethasone

dipropionate),

salicylic acid

ointment0,5mg/g+30mg/g, 30g

aluminium tube


N.V., Industriepark


den-Berg

Belgium D07XC01 1356510.06.2014

10.06.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

1406 Diprosalic

betamethasone

(betamethasone

dipropionate),

salicylic acid

lotion0,5mg/g+20mg/g, 30ml

plastic container-dropper

Cenexi HSC, 2 Rue

Louis Pasteur, 14200

Herouville Saint-

Clair

France D07XC 14740/111.12.2017

03.08.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1407 Diprospan

betamethasone

(betamethasone

dipropionate),

betamethasone

(betamethasone

sodium phosphate)

suspension for

injection

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

ampoules (5)


N.V., Industriepark


den-Berg

Belgium H02AB01 1457109.06.2015

09.06.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1408 Dirotonlisinopril (lisinopril

dihydrate)tablets

5mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA03 1693905.09.2017

05.09.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

304


dihydrate)tablets

10mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA03 1694005.09.2017

05.09.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary


dihydrate)tablets

20mg,


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

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA03 1694105.09.2017

05.09.2022PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1411 Disflatyl simethicone drops oral40mg/ml,

30ml glass bottle

Legacy

Pharmaceuticals

Switzerland GmbH,

Ruhrbergstrasse 21,

4127 Birsfelden

Switzerland A03AX13 1442108.04.2015

08.04.2020OTC

MEDA

Pharmaceuticals

Switzerland GmbH,

Hegnaustrasse 60,

8602 Wangen-

Bruttisellen,

Switzerland

1412 Disgren triflusal capsules hard300mg,


J. Uriach & Cia., S.A.

Av. Cami Reial, 51-

57, 08184 Palau-Solita

i Plegamans,

Barcelona

Spain B01AC18 1526722.01.2016

22.01.2021PoM

J. Uriach & Cia., S.A.

Av. Cami Reial, 51-

57, 08184 Palau-Solita

i Plegamans,

Barcelona, Spain

1413 DISTREPTAZAstreptokinase,

streptodornasesuppositories rectal

15000IU+1250IU; (6/1x6/)

in blister

"BIOMED-LUBLIN"

Wytwornia Surowic i

Szczepionek Spolka

Akcyjna, ul.

Uniwersytecka 10, 20-

029, Lublin

Poland B06AA55 1713807.11.2017

07.11.2022PoM

"BIOMED-LUBLIN"

Wytwornia Surowic i

Szczepionek Spolka

Akcyjna, ul.

Uniwersytecka 10, 20-

029, Lublin, Poland

1414 Dithylin

suxamethonium

(suxamethonium

iodide)

solution for i/v

injection

20mg/ml,

5ml ampoules (10) and

divider, ampoules 5ml in

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

and divider

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus M03AB01 1379905.09.2014

05.09.2019PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

305

1415 Dithylin-Darnitsa

suxamethonium

(suxamethonium

iodide)


20mg/ml,

5ml ampoules, in blister,

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

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Boryspilska Str.,13

Ukraine M03AB01 15787/103.10.2016

20.07.2021PoM

Darnitsa

Pharmaceutical Firm

PrJSC, 02093, Kiev,

Boryspilska Str.,13,

Ukraine

1416 Divigelestradiol (estradiol

hemihydrate)gel

1mg/g,

1g sachets (28)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser,

Orion Corporation,

Tengstrominkatu 8,

20360 Turku, Finland-

bulk manufacturer,

packager

Finland G03CA03 1506602.12.2015

02.12.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

1417 Divigelestradiol (estradiol

hemihydrate)gel

1mg/g,

0,5g sachets (28)

Orion Corporation,

Orionintie 1, 02200

Espoo-batch releaser,

Orion Corporation,

Tengstrominkatu 8,

20360 Turku, Finland-

bulk manufacturer,

packager

Finland G03CA03 1541209.03.2016

09.03.2021PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

1418 Dlianos

xylometazoline

(xylometazoline

hydrochloride)

spray nasal

1mg/ml,


with nebulizer

Sandoz Private

Limited, Plot No.

801/P, G.I.D.C.,

Ankleshwar 393 002,

Bharuch

India R01AA07 1324024.02.2014

24.02.2019OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, 1260 Nyon,

Switzerland

1419 Dlianos

xylometazoline

(xylometazoline

hydrochloride)

drops nasal

0,5mg/ml,


dropper

Sandoz Private

Limited, Plot No.

801/P, G.I.D.C.,

Ankleshwar 393 002,

Bharuch

India R01AA07 1324124.02.2014

24.02.2019OTC

Novartis Consumer

Health S.A., Route de

I`Etraz, 1260 Nyon,

Switzerland

306

1420 Dobutamin Hexal

dobutamine

(dobutamine

hydrochloride)

lyophilisate for


250mg,

glass vial (1)

Salutas Pharma

GmbH, Otto-von-

Guericke-Alle-1,

39179 Barleben-

batch releaser,

Wasserburger

Arzneimittelwerk

GmbH, Herderstrasse

1,2 und Molkerei-

Bauer-Strasse 18-

83512 Wasserburg,

Germany- bulk

manufacturer,

packager

Germany C01CA07 1667611.05.2017

11.05.2022PoM

Hexal AG,

Industriestrasse 25,

83607 Holzkirchen,

Germany

1421 Docetaxel docetaxelconcentrate for


20mg/ml,

glass vial 1ml (1)

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01CD02 1579120.07.2016

20.07.2021PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1422

Docetaxel Accord

160mg/8ml

concentrate for

solution for

infusion

docetaxelconcentrate for


20mg/ml,

8ml concentrate in 10ml

glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453204.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

307

1423

Docetaxel Accord

160mg/8ml

concentrate for

solution for

infusion



20mg/ml,


glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453404.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1424

Docetaxel Accord

20mg/ml

concentrate for

solution for

infusion



20mg/ml,


glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453604.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

308

1425

Docetaxel Accord

20mg/ml

concentrate for

solution for

infusion



20mg/ml,


glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453704.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1426

Docetaxel Accord

80mg/4ml

concentrate for

solution for

infusion



20mg/ml,


glass vial (1)

Accord Healthcare


Pinner Road, North




Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453304.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

309

1427

Docetaxel Accord

80mg/4ml

concentrate for

solution for

infusion



20mg/ml,


glass vial (1)

