BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH,...

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product Registration Number Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence Product Classification 1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as sodium salt, clavulanic acid 200mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma Sdn Bhd 06 October 2015 till 05 October 2020 POM 2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg as sodium salt, clavulanic acid 100mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma Sdn Bhd 06 October 2015 till 05 October 2020 POM 3 BRU07100003P Maxipime Injection 1g Cefepime HCl 1g Bristol Myers Squibb, Seromenta Italy Zuellig Pharma Sdn Bhd 06 October 2010 till 05 October 2015 POM 4 BRU07100004P Maxipime Injection 500mg Cefepime HCl 500mg Bristol Myers Squibb, Seromenta Italy Zuellig Pharma Sdn Bhd 06 October 2010 till 05 October 2015 POM 5 BRU08010001P Pharmaniaga Aciclovir Tablet 200mg Aciclovir 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 6 BRU08010002P Pharmaniaga Ketoconazole Tablet 200mg Ketoconazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 7 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 8 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 9 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 10 BRU08010006P Pharmaniaga Ciprofloxacin Tablet 250mg Ciprofloxacin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2010 till 05 October 2015 POM 11 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UK Zuellig Pharma Sdn Bhd 06 October 2015 till 05 October 2020 POM 12 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UK Zuellig Pharma Sdn Bhd 06 October 2015 till 05 October 2020 POM 13 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham Plc, UK Zuellig Pharma Sdn Bhd 06 October 2015 till 05 October 2020 POM BDMCA/RMP/1215 Page 1 of 143

Transcript of BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH,...

Page 1: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

No

Product

Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licenceProduct

Classification

1 BRU07100001P Augmentin Injection 1.2g

Co-Amoxiclav 1000/200 - Amoxicillin 1g

as sodium salt, clavulanic acid 200mg as

potassium salt

SmithKline Beecham PLC,

Worthing, West Sussex, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

2 BRU07100002P Augmentin Injection 600mg

Co-Amoxiclav 500/100 - Amoxicillin

500mg as sodium salt, clavulanic acid

100mg as potassium salt

SmithKline Beecham PLC,

Worthing, West Sussex, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

3 BRU07100003P Maxipime Injection 1g Cefepime HCl 1gBristol Myers Squibb,

Seromenta Italy

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

4 BRU07100004P Maxipime Injection 500mg Cefepime HCl 500mgBristol Myers Squibb,

Seromenta Italy

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

5 BRU08010001PPharmaniaga Aciclovir Tablet

200mgAciclovir 200mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

6 BRU08010002PPharmaniaga Ketoconazole

Tablet 200mgKetoconazole 200mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

7 BRU08010003PPharmaniaga Clarithromycin

Tablet 250mgClarithromycin 250mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

8 BRU08010004PPharmaniaga Fluconazole

150mg CapsulesFluconazole 150mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

9 BRU08010005PPharmaniaga Ciprofloxacin

Tablet 500mgCiprofloxacin 500mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

10 BRU08010006PPharmaniaga Ciprofloxacin

Tablet 250mgCiprofloxacin 250mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2010 till 05

October 2015POM

11 BRU08010009P Meronem Injection 1g Meropenem (as trihydrate) 1g AstraZeneca UK Ltd, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

12 BRU08020010P Meronem Injection 500mg Meropenem (as trihydrate) 500mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

13 BRU08020011P Bactroban Cream Mupirocin 2% SmithKline Beecham Plc, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 1 of 143

Page 2: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

14 BRU08020012PPharmaniaga Cephalexin

Capsule 500mgCephalexin 500mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

15 BRU08020013PPharmaniaga Metronidazole

Tablet 200mg Metronidazole 200mg

Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading

Company

06 October 2010 till 05

October 2015POM

16 BRU08020014P Baraclude Tablet 1mg Entecavir 1mg Bristol-Myers Squibb, USAZuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

17 BRU08020015P Baraclude Tablet 0.5mg Entecavir 0.5mg Bristol-Myers Squibb, USAZuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

18 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

19 BRU08020017P Bicafar Sterile 1g Cefoperazone 1gDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

20 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5mlDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

21 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5mlDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

22 BRU08020020P Diprivan 1%, 20ml Ampoule Propofol 0.1% Corden Pharma S.P.AZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

23 BRU08020021P Retrovir Capsule 100mg Zidovudine 100mg SmithKline Beecham Plc, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

24 BRU08020022P Bactroban Ointment Mupirocin 2%GlaxoSmithKline Philippines

Inc, Philippines

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

25 BRU08030023P Augmentin Tablet 625mg

Amoxycillin 500mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

26 BRU08030024P Augmentin Syrup 228mg/5ml

Amoxycillin 200mg/5ml (as trihydrate);

Clavulanic acid 28.5mg/5ml (as

Potassium Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

27 BRU08030025P Augmentin Syrup 457mg/5ml

Amoxycillin 400mg/5ml (as trihydrate);

Clavulanic acid 57mg/5ml (as Potassium

Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

28 BRU08030026P Augmentin Tablet 1g

Amoxycillin 875mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 2 of 143

Page 3: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

29 BRU08030027P Foban Cream Fusidic acid 2%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

30 BRU08030028P Androxyl Syrup 125mg/5ml Cefadroxil (as monohydrate)Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

31 BRU08030029P Androxyl Syrup 250mg/5ml Cefadroxil (as monohydrate)Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

32 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate)Duopharma (M) Sdn Bhd,

Malaysia

K-Seri Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

33 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1%Glaxo Operations UK

Limited, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

34 BRU08030032P Genta Eye Drop 0.3%w/v Gentamicin (as Sulphate)Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

35 BRU08030033P Zinacef Injection 250mg Cefuroxime (as sodium)GlaxoSmithKline

Manufacturing SPA, Italy.

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

36 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium)GlaxoSmithKline

Manufacturing SPA, Italy.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

37 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium)GlaxoSmithKline

Manufacturing SPA, Italy.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

38 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil)Glaxo Operations UK

Limited, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

39 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil)Glaxo Operations UK

Limited, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

40 BRU08040039P Solulexin Granules 125mg/5mlCefalexin Monohydrate equivalent to

Cefalexin 125mg/5ml

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

41 BRU08040040P Retrovir Syrup Zidovudine 50mg/5mlGlaxoSmithKline Inc.,

Canada

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

42BRU08040041PS1 &

BRU08040041PS2Zeffix Tablet Lamivudine 100mg

Glaxo Wellcome Operations

UK Ltd, UK (S1);

GlaxoSmithKline

Pharmaceuticals S.A., Poland

(S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

43 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mgGlaxoSmithKline

Pharmaceuticals S.A., Poland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

44 BRU08040043P Zoraxin Syrup Aciclovir 200mg/5mlDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

45 BRU08040044P Trizole TabletSulfamethoxazole 400mg; Trimethoprim

80mg

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 3 of 143

Page 4: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

46 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

47 BRU08040046P Genta-Bet Eye Drops

Gentamicin (as Sulphate) 0.3%,

Betamethasone Disodium Phosphate

0.1%

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

48 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2gDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

49 BRU08040049PDiflucan IV Infusion 2mg/ml

(50ml)Fluconazole 2mg/ml Pfizer PGM, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

50 BRU08040050P Sulperazone IM/IV 1gSulbactam (as Sodium) 500mg;

Cefoperazone (as Sodium) 500mg

Haupt Pharma Latina S.r.I.,

Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

51 BRU08040051P Beagenta Cream 0.1% Gentamicin (as Sulphate BP) 0.1%w/wUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

52 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2%Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015GSL

53 BRU08050053PPharmaniaga Aciclovir Tablet

400mgAciclovir 400mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

54 BRU08050054PPharmaniaga Cephalexin

Capsule 250mg

Cephalexin (as Anhydrous) Cephalexin

250mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

55 BRU08050055P Androxyl Capsule 250mgCefadroxil Monohydrate equivalent to

Cefadroxil 250mg

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

56 BRU08050056P Androxyl Capsule 500mg Cefadroxil (as Monohydrate) 500mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

57 BRU08050057P Quilaxin Tablet 400mg Pefloxacin Mesylate Dihydrate 400mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

58 BRU08050058P Ketozotan Tablet 200mg Ketoconazole 200mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

59 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

60 BRU08050061P Unocef Injection 1000mg (Vial) Ceftriaxone (as Sodium) 1000mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

61 BRU08050062PGarasent 280mg Injection (2ml

Ampoule)Gentamicin (as Sulphate BP) 280mg

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

62 BRU08050063P Solulexin Capsule 250mgCephalexin Monohydrate 262.95mg

equivalent to Cephalexin 250mg

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 4 of 143

Page 5: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

63 BRU08050064P Solulexin Capsule 500mg Cephalexin (as Monohydrate) 500mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

64 BRU08050065P Beavate-N Cream

Betamethasone-17-valerate equivalent

to Betamethasone 0.1%w/w; Neomycin

Sulphate 0.5%w/w

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

65 BRU08050066P Beagenta Eye/ Ear DropsGentamicin Sulphate equivalent to

Gentamicin 0.3%w/w

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

66 BRU08050067P Uphalexin Granules 125Cephalexin Monohydrate 138mg/5ml

equivalent to Cephalexin 125mg/5ml

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

67 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised)Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

68 BRU08050069P Plaquenil Tablet Hydroxychloroquine Sulphate 200mg Sanofi-Synthelabo Ltd, UK Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

69 BRU08050070P Betacin Eye Ear Drop

Neomycin Sulphate 0.5% w/v;

Betamethasone Sodium Phosphate

0.1%w/v

Duopharma (M)Sdn Bhd,

Malaysia

K-Seri Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

70 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/vHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

71 BRU08050072P Fobancort Cream

Fusidic acid 2%w/w; Betamethasone

Dipropionate 0.064%w/w equivalent to

Betamethasone 0.05%w/w

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

72 BRU08050073P Dezor Cream Ketoconazole 2%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

73 BRU08050074P Dezor Shampoo Ketoconazole 2%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

74 BRU08060075P Genta-Dex Eye DropsGentamicin 0.3% w/v; Dexamethsone

Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

75 BRU08060077P Aecoras OintmentEconazole Nitrate 10mg; Triamcinolone

Acetonide 1mg

Tai Guk Pharm Co. Ltd.,

Korea

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

76 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5mlUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

77 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 5 of 143

Page 6: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

78 BRU08060080P Beta Eye/ Ear Drops Betamethasone Sodium Phosphate 0.1%Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

79 BRU08060081P Betagen Eye/ Ear DropsGentamicin 0.3% w/v; Dexamethsone

Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

80 BRU08060082P Muprin Ointment Mupirocin 2.0%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

81 BRU08060083P Eryson Granules 200Erythromycin ethylsuccinate equiv. to

eryhtromycin 200mg/5ml

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

82 BRU08060084P Eryson Granules 400Erythromycin ethylsuccinate equiv. to

eryhtromycin 400mg/5ml

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

83 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/wUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

84 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

85 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

86 BRU08060088P Arava Tablet 10mg Leflunomide 10mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

87 BRU08060089P Arava Tablet 20mg Leflunomide 20mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

88 BRU08070090P Zinnat Suspension 125mg/5mlCefuroxime Axetil equivalent to

Cefuroxime 250mg

Glaxo Wellcome Bernard

Castle, United Kingdom

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

89 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/vAin Medicare Sdn Bhd,

Malaysia

Syarikat Pakatan

Indah

06 October 2015 till 05

October 2020POM

90 BRU08070092P Eryson Tablet 250Erythromycin Stearate BP equivalent to

Eryhthromycin 250mg

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

91 BRU08070093P Neomycin Cream Neomycin sulphate 0.5%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2010 till 05

October 2015POM

92 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w;

Triamcinolone Acetonide 0.1% w/w

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

93 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

94 BRU08070096P Betamox Capsule 250mgAmoxicillin Trihydrate equivalent to

Amoxicillin 250mg

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 6 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

95 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

96 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, SwedenZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

97 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, SwedenZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

98 BRU08070101P Zovirax Suspension 200mg/5ml Acyclovir 200mg/5mlGlaxoSmithKline GmbH & Co

Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

99 BRU08070102P Fortum® Injection 500mg Ceftazidime (as Pentahydrate) 500mgGlaxoSmithKline

Manufacturing SPA, Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

100 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1gGlaxoSmithKline

Manufacturing SPA, Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

101 BRU08080104P Beavate Cream 0.1%Betamethasone -17- valerate equiv. to

Betamethasone 0.1%

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

102 BRU08080106P Candazole Cream Clotrimazole 1.0%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020GSL

103 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1%Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

104 BRU08080108P Beprogent CreamBetamethasone (as dipropionate) 0.05%,

Gentamicin (as sulphate 0.1%)

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

105 BRU08080109P Unasyn Tablet 375mgSultamicillin (as tosilate) 375mg

(Ampicillin 250mg & Sulbactam 125mg)

Pfizer Global Supply Japan

Inc, Japan

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

106 BRU08080110PZovirax Dispersable Tablet

200mgAciclovir 200mg Glaxo Wellcome, S.A., Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

107 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, SpainZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

108 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2gGlaxoSmithKline

Manufacturing SPA, Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

109 BRU08080113P Uphalexin Capsule 250 Cephalexin (as monohydrate) 250mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

110 BRU08080114P Uphalexin Capsule 500 Cephalexin (as monohydrate) 500mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

111 BRU08080115PVaxcel Cefuroxime 750mg

InjectionCefuroxime (as sodium) 750mg

Kotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 7 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

112 BRU08080116P Vaxcel Ceftriaxone 1g Injection Ceftriaxone (as sodium) 1gKotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

113 BRU08080117P Axcel Fusi-Corte CreamFusidic acid 2%, Betamethasone (as 17-

valerate) 0.1%

Kotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

114 BRU08090118P Verorab Injection

Inactivated rabies virus (Wistar strain

RABIES PM/WI 38-1503-3M) produced

on VERO cell line, inactivated and purifed

Sanofi Pasteur, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

115 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

116 BRU08090120P Fobancort Ointment

Sodium Fusidate 2%w/w;

Betamethasone 0.05%w/w (as

Dipropionate 0.064%)

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

117 BRU08090121P Candacort CreamClotrimazole 1.0% w/w; Hydrocortisone

1.0%w/w

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

118 BRU08090122P Hepsera Tablet 10mg Adefovir dipivoxil 10mgGlaxosmithKline (Tianjin)

Co.Ltd, China

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

119 BRU08090124PCiprobay® 200 Infusion

SolutionCiprofloxacin (as lactate) 200mg

Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

120 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2gKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

121 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/wKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

122 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/wKotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

123 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1gKotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

124 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/wKotra Pharm (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020GSL

125 BRU08090130PCiprobay 100 Infusion Solution

x 50mlCiprofloxacin (as lactate) 100mg

Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020P

126 BRU08090131P Beamoxy Capsule 500 Beamoxy Capsule 500Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

127 BRU08090132P Aroxin Capsule 250mg Amoxicillin (as trihydrate) 250mg

Agila Specialties Private

Limited, India; Medreich

Limited Unit-1, Bangalore,

India

G & H Trading

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 8 of 143

Page 9: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

128 BRU08090133NPDhamol Suspension

250mg/5mlParacetamol 250mg/5ml

Drug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020P

129 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020GSL

130 BRU08100135P Betamox Capsule 500mgBRU08090127P

Duopharma (M) Sdn Bhd

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

131 BRU08100136PZovirax Dispersable Tablet

800mgAciclovir 800mg Glaxo Wellcome S.A., Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

132 BRU08100137P Neo Deca Eye/Ear Drop

Neomycin Sulphate 0.5%;

Dexamethasone Sodium Phosphate 0.1%

w/w

CCM Pharmaceutical Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

133 BRU08100138P Uphalexin Granules 250 Cephalexin (as Monohydrate) 250mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

134 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl monohydrate)

500mg

Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

135 BRU08100140PAvelox Infusion Solution

0.4g/250mlMoxifloxacin (as Hydrochloride) 400mg

Bayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

136 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mgBayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

137 BRU08100142P Candazole Lotion Clotrimazole 1%w/wHoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020GSL

138 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mgDrug Houses of Australia Pte

Ltd

G & H Trading

Company

06 October 2015 till 05

October 2020POM

139 BRU08100144P Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5mlDrug Houses of Australia Pte

Ltd

G & H Trading

Company

06 October 2015 till 05

October 2020P

140 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mgDrug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020P (1000's)

141 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/wSunward Pharmaceutical

Sdn Bhd Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020P

142 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mgDrug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

143 BRU08100148P Erythro Ethyl GranulesErythromycin (as ethyl succinate)

200mg/5ml

Drug Houses of Australia

Pte. Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

144 BRU08100149P Eryhthro Tablets 250mg Erythromycin (as stearate) 250mgDrug Houses of Australia

Pte. Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

145 BRU08110150PAvaxim 160U Suspension for

Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM

strain) 160u/0.5mlSanofi Pasteur France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 9 of 143

Page 10: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

146 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

147 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mgGlaxoSmithKline

Manufacturing SPA Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

148 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/wKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

149 BRU08110154PAxcel Eryhthromycin ES Tablet

400mgErythromycin (as ethyl succinate) 400mg

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

150 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mgKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

151 BRU08110156PAxcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

152 BRU08110157P Soden Tablet 275mg Naproxen Sodium BP 275mgDrug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

153 BRU08110158NPDhamol Suspension

120mg/5mlParacetamol BP 120mg/5ml

Drug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020GSL (100mL)

154 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/wSunward Pharmaceutical

Sdn Bhd Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020GSL

155 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl

100mgGlaxoSmithKline Inc Canada

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

156 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

157 BRU08110163PCoAprovel 150/12.5mg Film-

coated Tablet

Irbesartan 150mg, Hydrochlorothiazide

12.5mg

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

158 BRU08110164P Dhaperazine Tablet 5mg Prochlorperazine (as maleate) 5mgDrug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

159 BRU08110165P Betasone Cream 0.1%w/wBetamethasone (as 17-valerate)

0.1%w/w

Drug Houses of Australia Pte

Ltd

G & H Trading

Company

06 October 2015 till 05

October 2020POM

160 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate)

250mg

Bayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

161 BRU08120167PAxcel Cephalexin 250mg

CaspuleCephalexin (as Monohydrate) 250mg

Kotra Pharma (M) Sdn Bhd

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

162 BRU08120168PAxcel Cephalexin 125mg

SuspensionCephalexin (as Monohydrate) 125mg

Kotra Pharma (M) Sdn Bhd

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

163 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 10 of 143

Page 11: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

164 BRU08120170P Hydrocrotisone Cream 1% w/w Hydrocortisone acetate BP 1%w/wUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

165 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

166 BRU08120172P Betamox Tablet 125 Amoxicillin (as trihydrate) 125mgDuopharma (M) Sdn Bhd

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

167 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

168 BRU08120174P Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP 5mg/5mlDrug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

169 BRU08120175P Phenexpect SyrupPer 5ml - Diphenhydramine (as HCl)

12.5mg, Ammonium Chloride 135mg

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

170 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05% w/vDrug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

171 BRU08120177P Beprosalic LotionBetamethasone (as dipropionate) 0.05%,

Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

172 BRU08120178P Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP 2mg/5mlDrug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

173 BRU08120179P Dhasedyl Syrup

Per 5ml - Promethazine (as HCl) 3.85mg,

Epherdrine (as HCl) 6.0mg, Codeine (as

phosphate) 9.0mg

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

174 BRU08120180PZithromax Film-coated Tablet

250mgAzithromycin (as dihydrate) 250mg

Haupt Pharma Latina S.r.l,

Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

175 BRU09010181P Unasyn 0.75mg IM/IVAmpicillin (as sodium) 500mg; Sulbactam

(as sodium) 250mg

Haupt Pharma Latina S.r.l,

Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

176 BRU09010182P Unasyn 3.0g IM/IVAmpicillin (as sodium) 2000mg;

Sulbactam (as sodium) 1000mg

Haupt Pharma Latina S.r.l,

Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

177 BRU09010183PVaxcel Ceftriaxone-500mg

InjectionCeftriaxone (as sodium) 500mg

Kotra Pharma (M) Sdn Bhd

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

178BRU09010184PS1;

BRU09010184PS2 Aroxin granules 125mg/5ml Amoxicillin (as trihydrate) 125mg/5ml

Drug Houses of Australia Pte

Ltd, Singapore (S1);