Accord Healthcare


Pinner Road, North








Ahmedabad, 382 210,

Gujarat, India-bulk


packager, Accord





secondary packager

UK L01CD02 1453504.06.2015

04.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1428 Docetaxel Ebewe docetaxelconcentrate for


10mg/ml,

2ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD02 1626719.12.2016

19.12.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

1429 Docetaxel Ebewe docetaxelconcentrate for


10mg/ml,

8ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01CD02 1626819.12.2016

19.12.2021PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

1430 Doktor Mom

adhatoda vasika,

aloe barbadensis,

ocimum sanctum,

inula racemosa,

zingiber officinale,

curcuma longa,

solanum indicum,

piper cubeba,

glycyrrhiza glabra,

terminalia belerica,

levomenthol

syrup

6mg/ml+5mg/ml+

10mg/ml+2mg/ml+

1mg/ml+5mg/ml+

2mg/ml+1mg/ml+

6mg/ml+2mg/ml+

0,6mg/ml,

100ml, 150ml plastic


Unique

Pharmaceutical

Laboratories, Plot N0

215, 216, G.I.D.C

Industrial Area,

Panoli: 394 116,

Gujarat State

IndiaR05CA10;

herbal drug13257/1

18.04.2017

24.02.2019OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

310

1431 Doktor MOM Fito

camphor,

levomenthol,

nutmeg oil,

turpentine oil,

thymol, eucalyptus

oil

ointmentc for

external use

1.05g/20g+ 0.61g/20g+

0,11ml/20g+ 1,11ml/20g+

0,02g/20g+ 0,3ml/20g,


Unique

Pharmaceutical

Laboratories (a

division of J. B.

Chemicals &

Pharmaceuticals Ltd.),

Plot N 304-308,

G.I.D.C. Industrial

Area, Panoli: 394 116,

Gujarat State

IndiaR05X;

herbal drug15370/1

27.09.2016

26.02.2021OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

1432

Doktor MOM

herbal cough

lozenges

glycyrrhiza glabra,



levomenthol

lozenges with orange

flavour

15mg+10mg+10mg+7mg,

in strip (20/4x5/)

Unique

Pharmaceutical

Laboratories, Survey

No. 101/2 and 102/1,

Daman Industrial

Estate, Kadaiya,

Daman-396 210

IndiaR05CA10;

herbal drug 14442

04.05.2015

04.05.2020OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

1433

Doktor MOM

herbal cough

lozenges

glycyrrhiza glabra,



levomenthol

lozenges with lemon

flavour

15mg+10mg+10mg+7mg,

in strip (20/4x5/)

Unique

Pharmaceutical


No. 101/2 and 102/1,

Daman Industrial

Estate, Kadaiya,

Daman-396 210

IndiaR05CA10;

herbal drug 14443

04.05.2015

04.05.2020OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

1434

Doktor MOM

herbal cough

lozenges

glycyrrhiza glabra,



levomenthol

lozenges with berries

flavour

15mg+10mg+ 10mg+7mg,

in strip (20/4x5/)

Unique

Pharmaceutical


No. 101/2 and 102/1,

Daman Industrial

Estate, Kadaiya,

Daman-396 210

IndiaR05CA10;

herbal drug 14444

04.05.2015

04.05.2020OTC

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

1435 DolEx

diclofenac

(diclofenac sodium),


hydrochloride)

solution for i/m

injection

37,5mg/ml+ 10mg/ml,

2ml glass vials (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


04.03.2014

04.03.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

311

1436 Doloforte Denk

tramadol (tramadol

hydrochloride),

paracetamol

tablets film-coated37,5mg+325mg,


Denk Pharma GmbH


84529 Tittmoning

Germany N02AJ13 1669423.05.2017

23.05.2022PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

1437 Dolpassketorolac (ketorolac

tromethamine)


i/m injection

30mg/ml,

1ml glass vial (5)

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9

Republic of


04.03.2014

04.03.2019PoM

Liqvor CJSC, 0089,

Yerevan, str.

Kochinyan, 7/9,

Republic of Armenia

1438 Domosedan gel

detomidine

(detomidine

hydrochloride)

gel oromucosal7,6mg/ml,

3ml pre-filled syringe (1)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland

QN05CM90;

veterinary

drug

1589223.08.2016

23.08.2021OTC

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

1439 DONA

glucosamine

(glucosamine

sulfate)

powder for oral

solution

1500mg,

sachets (20, 30)

Rottapharm Ltd.,

Damastown Industrial

Park, Mulhuddart,

Dublin 15

Ireland M01AX05 1547302.04.2016

02.04.2021PoM

Rottapharm S.p.A.,

Galleria Unione 5,

20122, Milan, Italy

1440 DONA

ampoule A-

glucosamine

(glucosamine

sulfate), ampoule B-

solvent

solution for i/m

injection

200mg/ml; (6) ampoule A

2ml, (6) ampoule B 1ml

Biologici Italia

Laboratories S.r.l., via

Filippo Serpero, 2 -

20060 Masate (MI)

Italy M01AX05 15474/108.06.2017

02.04.2021PoM

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

1441 Donormyl

doxylamine

(doxylamine

succinate)

tablets coated

15mg,

in plastic container, (10,

30)

UPSA SAS, 304,

avenue du Docteur

Jean Bru, 47000

AGEN

France R06AA09 13653/107.07.2017

08.07.2019PoM

UPSA SAS, 3, rue

Joseph Monier- 92500

Rueil- Malmaison,

France

1442 Dopegyt

methyldopa

(methyldopa

sesquihydrate)

tablets250mg,



PLC, 9900, Kormend,

Matyas Kiraly u. 65

Hungary C02AB01 1540309.03.2016

09.03.2021PoM


PLC, 1106 Budapest,


Hungary

1443 Dopmin

dopamine

(dopamine

hydrochloride)

concentrate for


40mg/ml,

5ml ampoules (5)

Orion Corporation,

Orionintie 1, 02200

Espoo

Finland C01CA04 1490024.09.2015

24.09.2020PoM

Orion Corporation,

Orionintie 1, 02200

Espoo, Finland

312

1444 Dorzopt

dorzolamide

(dorzolamide

hydrochloride)

drops eye20mg/ml,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A

Romania S01EC03 1611910.11.2016

10.11.2021PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1445 Dostinex cabergoline tablets

0,5mg,

in glass container (2) and

(8)

Pfizer Italia S.r.L.,

Localita Marino del

Tronto, 63100 Ascoli

Piceno

Italy G02CB03 1722708.12.2017

08.12.2022PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1446 Doxiproct

calcium dobesilate

(calcium dobesilate

monohydrate),


hydrochloride)

ointment

40mg/g+20mg/g, 30g

aluminium tube and

cannula

OM Pharma S.A., Rua

da Industria, 2 Quinta

Grande, 2610-088

Amadora, Lisbon

Portugal C05AX 1438316.04.2015

16.04.2020OTC

OM Pharma S.A., Rua


Grande, 2610-088

Amadora, Lisbon,

Portugal

1447 Doxiproct Plus

calcium dobesilate

(calcium dobesilate

monohydrate),


hydrochloride),

dexamethasone

(dexamethasone

acetate)

ointment

40mg/g+20mg/g+

0,25mg/g,

20g aluminium tube

OM Pharma S.A., Rua


Grande, 2610-088

Amadora, Lisbon

Portugal C05AX03 1429819.03.2015

19.03.2020PoM

OM Pharma S.A., Rua


Grande, 2610-088

Amadora, Lisbon,

Portugal

313

1448

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,


Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14672/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1449

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

5ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14673/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

314

1450

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate solution

for infusion

2mg/ml,


Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14674/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1451

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14675/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

315

1452

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

50ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14676/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1453

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14677/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

316

1454

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

25ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14678/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1455

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14679/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

317

1456

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

10ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas






Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14680/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1457

Doxorubicin

2mg/ml

Concentrate for

Solution for

Infusion

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

5ml glass vial (1)

Accord Healthcare


Pinner Road, North




packager- Intas


Plot No 457 & 458 &



Sanand, District-

Ahmedabad, 382 210,


packager- Accord





UK L01DB01 14681/109.07.2015

29.06.2020PoM

Accord Healthcare

Limited, Sage

House,319 Pinner

Road, North Harrow,

Middlesex, HA1 4HF,

UK

1458Doxorubicin

EBEWE

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

5ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01DB01 1404319.12.2014

19.12.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

318

1459Doxorubicin

EBEWE

doxorubicin

(doxorubicin

hydrochloride)

concentrate for


2mg/ml,

25ml glass vial

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee

Austria L01DB01 1404419.12.2014

19.12.2019PoM

EBEWE Pharma Ges.

m.b.H. Nfg. KG,


4866 Unterach am

Attersee, Austria

1460Doxorubicin

hydrochloride

doxorubicin

(doxorubicin

hydrochloride)

powder lyophilized

for solution for

injection

10mg,

10ml glass vial

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01DB01 1284217.09.2013

17.09.2018PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1461Doxorubicin

hydrochloride

doxorubicin

(doxorubicin

hydrochloride)

powder lyophilized

for solution for i/v

injection

10mg,


Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30

Belarus L01DB01 1708412.10.2017

12.10.2022PoM

Belmedpreparaty

RUE, 220007, Minsk,

Fabritsius St., 30,

Belarus

1462 Doxotil

doxorubicin

(doxorubicin

hydrochloride)


5ml glass vial


km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L01DB01 1372324.07.2014

24.07.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51


1463 Doxotil

doxorubicin

(doxorubicin

hydrochloride)


25ml glass vial


km Marathonos

Avenue, 153 51

Pallini Attiki

Greece L01DB01 1372424.07.2014

24.07.2019PoM

Genepharm S.A.,

18th km Marathonos

Avenue, 153 51


1464 Doxy-500 WS

doxycycline

(doxycycline

hyclate)

powder oral500mg/g,


Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

the Netherlands

QJ01AA02;

veterinary

drug

1414229.12.2014

29.12.2019PoM

Interchemie werken

'De Adelaar' B.V.,

Metaalweg 8, 5804

CG Venray

1465 Doxycycline

doxycycline

(doxycycline

hyclate)

capsules100mg,


Medicamen Biotech

Ltd, SP-1192 A&B,

Phase IV,Industrial

Area,Bhiwadi,Dist.

Alwar (Rajasthan)

India J01AA02 1217101.02.2013

01.02.2018PoM

Troge Medical

GmbH, Milchstrasse

19, D-20148

Hamburg, Germany

319

1466 Doxycycline

doxycycline

(doxycycline

hyclate)

capsules100mg,


Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30

Belarus J01AA02 1244507.05.2013

07.05.2018PoM

Belmedpreparaty

RUP, 220007, Minsk,

Fabritsius St., 30,

Belarus

1467 Doxycycline

doxycycline

(doxycycline

hyclate)

capsules100mg,

in blister (8)

Chanelle Medical,

Loughrea, Co. Galway Ireland J01AA02 12543

06.06.2013

06.06.2018PoM

Ritm Farm LTD, 11/2

Totovents Street,

Apartment 34,

Yerevan, Armenia

1468 Doxycycline

doxycycline

(doxycycline

hyclate)

capsules

100mg,


20/2x10/)

Open joint stock


zavod medicinskikh

preparatov" 64,



Belarus J01AA02 1410729.12.2014

29.12.2019PoM

Open joint stock


zavod medicinskikh

preparatov" 64,


222518, Minsk

region, Belarus

1469Doxycycline-

Asteria

doxycycline

(doxycycline

hyclate)

capsules

100mg,


100/10x10/)

Hankook Korus

Pharm Co., Ltd, 30,


si, Chungcheongbuk-

do

Korea Sourth J01AA02 1517317.12.2015

17.12.2020PoM

GL Corporation,

Woori Venture

Tower #201, 70,

Seonyu-ro,

Yeongdeungpo-ku,

Seoul, South Korea

1470 Doxy-Denk 100

doxycycline

(doxycycline

hyclate)

tablets100mg,


Artesan Pharma

GmbH & Co. KG,

Wendlandstrasse 1,

29439 Luchow

Germany J01AA02 1273023.07.2013

23.07.2018PoM

Denk Pharma GmbH

& Co. KG,


81675 Munchen,

Germany

1471Dr. Theiss

Bronchosept

thyme liquid

extract, star anise

oil

drops oral250mg/g+50mg/g, 30ml

bottle-dropper

Dr.Theiss Naturwaren

GmbH,

Michelinstrasse 10, D-

66424 Homburg

Saarland

GermanyR05CA;

herbal drug 14604

03.07.2015

03.07.2020OTC


GmbH,


66424 Homburg

Saarland, Germany

320

1472Dr. Theiss ribwort

plantain syrupribwort plantain syrup

50mg/g,


bottle


GmbH,


66424 Homburg

Saarland

GermanyR05CA

herbal drug13652

08.07.2014

08.07.2019OTC


GmbH,


66424 Homburg

Saarland, Germany

1473 Dramina dimenhydrinate tablets

50mg,

in blister (5/1x5/,

10/1x10/)