Medreich Limited Unit-1,

India (S2)

G & H Trading

Company

06 October 2015 till 05

October 2020POM

179 BRU09010185P Pacofen TabletParacetamol 500mg; Codeine Phosphate

8mg; Caffeine anhydrous 30mg

Drug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 11 of 143

Page 12: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

180 BRU09010186P Plavix Tablet 75mgClopidogrel (as Hydrogen Sulphate)

75mg

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

181 BRU09010187PSymbicort Turbuhaler

160/4.5mcg dose

Budenoside 160mcg; Formoterol

fumarate dihydrate 4.5mcg

AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

182 BRU09010188PCoAprovel 300/12.5mg film-

coated tablet

Irbesartan 300mg; Hydrochlorothiazide

12.5mg

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

183 BRU09010189P Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5mlDrug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

184 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mgDrug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

185BRU09010191PS1 &

BRU09010191PS2Coversyl 8mg tablet Perindopril tert-butylamine 8mg

Les Laboratoires Servier

Industrie, France (S1) &

Kotra Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

186 BRU09010192P Dhacopan Tablet Hyoscine (as butylbromide) BP 10mgDrug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

187 BRU09010193P Fleming Tablet 1g

Amoxicillin (as trihydrate) 875mg;

Clavulanic acid (as Potassium

Clavulanate) 125mg

Medreich Limited IndiaAsterix United (B)

Sdn Bhd

06 October 2010 till 05

October 2015POM

188 BRU09010194PPulmicort turbuhaler

100mcg/doseBudenoside 100mcg

AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

189 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/mlSanofi Aventis Deutschland,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

190 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/wGlaxo Wellcome Opertions,

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

191 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/wJubilant HollisterStier

General Partnership, Canada

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

192 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml

Famar Health Care Services

Madrid S.A.U., Madrid,

Spain

Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

193 BRU09020199P Dhatrin Paediatric Suspension Trimethoprim BP 40mg/5ml;

Sulphamethoxazole BP 200mg/5ml

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

194 BRU09020200P Amedin 10 Tablet Amlodipine BP (as besilate) 10mg Medreich Limited IndiaAsterix United (B)

Sdn Bhd

06 October 2010 till 05

October 2015POM

195 BRU09020201NPDhamol Suspension

500mg/5mlParacetamol BP 500mg/5ml

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020P

196 BRU09020202P Amedin 5 Tablet Amlodipine BP (as besilate) 5mg Medreich Limited IndiaAsterix United (B)

Sdn Bhd

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 12 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

197 BRU09020203P Fleming Tablet 625mg

Amoxicillin (as trihydrate) 500mg;

Clavulanic acid (as Potassium

Clavulanate) 125mg

Medreich Limited IndiaAsterix United (B)

Sdn Bhd

06 October 2010 till 05

October 2015POM

198 BRU09020204P Beamoxy Tablet 500 Amoxicillin (as trihydrate 575mg) 500mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

199 BRU09020205P Fedac SyrupPseudoephedrine 30mg/5ml; Triprolidine

1.25mg/5ml

Drug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

200 BRU09020206PBricanyl Turbuhaler

0.5mg/doseTerbutaline Sulphate 0.5mg/dose

AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

201 BRU09020207P Beprosalic OintmentBetamethasone (as Dipropionate

0.064%) 0.05% & Salicylic acid 3% w/w

HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

202 BRU09020208P Beprogel Topical SolutionBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

203 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/vHOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

204 BRU09020210P Declovir Cream Acyclovir 5.0% w/wHOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

205 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901) 100units/mlSanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

206 BRU09020212P Glucobay 50 Tablet Acarbose 50mgBayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

207 BRU09030213P 3TC Tablet 150mg Lamivudine 150mgGlaxo Wellcome Operaions,

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

208 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/mlGlaxoSmithKline Inc.,

Canada

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

209 BRU09030215P Dhatrin TabletSulphamethoxazole BP 400mg;

Trimethoprim BP 80mg

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

210 BRU09030216PCordarone Injection

150mg/3mlAmiodarone 150mg/3ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

211BRU09030217PS1 &

BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg

Les Laboratoires Servier

Industrie, France (S1); Kotra

Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 13 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

212

BRU09030218P0.5g

S &

BRU09030218P0.5g

A

Tetavax Suspension for

Injection (Single dose 0.5ml)Purified Tetanus Toxoid Sanofi Pasteur, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

213 BRU09030219PCataflam 1.5% Oral Drops

SuspensionDiclofenac Sodium 15mg/ml Novartis Farma SpA, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

214 BRU09030220P Vaxigrip Influenza Vaccine

Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.5ml dose:

A/California/07/2009 NYMC X-179A

(H1N1) 15 mcg HA **;

A/South Australia/55/2014 IVR 175

(H3N2)15 mcg HA **;

B/Phuket/3073/2013(Yamagata lineage)

15 mcg HA **; B/Brisbane/60/2008

(Victoria lineage) 15 mcg HA ** (SH2015)

Note - * Propagated in fertilized hens’

egg from healthy chicken flocks

** haemagglutinin

Sanofi Pasteur, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

215 BRU09030221PLignocaine HCl BP Injection 1%

(5ml)

Lidocaine HCl (Lignocaine HCl) 1%

(50mg/5ml)

Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

216 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mgIPR Pharmaceuticals Inc.,

Puerto Rico

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

217 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mgIPR Pharmaceuticals Inc.,

Puerto Rico

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

218 BRU09030224P Beprosone OintmentBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

219 BRU09030225P Beprosone CreamBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

220 BRU09030226P Benosone-N CreamBetamethasone (as Valerate 0.12%) 0.1%

w/w; Neomycin Sulphate 0.5%w/w

HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

221 BRU09030227P Pocin H Ear DropNeomycin Sulphate B.P. 3,400 i.u.;

Polymyxin B Sulphate B.P.10,000 i.u;

Hydrocortisone B.P.10mg

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 14 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

222 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/wHOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

223 BRU09040229PUnasyn Powder for Oral

Suspension 250mg/5mlSultamicillin (as tosilate) 250mg

Pfizer Global Supply Japan,

Inc., Japan

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

224 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mgKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

225 BRU09040231P Knowful Capsule 400mg Piracetam 400mgYSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B)

Sdn Bhd

06 October 2015 till 05

October 2020POM

226

BRU09040232P0.5g

V &

BRU09040232P0.5g

S

Stamaril Vaccine

Live attenuated Yellow Fever Virus 17 D-

204 strain (per 0.5ml - Not less than 1000

LD50 units of the virus)

Sanofi Pasteur, Campus

Merieux & Sanofi Pasteur,

Parc Insutrial d'Incarville,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

227 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mgDelpharm Huningue S.A.S.,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

228 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mgYSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B)

Sdn Bhd

06 October 2015 till 05

October 2020POM

229 BRU09040235PVoltaren 75mg/3ml solution

for injectionDiclofenac Sodium 75mg/3ml

Novartis Pharma Stein, ag,

Switzerland; Lek

Pharmaceuticals d.d,

Slovenia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

230 BRU09040236P Vaxigrip Paediatric Injection

Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.25ml dose:

A/California/7/2009 (H1N1)pdm09-

derived strain used NYMC X-179A

7.5mcg HA**; A/Texas/50/2012(H3N2)-

derived strain used NYMC X-223A

7.5mcg HA**; B/Massachusetts/02/2012

15mcg HA** Note - *

Propagated in fertilized hens’ egg from

healthy chicken flocks

** haemagglutinin

Sanofi Pasteur, Campus

Merieux & Sanofi Pasteur,

Parc Insutrial d'Incarville,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

231 BRU09040237PDepo-Medrol Sterile Aqueous

Suspension 40mg/ml (5ml)Methylprednisolone Acetate 200mg/5ml

Pfizer Manufacturing

Belgium NV, Belgium

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 15 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

232 BRU09040238P Typhim Vi Vaccine (20 doses)

Per 0.5ml - Purified Vi Capsular

Polysaccharide of Salmonella typhi (Ty2

strain)

Sanofi Pasteur, Campus

Merieux & Sanofi Pasteur,

Parc Insutrial d'Incarville,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

233 BRU09040239PBupivacaine Hydrochloride BP

0.5% w/v injectionBupivacaine hydrochloride BP 0.5%w/v

Pfizer (Perth) Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

234 BRU09040240P Rhinathiol Capsule 375mg Carbocisteine 375mgSanofi-aventis Egypt s.a.e.,

EgyptMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

235 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mgPfizer Pharmaceutical LLC,

Vega Baja Puerto Rico

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

236 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SPA, ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

237 BRU09040243P T3 Mycin GelClindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

238 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/wHOE Pharmaceutical Sdn

Bhd, MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

239 BRU09040245P Bisacodyl Suppositroies Bisacodyl (micronised) 10mgYSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B)

Sdn Bhd

06 October 2015 till 05

October 2020P

240 BRU09040246P U-Closone Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

241 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, SwedenG & H Trading

Company

06 October 2015 till 05

October 2020POM

242 BRU09050248NP Dhactulose Syrup Lactulose 67%w/wDrug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020

GSL (200mL)

& P(1L)

243 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

244 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine 4mg,

Indapamide 1.25mg

Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

245 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mgDrug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

06 October 2010 till 05

October 2015POM

246 BRU09050252P Glucobay Tablet 100mg Acarbose 100mgBayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

247 BRU09050253P Benosone-N OintmentBetamethasone (as valerate 0.12% w/w)

0.01%, Neomycin Sulphate 0.50%w/w

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

248 BRU09050254P Benosone Ointment Betamethasone 0.01% w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 16 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

249 BRU09050255P Mycosone Cream

Miconazole nitrate 2% w/w,

Hydrocortisone ( as acetate1.12%) 1%

w/w

Sunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

250 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

251 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/vHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

252 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/wSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

253 BRU09060259PVaxcel Cefuroxime 1.5g

InjectionCefuroxime (as sodium) 1.5g

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

254 BRU09060260PTetavax Suspension for

InjectionTetanus toxoid 40i.u/0.5ml dose

Sanofi Pasteur, Lyon,

Pasteur

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

255 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mgUpha Pharmaceutical Mfg

(M) Sdn Bhd

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

256 BRU09060262P Betamox Tablet 250mg Amoxicillin (as trihydrate) 250mgDuopharma (M) Sdn Bhd

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

257 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Pharma SPA, ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

258 BRU09060264P Voltaren 12.5mg Suppositories Diclofenac Sodium 12.5mgDelpharm Huningue S.A.S.,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

259 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mgDelpharm Huningue S.A.S.,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

260 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

261 BRU09060267NP Uphamol 250 Syrup Paracetamol 250mg/5mlUpha Pharmaceutical Mfg

(M) Sdn Bhd

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015GSL (60mL)

262 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/wSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

263 BRU09060269P Zorax Cream Aciclovir 5%w/wSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

264 BRU09060270P Nexium mups 20mgEsomeprazole (as magnesium trihydrate)

20mgAstraZeneca AB, Sweden

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

265 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

266 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC,

Vega Baja Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 17 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

267 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia

Pty Ltd, Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

268 BRU09070275P Unasyn IM/IV 1.5g

Sulbactam (as sodium 546.4mg) 500mg

& Ampicillin (as sodium 1084.6mg)

1000mg

Haupt Pharma Latina S.r.l,

Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

269 BRU09070276PFleming Oral Suspension

228.5mg/5ml

Amoxicillin (as trihydrate) 200mg/5ml;

Clavulanic acid (as Potassium

clavulanate) 28.5mg/5ml

Medreich Limited,

Bengalore, India

Asterix United (B)

Sdn Bhd

06 October 2010 till 05

October 2015POM

270 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain)

80u per 0.5ml

Sanofi Pasteur, Lyon,

Pasteur

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

271 BRU09070278P Fedac TabletPseudoephedrine HCl 60mg; Triprolidine

HCl 2.5mg

Drug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

272 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgKemwell AB, Bjorkgatan 30,

SE-751 82 Uppsala, Sweden.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

273 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg GlaxoSmithKline Australia

Pty Ltd., Australia

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

274 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia.

G & H Trading

Company

06 October 2015 till 05

October 2020POM

275 BRU09070282P Hydrocortisone Cream 1% w/w Hydrocortisone acetate 1%w/wSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

276 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., BelgiumZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

277 BRU09070284P Nexium mups 40mgEsomeprazole (as magnesium trihydrate)

40mgAstraZeneca AB, Sweden

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

278 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., BelgiumZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

279 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

280 BRU09070288P Diane-35 TabletCyproterone acetate 2mg;

Ethinylestradiol 0.035mg

Bayer Weimar GmbH und

Co. KG, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

281 BRU09070289P Amaryl 3mg Tablet Glimepiride Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

282 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 18 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

283 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., ItalyHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

284 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/wBeacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015GSL

285 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg Delpharm Reims,FranceHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

286 BRU09080294P Euvax B Vaccine, RecombinantPurified Hepatitis B surface antigen

(HBsAg) 200µg/10mlLG Life Science Ltd, Korea

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

287 BRU09080295PPulmicort® Turbuhaler®

200mcg/dose

Budesonide (micronised) Ph Eur

200mcg/doseAstraZeneca AB, Sweden

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

288 BRU09080296P Epilim Intravenous 400mg/ vial Sodium Valproate 400mgGruppo Lepetit S.R.L. Italy

Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

289 BRU09080297P Tritace® 5mg Tablet Ramipril 5mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

290 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

291 BRU09080299PBeafemic Suspension

50mg/5mlMefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

292BRU09080300PS1 &

BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg

Les Laboratoires Servier

Industrie, France (S1) &

Kotra Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

293 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

294 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

295 BRU09080303P Spiriva® 18mcg Tiotropium 18mcg (as Bromide

Monohydrate 22.5mcg)

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

296 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mgBeacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

297 BRU09080305NP Poro Suppository 250mg Paracetamol 250mgYSP Industries (M) Sdn Bhd,

Malaysia

Asterix United Sdn

Bhd

06 October 2015 till 05

October 2020GSL

298 BRU09080306P Strimox-250 Capsule Amoxicillin (as trihydrate) 250mg Strides Arcolab Ltd., IndiaG & H Trading

Company

06 October 2010 till 05

October 2015POM

299 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromideDelpharm Reims

S.A.S,France

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 19 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

300 BRU09080308PAtrovent N 20µg/ puff

Metered Dose Inhaler

Ipratropium bromide anyhdrous 20mcg

(as monohydrate 21mcg)

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

301 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

302 BRU09080311P Carinox CapsulePseudoephedrine sulphate 120mg;

Loratadine 5mg

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

303 BRU09090312PEuvax B Vaccine, Recombinant

(100µg/5ml)

Purified Hepatitis B surface antigen

(HBsAg) 100µg/5mlLG Life Science Ltd, Korea

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

304 BRU09090313P Typhim Vi Single DosePurified Vi Capsular polysaccharides of

Salmonella typhi (Ty2 strain) 25µg/0.5ml

Sanofi Pasteur, Campus

Merieux, France & Sanofi

Pasteur, Parc industrial

d'Incarville, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

305 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

306 BRU09090315P Amaryl 2mg Tablet Glimepride 2mg Sanofi-aventis S.p.A, Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

307 BRU09090316P Lamisil® 250mg Tablet Terbinafine HCl 250mgNovartis Pharmaceuticals UK

Limited, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

308 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mgNovartis Farma S.p.A, Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

309 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mgNovartis Urunleri, Istanbul

Turkey

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

310 BRU09090319PTETRAct-HIB (Act-HIB-

D.T.COQ/D.T.P) Vaccine

Act-HIB (Powder) - Haemophilus

influenza type b polysacharride

conjugated with tetanus protein 10µg;

D.T.COQ/D.T.P (Suspension) - purified

diphteria toxoid not less than 30iu,

purified tetanus toxoid not less than

60iu, Bordetella pertusis not less than

4iu

Sanofi Pasteur, Campus

Merieux, France; Sanofi

Pasteur, Parc industrial

d'Incarville, France & Sanofi

Pasteur, Gruppo Lepeptit,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

311 BRU09090320P Zyrtec-D TabletCetirizine Dihydrochloride 5mg;

Pseudoephedrine HCl 120mgUCB Farchim SA, Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

312 BRU09090321PMono-Tildiem SR 200mg

CapsuleDiltiazem HCl 200mg

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 20 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

313 BRU09090322P Actilyse® Treatment-SetRecombinant Human Tissue-type

Plasminogen Activator (alteplase) 50mg

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

314 BRU09090323P Zoraxin Tablet 400mg Aciclovir 400mgDuopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

315 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

316 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020P (100x10's)

317 BRU09090326P Micardis 40mg Tablet Telmisartan 40mg

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

318 BRU09090327P Metalyse Injection 10,000units Tenecteplase 10,000units (50mg)

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

319 BRU09090328NP Hemo RidTM TabletMiconised Diosmin 450mg; Micronised

Hesperidine 50mg

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015GSL

320 BRU09090329P Exforge Tablet 5mg/80mgAmlodipine 5mg (as besylate 6.94mg);

Valsartan 80mg

Novartis Farmaceutica SA ,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

321 BRU09100330P Imovax Polio Vaccine

Inactivated Polio Virus: Type 1

(40DU/0.5mL), Type 2 (80DU/0.5mL),

Type 3 32DU/0.5mL)

Sanofi Pasteur, Lyon, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

322 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

323 BRU09100332P H-Cort Cream Hydrocortisone 1%w/wHOE Pharmaceutical Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

324 BRU09100333P Pneumo 23 Vaccine

Polysaccharides of Streptococcus

pneumoniae serotypes (1, 2, 3, 4, 5, 6B,

7F, 8, 9N, 9V,10A, 11A, 12F, 14, 15B, 17F,

18C, 19A, 19F, 20, 22F, 23F, 33F)

Sanofi Pasteur, Mercy

I'Etoile, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

325 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical

Sdn Bhd, Malaysia.

G & H Trading

Company

06 October 2015 till 05

October 2020POM

326 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia

Pty Ltd, Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 21 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

327 BRU09100336NP Sunquadin Lozenges Dequalinium ChlorideSunward Pharmaceutical

Sdn Bhd, Malaysia.

G & H Trading

Company

06 October 2015 till 05

October 2020POM

328 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mgPfizer Australia Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

329 BRU09100338NPUphamol 250 Suspension

(Fruity)Paracetamol 250mg/5mL

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

330 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mgSanico NV Industriezone,

Belgium

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

331 BRU09100340P Pontalon Capsule Mefenamic acid 250mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

06 October 2015 till 05

October 2020POM

332 BRU09100341P Clexane 6000 Anti-Xa IU/0.6mL Enoxaprin Sodium (Porcine in origin)Aventis Intercontinental,

France

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

333 BRU09100342NP Maalox Plus Tablet

Aluminium hydroxide dried gel 200mg,

Magnesium hydroxide 200mg,

Simethicone 26.25mg (correspond to

25mg of polydiemthylsiloxane)

Sanofi-Aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020GSL

334 BRU09100343P Neurontin 600mg Tablet GabapentinPfizer Pharmaceutical LLC,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

335 BRU09100345P LipitorTM 40mg TabletAtorvastatin (as Calcium 43.38mg-

crystalline) 40mg

Pfizer pharmaceuticals LLC,

vega baja Puerto Rico, USA

G & H Trading

Company

06 October 2015 till 05

October 2020POM

336 BRU09100346NP Suniton TabletParacetamol 450mg, Orphenadrine

Citrate 35mg

Sunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

337 BRU09100347P SCMC Plus Syrup 250mg/5mLS-carboxy-methylcysteine 250mg/5mL

(Carbocisteine)

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

338 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

339 BRU09100349P Actonel® 35mg TabletRisedronate sodium 35mg (equivalent to

32.5mg risedronic acid)Norwich Pharmaceuticals

Inc., USAMedipharm Sdn Bhd

06 October 2010 till 05

October 2015POM

340 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901)Sanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

341 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UKZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 22 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

342 BRU09110354P LipitorTM 10mg TabletAtorvastatin (as calcium 10.85mg -

crystalline) 10mg

Pfizer pharmaceutical LLC,

vega baja Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

343 BRU09110355P RotarixTM Vaccine

1 reconstituted dose (1ml) contains live

attenuated human rotavirus RIX4414

strain not less than 106.0 CCID50

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

344 BRU09110356PClexane 4000 Anti-Xa IU/0.4mL

(40mg/0.4ml)

Enoxaprin Sodium 40mg/0.4ml (Porcine

in origin)

Aventis Intercontinental,

France

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

345 BRU09110357PAtrovent Unit Dose Vial (UDV)

250mcg/2ml

Ipratropium bromide anhydrous 250mcg

(as monohydrate 261mcg)Laboratoire Unither, France

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

346 BRU09110358PMicardis Plus 40mg/12.5mg

Tablet

Telmisartan 40mg; Hydrochlorothiazide

12.5mg

Boehringer Ingelheim

Pharma GmbH, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

347 BRU09110359P Allavin ExpectorantDiphenhydramine HCl 14mg/5ml;

Ammonium Chloride 135mg/5ml

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

348 BRU09110360P Nitrocine Ampoules 0.1% Nitroglycerin 1mg/10mlJenahexal Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

349 BRU09110361P Uphamol 500 Tablet Paracetamol 500mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

350 BRU09110362P Carin Tablet 10mg Loratadine 10mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015

P

351 BRU09110363PRhinathiol 2% for Children

SyrupCarbocisteine 100mg/5ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

352 BRU09110364PArepanrixTM H1N1 Pandemic

Influenza Vaccine

After mixing 1 dose (0.5ml) contains:

Split influenza virus, inactivated,

containing antigen* equivalent to:

A/California/7/2009 (H1N1)v-like virus

3.75mcg** (Note:* propagated in egg;

** haemagglutinin .) Adjuvant:ASO3 -

Squalene 10.69mg; DL-α-tocopherol

11.86mg & polysorbate 80 4.86mg

Antigen - ID Biomedical

Corporation of Quebec,

GlaxoSmithKline Biologicals

North America, Quebec,

Canada.