JADRAN-GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka

Croatia R06AX 1710123.10.2017

23.10.2022OTC

JADRAN-GALENSKI

LABORATORIJ d.d.,

Svilno 20, 51000

Rijeka, Croatia

1474 Drapolene

cetrimide,

benzalkonium

chloride

cream0,2%+0,01%,

55g in plastic tube

GlaxoSmithKline


189 Grunwaldzka


Poland D08AJ 1258705.06.2013

05.06.2018OTC

Glaxo Wellcome UK

Limited, Stockley

Park, Middlesex, UB

11 1BT, UK

1475 Driptane

oxybutynin

(oxybutynin

hydrochloride)

tablets5mg,

in blister (30)

Recipharm Fontaine,

Rue des Pres Potets,

21121 Fontaine les

Dijon

France G04BD04 12266/213.05.2015

07.03.2018PoM

Laboratoires Fournier

SAS, 42 Rue Rouget

de Lisle, 92150

Suresnes, France

1476 Drotaverine

drotaverine

(drotaverine

hydrochloride)


2ml ampoules (10)

Open Joint Stock

Company

"Borisovskiy zavod

Medicinskikh

Preparatov" (64/27,



Belarus A03AD02 1289107.10.2013

07.10.2018PoM

Open Joint Stock

Company

"Borisovskiy zavod

medicinskikh

preparatov" (64/27,

Chapayev str.,

Borisov 222120,


321

1477Drotaverine

hydrochloride

drotaverine

(drotaverine

hydrochloride)

tablets40mg,


Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov


Belarus A03AD02 1685210.07.2017

10.07.2022OTC

Open joint stock


zavod medicinskikh

preparatov" 64, ul.

Chapaeva, Borisov

222518, Minsk

region, Belarus

1478 Duac

clindamycin

(clindamycin

phosphate), benzoyl

peroxide

gel for external use10mg/g+50mg/g, 15g

aluminium tube

Glaxo Operations UK

Limited, Harmire


Co Durham DL12

8DT

UK D10AF51 1492920.10.2015

20.10.2020PoM

GlaxoSmithKline UK

Limited, 980 Great

West Road,


TW8 9GS, UK

1479 Duodart

dutasteride,

tamsulosin

(tamsulosin

hydrochloride)

capsules0,5mg+0,4mg,


Catalent Germany

Schorndorf GmbH,

Steinbeisstrasse 1und

2, 73614, Schorndorf -

packager, batch

releaser (Catalent

France Beinheim SA,

74 rue Principale,

67930 Beinheim,

France - dutasteride

soft capsules

manufacturer

(intermediate)),

(Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh, Germany -

tamsulosin pellets

manufacturer

(intermediate))

Germany G04CA52 13559/126.10.2017

10.06.2019PoM

GlaxoSmithKline

GmbH & Co. KG,

Prinzregentenplatz 9,

81675 Munich,

Germany

1480 Duotravtravoprost, timolol

(timolol maleate)drops eye (solution)

40mcg/ml+ 5mg/ml,

2,5ml plastic vial

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs

Belgium S01ED51 1368625.07.2014

25.07.2019PoM

S.A. Alcon-Couvreur

N.V., Rijksweg 14

2870 Puurs, Belgium

322

1481 Duovit

vitamin A, vitamin

D3, vitamin C,

vitamin B1, vitamin

B2, vitamin B6,

vitamin B12,

vitamin PP, folic

acid, vitamin B5,

vitamin E, calcium

hydrophosphate

dihydrate, ferrous

fumarate, copper

sulfate

pentahydrate, zinc

sulfate

heptahydrate,

magnesium lactate

dihydrate,

manganese sulfate

monohydrate,

sodium molybdate

dihydrate

tablets coated

2,94mg+0,2mg+

60mg+1mg+ 1,2mg+2mg+

3mcg+13mg+

0,4mg+5mg+

10mg+64,5mg+

30,3mg+4mg+

13,3mg+200mg+

3,1mg+0,22mg,

in blister (40/4x5+5/5

red+5 blue/)

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 1652717.03.2017

17.03.2022OTC

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1482 Duphalac lactulose syrup

667mg/ml,

200ml, 500ml, 1000ml,

15ml sachets (10)

ABBOTT Biologicals

B.V., Veerweg 12,

8121 AA Olst

the Netherlands A06AD11 1548230.03.2016

30.03.2021OTC

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

1483 Duphaston dydrogesterone tablets film-coated10mg,

blister (20/1x20/)

ABBOTT Biologicals

B.V., Veerweg 12,

8121 AA Olst

the Netherlands G03DB01 1548905.04.2016

05.04.2021PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

323

1484 Duplecor

atorvastatin

(atorvastatin L-

lysine), amlodipine

(amlodipine

besilate)



Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest) -


form manufacturer,

packager - S.C.

Gedeon Richter

Romania S.A. /99-105

Guza Voda street,

540306, Targu-Mures,

Romania/)

Hungary C10BX03 1297028.10.2013

28.10.2018PoM

Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest,

Hungary)

1485 Duplecor

atorvastatin

(atorvastatin L-

lysine), amlodipine

(amlodipine

besilate)



Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest) -


form manufacturer,

packager - S.C.

Gedeon Richter


Guza Voda street,


Romania/)

Hungary C10BX03 1297128.10.2013

28.10.2018PoM

Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest,

Hungary)

1486 Duplecor

atorvastatin

(atorvastatin

calcium),

amlodipine

(amlodipine

besilate)



Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest) -


form manufacturer,

packager - S.C.

Gedeon Richter


Guza Voda street,


Romania/)

Hungary C10BX03 1297228.10.2013

28.10.2018PoM

Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest,

Hungary)

324

1487 Duplecor

atorvastatin

(atorvastatin L-

lysine), amlodipine

(amlodipine

besilate)



Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest) -


form manufacturer,

packager - S.C.

Gedeon Richter


Guza Voda street,


Romania/)

Hungary C10BX03 1297328.10.2013

28.10.2018PoM

Gedeon Richter OJSC

(Gyomroi ut 19-21,

1103 Budapest,

Hungary)

1488 Duspatalin

mebeverine

(mebeverine

hydrochloride)

capsules hard

prolonged-release

200mg,


Abbott Healthcare

SAS, Route de


Maillard, 01400

Chatillon sur

Chalaronne

France A03AA04 1541409.03.2016

09.03.2021PoM

ABBOTT Healthcare

Products B.V., C.J.

van Houtenlaan 36,

NL-1381 CP Weesp,

the Netherlands

1489 Dymista

azelastine(azelastine

hydrochloride),

fluticasone

(fluticasone

propionate)

spray nasal

(suspension)

137mcg/dose+

50mcg/dose,

23g (17ml suspension/not

less than 120 doses) glass

bottle with dispenser

MEDA Pharma

GmbH & Co. KG,


Bad Homburg - batch

releaser; Cipla Ltd,

Plot NO. 9, 10, Indore

Special Economic

Zone, Phase II,

Pithampur, district

Dhar, Madhya

Pradesh 454 775,

India - bulk

manufacturer,

packager

Germany R01AD58 1697105.09.2017

05.09.2022PoM

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

1490 Dysmenorm

agnus castus,

pulsatilla trit.D3,

rosmarinus

officinalis trit.D2,

apis mellifica

trit.D3

tablets

125mg+25mg+

25mg+25mg,


Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,


Karlsruhe

Germany

G02C;

homeopathic

drug

1427519.03.2015

19.03.2020OTC

Deutsche

Homoopathie-Union

DHU-Arzneimittel

GmbH & Co. KG,


Karlsruhe, Germany

325

1491 Dysport

clostridium

botulinum type A

toxin-

haemagglutinin

complex

powder lyophilized

for solution for

injection

500U,

glass vial (1)

Ipsen Biopharm

Limited, Ash Road,

Wrexham Industrial

Estate, Wrexham,

LL13 9UF for Ipsen

Pharma, 65 quai

Georges Gorse,92100


France

UK M03AX01 1568608.06.2016

08.06.2021PoM

1492 Ecobol

amoxicillin

(amoxicillin

trihydrate)

tablets

250mg,


10/1x10/, 20/4x5/,

20/2x10/)

"AVVA RUS" JSC,

53a, Luganskaya Str.,

Kirov, 610044

Russia J01CA04 1604717.10.2016

17.10.2021PoM

"AVVA RUS" JSC,

30/9, Krylatskie

Holmy, Moscow,

121614, Russia

1493 Ecobol

amoxicillin

(amoxicillin

trihydrate)

tablets

500mg,


10/1x10/, 20/4x5/,

20/2x10/)

"AVVA RUS" JSC,

53a, Luganskaya Str.,

Kirov, 610044

Russia J01CA04 1604817.10.2016

17.10.2021PoM

"AVVA RUS" JSC,

30/9, Krylatskie

Holmy, Moscow,

121614, Russia

1494 Edarbiazilsartan

medoxomiltablets

40mg,


Takeda Ireland Ltd.,

Bray Business Park

Kilruddery Co.

Wicklow-batch

releaser, packager,

Takeda

Pharmaceutical

Company Limited,

Osaka Plant, 17-85,

Jusohonmachi 2-

chome, Yodogawa-

ku, Osaka, 532-8686,

Japan-bulk

manufacturer

Ireland C09CA09 1566508.06.2016

08.06.2021PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

326

1495 Edarbiazilsartan

medoxomiltablets

80mg,



Bray Business Park

Kilruddery Co.

Wicklow-batch

releaser, packager,

Takeda

Pharmaceutical

Company Limited,

Osaka Plant, 17-85,

Jusohonmachi 2-

chome, Yodogawa-

ku, Osaka, 532-8686,

Japan-bulk

manufacturer

Ireland C09CA09 1566608.06.2016

08.06.2021PoM

Takeda Pharma A/S,

Dybendal Alle 10,

2630 Taastrup,

Denmark

1496 Edarbi Clo

azilsartan

medoxomil,

chlortalidone

tablets film-coated40mg +25mg,



Bray Business Park

Kilruddery Co.

Wicklow-batch

releaser, packager,

Takeda

Pharmaceutical

Company Limited,

Osaka Plant, 17-85,

Jusohonmachi 2-

chome, Yodogawa-

ku, Osaka, 532-8686,

Japan -bulk

manufacturer

Ireland C09DA09 1714407.11.2017

07.11.2022PoM

Takeda

Pharmaceuticals USA,

Inc, One Takeda

Parkway,

Deerfield,Illinois

60015, USA

1497 Edarbi Clo

azilsartan

medoxomil,

chlortalidone




Bray Business Park

Kilruddery Co.

Wicklow-batch

releaser, packager,

Takeda

Pharmaceutical

Company Limited,

Osaka Plant, 17-85,

Jusohonmachi 2-

chome, Yodogawa-

ku, Osaka, 532-8686,

Japan -bulk

manufacturer

Ireland C09DA09; 1714507.11.2017

07.11.2022PoM

Takeda

Pharmaceuticals USA,

Inc, One Takeda

Parkway,

Deerfield,Illinois

60015, USA

327

1498 Edicin

vancomycin

(vancomycin

hydrochloride)

powder for solution

for i/v injection

1000mg,

glass vial

Lek Pharmaceuticals


57, 1526 Ljubljana

Slovenia J01XA01 1592123.08.2016

23.08.2021PoM

Lek Pharmaceuticals


57, 1526 Ljubljana,

Slovenia

1499 Ednytenalapril (enalapril

maleate)tablets

5mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA02 1401026.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary


maleate)tablets

10mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA02 1401126.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary


maleate)tablets

20mg,


Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09AA02 1401226.11.2014

26.11.2019PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1502 Edurant rilpivirine tablets film-coated25mg,


Janssen-Cilag S.p.A.,

Via C. Janssen, 04100

Borgo San Michele,

Latina

Italy J05AG05 1564024.05.2016

24.05.2021PoM

Johnson & Johnson

LLC, 121614,

Moscow, Krylatskaya


Russia

1503 Efferalgan paracetamol suppositories rectal80mg

(10/2x5/)

UPSA SAS, 304,

avenue du Docteur

Jean Bru, 47000

AGEN, France

France N02BE01 13408/107.07.2017

14.04.2019OTC

UPSA SAS, 3, rue


Rueil- Malmaison,

France


(10/2x5/)

UPSA SAS, 304,

avenue du Docteur

Jean Bru, 47000

AGEN, France

France N02BE01 13409/107.07.2017

14.04.2019OTC

UPSA SAS, 3, rue


Rueil- Malmaison,

France

328


(10/2x5/)