Adjuvant - GlaxoSmithKline

Biologicals SA, Rixensart,

Belgium

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

353 BRU09120365P Tienam IV Injection 500mgImipenem (as monohydrate) 500mg &

Cilastatin Sodium 500mg

Merck Sharp & Dohme Corp,

USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 23 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

354BRU09120366PS1 &

BRU09120366PS2

Opvero (Oral trivalent

poliomyelitis vaccine)

Each 0.1mL (2 drops) contains: Type1

poliomyelitis virus (LS-c2ab strain) ≥ 106.0

CCID50; Type2 poliomyelitis virus

(p712,Ch,2ab strain) ≥ 105.0 CCID50;

Type3 poliomyelitis virus (Leon 12a1b

strain) ≥ 105.8 CCID50;

Sanofi Pasteur, Campus

Merieux, France (S1); Sanofi

Pasteur, Parc industrial

d'Incarville, France (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

355 BRU09120367P Dilantin 100mg Capsule Phenytoin SodiumPfizer Australia Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

356 BRU09120368P Modalim 100mg Tablet Ciprofibrate 100mg Sanofi Winthrop Limited, UK Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

357 BRU09120369P Oral Aid LotionLignocaine HCl 2.5%; Triamcinolone

Acetonide 0.1%; Chlorhexidine HCl 0.5%

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

358 BRU09120370P Primperan 10mg/2ml Injection Metoclopramide HCl 10mg/2mlSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

359 BRU09120371P Tritace 10mg Tablet Ramipril 10mg Sanofi-aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

360 BRU09120372P Mono-Tildiem SR 300mg Diltiazem HCl 300mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

361 BRU09120373P Micardis® 80mg Tablet Telmisartan 80mgBoehringer Ingelheim

Pharma GmbH, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

362 BRU09120374PMicardis Plus 80mg/12.5mg

Tablet

Telmisartan 80mg; Hydrochlorothiazide

12.5mg

Boehringer Ingelheim

Pharma GmbH, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

363 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

364 BRU09120376NP Poro Suppository 125mg Paracetamol 125mgY.S.P Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

06 October 2015 till 05

October 2020POM

365 BRU09120377PVascor 40mg Film-coated

TabletSimvastatin 40mg

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

366 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015P

367 BRU09120379PCovastin Film-coated Tablet

10mgSimvastatin 10mg

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

368 BRU09120380P Metformin Tablet 500 Metformin HCl 500mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 24 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

369BRU09120381PS1 &

BRU09120381PS2

Co-Diovan 80/12.5 Film-coated

Tablets

Valsartan 80mg; Hydrochlorothiazide

12.5mg

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Farma S.p.A., Italy (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

370 BRU09120382PRhinathiol® Promethazine

syrup

Carbocisteine 100mg/5ml; Promethazine

HCl 2.5mg/5ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

371 BRU09120383PMethotrexate Injection BP

1000mg/10mlMethotrexate 1000mg/10ml

Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

372 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mgGlaxoSmithKline Australia

Pty Ltd. Australia

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

373BRU10010385PS1 &

BRU10010385PS2Coversyl 4mg Tablet Perindopril tert-butylamine 4mg

Les Laboratoires Servier

Industrie, France (S1) &

Kotra Pharma (M) Sdn Bhd.,

Malaysia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

374 BRU10010386PAtrovent Unit Dose Vial

0.5mg/2ml

Ipratropium bromide (as monohydrate)

500mcg/2ml

Laboratoires Unither,

Amiens cedex, France

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

375 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mgBeacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

376 BRU10010388P Exforge Tablet 5mg/160mgAmlodipine 5mg (as besylate 6.94mg);

Valsartan 160mg

Novartis Farmaceutica SA,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

377 BRU10010389P Taxotere 80mg/2ml VialDocetaxel anhydrous (as trihydrate)

80mg

Sanofi-Aventis Deutschland

GmbH, GermanyMediPharm Sdn Bhd

06 October 2015 till 05

October 2020POM

378

BRU10010390NPS1,

BRU10010390NPS2

&

BRU10010390NPS3

Dulcolax 5mg Tablet Bisacodyl 5mg

Boehringer Ingelheim Korea

(S1); Boehringer Ingelheim

France (S2); Delpharm Reims

S.A.S., France (S3)

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

379BRU10010391PS1 &

BRU10010391PS2Diovan 80mg Tablet Valsartan 80mg

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Farma S.A., Spain (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

380BRU10010392PS1 &

BRU10010392PS2

Co-Diovan 160/25 Film-coated

Tablets

Valsartan 160mg; Hydrochlorothiazide

25mg

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Farma S.p.A., Italy (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 25 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

381 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP 4mg/5mlUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015P

382 BRU10010394PIsoket 0.1% Solution for

InjectionIsosrobide Dinitrate 0.1%

Jenahexal Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

383 BRU10010395P Isoket SprayIsosrobide Dinitrate 1.25mg per

actuationSchwarz Pharma Ltd, Ireland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

384 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

385 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

386 BRU10010399P Seretide Accuhaler 50/500Salmeterol 50mcg (as Xinafoate),

Fluticasone propionate 500mcgGlaxoSmithKline LLC, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

387 BRU10010400P Cisplatin Injection 10mg/10ml Cisplatin 10mg/10mlPfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

388 BRU10010401P VentolinTM Tablet 4mg Salbutamol 4mg (as Sulphate 4.8mg) Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

389 BRU10020402PSolu-Medrol Sterile Powder

500mg

Methyprednisolone (as Sodium

succinate) 500mg

Pfizer Manufacturing

Belgium N.V., Belgium

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

390 BRU10020403P Losec 40mg IV Injection Omeprazole (as sodium) 40mg AstraZencea AB, SwedenZuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

391 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

392 BRU10020405P Vascor Tablet 20mg SimvastatinUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

393 BRU10020406PCombivent Unit Dose Vial

500mcg

Per 2.5ml - Ipratropium bromide (as

monohydrate 522mcg) 500mcg;

Salbutamol 2.5mg (as sulphate 3.013mg)

Boehringer Ingelheim

Limited, United Kingdom

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

394 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

395 BRU10020408P Guadex LinctusPer 5ml - Dextromethorphan

Hydrobromide 15mg; Guaifenesin 100mg

Hoe Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 26 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

396BRU10020409PS1 &

BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Farma S.A., Spain (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

397 BRU10020410P Etoposide 100mg/5ml Injection Etoposide 100mg/5mlPfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

398 BRU10020411P Decondine SyrupPer 5ml - Triprolidine HCl 1.25mg;

Pseudoephedrine HCl 30mg

Sunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

399 BRU10020412P Seretide Accuhaler 50/100Salmeterol 50mcg (as Xinafoate),

Fluticasone propionate 100mcgGlaxoSmithKline LLC, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

400 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

401 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020P

402 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer Pharma AG, GermanyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

403 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mgPfizer Pharmaceutical LLC,

Puerto Rico

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

404 BRU10020417PIsosorbide Dinitrate Tablet

10mgIsosorbide Dinitrate BP 10mg

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

405 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mgNovartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

406 BRU10020419P Adalat® LA 20 Tablet Nifedipine 20mg Bayer Pharma AG, GermanyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

407 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

408 BRU10030422P Beten 50mg Tablet Atenolol 50mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

409 BRU10030423PRhinathiol 5% Adult

Expectorant SyrupCarbocisteine 5g/100ml

Unither Liquid

Manufacturing, FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020P

410 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mgInstituto De Angeli S.R.L.,

Italy

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

411 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 27 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

412 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

413 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, GermanyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

414 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mgSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

415 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2mlPfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

416 BRU10030431P Deco Expectorant

Per 5ml - Guaifenesin/ Guaicol Glycerol

Ether USP 100mg; Tripolidine HCl

1.25mg; Pseudoephedrine HCl 30mg

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

06 October 2010 till 05

October 2015P

417 BRU10030432P Cisplatin Injection 50mg/50ml Cisplatin USP 50mg/50mlPfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

418 BRU10030433PTerramycin Ophthalmic

Ointment

Per g - Oxytetracycline 5mg; Polymyxin B

10,000units

PT Pfizer (Indonesia),

Indonesia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

419 BRU10030435PAdriamycin CS Injection

50mg/25mlDoxorubicin HCl 50mg/25ml

Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

420 BRU10030436NP Maalox® Plus Suspension

Per 5ml - Aluminium hydroxide 225mg;

Magnesium hydroxide 200mg;

Simethicone USP 25mg

Sanofi Aventis S.p.A., Italy Medipharm Sdn Bhd06 October 2015 till 05

October 2020GSL

421 BRU10030437P Seretide Evohaler 50

Salmeterol Xinafoate (micronised)

25mcg; Fluticasone Propionate

(micronised) 50mcg

Glaxo Wellcome Production,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

422 BRU10030438P Miacalcic® Ampoules 100IU Calcitonin salmon, synthetic 100IUNovartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

423 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

424 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mgDaiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

425 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Pfizer PGM, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

426 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Pfizer PGM, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

427 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Pfizer PGM, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 28 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

428 BRU10040444NP Cartril-S 500mg Capsule

Glucosamine HCl 472.5mg equivalent to

Glucosamine content in Glucosamine

Sulphate 500mg

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015

GSL

429 BRU10040445P Seretide Accuhaler 50/250Salmeterol (as Xinafoate) 50mcg;

Fluticasone Propionate 250mcgGlaxoSmithKline LLC, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

430 BRU10040447P Ventolin Tablet 2mg Salbutamol (as sulphate) 2mgAspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

431 BRU10040448PZyrtec® Film-coated Tablet

10mgCetrizine HCl 10mg

UCB Farchim S.A.,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

432 BRU10040450P Seretide 125 EvohalerSalmeterol (as Xinafoate, micronised)

25mcg; Fluticasone Propionate 125mcg

Glaxo Wellcome Production,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

433 BRU10040452P Nitroderm TTS® 10Glyceral trinitrate/ nitroglycerin 50mg

(10mg/24hr)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

434 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, FinlandZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

435 BRU10040454NP ColimixTM Syrup

Per 5ml - Simethicone (activated

dimethicone) 50mg; dicylcomine HCl

5mg

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

436 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5%

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

437BRU10040457PS1 &

BRU10040457P S2Co-Diovan 160/12.5mg Tablets

Valsartan HCl 160mg;

Hydrochlorothiazide 12.5mg

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Pharma S.p.A., Italy (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

438 BRU10040458P Zyrtec® Oral Drops 10mg/ml Cetrizine diHCl 10mg/mlAesica Pharmaceuticals

S.r.L., Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

439 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte

Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

440 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mgSunward Pharmaceutical Pte

Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

441 BRU10040461PCytarabine® Injection 1000mg

in 10mlCytarabine 1000mg/10ml

Pfizer (Perth) Pty, Ltd.,

Australia

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

442 BRU10040462P Exelon Oral Solution 2mg/mlRivastigmine 2mg/ml (as hydrogen

tartrate)

Novartis Pharma S.A.S.,

France

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

443 BRU10050463PNebido 1000mg/4ml, Solution

for Injection

Testosterone undecanoate 250mg(equiv.

to testosterone 157.9mg)Bayer Pharma AG, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 29 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

444 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5mlBoehringer Ingelheim,

France

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020P

445 BRU10050466NPUphamol Suspension 250

(Orange)Paracetamol 250mg/5ml

Upha Pharmaceuticals Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2010 till 05

October 2015POM

446 BRU10050467PTaxotere® 20mg/0.5ml

Concentrate and solvent for

solution for Infusion

Docetaxel 20mg/0.5ml (as trihydrate)Sanofi-Aventis Deutschland

GmbH, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

447 BRU10050468P

Remicade Powder for

Concentrate for Solution for

Infusion 100mg/vial

Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

448 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

449 BRU10050471PZyvox Infusion Bag

600mg/300mlLinezolid 600mg/300ml

Fresenius Kabi Norge As,

Norway

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

450 BRU10050472P Panadeine TabletCodeine Phosphate 8mg, Paracetamol

500mgSanofi India Limited, India

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

451 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mgOno Pharmaceutical Co Ltd,

JapanMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

452 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

453 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%)Aesica Pharmaceuticals

S.r.L., Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

454 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Pfizer PGM, FranceZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

455 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg

Novartis Saglik Gida ve

Tarim Urunleri San. Ve

Tic.A.S., Istanbul, Turkey

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

456 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mgPT Aventis Pharma,

IndonesiaMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

457 BRU10050479PCozaar 100mg film-coated

tabletLosartan Potassium 100mg

Merck Sharp & Dohme Ltd

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

458 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/MlZoetis P&U LLC, Kalamazoo,

USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

459 BRU10050482PIlomedin Infusion Solution

50mcg/0.5ml

Illoprost 50mcg/0.5mL (as Illoprost

trometamol 67mcg/0.5mL)Berlimed SA Spain

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

BDMCA/RMP/1215 Page 30 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

460 BRU10060483P Starlix Tablet Nateglinide 120mgNovartis Farma S.p.A., Torre

Annunziata, Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

461 BRU10060484P Miacalcic 50IU Ampoules Salmon calcitonin, synthetic 50IU/1mlNovartis Pharma Stein AG,

Switzerland.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

462 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mgSunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020P

463 BRU10060486P Daonil Tablet 5mg Glibenclamide 5mgPT Aventis Pharma,

IndonesiaMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

464 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg) Sunward Pharmaceutical

Sdn. Bhd., Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

465 BRU10060488P Lescol capsule 40mg Fluvastatin (as the sodium salt) 40mgNovartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

466 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mgNovartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

467 BRU10060490P Lescol capsule 20mg Fluvastatin (as the sodium salt) 20mgNovartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

468 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical

Sdn. Bhd., Malaysia

G & H Trading

Company

06 October 2015 till 05

October 2020POM

469 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg

Novartis Saglik Gida ve

Tarim Urunleri San. Ve

Tic.A.S., Istanbul, Turkey

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

470 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mgDaiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

471 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mgPfizer Australia Pty. Ltd.,

NSW Australia.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

472 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mgUnither Liquid

Manufacturing, France.Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

473 BRU10060496P Stilnox 10mg film-coated tablet Zolpidem tartrate 10mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

474 BRU10060497P Hyosun syrupHyoscine-N-Butylbromide (Scopolamine

Butylbromide) 5mg/5ml

Sunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

475 BRU10060498P Nalol Tablet 40mg Propranalol HCl 40mgSunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

476 BRU10060499P Exelon capsule 1.5mgRivastigmine 1.5mg (as hydrogen tartrate

2.4mg)

Novartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

477 BRU10060500PSyntocinon 10IU solution for

injectionSynthetic Oxytocin 10IU/ml

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 31 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

478 BRU10060501P Exelon capsule 6mgRivastigmine 6mg (as hydrogen tartrate

9.6mg)

Novartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

479 BRU10060502PZyvox film-coated tablet

600mgLinezolid 600mg

Pfizer Pharmaceuticals LLC,

Puerto Rico, United States

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

480 BRU10060503P Zocor 5mg film-coated tablet SimvastatinMerck Sharp & Dohme Ltd.,

United Kingdom

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

481 BRU10060504P Sifrol tablet 0.125mg

Pramipexole 0.088mg (eqv. to

Pramipexole dihydrochloride

monohydrate 0.125mg)

Boehringer Ingelheim

Pharma GmbH & Co.

Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

482 BRU10060505PMyfortic Gastro-Resistant

tablet 180mg

Mycophenolic Acid 180mg (as Sodium

Salt 192.4mg)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

483 BRU10070506P Phensedyl Dry Cough LinctusPer 5ml - Promethazine HCl 3.6mg;

Pholcodine 4mg; Ephedrine HCl 7.2mg

Sanofi-Aventis Pakistan

Limited, Pakistan

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

484 BRU10070507P Miacalcic® Nasal Spray 200IU Salmon calcitonin, synthetic 200IUDelpharm Huningue S.A.S.,

Switzerland.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

485 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mgPfizer Australia Pty. Ltd.,

NSW Australia.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

486 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mgSunward Pharmaceutical

Pte. Ltd., Singapore G & H Trading Company

06 October 2015 till 05

October 2020P

487 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mgSunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020

GSL (6's) & P

(60's)

488 BRU10070511P Decondine TabletTripolidine HCl 2.5mg; Pseudoephedrine

HCl 60mg

Sunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

489 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mgSunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

06 October 2015 till 05

October 2020POM

490 BRU10070513P Desferal 500mg Desferrioxamine Methane SulphonateNovartis Pharma Stein AG,

Switzerland.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

491 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

492 BRU10070515P Zaricort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

493 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mgMerck Sharp & Dohme Ltd.,

United Kingdom

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

494 BRU10070517PSingulair® Chewable Tablet

5mgMontelukast (as sodium) 5mg

Merck Sharp & Dohme Ltd.,

United Kingdom

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

495 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2mlGlaxoSmithKline

Manufacturing SpA., Italy

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 32 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

496 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mgPharmacia & Upjohn

Company, Kalamazoo, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

497 BRU10070520P Exelon® 4.5mg CapsuleRivastigmine 4.5mg (as Rivastigmine

hydrogen tartrate 7.2mg)

Novartis Farmaceutica S.A.,

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

498 BRU10070521PEpilim Chrono 500mg Scored

Film-coated Tablet

Sodium valproate 500mg (Sodium

valproate 333mg & Valproic acid 145mg)

Sanofi Winthrop Industries,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

499 BRU10070522PRitalin® Modified Release

Capsule 30mgMethylphenidate HCl 30mg

Elan Holdings Inc., United

States

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

500 BRU10080523P Exforge 10/160mg FC TabletAmlodipine 10mg (as besylate);

Valsartan 160mg

Novartis Pharma Stein AG

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

501 BRU10080524PZometa Concentrate for

Solution for Infusion 4mg/5ml

Zoledronic Acid (anhydrous) 4mg

corresponding to zoledronic acid

monohydrate 4.264mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

502 BRU10080527P Mediaxal Tablet 150mg Benfluorex Hydrochloride 150mgLes Laboratoires Servier

Industrie France

Zuellig Pharma Sdn

Bhd

06 October 2010 till 05

October 2015POM

503 BRU10080528P Imovane 7.5mg Tablet Zopiclone 7.5mg Aventis International France Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

504 BRU10080529P Nasacort Aqueous Nasal SparyTriamcinolone Acetonide

55mcg/actuationAventis Pharma UK Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

505 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mgNovartis Pharmaceuticals SA

Spain

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

506 BRU10080531P Proctosedyl Suppositories

Chinchocaine 5mg; Framycetin sulphate

10mg; Hydrocortisone 5mg; Aesculin

10mg

PT Aventis Pharma,

IndonesiaMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

507 BRU10080532PProstin VR Paediatric® Sterile

Solution 500mcgAlprostadil 500mcg/ml

Pharmacia & Upjohn

Company, USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

508 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA ItalyZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

509BRU10080534PS1;

BRU10080534PS2 Fosamax 70mg Tablet

Alendronate sodium 91.37 (as trihydrate)

equivalent to alendronic acid 70mg

Merck Sharp & Dohme

(Italia) SpA, Italy (S1); Aesica

Pharmaceuticals GmbH,

Germany (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

510BRU10080535PS1;

BRU10080535PS2

Telfast-D Extended Release

TabletFexofenadine hydrochloride 60mg ;

Pseudoephedrine HCl 120mg

Sanofi-Aventis US LLC USA

(S1); Sanofi Winthrop

Industrie, France (S2)

Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 33 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

511 BRU10080536P Claforan 1.0g Injection Cefotaxime 1g (as Sodium 1.048g) Patheon UK Ltd, England, UK Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

512 BRU10080538PImmucyst ® BCG

Immnuotherapeutic 81mg/vialBacillus Calmette-Guerin 81mg

Sanofi Pasteur Limited,

Toronto, Ontario, Canada

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

513 BRU10090539P Singulair Tablet 4mgMontelukast 4mg (as sodium 4.16mg)

Merck Sharp & Dohme Ltd

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

514 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mgMerck Sharp & Dohme Ltd

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

515 BRU10090541PLanoxin Paediatric/ Geriatric

ElixirDigoxin 0.05mg/mL

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

516BRU10090542PS1;

BRU10090542PS2 Singulair Oral Granules 4mg

Montelukast Sodium (free acid

equivalent) 4mg

Merck Sharp & Dohme Corp.