UPSA SAS, 304,

avenue du Docteur

Jean Bru, 47000

AGEN, France

France N02BE01 13410/107.07.2017

14.04.2019OTC

UPSA SAS, 3, rue


Rueil- Malmaison,

France

1506 Efferalgan paracetamol solution oral

30mg/ml,


measuring spoon

UPSA SAS, 304,

avenue du Docteur

Jean Bru, 47000

AGEN, France

France N02BE01 14687/110.10.2017

29.06.2020OTC

UPSA SAS, 3, rue


Rueil- Malmaison,

France

1507 Efferalgan paracetamol tablets effervescent500mg,

in strip (16/4x4/)

UPSA SAS, 979,

Avenue des Pyrenees,

47520 Le Passage

France N02BE01 1703226.09.2017

26.09.2022OTC

UPSA SAS, 3, rue


Rueil- Malmaison,

France

1508 Efisol

dequalinium

(dequalinium

chloride), ascorbic

acid

lozenges

0,25mg+30mg,


40/2x20/)

Balkanpharma-

Razgrad AD, 68,

Aprilsko vastanie

Blvd, 7200 Razgrad

Bulgaria R02AA 1603717.10.2016

17.10.2021OTC

Balkanpharma-

Dupnitsa AD, 3,

Samokovsko shosse

str., 2600 Dupnitsa,

Bulgaria

1509 Efloran metronidazole solution for infusion5mg/ml,

100ml glass bottle

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto

Slovenia J01XD01 1609010.11.2016

10.11.2021PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

1510 Egilok

metoprolol

(metoprolol

tartrate)

tablets25mg,



PLC 9900, Kormend,

Matyas kiraly u. 65 -

batch releaser,

packager (Egis

Pharmaceuticals PLC,

1165 Budapest,


120, Hungary -bulk

manufacturer)

Hungary C07AB02 13526/122.04.2015

30.05.2019PoM


PLC, Hungary 1106

Budapest, Kereszturi

ut 30-38

329

1511 Egilok

metoprolol

(metoprolol

tartrate)

tablets50mg,



PLC 9900, Kormend,


batch releaser,

packager (Egis


1165 Budapest,


120, Hungary -bulk

manufacturer)

Hungary C07AB02 13527/122.04.2015

30.05.2019PoM


PLC, Hungary 1106


ut 30-38

1512 Egilok

metoprolol

(metoprolol

tartrate)

tablets100mg,

in glass container (30, 60)


PLC 9900, Kormend,


batch releaser,

packager (Egis


1165 Budapest,


120, Hungary -bulk

manufacturer)

Hungary C07AB02 13528/122.04.2015

30.05.2019PoM


PLC, Hungary 1106


ut 30-38

1513 Egistrozol anastrozole tablets coated

1mg,


30/3x10/, 90/9x10/)


PLC, 1165 Budapest,



(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 -

packager)

Hungary L02BG03 1392829.10.2014

29.10.2019PoM


PLC, 1106 Budapest,


Hungary

330

1514 Egistrozol anastrozole tablets coated

1mg,


30/3x10/, 90/9x10/)


PLC, 1165 Budapest,



(Synthon Hispaina,

S.L., Castello,

1,Poligono Las

Salines, 08830 Sant

Boi De Llobregat,

Spain - bulk

manufacturer,

packager)

Hungary L02BG03 1392929.10.2014

29.10.2019PoM


PLC, 1106 Budapest,


Hungary

1515 Eglonyl sulpiride tablets200mg,


Delpharm Dijon, 6,

Boulevard de l`

Europe 21800,

Quetigny

France N05AL01 1697405.09.2017

05.09.2022PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

1516 Eglonyl sulpiride capsules50mg,


Delpharm Dijon, 6,

Boulevard de l`

Europe 21800,

Quetigny

France N05AL01 1707905.10.2017

05.10.2022PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

1517 Eglonyl sulpiridesolution for i/m

injection

50mg/ml,

2ml ampoules,

in blister (6/1x6/)

Delpharm Dijon, 6,

Boulevard de l`

Europe 21800,

Quetigny

France N05AL01 1712907.11.2017

07.11.2022PoM

Sanofi-Aventis

France, 1-13,

boulevard Romain


France

1518 Egolanza

olanzapine

(olanzapine

dihydrochloride

trihydrate)

tablets film-coated

5mg,


56/8x7/)


PLC, 1165 Budapest,


124

Hungary N05AH03 14285/116.11.2017

19.03.2020PoM


PLC, 1106 Budapest,


Hungary

1519 Egolanza

olanzapine

(olanzapine

dihydrochloride

trihydrate)

tablets film-coated

15mg,


56/8x7/)


PLC, 1165 Budapest,


121

Hungary N05AH03 14286/116.11.2017

19.03.2020PoM


PLC, 1106 Budapest,


Hungary

331

1520 Egolanza

olanzapine

(olanzapine

dihydrochloride

trihydrate)

tablets film-coated

20mg,


56/8x7/)


PLC, 1165 Budapest,


123

Hungary N05AH03 14287/116.11.2017

19.03.2020PoM


PLC, 1106 Budapest,


Hungary

1521 Egolanza

olanzapine

(olanzapine

dihydrochloride

trihydrate)

tablets film-coated

7,5mg,


56/8x7/)


PLC, 1165 Budapest,


122

Hungary N05AH03 14288/116.11.2017

19.03.2020PoM


PLC, 1106 Budapest,


Hungary

1522 Egolanza

olanzapine

(olanzapine

dihydrochloride

trihydrate)

tablets film-coated

10mg,


56/8x7/)


PLC, 1165 Budapest,


120

Hungary N05AH03 14289/116.11.2017

19.03.2020PoM


PLC, 1106 Budapest,


Hungary

1523 Ekvator

amlodipine

(amlodipine

besilate), lisinopril

(lisinopril

dihydrate)

tablets

5mg+20mg,


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


Gyomroi ut 19-21,

1103 Budapest

Hungary C09BB03 1328304.03.2014

04.03.2019PoM

Gedeon Richter


21, 1103 Budapest,

Hungary

1524 Ekvator


dihydrate),

amlodipine

(amlodipine

besilate)

tablets

20mg+10mg,


60/6x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09BB03 1488724.09.2015

24.09.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

1525 Ekvator


dihydrate),

amlodipine

(amlodipine

besilate)

tablets

10mg+5mg,


60/6x10/)