USA (S1); DSM

Pharmaceuticals, Inc., USA

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

517 BRU10090543P Frisium® 10mg Tablet Clobazam 10mgSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

518 BRU10090544P Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg

Merck Sharp & Dohme

(Italia) SpA, Italy & MSD

International GmbH

(Singapore Branch),

Singapore

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

519 BRU10090545P Zocor 10mg Tablet Simvastatin 10mgMerck Sharp & Dohme Ltd.,

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

520 BRU10090546P Zocor 40mg Tablet Simvastatin 40mgMerck Sharp & Dohme Ltd.,

UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

521 BRU10090547P Bonefos 800mg Tablet

Disodium Clodronate Tetrahydrate

1000mg equivalent to Disodium

Clodronate (anhydrous) 800mg

Bayer Oy, FinlandZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

522 BRU10090548PSuprefact® 1mg/ml Injection

SolutionBuserelin 1.00mg/ml (as acetate 1.05mg)

Aventis-Pharma Deutshland

GmbH, GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

523 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mgN.V. Organon, The

Netherlands

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

524 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Elan Holdings Inc., USAZuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

525 BRU10090551PZoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to

Goserelin 10.8mgAstraZeneca UK Ltd, UK

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/1215 Page 34 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

526 BRU10090552PHarnal OCAS 400mcg Film-

coated tablet

Tamsulosin (as hydrochloride 400mcg)

367mcg

Astellas Pharma Europe BV,

The Netherlands

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

527 BRU10090553P ActifedTM Expectorant (100ml)

Triprolidine hydrochloride 1.25mg/5mL;

Pseudoephedrine hydrochloride

30mg/5mL; Guaiphenesin 100mg/5mL

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020P

528 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg

MSD International GmbH

(Puerto Rico Branch) LLC.,

Puerto Rico, USA.

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

529BRU10090555PS1;

BRU10090555PS2 Elomet Cream 0.1% Mometasone Furoate 0.1%

Schering-Plough Labo N.V.,

Belgium (S1); PT. Merck

Sharp Dohme Pharma Tbk,

Indonesia (S2)

Zuellig Pharma Sdn

Bhd

06 October 2015 till 05

October 2020POM

530 BRU10100556PMyfortic Gastro-Resistant

tablet 360mgMycophenolic (as sodium) acid 360mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

531 BRU10100557PIntron A* 30 million IU Solution

for Injection, Multidose PenInterferon Alfa-2b 30 million IU

Schering-Plough (Brinny)

Co., Ireland

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

532 BRU10100558PGyno-Trosyd Vaginal Tablet

100mgTioconazole 100mg

Heinrich Mack Nachf, Pfizer

Inc., Heinrich Mack Nachf

GmbH & Co KG, Heinrich

Mack Strasse 35, 89257,

Illertissen, Germany.

Zuellig Pharma Sdn

Bhd

28 October 2010 till 27

October 2015POM

533 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate) 3mgNovartis Farmaceutica S.A.

Spain

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

534BRU10100560PS1;

BRU10100560PS2

Arcoxia 60mg Film-coated

tabletEtoricoxib 60mg

Merck Sharp & Dohme

Corp., USA (S1)and Frosst

Iberica S.A., Spain (S2)

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

535 BRU10100561P Proctosedyl Ointment

Cinchocaine hydrochloride 0.5%;

Framycetin sulphate 1.0%;

Hydrocortisone 0.5%; Aesculin 1.0%

Patheon UK Ltd., England Medipharm Sdn Bhd28 October 2015 till 27

October 2020POM

536 BRU10100562P Exelon® Patch 10Rivastigmine Base 18mg / 10cm2

(9.5mg/24h)

LTS Lohmann Theraphie-

System AG, Germany

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

537 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2 (4.6mg/24

hours)

LTS Lohmann Theraphie-

System AG, Germany

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

BDMCA/RMP/1215 Page 35 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

538 BRU10100564PATGAM® Sterile Solution

50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-

thymocyte globulin (equine) 250mg/5mL

Pharmacia & Upjohn

Company, USA

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

539 BRU10100565P Ezetrol 10mg Tablet Ezetimibe 10mg

1) MSD International GmbH

(Puerto Rico Branch) LLC,

Puerto Rico; 2) MSD

International GmbH

(Singapore Branch),

Singapore

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

540BRU10100566PS1;

BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg

Merck Sharp & Dohme

Corp., USA (S1)and Frosst

Iberica S.A., Spain (S2)

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

541 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Traidng

Company

28 October 2015 till 27

October 2020POM

542 BRU10100568PZithromax Powder For Oral

Suspension 200mg/5mlAzithromycin (as dihydrate) 200mg/5ml

Haupt Pharma Latina S.r.I.,

Italy

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

543 BRU10100569PFosamax Plus 70/2800mcg

Tablets

Alendronic (as sodium 91.37) acid 70mg

& (Vitamin D3 100,000 IU/g)

Cholecalciferol 2800mcg

MSD Frosst Iberica, SpainZuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

544 BRU10100571P Arimidex 1mg tablet Anastrozole 1mgAstraZeneca

Pharmaceuticals USA

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

545 BRU10100572P

Casprin Enteric

Microencapsulated Capsule

100mg

Aspirin 100mgY.S.P. Industries (M) Sdn

Bhd, Malaysia.

Asterix United (B)

Sdn Bhd

28 October 2015 till 27

October 2020POM

546 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mgY.S.P. Industries (M) Sdn

Bhd, Malaysia.

Asterix United (B)

Sdn Bhd

28 October 2015 till 27

October 2020POM

547BRU10100575PS1 &

BRU10100575PS2Renitec® 10mg Tablet Enalapril maleate 10mg

(S1) Merck Sharp & Dohme

Ltd., United Kingdom; (S2)

Merck Sharp & Dohme

(Australia), Australia

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

548 BRU10100576PAlbutein® Solution for Infusion

25% Albumin (Human) 25% Grifols Biologicals Inc., USA

Hongkiat Trading &

Company

28 October 2015 till 27

October 2020POM

549 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg

MSD International GmbH

(Puerto Rico Branch) LLC.,

Puerto Rico, USA.

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

550 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/mlY.S.P. Industries (M) Sdn

Bhd, Malaysia.

Asterix United (B)

Sdn Bhd

28 October 2015 till 27

October 2020

P (100ml) &

POM (4L)

BDMCA/RMP/1215 Page 36 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

551BRU10100579PS1 &

BRU10100579PS1Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg

Merck Sharp & Dohme

(Italia) S.p.A., Italy (S1);

MSD International GmbH

(Singapore Branch),

Singapore (S2)

Zuellig Pharma Sdn

Bhd

28 October 2015 till 27

October 2020POM

552 BRU10110580PIntron A* 18million IU Solution

for Injection, Multidose PenInterferon Alfa-2b 18 million IU

Schering-Plough (Brinny)

Co., Ireland

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

553BRU10110581PS1;

BRU10110581PS2JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg

Merck Sharp & Dohme

(Italia) S.p.A., Pavia, Italy

(S1); Merck Sharp & Dohme

Ltd, England (S2)

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

554BRU10110582PS1;

BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg

Merck Sharp & Dohme

Corp., USA (S1)and Frosst

Iberica S.A., Spain (S2)

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

555BRU10110583PS1 &

BRU10110583PS2Renitec® 20mg Tablet Enalapril maleate 20mg

(S1) Merck Sharp & Dohme

Ltd., United Kingdom; (S2)

Merck Sharp & Dohme

(Australia), Australia

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

556 BRU10110584P Zocor 20mg Film-coated Tablet Simvastatin 20mgMerck Sharp & Dohme Ltd.,

Northumberland, UK

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

557 BRU10110585P Sifrol® Tablet 1mg

Pramipexole dihydrochloride

monohydrate 1mg (equivalent to 0.7mg

pramipexole)

Boehringer Ingelheim

Pharma GmbH & Co. KG,

Germany

Hongkiat Trading &

Company

24 November 2015 till

23 November 2020POM

558 BRU10110587PMetoclopramide Syrup

5mg/5mlMetoclopramide hydrochloride 5mg/5ml

Sunward Pharmaceutical Pte

Ltd, Singapore

G & H Traidng

Company

24 November 2015 till

23 November 2020POM

559 BRU10110588NP Suntacid Tablet

Aluminium Hydroxide 250mg,

Magnesium Trisilicate 250mg,

Simethicone 30mg

Sunward Pharmaceutical Pte

Ltd, Singapore

G & H Traidng

Company

24 November 2015 till

23 November 2020GSL

560 BRU10110589P Fosamax® Tablet 10mg Alendronic (as sodium 13.05) acid 10mg Merck & Co Inc., USAZuellig Pharma Sdn

Bhd

24 November 2010 till

23 November 2015POM

561 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UKZuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

BDMCA/RMP/1215 Page 37 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

562 BRU10110591PVoren Enteric Coated Tablet

25mgDiclofenac Sodium 25mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 November 2015 till

23 November 2020POM

563 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

564 BRU10110593PVoren Enteric Coated Tablet

50mgDiclofenac Sodium 50mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 November 2015 till

23 November 2020POM

565BRU10110594PS1 &

BRU10110594PS2Vytorin™ Tablets 10mg/80mg Ezetimibe 10mg; Simvastatin 80mg

Merck Sharp & Dohme

(Italia) S.p.A., Italy (S1) ;

MSD International GmbH

(Singapore Branch),

Singapore (S2)

Zuellig Pharma Sdn

Bhd

24 November 2010 till

23 November 2015POM

566 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/mlGlaxoSmithKline

Manufacturing S.p.A., Italy

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

567 BRU10110596PBeconase™ Aqueous Nasal

Spray

Beclomethasone Dipropionate (as

monohydrate)Glaxo Wellcome S.A., Spain

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

568 BRU10110597P Campto 40mg/2ml InjectionIrinotecan hydrochloride trihydrate

40mg/2ml

Pfizer (Perth) Pty Ltd.,

Australia

Zuellig Pharma Sdn

Bhd

24 November 2015 till

23 November 2020POM

569BRU10120599PS1;

BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg

Merck Sharp & Dohme

(Italia) S.p.A., Pavia, Italy

(S1); Merck Sharp & Dohme

Ltd, England

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

570 BRU10120600PRitalin® LA Modified Release

Capsule 40mgMethylphenidate hydrochloride 40mg

Elan Holdings Inc., United

States

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

571 BRU10120601P Mercilon TabletDesogestrel 0.15mg & Ethinylestradiol

0.02mg

Organon (Ireland) Ltd.,

Irelnad

Zuellig Pharma Sdn

Bhd

29 December 2010 till

28 December 2015POM

572 BRU10120602POrgalutron Solution for

Injection 0.25mg/0.5mlGanirelix acetate 0.25mg/0.5ml

Vetter Pharma-Fertigung

GmbH & Co. KG, Germany

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

BDMCA/RMP/1215 Page 38 of 143

Page 39: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

573BRU10120603PS1 &

BRU10120603PS2Renitec® Tablet 5mg Enalapril maleate 5mg

(S1) Merck Sharp & Dohme

Ltd., United Kingdom; (S2)

Merck Sharp & Dohme

(Australia), Australia

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

574 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%PT. Merck Sharp Dohme

Pharma Tbk, Indonesia

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020P

575 BRU10120605P Clarityne Tablet 10mg Loratadine 10mgPT. Merck Sharp Dohme

Pharma Tbk, Indonesia

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020P

576 BRU10120606P Frotin Pessaries Metronidazole 250mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

29 December 2015 till

28 December 2020POM

577 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

29 December 2015 till

28 December 2020POM

578 BRU10120608P Methergin Tablet 0.125mg Methylergometrine maleate 0.125mg

Novartis Pharma

Produktions GmbH,

Germany

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

579 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe

B.V., The Netherlands

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

580 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

29 December 2015 till

28 December 2020POM

581 BRU10120612PFlixonase Aqueous Nasal Spray

0.05%

Fluticasone propionate (micronised)

50mcgGlaxo Wellcome S.A., Spain

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

582BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection 50mg/5ml

(10mg/ml)Rocuronium Bromide 50mg/5ml

N.V. Organon, The

Netherlands; Hameln

Pharmaceuticals GmbH,

Germany

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

583 BRU10120614P Clomid Tablet 50mg Clomifene Citrate 50mg Patheon France S.A., France Medipharm Sdn Bhd29 December 2015 till

28 December 2020POM

584 BRU10120615P FlixotideTM EvohalerTM 125mcg Fluticasone propionate 125mcg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

BDMCA/RMP/1215 Page 39 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

585 BRU10120616P LEVITRA® Film-coated TabletVardenafil 5mg (as monohydrochloride

trihydrate)Bayer Pharma AG., Germany

Zuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

586 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UKZuellig Pharma Sdn

Bhd

29 December 2015 till

28 December 2020POM

587BRU11010619PS1;

BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as phosphate) 100mg

Merck Sharp & Dohme

(Italia) S.p.A., Pavia, Italy

(S1); Merck Sharp & Dohme

Ltd, England

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

588 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mgNovartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

26 January 2011 till 25

January 2016POM

589 BRU11010622P Bonefos® 400mg CapsulesAnhydrous Disodium Clodronate (as

tetrahydrate 500mg) 400mgBayer Oy, Finland

Zuellig Pharma Sdn

Bhd

26 January 2011 till 25

January 2016POM

590 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 January 2011 till 25

January 2016POM

591 BRU11010624P Elomet Ointment 0.1% Mometasone Furoate (as anhydrous)PT. Merck Sharp Dohme

Pharma Tbk, Indonesia

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

592 BRU11010625 Implanon® 68mg ImplantEtonogestrel (Micronised) [Org3236]

68mg

N.V. Organon, The

Netherlands

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

593 BRU11010626NP Poro Tablet 500mg Paracetamol 500mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 January 2011 till 25

January 2016

GSL (10 x

10's), P

(100x10's &

3,000's)

594 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mgNovartis Farma S.p.A.,

Torree Annunziata, Italy

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

595 BRU11010628POxy-Nase Paediatric Nasal

Spray 0.025%Oxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G&H Trading

Company

26 January 2016 till 25

January 2021P

596 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mgGlaxo Wellcome GmbH &

Co., Germany

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

597 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mgNovartis Farma S.p.A.,

Torree Annunziata, Italy

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

598 BRU11010632P Comtan® Tablet 200mg Entacapone 200mgOrion Corporation, Espoo,

Finland

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

599 BRU11010633P DF118 Tablet DihydrocodeineGlaxoSmithKline South

Africa (Pty) Ltd., South Africa

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

600 BRU11010635P Zantac SyrupTM 150mg/10mlRanitidine (as hydrochloride)

150mg/10ml

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

BDMCA/RMP/1215 Page 40 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

601 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 January 2011 till 25

January 2016POM

602 BRU11010637PEngerixTM-B Adult Dose

Vaccine 20mcg/ml

Purified Hepatitis B Surface Antigen

(HBsAg) 20mcg/ml

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

603 BRU11010638P HavrixTM720 Junior VaccineInactivated Hepatitis A virus antigen

(HAV), HM175 strain 720 EL.U

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

604 BRU11010639P HiberixTM Vaccine

Purified polyribosyl-ribitol-phosphate

capsular polyaccharide (PRP) of

Haemophilus influenza type b (Hib) 10µg

covalently bound to 20-40µg tetanus

toxoid

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

605 BRU11010640P Microgynon® 30 TabletLevonorgestrel 0.15mg, Ethinylestradiol

0.03mg

Bayer Weimar GmbH und

Co., KG, Germany

Zuellig Pharma Sdn

Bhd

26 January 2016 till 25

January 2021POM

606 BRU11010641P Ami-hydrotride TabletAmiloride hydrochloride 5mg &

Hydrochlorthiazide 50mg

Upha Pharmaceutical Mfg

(M) Sdn Bhd., Malaysia

Hongkiat Trading &

Company

26 January 2011 till 25

January 2016POM

607 BRU11010642P Virless Tablets 200mg Acyclovir 200mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 January 2011 till 25

January 2016POM

608 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Pfizer PGM, FranceZuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

609 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., ItalyZuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

610 BRU11020645P OroxineTM Tablet 100mcgLevothyroxine (as sodium) anhydrous

100mcg

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

611 BRU11020646P ActifedTM Syrup

Triprolidine Hydrochloride BP

1.25mg/5ml; Pseudoephedrine

hydrochloride BP 30mg/5ml

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021

P (60ml &

100ml)

612 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5mlDelpharm Huningue S.A.S.,

France

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

613 BRU11020648PGlivec® 100mg Film-coated

TabletImatinib (as mesylate) 100mg

Novartis Pharma

Produktions GmbH,

Germany

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

614 BRU11020649PSandostatin® Ampoules

0.05mg/mlOctreotide (as acetate) 0.05mg/ml

Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

BDMCA/RMP/1215 Page 41 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

615 BRU11020650PLevitra® film-coated Tablet

20mg

Vardenafil (as monochloride trihydrate)

20mgBayer Pharma AG., Germany

Zuellig Pharma Sdn

Bhd

24 February 2016 till

23 February 2021POM

616 BRU11020651PFormoxol I.V. Injection "Yung

Shin"Paclitaxel 6mg/ml

Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

24 February 2011 till

23 February 2016POM

617 BRU11020652PUrosin® Film-coated Tablet

50mgAtenolol 50mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 February 2011 till

23 February 2016POM

618 BRU11020653PIbuprofen Film-coated Tablet

400mgIbuprofen 400mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 February 2011 till

23 February 2016P

619 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5mlDrug House of Australia Pte

Ltd., Singapore

G & H Trading

Company

24 February 2011 till

23 February 2016POM

620 BRU11020655P Voren GelDiclofenac Sodium 10mg/g (as Diclofenac

Acid Diethylamine)

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 February 2011 till

23 February 2016GSL

621 BRU11020656PAtacor 20mg Film-coated

TabletsAtorvastatin (as Calcium) 20mg Actavis hf., Iceland

K-Seri Pharma Sdn

Bhd

24 February 2011 till

23 February 2016POM

622 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/wY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 February 2011 till

23 February 2016POM

623 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride) 150mgDrug House of Australia

(Asia) Pte Ltd., Singapore

G & H Trading

Company

24 February 2011 till

23 February 2016POM

624BRU11030659PS1 &

BRU11030659PS2Vytorin Tablet 10mg/40mg Ezetimibe 10mg, Simvastatin 40mg

MSD International gmbH

(Singapore Branch),

Singapore (S1); Merck Sharp

& Dohme (Italia) S.p.A., Italy

(S2)

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

625 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05%HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

26 March 2016 till 25

March 2021P

626 BRU11030661PPrimperan® 10mg

SuppositoriesMetoclopramide 10mg

Unither Liquid

Manufacturing, France.

Zuellig Pharma Sdn

Bhd

26 March 2011 till 25

March 2016POM

627 BRU11030662PFucon Film Coated Tablet

10mgHysocine-n-butylbromide 10mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 March 2011 till 25

March 2016POM

BDMCA/RMP/1215 Page 42 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

628 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 March 2011 till 25

March 2016POM

629 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

630 BRU11030667P Clarinase Syrup 5mg/5mlPer 5ml: Loratadine 5mg,

Pseudoephedrine Sulphate 60mg

Sanofi Aventis Argentina

S.A., Argentina

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021P

631 BRU11030668P

Vivaxim Suspension and

Solution for Suspension for

Injection

Inactivated Hepatitis A Virus, GBM strain

160 antigen units

Sanofi Pasteur, Parc

industriel d'Incarville, France

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

632BRU11030669PS1;

BRU11030669PS2

Caelyx 2mg/ml Concentrate for

InfusionDoxorubicin HCl 2mg/ml

Alza Corporation, USA (S1);

GlaxoSmithKline

Manufacturing S.P.A., Italy

(S2)

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

633 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH, GermanyZuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

634 BRU11030671P Hyzaar Forte Tablet 100/25mgLosartan potassium 100mg,

Hydrochlorothiazide 25mg

Merck Sharp & Dohme Ltd.,

UK

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

635 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mgGlaxoSmithKline

Pharmaceuticals S.A., Poland

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

636 BRU11030673PTopistin® Solution for IV

Infusion 200mg/100mlCiprofloxacin (as lactate) 200mg/100ml

Elpen Pharmaceutical Co.,

Inc., Greece.

G & H Trading

Company

26 March 2011 till 25

March 2016POM

637 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5mlGlaxo Wellcome Production,

France

Zuellig Pharma Sdn

Bhd

26 March 2016 till 25

March 2021POM

638 BRU11040675PPuregon® 600iu/0.72ml

Solution for Injection

Recombinant follicle-stimulating

hormone (FSH) (follitrophin beta) [Org

32489] 600iu/0.72ml

Vetter Pharma-Fertigung

GmbH & Co. KG.,

Mooswiesen, Revensburg,

Germany and Vetter Pharma-

Fertigung GmbH & Co. KG.,

Schutzenstrasse,

Ravensburg, Germany

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

639BRU11040676PS1;

BRU11040676PS2 Tazocin EF 4.5g

Piperacillin (asmonohydrate) 4g;

Tazobactam (as sodium) 0.5g

Wyeth Lederle S.r.I, Catania,

Italy (S1); Pfizer Biotech

Corporation,

Hsinchu Plant, Taiwan-

Republic of China (S2)

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

BDMCA/RMP/1215 Page 43 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

640 BRU11040677PVaxigrip Suspension for

Injection

Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.5ml dose:

A/California/7/2009 (H1N1)pdm09-

derived strain used NYMC X-179A)

15mcg HA**; A/Texas/50/2012(H3N2)-

derived strain used NYMC X-223A 15mcg

HA**; B/Massachusetts/2/2012-derived

strain used NYMC BX-51B 15mcg HA**

Note - * Propagated in fertilized hens’

egg from healthy chicken flocks

** haemagglutinin

Sanofi Pasteur, Lyon, FranceZuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

641 BRU11040678PEuvax B Adult Vaccine

RecombinantPurified HBs-Ag 20mcg LG Life Science Ltd., Korea

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

642 BRU11040679PTrandateTM Injection 5mg/ml x

5mlLabetalol HCl 25mg/5ml

United Biomedical Inc (UBI)

Asia Ltd., Taiwan

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

643BRU11040680PS1 &

BRU11040680PS2 Puregon® 50IU/0.5ml Solution

for Injection

Follitrophin Beta (recombinant follicale-

stimulating hormone (FSH) 50IU/0.5ml

Organon (Ireland) Ltd.,

Dublin, Ireland (S1);

N.V.Organon, The

Netherlands (S2)

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

644 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/vHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

30 April 2016 till 29

April 2021P

645 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mgSunward Pharmaceutical Pte

Ltd., Singapore

G & H Trading

Company

30 April 2016 till 29

April 2021POM

646 BRU11040683PSandostatin® LAR® Injection

10mgOctreotide 10mg Biochemie GmbH, Austria

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

647 BRU11040684PVfend TM Film-Coated Tablets

200mgVoriconazole 200mg Pfizer Italia S.R.L, Italy

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

648 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mgY.S.P Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

30 April 2011 till 29

April 2016POM

649 BRU11040687PMultaq 400mg Film-coated

Tablet

Dronedarone 400mg (equiv.

Dronedarone HCl 426mg)

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

30 April 2011 till 29

April 2016POM

650 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

BDMCA/RMP/1215 Page 44 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

651 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mgY.S.P Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

30 April 2011 till 29

April 2016POM

652 BRU11040690PEngerixTM-B Paediatric Vaccine

10mcg/0.5mlPurified HBs-Ag 10mcg

GlaxoSmithKline Biologicals

SA., Belgium

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

653 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

30 April 2016 till 29

April 2021POM

654 BRU11040692P Fedac Compound Linctus

Per 5ml- Triprolidine HCl BP 1.25mg;

Pseudoephedrine HCl BP 30mg; Codeine

Phosphate BP 10mg

Drug House of Australia Pte

Ltd., Singapore

G & H Trading

Company

30 April 2011 till 29

April 2016POM

655 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mgY.S.P Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

30 April 2011 till 29

April 2016POM

656 BRU11040694PStalevo® 100/25/200mg Film-

coated Tablet

Levodopa 100mg; Carbidopa 25mg;

Entacapone 200mg

Orion Corporation, Espoo,

Finland

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

657 BRU11040695PRevoladeTM Film-coated Tablet

25mg

Eltrombopag 25mg [as free acid] (as

olamine)

Glaxo Operations UK Ltd

(trading as Glaxo Wellcome

Operations), UK

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

658 BRU11040696PCoversyl® Film-coated Tablet

10mg

Perindopril arginine 20mg (equiv to

perindopril 6.790mg)

Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

659 BRU11040697PAtorvastatin Winthrop® 20mg

Film-coated TabletAtorvastatin 20mg (as calcium 20.68mg)

Zentiva k.s., Prague, Czech

RepublicMedipharm Sdn Bhd

30 April 2011 till 29

April 2016POM

660 BRU11040698P SeroxatTM CR Tablet 12.5mgParoxetine 12.5mg (as Paroxetine HCl

hemihydrate)

GlaxoSmithKline Inc.,

Ontario, Canada

Zuellig Pharma Sdn

Bhd

30 April 2016 till 29

April 2021POM

661 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised) 27.5µg

/spray

Glaxo Operations UK Ltd,

United Kingdom

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

662 BRU11050700P Tetraxim Vaccine

Purified diphteria toxoid ≥ 30IU; purified

tetanus toxoid ≥ 40IU; Bordetella

pertusis antigens: Adsorbed purified

pertusis toxoid 25µg, Adsorbed purified

filamentous haemagglutinin 25µg ;

Inactivated poliomyelitis virus: Type 1 40

D units, Type 2 8 Dunits, Type 3 32

Dunits.

Sanofi Pasteur, Campus

Merieux, France; Sanofi

Pasteur, Parc industriel

d'Incarville, France

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

663 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mgPfizer Manufacturing

Belgium N.V., Belgium

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

664 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mgSunward Pharmaceutical Pte

Ltd., Singapore

G & H Trading

Company

25 May 2016 till 24

May 2021POM

BDMCA/RMP/1215 Page 45 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

665 BRU11050703PLevitra Film-coated Tablets

10mg

Vardenafil (as monohydrochloride

trihydrate) 10mgBayer Pharma AG., Germany

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

666 BRU11050704PVentolin Solution for

Intravenous Infusion 5mg/5mlSalbutamol (as sulphate) 5mg/5ml

GlaxoSmithKline

Pharmaceutical S.p.A., Italy

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

667 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mgUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

25 May 2011 till 24

May 2016P (5 x 50's)

668 BRU11050706PZofran Injection Flexi-Amp

AmpoulesOndansetron HCl Dihydrate 8mg/4ml

GlaxoSmithKline Australia

Pty Ltd.m Australia

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

669 BRU11050707PCaverject 20mcg Powder and

solvent for injectionAlprostadil 20µg

Pfizer Manufacturing

Belgium N.V., Belgium

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

670 BRU11050708NP Essentiale Forte N Capsule

Phospholipids fatty mass 392mg

(equivalent to 300mg phospholipids

from soya beans containing 76% of (3-sn-

phosphatidyl) choline)

A. Nattermann & Cie.

GmbH., GermanyMedipharm Sdn Bhd

25 May 2011 till 24

May 2016GSL (50's)

671 BRU11050709P Diosper Film-coated Tablets Diosmin 450mg. Hesperidin 50mgKleva S.A. Pharmaceutical,

Greece

G & H Trading

Company

25 May 2011 till 24

May 2016

GSL (3 x 10's)

P (50 x 10's)

672 BRU11050710P Coveram Tablets 5mg/5mg

Perindopril arginine 5mg (equiv. to

perindopril 3.395mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries

Ltd., Ireland

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

673 BRU11050711P Penrazol Capsule 20mg Omeprazole 20mgElpen Pharmaceutical Co.

Inc., Greece

G & H Trading

Company

25 May 2011 till 24

May 2016POM

674 BRU11050712P Tracrium Injection 25mg/2.5ml Atracurium besylate 25mg/2.5mlGlaxoSmithKline

Manufactuirng S.p.A., Italy

Zuellig Pharma Sdn

Bhd

25 May 2016 till 24

May 2021POM

675 BRU11050713P Aricept Tablet 10mgDonepezil HCl 10mg (equiv. Donepezil

free base 9.12mg)Eisai Taiwan Inc., Taiwan Medipharm Sdn Bhd

25 May 2011 till 24

May 2016POM

676 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg)GlaxoSmithKline (Tianjin) Co.

Ltd., PR China

Zuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

677 BRU11060715POxy-Nase Paediatric Nasal

Drop 0.025%w/vOxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

02 July 2016 till 01 July

2021POM

678 BRU11060716P Vfend 50mg film-coated Tablet Voriconazole 50mg Pfizer Italia S.R.L., ItalyZuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

679 BRU11060717P Protaxos 2g Strontium Ranelate 2632mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

680 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH, GermanyZuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

BDMCA/RMP/1215 Page 46 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

681 BRU11060719PAmlodipine Winthrop Tablet

5mgAmlodipine (as besilate)

Unichem Laboratories

Limited, Goa, IndiaMedipharm Sdn Bhd

02 July 2011 till 01 July

2016POM

682 BRU11060720P Virless Tablet 800mg Acyclovir 800mgY.S.P. Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

02 July 2011 till 01 July

2016POM

683 BRU11060721PAtorvastatin Winthrop® 40mg

TabletAtorvastatin 40mg (as Calcium 41.36mg) Zentiva k.s., Czech Republic Medipharm Sdn Bhd

02 July 2011 till 01 July

2016POM

684 BRU11060722P Propecia 1mg Tablet Finasteride 1mgMerck Sharp & Dohme,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

685 BRU11060723PSeroquel XR Extended-Release

Tablets 50mg

Quetiapine 50mg (as fumarate

57.560mg)

AstraZeneca Pharmaeuticals

LP, USA

Zuellig Pharma Sdn

Bhd

02 July 2016 till 01 July

2021POM

686 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mgAstella Pharma Europe B.V.,

The Netherlands

Zuellig Pharma Sdn

Bhd

27 July 2011 till 26 July

2016POM

687 BRU11070725P InfanrixTM Hib

Diphteria toxoid min. 30IU, Tetanus

toxoid min. 40IU, Pertussis toxoid (PT)

25mcg, Conjugate Haemophilus

influenzae type b capsular

polysaccharide 10mcg coupled to 20 to

40mcg tetanus toxoid

GlaxoSmithKline Biologicals

s.a., Belgium

Zuellig Pharma Sdn

Bhd

27 July 2011 till 26 July

2016POM

688 BRU11070726PInfanrixTM Suspension for

Injection

Diphteria toxoid min. 30IU, Tetanus

toxoid min. 40IU, Pertussis toxoid (PT)

25mcg

GlaxoSmithKline Biologicals

s.a., Belgium

Zuellig Pharma Sdn

Bhd

27 July 2011 till 26 July

2016POM

689 BRU11070727P SW Bena-Expectorant

Per 5ml: Diphenhydramine HCl 10mg,

Ammonium Chloride 102mg, Sodium

Citrate 46mg

Sunward Pharmaceutical Pte

Ltd., Singapore

Zuellig Pharma Sdn

Bhd

27 July 2011 till 26 July

2016POM

690 BRU11070728P

Fluarix Inactivated Split

Infuenza Vaccine (2014

Northern Hemisphere)

Purified, inactivated influenza virus of

the following strains:A/California/7/2009

(H1N1) pdm09-like strain [variant

A/Christchurch/16/2010 (NIB-74xp)]

15mcgHA; A/Texas/50/2012 (H3N2)-like

strain [variant A/Texas/50/2012 (NYMC X-

223A)] 15mcg HA;

B/Massachusetts/02/2012-like strain

[variant B/Massachusetts/02/2012

(NYMC BX-51B)] 15mcg HA

GlaxoSmithKline Biologicals

s.a., Dresden, Germany

Zuellig Pharma Sdn

Bhd

27 July 2011 till 26 July

2016POM

BDMCA/RMP/1215 Page 47 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

691 BRU11070729P Priorix TM

Composition of Priorix™ per dose

(0.5ml): Live attenuated measles virus

(Schwarz strain) ≥103.0 CCID50, Live

attenuated mumps virus (RIT4385 strain)

≥103.7 CCID50, Live attenuated rubella

virus (Wistar RA 27/3 strain) ≥103.0

CCID50

GlaxoSmithKline Biologicals

s.a., Belgium; FIDIA

Farmaceutici S.p.a., Italy

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

692 BRU11070730PMirena® Intrauterine System

20mcg/24hrLevonorgestrel 52mg Bayer Oy, Finland

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

693 BRU11070731PAmlodipine Winthrop® 10mg

TabletAmlodipine 10mg (as besilate)

Unichem Laboratories

Limited, Goa, IndiaMedipharm Sdn Bhd

27 July 2011 till 26 July

2016POM

694 BRU11070732P Zoral 400 Tablet 400mg Acyclovir USP 400mgDrug House of Australia Pte

Ltd., Singapore

G & H Trading

Company

27 July 2011 till 26 July

2016POM

695 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl dihydrate) GlaxoSmithKline Australia

Pty Ltd., Australia

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

696 BRU11070734PSyntometrine® Injection

5IU/ml AmpouleOxytocin 5IU/ml

Novartis Pharma Steing AG.,

SwitzerlandMedipharm Sdn Bhd

27 July 2011 till 26 July

2016POM

697 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/wHOE Pharmaceuticals Sdn

Bhd., Malaysia

G & H Trading

Company

27 July 2016 till 26 July

2021POM

698 BRU11070736P Coveram 5/10mg Tablet

Perindopril arginine 5mg (equiv. to

3.395mg perindopril) and amlodipine

10mg (as besilate 13.870mg)

Servier (Ireland) Industries

Ltd, Ireland

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

699 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

700BRU11070738PS1;

BRU11070738PS2 Diamicron® MR 60mg Tablet Gliclazide 60mg

Les Laboratoires Servier

Industrie, France (S1); Kotra

Pharma (M) Sdn. Bhd,

Malaysia (S2)

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

701 BRU11070739P Fedac DM Linctus

Per 5ml: Triprolidine HCl 12.5mg,

Pesudoephedrine HCl 30mg,

Dextrometorphan HBr 10mg

Drug House of Australia Pte

Ltd., Singapore

G & H Trading

Company

27 July 2011 till 26 July

2016POM

702 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml

GlaxoSmithKline

Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

703 BRU11070741P Coralan® Tablet 2.5mg Ivabradine 7.5mg (as HCl 8.085mg)Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

27 July 2016 till 26 July

2021POM

BDMCA/RMP/1215 Page 48 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

704 BRU11080742PAclasta 5mg/10ml Solution for

Infusion

Zolendranic acid (anhydrous) 5mg (as

zolendranic acid monohydrate 5.33mg)

Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

705 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcgGlaxoSmithKline Australia

Pty Ltd., Australia

Zuellig Pharma Sdn

Bhd

25 August 2011 till 24

August 2016POM

706 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mgGlaxoSmithKline Australia

Pty Ltd., Australia

Zuellig Pharma Sdn

Bhd

25 August 2011 till 24

August 2016POM

707 BRU11080745PGlivec® 400mg Film-coated

TabletImatinib (as mesylate) 400mg

Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

708 BRU11080746PStalevo 50/12.5/200mg film-

coated tablet

Levodopa 50mg, Carbidopa 12.5mg,

Entacapone 200mg

Orion Corporation, Espoo,

Finland

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

709

BRU11080747PS1,

BRU11080747PS2,

BRU11080747PS3

Pentaxim Vaccine

Composition of final container per dose

(0.5ml): TETRAXIM - Purified diphteria

toxoid ≥ 30 I.U; Purified tetanus toxoid

≥40 I.U; Adsorbed purified pertusis

toxoid 25µg; Inactivated poliomyeltis

virus type1 40 DU, type 2 8DU, type 3 32

DU; Act-HIB - Polysaccharide of

Haemophilus influenza type b

conjugated to tetanus protein 10µg

Sanofi Pasteur, Campus

Merieux, Marcy I'Etoile,

France (S1); Sanofi Pasteur,

Parc Industriel d'Incarville,

France (S2); Sanofi Pasteur,

Gruppo Lepeptit, Angani,

Italy (S3)

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

710 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydratePfizer (Perth) Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

711 BRU11080749P Econazine CreamEconazole nitrate 1% w/w,

Triamcinolone actonide 0.1% w/w

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

712 BRU11080750PFrotin Film Coated 200mg

Tablet Metronidazole 200mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

713 BRU11080751PUrosin Film Coated Tablet

100mgAtenolol 100mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

714 BRU11080752P TwinrixTM Vaccine

Hepatitis A virus antigen 720 ELISA units;

r-DNA hepatitis B virus surface antigen

(HBsAg)* 20µg *Thiomersal-free

HBsAg purified bulk

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

715 BRU11080753P Fukole Capsule 150mg Fluconazole 150mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

716 BRU11080754P CoAprovel Tablet 300/25mgIrbesartan 300mg, Hydrochlorothiazide

25mg

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

25 August 2011 till 24

August 2016POM

BDMCA/RMP/1215 Page 49 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

717 BRU11080755P SeroxatTM CR Tablet 25mgParoxetine 25mg(as Paroxetine

hydrochloride hemihydrate)

GlaxoSmithKline Inc.,

Canada

Zuellig Pharma Sdn

Bhd

25 August 2016 till 24

August 2021POM

718 BRU11080757P Orphenadol® TabletOrphenadrine Citrate 50mg, Paracetamol

325mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

719 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

720 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

721 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

25 August 2011 till 24

August 2016POM

722 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

27 September 2011 till

26 September 2016POM

723 BRU11090763P Infanrix HexaTM

Composition of reconstiitiuted DTPa-HBV-

IPV+Hib Vaccine per dose (0.5ml):

Diphteria toxoid min. 30 I.U; Tetanus

toxoid min. 40 I.U; Pertusis toxoid (PT)

25µg; Filamentous haemagglutinin (FHA),

adsorbed 25µg; Pertactin, adsorbed 8µg;

r-DNA Hepatitis B surface antigen (HBsAg

purified) 10µg; Inactivated poliomyeltis

virus type I 40 DU, Inactivated

poliomyeltis virus type II 8DU,

Inactivated poliomyeltis virus type III 32

DU;Conjugate of Haemophilus influenza

type b capsular polysaccharide (PRP) and

tetanus toxoid 10µg PRP and ~25µg T

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

27 September 2011 till

26 September 2016POM

724 BRU11090764PEloxatin 5mg/ml Concentrate

for Solution for Infusion (10ml)Oxaliplatin 50mg/10ml

Sanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

27 September 2011 till

26 September 2016POM

725 BRU11090765PEloxatin 5mg/ml Concentrate

for Solution for Infusion (20ml)Oxaliplatin 100mg/20ml

Sanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

27 September 2011 till

26 September 2016POM

BDMCA/RMP/1215 Page 50 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

726 BRU11090766P InfanrixTM-IPV Vaccine

Composition per dose (0.5ml): Diphteria

toxoid (DT), adsorbed min. 30 I.U;