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest

Hungary C09BB03 1488824.09.2015

24.09.2020PoM

Gedeon Richter PLC,

Gyomroi ut 19-21,

1103 Budapest,

Hungary

332

1526 Elafra leflunomide tablets film-coated10mg,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A - secondary

packager, batch


manufacturer,

primary packager -

Haupt Pharma

Muenster GmbH,

Schleebruggenkamp

15, 48159 Muenster,

Germany)

Romania L04AA13 12640/130.08.2013

04.07.2018PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1527 Elafra leflunomide tablets film-coated20mg,


S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A - secondary

packager, batch


manufacturer,

primary packager -

Haupt Pharma

Muenster GmbH,

Schleebruggenkamp

15, 48159 Muenster,

Germany)

Romania L04AA13 12641/130.08.2013

04.07.2018PoM

S.C. Rompharm

Company S.R.L.,

Ilfov, 075100


Nr. 1A, Romania

1528 Elenium chlordiazepoxide tablets coated10mg,


Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw

Poland N05BA02 1581420.07.2016

20.07.2021PoM/UC

Tarchomin

Pharmaceutical

Works "Polfa" S.A.,


176 Warsaw, Poland

1529Eleutherococcus

extract liquid

eleutherococcus

senticosus rhizomes

with roots

extract for oral

administration

(liquid)

1mg/ml,

50ml glass bottle

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260

RussiaA13A

herbal drug 13735/2

30.12.2016

24.07.2019OTC

Tatchempharmprepar

aty JSC, 420091

Kazan, str.

Belomorskaya 260,

Russia

333

1530 Elevit Pronatal

vitamin A, vitamin

D3, vitamin E,

vitamin C, folic

acid, vitamin

B1,vitamin B2,

vitamin B6, vitamin

B12, nicotinamide,

biotin, calcium

pantothenate,

calcium,

magnesium,

phosphor, ferrum,

zinc, copper,

manganese

tablets film-coated

3600IU+500IU+

15mg+100mg+

0,8mg+1,6mg+

1,8mg+2,6mg+

4mcg+19mg+

0,2mg+10mg+

125mg+100mg+

125mg+60mg+

7,5mg+1mg+1mg, in

blister (30/3x10/,

100/10x10/)

Rottendorf Pharma

GmbH, Ostenfelder

Strasse 51-61, 59320

Ennigerloh

Germany A11AA 1486318.09.2015

18.09.2020OTC

Bayer Consumer Care

AG, Peter Merian-


Switzerland

1531 Elidel pimecrolimus cream10mg/g,

15g aluminium tube

MEDA Pharma

GmbH & Co. KG,


Bad Homburg - batch


manufacturer,

packager - Novartis

Pharma Produktions

GmbH, Oeflinger

Strasse 44, 79664

Wehr ,Baden

Wurttemberg,

Germany)

Germany D11AH02 1313910.01.2014

10.01.2019PoM

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

1532 Elidel pimecrolimus cream10mg/g,

15g aluminium tube

MEDA

Manufacturing,

Avenue JF Kennedy,

33700 Merignac

France D11AH02 1474503.08.2015

03.08.2020PoM

MEDA Pharma

GmbH & Co. KG,


Bad Homburg,

Germany

334

1533 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

7,5mg,

syringe A tray contains

pre-filled syringe A with

343mg solvent, plunger

rod for syringe B, syringe

B tray contains pre-filled

syringe B with 7,5mg

lyophilized powder and

needle

Astellas Pharma

Europe B.V.,

Hogemaat 2, NL-7942

JG Meppel - batch


manufacturer,

packager - Tolmar

Inc., 701 Centre

Avenue, Ft. Collins,

CO 80526, USA)

the Netherlands L02AE02 1286617.09.2013

17.09.2018PoM

Astellas Pharma

Europe B.V.

Elisabethhof 19, 2353

EW Leiderdorp, the

Netherlands

1534 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

22,5mg,



457mg solvent and

plunger rod for syringe B,

syringe B tray contains

pre-filled syringe B with

29,2mg lyophilized

powder and needle

Astellas Pharma

Europe B.V.,

Hogemaat 2, NL-7942

JG Meppel - batch


manufacturer,

packager - Tolmar

Inc., 701 Centre


CO 80526, USA)


17.09.2018PoM

Astellas Pharma

Europe B.V.


EW Leiderdorp, the

Netherlands

1535 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

45mg,



434mg solvent and

plunger rod for syringe B,

syringe B tray contains

pre-filled syringe B with

59,2mg lyophilized

powder and needle

Astellas Pharma

Europe B.V.,

Hogemaat 2, NL-7942

JG Meppel - batch


manufacturer,

packager - Tolmar

Inc., 701 Centre


CO 80526, USA)


17.09.2018PoM

Astellas Pharma

Europe B.V.


EW Leiderdorp, the

Netherlands

335

1536 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

7,5mg,

syringe A-343mg solvent

and B syringe plunger in

plastic container, syringe

B-10,6mg lyophilized

powder and needle in

plastic container

MediGene AG,

Lochhamerstrasse

11/15, 82152

Planegg/Martinsried -

batch releaser;

(Tolmar Inc., 701

Centre Avenue, Ft.

Collins, CO 80526,

USA- syringe A &

syringe B bulk

manufacturer,

packager)

Germany L02AE02 1336804.04.2014

04.04.2019PoM

Astellas Pharma

Europe B.V., the

Netherlands


EW Liederdorp the

Netherlands

1537 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

22,5mg; syringe A-457mg

solvent and B syringe

plunger in plastic

container, syringe B-

29,2mg lyophilized


plastic container

MediGene AG,

Lochhamerstrasse

11/15, 82152


batch releaser;

(Tolmar Inc., 701

Centre Avenue, Ft.

Collins, CO 80526,

USA- syringe A &

syringe B bulk

manufacturer,

packager)

Germany L02AE02 1336904.04.2014

04.04.2019PoM

Astellas Pharma

Europe B.V., the

Netherlands


EW Liederdorp the

Netherlands

1538 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized


injection

45mg,

syringe A-434mg solvent

and B syringe plunger in

plastic container; syringe

B-59,2mg lyophilized


plastic container

MediGene AG,

Lochhamerstrasse

11/15, 82152


batch releaser;

(Tolmar Inc., 701

Centre Avenue, Ft.