Tetanus toxoid (TT), adsorbed min. 40

I.U; Pertusis toxoid (PT), adsorbed 25µg;

Filamentous haemagglutinin (FHA),

adsorbed 25µg; Pertactin, adsorbed 8µg;

Inactivated poliomyeltis virus type I 40

DU, Inactivated poliomyeltis virus type II

8DU, Inactivated poliomyeltis virus type

III 32 DU

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

27 September 2011 till

26 September 2016POM

727 BRU11090767PSandimmun Neoral® Oral

Solution 100mg/mlCiclosporin A 100mg/ml

Novartis Pharma S.A.S.,

France

Zuellig Pharma Sdn

Bhd

27 September 2016 till

26 September 2021POM

728 BRU11090768P Hyzaar® Tablet 50/12.5mgLosartan Potassium 50mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UK

Zuellig Pharma Sdn

Bhd

27 September 2016 till

26 September 2021POM

729 BRU11090769PHyzaar® Plus Tablet

100/12.5mg

Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UK

Zuellig Pharma Sdn

Bhd

27 September 2016 till

26 September 2021POM

730 BRU11090770PFlebogamma 5% DIF Solution

for Infusion (100mL)

Human Normal Immunoglobulin

50mg/ml

Instituo Grifols S.A.,

Barcelona, Spain

Hongkiat Trading &

Company

27 September 2011 till

26 September 2016POM

731 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mgAstraZeneca Pharmaeuticals

LP, USA

Zuellig Pharma Sdn

Bhd

27 September 2011 till

26 September 2016POM

732 BRU11090772PDiabetamin Film-coated Tablet

500mgMetformin HCl 500mg Hovid Bhd, Perak, Malaysia

G & H Trading

Company

27 September 2011 till

26 September 2016POM

733 BRU11090773P Tidact Gel 1%Clindamycin 10mg/g (as phosphate

11.9mg/g)

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

27 September 2011 till

26 September 2016POM

734 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., ItalyZuellig Pharma Sdn

Bhd

27 September 2016 till

26 September 2021POM

735 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

27 September 2011 till

26 September 2016POM

BDMCA/RMP/1215 Page 51 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

736 BRU11090776P Virless Cream Acyclovir 50mg/gY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

27 September 2011 till

26 September 2016POM

737 BRU11090777P Solian® 100mg Scored Tablet Amisulpiride 100mgSanofi Winthrop Industrie,

FranceMediPharm Sdn Bhd

27 September 2011 till

26 September 2016POM

738 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, MalaysiaG & H Trading

Company

27 September 2011 till

26 September 2016POM

739 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mgEisai Co., Ltd, Saitama

Prefecture, JapanMediPharm Sdn Bhd

31 October 2011 till 30

October 2016POM

740 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mgEisai Co., Ltd, Saitama

Prefecture, JapanMediPharm Sdn Bhd

31 October 2011 till 30

October 2016POM

741BRU11100781PS1 &

BRU11100781PS2

Puregon® 100IU/0.5ml

Solution for Injection

Follitropin beta (recombinant follicle-

stimulating hormone - FSH) 100IU/0.5ml

Organon (Ireland) Ltd.,

Dublin, Ireland (S1) & N.V.

Organon, The Netherlands

(S2)

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

742 BRU11100782P Gardasil Vaccine

HPV Type 6 L1 protein 20mcg/0.5ml; HPV

Type 11 L1 protein 40mcg/0.5ml; HPV

Type 16 L1 protein 40mcg/0.5ml; HPV

Type 18 L1 protein 20mcg/0.5ml

Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

743 BRU11100783PTypherixTM Vi Polysccharide

Typhoid Vaccine 25mcg/0.5ml Vi Polysaccaharide of Salmonella TyphiGlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

31 October 2011 till 30

October 2016POM

744 BRU11100784PSandostatin® ampoules

0.1mg/mlOctreotide (as acetate) 0.1mg/ml

Novartis Pharma Stein A.G.,

Switzerland

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

745 BRU11100785PAtorvastatin Winthrop® 10mg

film-coated TabletsAtorvastatin 10mg (as calsium 10.34mg) Zentiva k.s., Czech Republic MediPharm Sdn Bhd

31 October 2011 till 30

October 2016POM

746 BRU11100786PStalevo® 150/37.5/200mg Film-

coated Tablet

Levodopa 150mg; Carbidopa 37.5mg;

Entacapone 200mg

Orion Corporation Fermion,

Finland

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

747 BRU11100787P Coveram Tablet 10mg/5mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries

Ltd., Ireland

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

748 BRU11100788PCoversyl® Fim-coated Tablet

5mg

Perindopril arginine 5mg (eqv.

Perindopril 3.395mg)

Les Laboratoires Servier

Industrie, Gidy, France

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

749 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mgEisai Co., Ltd, Saitama

Prefecture, JapanMediPharm Sdn Bhd

31 October 2011 till 30

October 2016POM

750 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA

strain)

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

31 October 2011 till 30

October 2016POM

BDMCA/RMP/1215 Page 52 of 143

Page 53: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

751 BRU11100791P Coveram Tablet 10mg/10mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 10mg

(as besilate 13.870mg)

Servier (Ireland) Industries

Ltd., Ireland

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

752 BRU11100792P Voker Film Coated Tablet 20mg Famotidine 20mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

31 October 2011 till 30

October 2016POM

753 BRU11100793P Solian® 400mg Scored Tablet Amisulpride 400mgSanofi Winthrop Industrie,

FranceMediPharm Sdn Bhd

31 October 2011 till 30

October 2016POM

754 BRU11100794PClarityn-D 12HR EXTENDED

RELEASE TABLET 5mg/120mg

Loratadine 5mg, Pseudoephedrine

sulphate 120mg

Schering Plough Labo N.V.,

Belgium

Zuellig Pharma Sdn

Bhd

31 October 2016 till 30

October 2021POM

755 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcgMerck KGaA., Darmstadt,

Germany

Zuellig Pharma Sdn

Bhd

31 October 2011 till 30

October 2016POM

756 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mgMerck KGaA., Darmstadt,

Germany

Zuellig Pharma Sdn

Bhd

31 October 2011 till 30

October 2016POM

757 BRU11110797P OnglyzaTM Tablet 2.5mgSaxagliptin 2.5mg (as HCl anhydrous

2.79mg)

Bristol-Myers Squibb

Company, Indiana, USA

Zuellig Pharma Sdn

Bhd

24 November 2011 till

23 November 2016POM

758 BRU11110798P OnglyzaTM Tablet 5mgSaxagliptin 5mg (as HCl anhydrous

5.58mg)

Bristol-Myers Squibb

Company, Indiana, USA

Zuellig Pharma Sdn

Bhd

24 November 2011 till

23 November 2016POM

759 BRU11110799PSandostatin® LAR® Injection

20mgOctreotide (as acetate) 20mg Sandoz GmbH, Austria

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

760 BRU11110800PSandostatin® LAR® Injection

30mgOctreotide (as acetate) 30mg Sandoz GmbH, Austria

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

761 BRU11110802P GardasilTM Vaccine (Syringe)

Per 0.5ml dose - HPV Type 6 L1 protein

20mcg; HPV Type 11 L1 protein 40mcg;

HPV Type 16 L1 protein 40mcg; HPV Type

18 L1 protein 20mcg

Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

762 BRU11110803PNexavar® 200mg Film-coated

TabletsSorafenib Tosylate 200mg

Bayer Pharma AG.,

Leverkusen, Germany; Bayer

Healthcare Manufacturing

S.r.l., Italy

Zuellig Pharma Sdn

Bhd

24 November 2011 till

23 November 2016POM

763 BRU11110804PPEG Intron CLEARCLICK for

Injection 150mcg/0.5ml

Recombinant interferon alfa-2b 150mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH

(Singapore Branch),

Singapore Singapore

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

BDMCA/RMP/1215 Page 53 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

764 BRU11110805PPEG Intron CLEARCLICK for

Injection 120mcg/0.5ml

Recombinant interferon alfa-2b 120mcg

(pegylated to monoethoxy polyethylene

glycol)

Schering-Plough Ltd.,

Singapore

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

765 BRU11110806PPEG Intron CLEARCLICK for

Injection 100mcg/0.5ml

Recombinant interferon alfa-2b 100mcg

(pegylated to monoethoxy polyethylene

glycol)

Schering-Plough Ltd.,

Singapore

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

766 BRU11110807PPEG Intron CLEARCLICK for

Injection 80mcg/0.5ml

Recombinant interferon alfa-2b 80mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH

(Singapore Branch),

Singapore Singapore

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

767 BRU11110808PPEG Intron CLEARCLICK for

Injection 50mcg/0.5ml

Recombinant interferon alfa-2b 50mcg

(pegylated to monoethoxy polyethylene

glycol)

MSD International GmbH

(Singapore Branch),

Singapore Singapore

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

768 BRU11110809PDalacin CTM Sterile Solution

150mg/ml x 2ml ampouleClindamycin Phosphate 300mg

Pfizer Manufacturing

Belgium N.V., Puurs,

Belgium

Zuellig Pharma Sdn

Bhd

24 November 2016 till

23 November 2021POM

769 BRU11110810P LeukeranTM Tablet 2mg Chlorambucil 2mgExcella GmbH., Feucht,

Germany

Zuellig Pharma Sdn

Bhd

24 November 2011 till

23 November 2016POM

770 BRU11110811P Aricept® Tablet 5mgDonepezil HCl 5mg (equiv. to Donepezil

free base 4.56mg)

Eisai Taiwan Inc., Tainan

Hsien, TaiwanMediPharm Sdn Bhd

24 November 2011 till

23 November 2016POM

771 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcgMerck KGaA., Darmstadt,

Germany

Zuellig Pharma Sdn

Bhd

24 November 2011 till

23 November 2016POM

772 BRU11110813PKetipinor Film-coated Tablet

200mg

Quetiapine 200mg (as fumarate

230.36mg)

Orion Corporation, Espoo,

Finland

Hongkiat Trading &

Company

24 November 2011 till

23 November 2016POM

773 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 November 2011 till

23 November 2016POM

774 BRU11110815P Granocyte® 34 InjectionLenograstim (rHug-CSF) 33.6 million IU

(equiv. to 263 mcg)/ vial

Sanofi Winthrop Industrie,

FranceMediPharm Sdn Bhd

24 November 2011 till

23 November 2016POM

775 BRU11120816PEuvax B Pediatric Vaccine

Recombinant (10mcg/0.5ml)Purified HBs-Ag 10mcg/0.5ml LG Life Science Ltd., Korea

Zuellig Pharma Sdn

Bhd

22 December 2016 till

21 December 2021POM

BDMCA/RMP/1215 Page 54 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

776 BRU11120817PPuregon® 300IU/0.36 ml

Solution for Injection

Recombinant follicle-stimulating

hormone (FSH) (follitrophin beta) [Org

32489] 600iu/0.72ml

Vetter Pharm-Fertigung

GmbH & Co. KG.,

Schutzenstrasse,

Ravensburg, Germany:

Vetter Pharm-Fertigung

GmbH & Co. KG.,

Mooswiesen, Ravensburg,

Germany; Vetter Pharma-

Fertigung GmbH & Co. KG,

Eisenbahnstrasse,

Langenargen, Germany and

Vetter Pharma-Fertigung

GmbH & Co. KG,

Holbeinstrassee,

Zuellig Pharma Sdn

Bhd

22 December 2016 till

21 December 2021POM

777 BRU11120818P Clarityn Syrup Loratadine 1mg/mlPT. Merck Sharp Dohme

Pharma Tbk, Indonesia

Zuellig Pharma Sdn

Bhd

22 December 2016 till

21 December 2021P

778 BRU11120819P SynflorixTM Vaccine

1 dose (0.5ml) contains: Pneumococcal

polysaccharide serotype 11,2 - 1mcg,

Pneumococcal polysaccharide serotype

41,2 - 3mcg, Pneumococcal

polysaccharide serotype 51,2 - 1mcg,

Pneumococcal polysaccharide serotype

6B1,2 - 1mcg, Pneumococcal

polysaccharide serotype 7F1,2 - 1mcg,

Pneumococcal polysaccharide serotype

9V1,2 - 1mcg, Pneumococcal

polysaccharide serotype 141,2 - 1mcg,

Pneumococcal polysaccharide

serotype18C1,3 - 3mcg, Pneumococcal

polysaccharide serotype 19F1,4 - 3mcg,

Pneumococcal polysaccharide serotype

23F1,2 - 1mcg

GlaxoSmithKline Biologicals

SA, Rixensart Belgium

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

779 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)

100mcg

Glaxo Wellcome S.A.,

Burgos, Spain

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

BDMCA/RMP/1215 Page 55 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

780 BRU11120821PMencevaxTM ACWY Vaccine (1

Dose)

Per 0.5ml : Meningococcal purified

polysaccharides of: Serogroup A - 50mcg,

Serogroup C - 50mcg Serogroup W135 -

50mcg Serogroup W135 - 50mcg

Serogroup Y - 50mcg

GlaxoSmithKline Biologicals

SA, Rixensart Belgium

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

781 BRU11120822PRevoladeTM Film-coated

Tablets 50mg

Eltrombopag olamine (eq. to

Eltrombopag 50mg as Eltrombopag free

acid)

Glaxo Operations UK Ltd

(trading as Glaxo Wellcome

Operations) United Kingdom

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

782 BRU11120823P Coversyl® Plus 5mgPerindopril arginine 5mg (as besilate

3.395mg); Indapamide 1.25mg

Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

783 BRU11120824P Yasmin® Film-coated TabletsDrospirenone 3mg, Ethinylestradiol

0.03mg

Bayer Weimar GmbH und

Co. KG (WEIMAR PLANT),

Germany

Zuellig Pharma Sdn

Bhd

22 December 2011 till

21 December 2016POM

784 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mgLes Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

22 December 2016 till

21 December 2021GSL

785 BRU11120827PMethycobal Injection

500mcg/mlMecobalamin 500mcg Eisai Co., Ltd, Japan MediPharm Sdn Bhd

22 December 2011 till

21 December 2016POM

786 BRU11120828PFlebogamma® 5% DIF Solution

for Infusion (200ml)

Human Normal Immunoglobulin

10g/200mL (50mg/ml)Instituto Grifols, S.A., Spain Hongkiat Trading

22 December 2011 till

21 December 2016POM

787 BRU11120829NP Shintamet film coated Tablet Cimetidine 400mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016POM

788 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/wY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016GSL

789 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016POM

790 BRU11120832P Clopivid Tablet 75mgClopidogrel 75mg (as hydrogen sulphate

97.90mg)Hovid Bhd, Malaysia

G & H Trading

Company

22 December 2011 till

21 December 2016POM

791 BRU11120833PShincort Injection “Yung Shin”

10mg/mlTriamcinolone Acetonide 50mg/5ml

Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan ROC

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016POM

BDMCA/RMP/1215 Page 56 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

792 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, MalaysiaG & H Trading

Company

22 December 2011 till

21 December 2016POM

793 BRU11120835P Indomen Capsule 25mg Indomethacin 25mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016POM

794 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

22 December 2011 till

21 December 2016POM

795 BRU11120837PPrimacort® 10mg/10ml

InjectionMilrinone 10mg/10ml (as lactate)

Sanofi Winhtrop Industrie,

FranceMediPharm Sdn Bhd

22 December 2011 till

21 December 2016POM

796 BRU11120838NPChamps D-Worms 6 Chewable

Tablet (Chocolate)Albendazole 200mg

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

22 December 2011 till

21 December 2016GSL

797 BRU11120839PEpilim® 200 Enteric Coated

TabletsSodium Valproate 200mg

Sanofi-Synthelabo Ltd.,

United KingdomMediPharm Sdn Bhd

22 December 2011 till

21 December 2016POM

798 BRU12010840PInfanrixTM-IPV+Hib Vaccine

(DTPa-IPV+Hib)

1 dose (0.5ml) contains: Diphteria toxoid

(DT) Min 30 I.U.; Tetanus toxoid (TT) Min

40 I.U.; Pertussis toxoid (PT) Min 25mcg;

Filamentous haemagglutinin (FHA)

25mcg; Pertactin (69Kda Outer

membrance protein) 8mcg; Inactivated

Polio Virus Type 1 (Mahoney seed)

40DU; Inactivated Polio Virus Type 2

(MEF-1 seed) 8DU; Inactivated Polio

Virus Type 3 (Saukett seed) 32DU;

Conjugate of purified capsular

polysaccharide (10mcg) of Haemophilus

influenza type b covalently bound to

approximately 30mcg to 50 mcg tetanus

toxoid

GlaxoSmithKline Biologicals

SA, Rixensart Belgium;

GlaxoSmithkline Biologicals

S.A., France

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

799 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mgPfizer Pharmaceuticals LLC,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

800 BRU12010842PValdoxan® 25mg film-coated

tabletAgomelatine 25mg

Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

BDMCA/RMP/1215 Page 57 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

801 BRU12010843P Zofran Tablet 4mgOndansetron (as Hydrochloride

Dihydrate) 4mg

Glaxo Wellcome GmbH &

Co., Germany

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

802 BRU12010844PFlebogamma® 5% DIF Solution

for Infusion (50ml)

Human Normal Immunoglobulin

2.5g/50mL (50mg/ml)Instituto Grifols, S.A., Spain

Hongkiat Trading &

Co

01 February 2012 till

31 January 2017POM

803 BRU12010845P Coralan® Tablet 5mgIvabradine 5mg eq. to 5.39mg ivabradine

hydrochloride

Les Laboratoires Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

804 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mgAstrazeneca

Pharmaceuticals LP, USA

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

805 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mgAstrazeneca

Pharmaceuticals LP, USA

Zuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

806 BRU12010848P Chemix tabletTrimethoprim 80mg, Sulfamethoxazole

400mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

01 February 2012 till

31 January 2017POM

807 BRU12010849P Sofradex ear/eye drops

Dexamethasone (as sodium

metasulphobenzoate) 0.05%w/v,

Framycetin sulphate 0.5% w/v,

Gramicidin 0.005% w/v

Patheon UK, UK MediPharm Sdn Bhd01 February 2012 till

31 January 2017POM

808 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

01 February 2012 till

31 January 2017POM

809 BRU12010851NP Princi-B Fort® tablet

Thiamin mononitrate 250mg, Pyridoxine

hydrochloride 250mg & Cyanocobalamin

1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd01 February 2012 till

31 January 2017P

810 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w)Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

01 February 2012 till

31 January 2017GSL

811 BRU12010853P Concor® 5mg tabletBisoprolol hemifumarate 5mg

Merck KGaA, GermanyZuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

812 BRU12010854PKetipinor film-coated tablet

100mg

Quetiapine (as fumarate 115.13mg)

100mgOrion Corporation, Finland

Hongkiat Trading &

Co

01 February 2012 till

31 January 2017POM

813 BRU12010855P Euthyrox® Tablet 50mgLevothyroxine sodium 50mcg

Merck KGaA, GermanyZuellig Pharma Sdn

Bhd

01 February 2012 till

31 January 2017POM

814 BRU12010856NPPanadol Suspension

250mg/5mlParacetamol 250mg/5ml

Smithkline Beecham,

Philippines

Kingston Beverage &

Creamery Sdn Bhd

01 February 2012 till

31 January 2017

60ml/120ml -

P

815 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Gruppo Lepetit S.r.I., ItalyAsterix United (B)

Sdn Bhd

01 February 2012 till

31 January 2017POM

816 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mgNovartis Pharma Stein AG.,

Switzerland

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

BDMCA/RMP/1215 Page 58 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

817 BRU12020859PEsonide Nasal Spray

100mcg/dose

Budesonide 2mg/ml equivalent to

100mcg/doseKleva S.A., Greece

G & H Trading

Company

29 February 2012 till

28 February 2017 POM

818 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mgY.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

29 February 2012 till

28 February 2017 POM

819 BRU12020861PThyrozol® 20mg Film-coated

TabletsThiamazole 20mg Merck KGaA, Germany

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

820 BRU12020862PKetipinor Film-coated Tablet

25mgQuetiapine (as fumarate 28.78mg) 25mg Orion Corporation, Finland

Hongkiat Trading &

Co

29 February 2012 till

28 February 2017 POM

821 BRU12020863P

Taxotere 20mg/1ml

concentrate for solution for

infusion

Docetaxel (as trihydrate) 20mg/mlSanofi-Aventis Deutschland

GmbH, GermanyMediPharm Sdn Bhd

29 February 2012 till

28 February 2017 POM

822 BRU12020864P Zanidip® Tablet 10mgLercanidipine Hydrochloride 10mg (eq.

to 9.4mg Lercanidipine)

Recordati Industria Chimica

& Farmaceutica S.p.A, Italy

Hongkiat Trading &

Co

29 February 2012 till

28 February 2017 POM

823BRU12020865PS1 &

BRU12020865PS2Nifedipine LA Tablet 30mg Nifedipine 30mg

Valpharma International

S.p.A, Italy (S1); Valpharma

S.A, Italy (S2)

G & H Trading

Company

29 February 2012 till

28 February 2017 POM

824 BRU12020866P

Apidra® Solostar® 100units/ml,

Solution for Injection in a Pre-

filled Pen

Insulin Glulisine 100units/mlSanofi-Aventis Deutschland

GmbH, GermanyMediPharm Sdn Bhd

29 February 2012 till

28 February 2017 POM

825 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/mlPfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

826 BRU12020868P Betnovate™ Cream

Betamethasone 0.1%w/w (as

Betamethasone 17-Valerate BP 0.122%

w/w)

Glaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

827 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/wGlaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

828 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing

Deutshland GmbH, Germany

Zuellig Pharma Sdn

Bhd

29 February 2012 till

28 February 2017 POM

829 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom 25mgSterling Drug (Malaya) Sdn

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 March 2012 till 29

March 2017

GSL

(12 x 10's)

BDMCA/RMP/1215 Page 59 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

830 BRU12030872NP Panadol® Pain Relief Patch

Glycol Salicylate 1.5%w/w, L-Menthol

1.0% w/w, DL-Camphor 0.5%w/w, DL-A-

Tocopherol Acetate 0.3%w/w

Teh Seng Pharmaceutical

Mfg Co., Ltd., Taiwan, ROC

Kingston Beverage &

Creamery Sdn Bhd

30 March 2012 till 29

March 2017 GSL

831 BRU12030873P LacipilTM Tablet 4mg Lacipidine 4mg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

832 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., SwedenZuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

833 BRU12030875P DetrusitolTM SR Capsule 4mgTolterodine L-Tartrate 4mg (equivalent

to Tolterodine 2.74mg)Pfizer Inc., USA

Zuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

834 BRU12030876NPEllgy Corns & Warts Treatment

SolutionSalicylic acid 17%w/v

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

30 March 2012 till 29

March 2017 P

835 BRU12030877PPuregon® 900IU/1.08ml

Solution for Injection

Follitropin Beta (Recombinant follicle-

stimulating hormone FSH) [Org 32489]

Vetter Pharma-Fertigung

GmbH & Co. KG.,

Schutzenstrasse,

Ravensburg, Germany;

Vetter Pharma-Fertigung

GmbH & Co. KG.,

Mooswiesn2, Ravensburg,

Germany; Vetter Pharma-

Fertigung GmbH & Co. KG.,

Eisenbahnstrasse,

Langenargen, Germany;

Vetter Pharma-Fertigung

GmbH & Co. KG.,

Holbeinstrasse, Ravensburg,

Germany

Zuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

836 BRU12030879PMethotrexate Injection BP

50mg in 2mlMethotrexate 50mg/2ml

Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

837 BRU12030880NP Aqua CreamEmulsifying Wax 8% w/w, White Soft

Paraffin 12%w/w, Liquid Paraffin 8%w/w

Upha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

30 March 2012 till 29

March 2017 GSL

838 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mgPfizer Pharmaceuticals LLC.,

vega Baja Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

839 BRU12030882PCancidas Powder for Injection

50mg/vialCaspofungin (as acetate) 50mg/vial

Laboratoires Merck Sharp &

Dohme Chibret, France

Zuellig Pharma Sdn

Bhd

30 March 2012 till 29

March 2017 POM

BDMCA/RMP/1215 Page 60 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

840 BRU12030883P Axcel Dextrozine SyrupDextromethorphan Hydrobromide

15mg/5ml; Promethazine HCl 3.6mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd30 March 2012 till 29

March 2017 POM

841 BRU12040884PDilantin Steri Vials 250mg in

5mlPhenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 POM

842 BRU12040885P

Jevtana® 60mg Concentrate

and Solvent for Solution for

Infusion

Cabazitaxel 60mg/1.5mlSanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

30 April 2012 till 29

April 2017 POM

843 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride)

GlaxoSmithKline

Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 POM

844 BRU12040887NPPanadol Suspension

120mg/5mlParacetamol 120mg/5ml

SmithKline Beecham, Cainta

Rizal, Philippines

Kingston Beverage &

Creamey Sdn Bhd

30 April 2012 till 29

April 2017

GSL

(60ml &

120ml)

845 BRU12040888PCancidas Powder for Injection

70mg/vialCaspofungin (as acetate) 70mg/vial

Laboratoires Merck Sharp &

Dohme Chibret, France

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 POM

846BRU12040889PS1 &

BRU12040889PS2

Nasonex Aqueous Nasal Spray

0.05%

Mometasone furorate monohydrate,

micronized 0.05%

Schering-Plough Labo N.V.,

Belgium (S1) & MSD

International GmbH

(Singapore Branch),

Singapore (S2)

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 POM

847BRU12040890PS1 &

BRU12040890PS2Cerazette® Tablet 75mcg Desogestrel 75mcg

N.V.Organon, The

Netherlands (S1) & Organon

Ireland Limited, Ireland (S2)

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 POM

848 BRU12040891P Axcel Diprodin ElixirDiphenhydramine HCl 12.5mg/5ml;

Ephedrine HCl 6mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29

April 2017 POM

849 BRU12040892NPAxcel Paracetamol-120 Syrup

(Cherry)Paracetamol 120mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29

April 2017 POM

850 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/wKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29

April 2017 POM

851 BRU12040894P Axcel Tridine SyrupTriprolidine HCl 1.25mg/5ml;

Pseudoephedrine HCl 30mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29

April 2017 POM

852 BRU12040895PAxcel Lignocaine Sterile Gel

2%w/w

Lignocaine HCl (Equiv. to anhydrous HCl)

2g/100g

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 30 April 2012 till 29

April 2017 POM

853 BRU12040896PNiquitin 21mg Transdermal

Patch

Nicotine 114mg (delivers 21mg/24

hours)

ALZA Corporation,

California, USA

Zuellig Pharma Sdn

Bhd

30 April 2012 till 29

April 2017 P

BDMCA/RMP/1215 Page 61 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

854 BRU12050897P VfendTM IV 200mg Voriconazole 200mg

Pharmacia & Upjohn

Company, USA (Repacker -

Pfizer PGM, France)

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

855 BRU12050898PLamictal Dispersible Tablet

5mgLamotrigine 5mg

GlaxoSmithKline

Pharmaceuticals SA.,

Poznan, Poland (Repacker -

GlaxoSmithKline Australia

Pty Ltd., ViCtoria, Australia)

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

856 BRU12050899PHycamtinTM Hard Capsule

0.25mgTopotecan 0.25mg (as hydrochloride)

GlaxoSmithKline

Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

857 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/mlSchering-Plough Labo N.V.,

Belgium

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

858 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/wRecipharm Parets S.L.,

Barcelona, Spain

Mc Quipp Technisell

Marketing Sdn Bhd24 May 2012 till 23

May 2017 P

859 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mgSchering-Plough Labo N.V.,

Belgium

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

860 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg

GlaxoSmithKline Dungravan

Ltd, Ireland (Repacker -

Sterling Drug (Malaya) Sdn

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn Bhd

24 May 2012 till 23

May 2017 GSL

861 BRU12050904PVaxcel Heparin Sodium

Injection 5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa)

25,000/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd 24 May 2012 till 23

May 2017 POM

862 BRU12050905PPregnyl® 5000IU Powder and

Solvent for Injection

Human Chorionic Gonadotrophin

5,000IU/ampouleMerck & Co. Inc., USA

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 POM

863 BRU12050906PNiquitin 7mg Transdermal

PatchNicotine 36mg/cm2 (delivers 7mg/24

hours)

ALZA Corporation,

California, USA

Zuellig Pharma Sdn

Bhd

24 May 2012 till 23

May 2017 P

864 BRU12050907NPEye Mo Moist Eye Lubricant

(Eye Drops)Hydroxypropyl Methycellulose 0.3%w/v

GlaxoSmithKline (Tianjin) Co

Ltd., China

Kingston Beverage &

Creamery Sdn Bhd

24 May 2012 till 23

May 2017 GSL

865 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mgEisai Co. Ltd., Saitama

Perfecture, JapanMedipharm Sdn Bhd

30 June 2012 till 29

June 2017 POM

866 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg

Pfizer Manufacturing

Deutschland GmbH,

Freiburg, Germany

Zuellig Pharma Sdn

Bhd

30 June 2012 till 29

June 2017 POM

BDMCA/RMP/1215 Page 62 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

867 BRU12060910NPPanadol® Soluble Tablet

500mgParacetamol 500mg

GlaxoSmithKline Australia

Pty Ltd, Ermington, NSW,

Australia

Kingston Beverage &

Creamery Sdn Bhd

30 June 2012 till 29

June 2017

GSL

(20's & 144's)

868 BRU12060911NPPanadol For Children Tablets

120mgParacetamol 120mg

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 June 2012 till 29

June 2017

GSL

(24's & 144's)

869 BRU12060912PCanesten GYN 1 Day Therapy

Vaginal Tablet 0.5gClotrimazole 500mg

Bayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

30 June 2012 till 29

June 2017 POM

870 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mgCorden Pharma GmbH,

Plankstadt, Germany

Zuellig Pharma Sdn

Bhd

30 June 2012 till 29

June 2017 POM

871 BRU12060914NP ENO Mint Fruit Salt

Sodium Bicarbonate Coarse 1.483g

(34.49%w/w); Sodium Bicarbonate Fine

0.495g (11.51%w/w); Citric Acid

Anhydrous 1.860g (43.26%w/w); Sodium

Carbonate Anhydrous 0.43g (10.0%w/w)

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 June 2012 till 29

June 2017 GSL (48's)

872 BRU12060915P Drapolene Cream

Cetrimide 0.2%w/w; Benzalkonium

Chloride Solution 0.02%w/w (equiv. to

Benzalkonium Chloride 0.01%w/w)

GlaxoSmithKline

Pharmacuetical SA, Poznan,

Poland

Kingston Beverage &

Creamery Sdn Bhd

30 June 2012 till 29

June 2017 GSL (55g)

873 BRU12060916P Rhewlin Gel 1%w/wDiclofenac Diethylamine equiv. to

Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte

Ltd, Singapore

Hongkiat Trading &

Company

30 June 2012 till 29

June 2017 GSL

874 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg

Pfizer Ireland

Pharmacueticals, Kildare,

Republic of Ireland

Zuellig Pharma Sdn

Bhd

30 June 2012 till 29

June 2017 POM

875 BRU12070918PBeclomet Nasal Aqua

50mcg/dose Nasal Spray

Beclomethasone dipropionate

50mcg/dose

Orion Corporation, Kuopio,

Finland

Hongkiat Trading &

Company

30 July 2012 till 29 July

2017 POM

876 BRU12070919PPanadol CF Cold and Flu

Caplets

Paracetamol 500mg; Pseudoephedrine

HCl 30mg; Chlorpheniramine 2mg

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 POM

877 BRU12070920NPPanadol® Biconvex Film-coated

Tablet 500mgParacetamol 500mg

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2012 till 29 July

2017

GSL

(50's, 3 x 10's

& 15 x 10's)

BDMCA/RMP/1215 Page 63 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

878 BRU12070921NP ENO Ginger Fruit Salt

Sodium Bicarbonate Coarse 1.462g

(34.002%w/w); Sodium Bicarbonate Fine

0.487g (11.316%w/w); Citric Acid

Anhydrous 1.834g (42.640%w/w);

Sodium Carbonate Anhydrous 0.425g

(9.892%w/w)

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2012 till 29 July

2017 GSL

879 BRU12070922NP ENO Fruit Salt

Sodium Bicarbonate Coarse 1.489g

(34.63%w/w); Sodium Bicarbonate Fine

0.496 (11.54%w/w); Citric Acid

Anhydrous 1.873g (43.58%w/w); Sodium

Carbonate Anhydrous 0.43g

(10.00%w/w)

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2012 till 29 July

2017 GSL

880 BRU12070923PCoversyl Plus 10mg/2.5mg

Tablet

Perindopril arginine 10mg (equiv. to

6.79mg perindopril); Indapamide 2.5mg

Servier (Ireland) Industries

Ltd, Ireland

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 POM

881 BRU12070924P RotarixTM oral SuspensionHuman rotavirus RIX4414 strain, not less

than 106.0 CCID50

GlaxoSmithKline Biological

SA, Belgium

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 POM

882 BRU12070925P CutivateTM CreamFluticasone propionate (micronised)

0.05%w/w

Glaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 POM

883 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/wGP Genzech Produktions

GmbH, Germany

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 GSL

884 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/wKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 July 2012 till 29 July

2017 POM

885 BRU12070928PSevoflurane Inhalation

Anaesthetic Liquid 100%Sevoflurane 100% (1ml/ml)

Baxter Healthcare Of Puerto

rico, USA

Zuellig Pharma Sdn

Bhd

30 July 2012 till 29 July

2017 POM

886 BRU12080929PNiquitin 14mg Transdermal

PatchNicotine 78mg (14mg/24hrs)

Alza Corporation, California,

USA

Zuellig Pharma Sdn

Bhd

29 August 2012 till 28

August 2017 P

887 BRU12080930NPDequadin® Lozenges (Citrus

Flavour)Dequalinium Chloride 0.25mg

Sterling Drug (Malaya) Sdn

Bhd., Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

29 August 2012 till 28

August 2017

GSL (6x4's &

24's)

888 BRU12080931P Rilutek Tablets 50mg Riluzole 50mgSanofi Winthrop Industrie,

Cedex, FranceMedipharm Sdn Bhd

29 August 2012 till 28

August 2017 POM

889 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg

Pfizer Ireland

Pharmaceuticals, Kildare,

Republic of Ireland

Zuellig Pharma Sdn

Bhd

29 August 2012 till 28

August 2017 POM

890 BRU12090933PXarelto® Film-coated Tablet

10mgRivaroxaban 10mg

Bayer Pharma AG,

Leverkusen, Germany

Zuellig Pharma Sdn

Bhd

27 September 2012 till

26 September 2017 POM

BDMCA/RMP/1215 Page 64 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

891 BRU12090934P Nif-Ten Capsule Atenolol 50mh; Nifedipine 20mgCorden Pharma GmbH,

Plankstadt, Germany

Zuellig Pharma Sdn

Bhd

27 September 2012 till

26 September 2017 POM

892 BRU12090935P PrepandrixTM Vaccine

Purified antigen fractions of inactivated

split virions A/Indonesia/05/2005

(H5N1)/PR8-IBCDC-RG2 - 0.375mcg

haemagglutinin/dose

GlaxoSmithKline Biologicals,

Zirkusstrabe, Germany

Zuellig Pharma Sdn

Bhd

27 September 2012 till

26 September 2017 POM

893 BRU12090937PTelfast 6mg/ml Oral

SuspensionFexofenadine Hydrochloride 6mg/ml

Sanofi-Aventis Farmceutica

Ltd, Vila Areiao Suzano-SP-

Brasil

Medipharm Sdn Bhd27 September 2012 till

26 September 2017 POM

894 BRU12090938PGlucophage® XR 750mg

Extended Release TabletMetformin HCl 750mg

Merck KGaA, Germany;

Merck Sante SAS, Semoy,

France

Zuellig Pharma Sdn

Bhd

27 September 2012 till

26 September 2017 POM

895 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mgMerck Sante SAS, Semoy,

France

Zuellig Pharma Sdn

Bhd

27 September 2012 till

26 September 2017 POM

896 BRU12100940NP Dermoplex Calamine CreamCalamine (Fine) 4.00%; Zinc Oxide 3.00%

w/w

Upha Pharmaceutical Mfg

(M) Sdn Bhd

Hongkiat Trading &

Company

31 October 2012 till 30

October 2017 GSL

897 BRU12100941PFragminTM Solution for

Injection 5,000IU (anti-

Xa)/0.2ml

Dalteparin Sodium 5,000IU (anti-

Xa)/0.2ml

Vetter Pharma-Fertigung

GmbH & Co., Germany

Zuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 POM

898 BRU12100942PProstin E2TM Vaginal Tablet

3mgDinoprostone 3mg

Sanico N.V., Turnhout,

Belgium

Zuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 POM

899 BRU12100943NP

Dianeal Low Calcium

(2.5mEq/L) Peritoneal Dialysis

Solution with 2.5% Dextrose

Dextrose 2.5g; Sodium Chloride 538mg;

Sodium Lactate 448mg; Calcium Chloride

dihydrate 18.3mg; Magnesium Chloride

Hexhydrate 5.08mg

Baxter Healthcare SA,

SingaporeMedipharm Sdn Bhd

31 October 2012 till 30

October 2017 POM

900 BRU12100944NPPotassium Chloride Tablet

600mg (Slow release)Potassium Chloride 600mg

Beacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

31 October 2012 till 30

October 2017 POM

901 BRU12100945NP Anucare SuppositoriesZinc Oxide 300mg; Balsam Peru 50mg;

Benzyl Benzoate 33mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

31 October 2012 till 30

October 2017 GSL

902 BRU12100946P Salbu-Air CFC Free InhalerSalbutamol Sulphate (micronised)

100mcg per actuation

Laboratorio Aldo-Union S.A.,

Barcelona

G & H Trading

Company

31 October 2012 till 30

October 2017 POM

903 BRU12100947PIlliadin Nasal Decongestant

Solution 0.01%Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany

Zuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 P

904 BRU12100948PRenvela (Sevelamer

Carbonate) Tablet 800mgSevelamer Carbonate 800mg

Genzyme Ireland Limited,

IrelandMedipharm Sdn Bhd

31 October 2012 till 30

October 2017 POM

BDMCA/RMP/1215 Page 65 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

905 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg

Pfizer Manufacturing

Deutschland GmbH,

Freiburg, Germany

Zuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 POM

906 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate 100mcg

per inhalation

3M Health Care Limited,

England

Zuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 POM

907 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, IrelandZuellig Pharma Sdn

Bhd

31 October 2012 till 30

October 2017 POM

908 BRU12110952P Panadol C TabletParacetamol 500mg; Pseudoephedrine

Hydrochloride 30mg

Sterling Drug (Malaya) Sdn

Bhd, Malaysia

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 P

909 BRU12110953PFragminTM Solution for

Injection 2,500IU (anti-

Xa)/0.2ml, Single dose syringe

Dalteparin Sodium 2,500IU (anti-

Xa)/0.2ml

Vetter Pharma-Fertigung

GmbH & Co., Germany

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

910 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mg

Pfizer Ireland

Pharmaceuticals, Kildare,

Republic of Ireland

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

911 BRU12110955PEprex® 4000 Prefilled Syringe

4000IU/0.4mlEpoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

912 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mgBeacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

27 November 2012 till

26 November 2017 GSL

913BRU12110957PS1;

BRU12110957PS2

Actrapid® 100IU/ml Solution

for InjectionInsulin Human (rDNA) 100iu/ml

Novo Nordisk A/S, Denmark

(S1); Novo Nordisk

Production SAS, France (S2)

Medipharm Sdn Bhd27 November 2012 till

26 November 2017 POM

914 BRU12110958P Tretino Cream 0.05% Tretionoin (Retinoic acid) 0.5mg/gY.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

27 November 2012 till

26 November 2017 POM

915 BRU12110959PEprex® 2000 Prefilled Syringe

2000IU/0.5mlEpoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

916 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mgLes Laboratories Servier

Industrie, France

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 GSL

917 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, SwitzerlandZuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