Collins, CO 80526,

USA- syringe A &

syringe B bulk

manufacturer,

packager)

Germany L02AE02 1337004.04.2014

04.04.2019PoM

Astellas Pharma

Europe B.V., the

Netherlands


EW Liederdorp the

Netherlands

336

1539 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized

and solvent for

solution for s/c

injection

7,5mg,

(I) syringe A- 343mg

solvent and plunger for

syringe B, in plastic pack,

(II)- syringe B- 10.6mg


needle, in plastic pack

Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel-batch

releaser, secondary

packager, Tolmar Inc.,

701 Centre Avenue,

Ft. Collins, CO 80526,

USA-bulk

manufacturer,

primary packager

(syringe A and

syringe B)


04.07.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1540 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized

and solvent for

solution for s/c

injection

45mg,




(II) syringe B- 59.2mg



Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel-batch

releaser, secondary


701 Centre Avenue,


USA-bulk

manufacturer,

primary packager

(syringe A and

syringe B)


04.07.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

1541 Eligard

leuprorelin

(leuprorelin

acetate)

powder lyophilized

and solvent for

solution for s/c

injection

22,5mg,




(II) syringe B- 29.2mg



Astellas Pharma

Europe B.V.,

Hogemaat 2, 7942 JG

Meppel-batch

releaser, secondary


701 Centre Avenue,


USA-bulk

manufacturer,

primary packager

(syringe A and

syringe B)


04.07.2021PoM

Astellas Pharma

Europe B.V.,

Sylviusweg 62, 2333

BE Leiden, the

Netherlands

337

1542 Eliquis apixaban tablets film-coated

2,5mg,


60/6x10/)

Bristol-Myers Squibb

S.R.L., Loc. Fontana

del Ceraso 03012

Anagni (FR)-batch

releaser, packager,


Manufacturing

Company, Puerto

Rico, State Road #3,

Km 77.5, Humacao,

00791, USA-bulk

manufacturer

Italy B01AF02 1461003.07.2015

03.07.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1543 Eliquis apixaban tablets film-coated

5mg,


60/6x10/)


S.R.L., Loc. Fontana

del Ceraso 03012

Anagni (FR)-batch

releaser, packager,


Manufacturing

Company, Puerto

Rico, State Road #3,

Km 77.5, Humacao,

00791, USA-bulk

manufacturer

Italy B01AF02 1469516.07.2015

16.07.2020PoM

Pfizer H.C.P.

Corporation, 235,


York 10017, USA

1544 Elocom

mometasone

(mometasone

furoate)

lotion1mg/g,

30ml plastic bottle

Schering-Plough

S.p.A., Via F.lli

Kennedy 5, 26833

Comazzo

Italy D07AC13 1229822.03.2013

22.03.2018PoM

Merck Sharp &

Dohme Idea AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1545 Elocom

mometasone

(mometasone

furoate)

lotion

1mg/g,

30ml plastic bottle with

dropper

Famar Montreal Inc.,

3535 Trans Canada

Highway, Pointe-

Claire, Quebec, H9R

1B4

Canada D07AC13 13406/211.12.2017

14.04.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, 6000

Lucerne 6,

Switzerland

338

1546 Elocom

mometasone

(mometasone

furoate)

ointment1mg/g,

15g aluminum tube


N.V., Industriepark


den-Berg

Belgium D07AC13 1425920.02.2015

20.02.2020PoM

Schering-Plough

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

1547 Elocom

mometasone

(mometasone

furoate)

cream1mg/g,

15g aluminium tube


N.V., Industriepark


den-Berg

Belgium D07AC13 1633030.12.2016

30.12.2021PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

1548 Elonva corifollitropin alfa solution for injection

150mcg/0,5ml, 0,5ml pre-

filled syringe and needle

(1)

Organon (Ireland)

Ltd., Drynam Road,

Swords, Co. Dublin -

batch releaser,

secondary packager,

Vetter Pharma-

Fertigung GmbH &

Co. KG,

Schutzenstrasse 87

and 99/101, D-88212

Ravensburg, Germany-

bulk manufacturer,

primary packager

Ireland

G03GA09;

new

indication

14120/129.12.2014

29.12.2019PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

1549 Elonva corifollitropin alfa solution for injection100mcg/0,5ml, 0,5ml pre-

filled syringeand needle

Organon (Ireland)

Ltd., Drynam Road,

Swords, Co. Dublin -

secondary packager,


manufacturer,

primary packager -

Vetter Pharma-

Fertigung GmbH &

Co. KG,

Schutzenstrasse 87

and 99/101, D-88212

Ravensburg,

Germany)

Ireland

G03GA09;

new

indication

14121/129.12.2014

29.12.2019PoM

Central East AG,

Weystrasse 20, P.O.

Box CH-6000

Lucerne 6,

Switzerland

339


150mcg/0,5ml,

0,5ml pre-filled syringe

(1) and needle

N.V. Organon,

Kloosterstraat 6, 5349

AB Oss- batch

releaser, secondary

packager, Vetter

Pharma-Fertigung

GmbH & Co. KG,

Schutzenstrasse 87

and 99/101, D-88212


bulk manufacturer,

primary packager

the Netherlands G03GA09 1696205.09.2017

05.09.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland


100mcg/0,5ml,

0,5ml pre-filled syringe

(1) and needle

N.V. Organon,

Kloosterstraat 6, 5349

AB Oss- batch

releaser, secondary

packager, Vetter

Pharma-Fertigung

GmbH & Co. KG,

Schutzenstrasse 87

and 99/101, D-88212


bulk manufacturer,

primary packager

the Netherlands G03GA09 1696305.09.2017

05.09.2022PoM

Schering-Plough

Central East AG,

Weystrasse 20, CH-

6000 Lucerne 6,

Switzerland

1552 Eludril PRO

chlorhexidine

(chlorhexidine

digluconate),

chlorobutanol

(chlorobutanol

hemihydrate)

solution for

mouthwash

1mg/ml+5mg/ml, plastic

bottle 90ml and

measuring cup

Pierre Fabre

Medicament

Production, site

Progipharm, Rue du

Lycee, 45500 Gien

France A01AB03 1581720.07.2016

20.07.2021OTC

Pierre Fabre

Medicament

Production, 45, place

Abel Gance, 92100

Boulogne, France

1553 Emanera

esomeprazole

(esomeprazole

magnesium)

capsules gastro-

resistant

20mg,

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 1418406.02.2015

06.02.2020PoM

KRKA d.d., Novo

mesto, Smarjeska

cesta 6, 8501 Novo

Mesto, Slovenia

340

LIST OF REGISTRED DRUGS IN ARMENIA (Up to 31.12.2017) · Greece R05CB06 15404 09.03.2016 09.03.2021...

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