BDMCA/RMP/1215 Page 66 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

918 BRU12110962P Tenol-100 Atenolol 100mgSunward Pharmaceutical Pte

Ltd, Singapore

G & H Trading

Company

27 November 2012 till

26 November 2017 POM

919 BRU12110963NP Polysilic III Suspension

Per 5ml contains Dried Aluminium

Hydroxide Gel 400mg; Magnesium

Trisilicate light 400mg; Simethicone

30mg

Beacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

27 November 2012 till

26 November 2017

GSL (200ml);

GSL (3.8L)

920 BRU12110964PExjade 125mg Dispersible

TabletsDeferasirox 125mg

Novartis Pharmas Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

921 BRU12110965PExjade 500mg Dispersible

TabletsDeferasirox 500mg

Novartis Pharmas Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

27 November 2012 till

26 November 2017 POM

922 BRU12110966NP Dhamotil TabletsDiphenoxylate HCl BP 2.5mg; Atropine

Sulphate 0.025mg

Drug Houses of Australia Pte

Ltd., Singapore

G & H Trading

Company

27 November 2012 till

26 November 2017 POM

923 BRU12120967PCervarixTM Vaccine (Prefilled

Syringe)

1 dose (0.5ml) contains: Human

Papillomavirus type 16 L1 protein 20mcg;

Human Papillomavirus type 18 L1 protein

20mcg; 3-O-desacyl-4'-monophosphoryl

lipid A (MPL) 50mcg; adsorbed on

aluminium hydroxide, hydrated (Al(OH)3)

0.5mcg Al3+

GlaxoSmithKine Biologicals

S.A., Rixensart, Belgium

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

924 BRU12120968NP

Dianeal Low Calcium

(2.5mEq/L) Peritoneal Dialysis

Sodium with 4.25% Dextrose

Per 100ml contains Calcium Chloride

18.3mg; Dextrose hydrous 4.25g;

Magnesium Chloride 5.08mg; Sodium

Chloride 538mg; Sdoium Lactate 448mg

Baxter Healthcare Asia,

Singapore

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

925 BRU12120969NP ENO Orange

Each 4.3g contains Citric Acid Anhydrous

1.851g; Sodium Bicarbonate Coarse

1.478g; Sodium Bicarbonate Fine 0.492;

Sodium Carbonate Anhydrous 0.43g

Sterling Drug (Malaya) Sdn

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn Bhd

27 December 2012 till

26 December 2017 GSL

926 BRU12120970PClementin Film Coated Tablet

625mg

Amoxicillin (as Trihydrate) 500mg;

Clavulanic Acid (as Potassium Salt)

125mg

Yung Shin Pharmaceutical

Ind. Co. Ltd., Taichung,

Taiwan

Asterix United (B)

Sdn Bhd

27 December 2012 till

26 December 2017 POM

BDMCA/RMP/1215 Page 67 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

927 BRU12120971PSurvanta® Beractant

Intratracheal SuspensionBeractant (as phospholipids) 25mg/ml Abbott Lab., Illinois, USA

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

928 BRU12120972PHumira Solution for Injection

40mg/0.8mlAdalimumab 40mg/0.8ml

Vetter-Pharma-Fertigung

GmbH & Co., KG,

Ravensburg, Germany

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

929 BRU12120973P ZyrprexaTM Tablet 10mg Olanzapine 10mg

Lily del Caribe Inc, Puerto

Rico, USA & Lilly S.A.,

Madrid, Spain

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

930 BRU12120974PSutentTM Hard Capsules

12.5mgSunitinib 12.5mg (as Malate)

Pfizer Italia S.r.l., Ascoli

Piceno, Italy

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

931 BRU12120975PStelara Solution for Injection in

pre-filled syringe 45mg/0.5mlUstekinumab 45mg/0.5ml

Baxter Pharmaceutical

Solutions LLC, Blommington,

United States

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

932 BRU12120976P Viagara 50mg Tablet Sildenafil 50mg (as Citrate)Pfizer Australia Pty Limited,

West Ryde, Australia

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

933 BRU12120977P Viagara 100mg Tablet Sildenafil 100mg (as Citrate)Pfizer Australia Pty Limited,

West Ryde, Australia

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

934 BRU12120978PAerrane (Isoflurane USP)

Inhalation LiquidIsoflurane USP 100%

Baxter Healthcare of Puerto

Rico, USA

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

935 BRU12120979PKogenate FS for Injection

250IU/vial

Antihaemophilic Factor (recombinant)

sucrose formulated 250IU

Bayer Healthcare LLC.,

United States

Zuellig Pharma Sdn

Bhd

27 December 2012 till

26 December 2017 POM

936 BRU12120980P Potcit MixturePer 5ml contains Potassium Citrate 1g;

Citric acid anhydrous 200mg

Beacons Pharmaceutical Pte

Ltd., Singapore

Hongkiat Trading &

Company

27 December 2012 till

26 December 2017 POM

937 BRU12120981P Garbose Tablet 100mg Acarbose 100mg

Y.S.P Industries (M) Sdn

Bhd., Selangor Darul Ehsan,

Malaysia

Asterix United (B)

Sdn Bhd

27 December 2012 till

26 December 2017 POM

938 BRU13010982PKombiglyzeTM XR Tablet

5/1000mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

1000mg

Bristol Myers Squibb

Company USA

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

BDMCA/RMP/1215 Page 68 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

939 BRU13010983PKombiglyzeTM XR Tablet

5/500mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

500mg

Bristol Myers Squibb

Company USA

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

940 BRU13010984PKombiglyzeTM XR Tablet

2.5/1000mg

Saxagliptin HCl 2.5mg (as anhydrous

2.79mg); Metformin Hydrochloride

1000mg

Bristol Myers Squibb

Company USA

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

941 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg

Recordati Industria Chimica

& Farmaceutica S.p.A.,

Milan, Italy

Hongkiat Trading &

Co

26 January 2013 till 25

January 2018 POM

942 BRU13010986NP Eye Mo Eye Drops

Boric acid 12.98mg/ml (1.298% w/v);

Sodium Borate (equivalent to)

2.04mg/ml (0.204%w/v)

GlaxoSmithKline (Tianjin) Co.

Ltd., China

Kingston Beverage &

Creamery Sdn Bhd

26 January 2013 till 25

January 2018 GSL

943 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mgY.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

26 January 2013 till 25

January 2018 POM

944 BRU13010988P Co-Trimexazole SuspensionPer 5ml - Sulphamethoxazole BP 200mg;

Trimethoprim 40mg

Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

26 January 2013 till 25

January 2018 POM

945 BRU13010989P Opticrom® Eye Drops 2% w/v Sodium Cromoglycate BP 2% w/vSanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

26 January 2013 till 25

January 2018 P

946 BRU13010990NPPanamol Paed. Suspension

120mg/5mlParacetamol 120mg/5ml

Beacons Pharmaceuticals

Pte ltd, Singapore

Hongkiat Trading &

Co

26 January 2013 till 25

January 2018 POM

947 BRU13010991PHumulin 30/70 Injection

100iu/ml (vial)

Human Insulin 100IU/ml (recombinant) -

30% Soluble insulin & 70% Isophane

Insulin

Eli Lilly and Co., USAZuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

948 BRU13010993PFML® Liquifilm Sterile

Opthalmic Solution 0.1%Fluorometholone 0.1%w/v

Allergan Pharmaceuticals

Ireland, IrelandMedipharm Sdn Bhd

26 January 2013 till 25

January 2018 POM

949 BRU13010994NPLacri-Lube S.O.P. Lubricants

Eye Ointment

Liquid Paraffin (Mineral Oil) 42.5%w/w;

Soft White Paraffin (White Petrolatum)

56.8% w/w

Allergan Sales LLC, United

StatesMedipharm Sdn Bhd

26 January 2013 till 25

January 2018 GSL

950 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w)LEO Laboratories Ltd (LEO

Pharma), Ireland

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

951 BRU13010996P Seretide Evohaler 25/125mcgPer actuation - Fluticasone propionate

125mcg; Salmetarol 25mcg (as xinafoate)Glaxo Wellcome SA Spain

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

952 BRU13010997P Glucophage® Tablet 850mgMetformin HCl 850mg (~Metformin

662.9mg)Merck Sante SAS, France

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

953 BRU13010998P Revlimid® Capsules 5mg Lenalidomide 5mg

Penn Pharmaceutical

Services Limited, UK &

Celgene International Sarl,

Switzerland

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

BDMCA/RMP/1215 Page 69 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

954 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/vAin Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

26 January 2013 till 25

January 2018 GSL

955 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

26 January 2013 till 25

January 2018 POM

956 BRU13011001P Ciloxan Eyedrops Per ml - Ciprofloxacin HCl 3mg (as

Ciprofloxacin HCl monohydrate 3.5%)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

26 January 2013 till 25

January 2018 POM

957 BRU13011002P One-Alpha® Capsule 1mcgAlfacalcidol 1mcg (1α-Hydroxy-vitamin

D3)

Leo Pharmaceutical

Products Ltd., A/S (Leo

Pharma), Denmark

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

958 BRU13011003PNimotop Infusion Solution

0.02%Nimodipine 0.01g/50ml

Bayer Schering Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

959 BRU13011004PGemzar 200mg Powder for

Solution for InfusionGemcitabine 200mg (as HCl)

Eli Lilly and Company,

Indiana, USA

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

960 BRU13011005P ZyprexaTM 5mg Tablet Olanzapine 5mgLilly del Caribe Inc., Puerto

Rico, USA

Zuellig Pharma Sdn

Bhd

26 January 2013 till 25

January 2018 POM

961 BRU13021006PCanesten GYN Vaginal Tablet

100mg - 3 day therapyClotrimazole 100mg

Bayer Consumer AG, Basel,

Switzerland

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

962 BRU13021008PPrevenar 13 Suspension for

Injection

Per 0.5ml - Pneumococcal Polysaccharide

Serotype 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C,

19A, 19F, 23F - 2.2mcg; Pneumococcal

Polysaccharide Serotype 6B - 4.4mcg

Baxter Pharmaceuticals

Solutions LLC, USA. & Pfizer

Ireland Pharmaceuticals,

Dublin, Ireland

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

963 BRU13021009PHemabate Sterile Solution

250mcg/ml

Carboprost (as tromethamine)

250mcg/ml

Pharmacia & Upjohn

Company, USA

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

964 BRU13021010PHumulin® 30/70 Injection

100iu/ml (catridge)

Human Insulin 100IU/ml (recombinant) -

30% Soluble insulin & 70% Isophane

Insulin

Eli Lilly and Company,

Indiana, USA

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 GSL

965 BRU13021011PExtraneal Peritoneal Dialysis

Solution 75g/L

Per 100ml: Icodextrin 7.5g; Sodium

Chloride 538mg; Sodium Lactate 448mg;

Calcium Chloride 25.7mg; Magnesium

Chloride 5.08mg

Baxter Healthcare SA,

SingaporeMedipharm Sdn Bhd

26 February 2013 till

25 February 2018 POM

966 BRU13021012P Afinitor Tablet 10mg Everolimus 10mgNovartis Pharma Stein AG,

Stein, Switzerland

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

BDMCA/RMP/1215 Page 70 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

967 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, MalaysiaG & H Trading

Company

26 February 2013 till

25 February 2018 POM

968 BRU13021014P Progynova® Tablet 2mg Estradiol Valerate 2mgDelpharm Lille SAS, Lys Les

Lannoy, Franc

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

969 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w)S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

26 February 2013 till

25 February 2018 POM

970 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mgBeacons Pharmaceutical Pte

Ltd, Singapore

Hongkiat Trading &

Co

26 February 2013 till

25 February 2018 POM

971 BRU13021017PHydrogen Peroxide Solution

6%

Hydrogen Peroxide 6% w/v (equivalent

to 20 volumes of oxygen)

Xepa-Soul Pattinson

(Malaysia) Sdn Bhd,

Malaysia

Hongkiat Trading &

Co

26 February 2013 till

25 February 2018 P

972 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

26 February 2013 till

25 February 2018 POM

973 BRU13021019PStilamin 3000 for Injection

3mg/ampouleSomatostatin (as acetate) 3mg

Merck Serono SA, Aubonne,

Switzerland

G&H Trading

Company

26 February 2013 till

25 February 2018 POM

974 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/ml

Y.S.P Industries (M) Sdn

Bhd, Selangor Darul Ehsan,

Malaysia

Asterix United (B)

Sdn Bhd

26 February 2013 till

25 February 2018

P

975 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/wHOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

26 February 2013 till

25 February 2018 GSL

976 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2mlYung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan, ROC

Asterix United (B)

Sdn Bhd

26 February 2013 till

25 February 2018 POM

977 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg

Noripharma Sdn Bhd,

Selangor Darul Ehsan,

Malaysia

K-Seri Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

978 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g Pfizer Canada Inc., CanadaZuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

979 BRU13021025NP Dhalgesic Rub 15% w/wMethyl salicylate 15% w/w; Menthol 5%

w/w; Camphor (racemic) 2% w/w

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

26 February 2013 till

25 February 2018 GSL

BDMCA/RMP/1215 Page 71 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

980 BRU13021026PKaletra Film-coated Tablet

200mg/50mgLopinavir 200mg; Ritonavir 50mg

AbbVie Deutschland GmbH

& Co. KG, Germany

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

981 BRU13021027P Sustanon 250

Per 1ml - Testosterone decanoate

100mg; Testosterone phenylpropionate

60mg; Testosterone isocaproate 60mg;

Testosterone propionate 30mg

[Equivalent to Testosterone 176mg/ml]

Merck Sharp & Dohme, the

Netherlands

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

982 BRU13021028P Holoxan for Injection Ifosfamide 1gBaxter Oncology GmbH,

Germany

Zuellig Pharma Sdn

Bhd

26 February 2013 till

25 February 2018 POM

983 BRU13031029NP Panadol Extend Tablet Paracetamol 665mgGlaxoSmithKline Australia

Pty Ltd, Australia

Kingston Beverage &

Creamery Sdn Bhd

28 March 2013 till 27

March 2018 GSL

984 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/wEncube Ethicals Private Ltd,

India

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 GSL

985 BRU13031032PPantaprazole Winthrop 20mg

Tablet

Pantoprazole (as sodium sesquihydrate)

20mg

Sanofi-Aventis S.P.Z.O.O.,

PolandMedipharm Sdn Bhd

28 March 2013 till 27

March 2018 POM

986 BRU13031033P Metoclopramide Tablet 10mgMetoclopramide HCl BP (equivalent to

Metoclopramide HCl anhydrous 10mg)

Drug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

987 BRU13031034P Loperamil Tablet 2mg Loperamide 2mgDrug House of Australia Pte

Ltd, Singapore

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

988 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mgBeacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Co

28 March 2013 till 27

March 2018 POM

989 BRU13031036P Dhacort Cream 1%w/wHydrocortisone acetate BP (micronised)

1% w/w

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

990 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mgY.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

28 March 2013 till 27

March 2018 POM

991 BRU13031038PSolcoseryl Dental Adhesive

Paste

Per g - Solcoseryl CMC 2.125mg;

Polidocanol 10mg

Legacy Pharmaceuticals

Switzreland GmbH,

Switzerland

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

992 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/vAin Medicare Sdn Bhd,

Malaysia

Syarikat Pakatan

Indah

28 March 2013 till 27

March 2018 POM

993 BRU13031040P Indapamide SR Tablet 1.5mg Indapamide 1.5mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

BDMCA/RMP/1215 Page 72 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

994 BRU13031041P Dhatifen Syrup 1mg/5mlKetotifen (as hydrogen fumarate)

1mg/5ml

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

995 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, MalaysiaG & H Trading

Company

28 March 2013 till 27

March 2018 POM

996 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, MalaysiaG & H Trading

Company

28 March 2013 till 27

March 2018 POM

997 BRU13031044P Zenmolin tablet 2mg Salbutamol (as sulphate) 2mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

998 BRU13031045PRecormon Pre-filled Syringe

2000IU/0.3mlErythropoetin Beta 2,000iu/0.3ml

Roche Diagnostics GmbH,

Germany

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

999 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH, GermanyZuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

1000 BRU13031047PRecormon Pre-filled Syringe

4000IU/0.3mlErythropoetin Beta 4,000iu/0.3ml

Roche Diagnostics GmbH,

Germany

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

1001 BRU13031048PD.T.Vax Suspension for

Injection in Multidose

Purified Diphteria Toxoid ≥ 30 i.u;

Purified Tetanus Toxoid ≥ 40 i.uSanofi Pasteur S.A., France

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

1002 BRU13031049PSaizen for Injection

3.33mg/vialSomatropin 3.33mg (10 IU)

Merck Serono S.A.,

Switzerland

G & H Trading

Company

28 March 2013 till 27

March 2018 POM

1003 BRU13031050P Isentress 400mg TabletRaltegravir 400mg (as potassium

434.4mg)

MSD Technology Singapore

Pte Ltd., Singapore

Zuellig Pharma Sdn

Bhd

28 March 2013 till 27

March 2018 POM

1004 BRU13041051P

Taxotere 80mg/4ml

Concentrate for Solution for

Infusion

Docetaxel trihydrate 80mg/4mlSanofi-Aventis Deutschland

GmbH, GermanyMedipharm Sdn Bhd

30 April 2013 till 29

April 2018 POM

1005 BRU13041052PFosamax Plus Tablet

70mg/5600IU

Alendronic Acid 70mg (as Sodium

91.37mg); Colecalciferol 140mcg

(5,600IU)

MSD Frosst Iberica, S.A.,

Madrid, Spain

Zuellig Pharma Sdn

Bhd

30 April 2013 till 29

April 2018 POM

1006 BRU13041053PGlucovance Tablet

500mg/2.5mg

Metformin HCl 500mg, Glibenclamide

2.5mg

Merck Sante SAS, Semoy,

France

Zuellig Pharma Sdn

Bhd

30 April 2013 till 29

April 2018 POM

1007BRU13041054PS1 &

BRU13041054PS2

Rebif ® Pre-filled Syringe

22mcg/0.5mlInterferon beta-1a 22mcg (6MIU) / 0.5ml

Merck Serono S.p.A.,

Modugno, Italy (S1); Merck

Serono S.A., Aubonne,

Switzerland

G & H Trading

Company

30 April 2013 till 29

April 2018 POM

1008 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mgY.S.P Industries (M) Sdn Bhd

Malaysia

K-Seri Pharma Sdn

Bhd

30 April 2013 till 29

April 2018 POM

BDMCA/RMP/1215 Page 73 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1009 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/wBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 GSL

1010 BRU13041057P Fucithalmic® Eye Drops 1% Fusidic acid 10mg/g (1.0%w/w)LEO Laboratories Ltd,

Dublin, Ireland

Zuellig Pharma Sdn

Bhd

30 April 2013 till 29

April 2018 POM

1011 BRU13041058PPegasys Pre-filled Syringe

180mcg/0.5mlPeginterferon alfa-2a 180mcg/0.5ml

F Hoffman-La Roche Ltd,

Switzerland; Roche

Diagnostic GmbH, Germany;

F Hoffman-La Roche Ltd,

Betriebsstandort Kaiseraugst

(Parenterals), Switzerland

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 POM

1012 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mgY.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

30 April 2013 till 29

April 2018 POM

1013 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Roche S.p.A., ItalyHongkiat Trading &

Co

30 April 2013 till 29

April 2018 POM

1014 BRU13041061PVenofer® Solution for Injection

100mg/5ml

Iron (III) [as Iron (III)-hydroxide sucrose

complex] 100mg/5ml

IDT Biologika GmbH,

Germany; BIPSO GmbH,

Germany

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 POM

1015 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/wBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 GSL

1016 BRU13041063P Apuzin tablet 25mg Captopril 25mgBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 POM

1017 BRU13041064PLezpain film-coated tablet

135mgMebeverine HCl 135mg

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 April 2013 till 29

April 2018 POM

1018 BRU13041065P Copegus Tablet 200mg Ribavarin 200mg

Hoffman-La Roche Inc., USA;

Patheon Inc., Ontario,

Canada

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 POM

1019 BRU13041066P Celexin 250 Film-coated Tablet Cephalexin 250mg (as monohydrate) Hovid Bhd, MalaysiaK-Seri Pharma Sdn

Bhd

30 April 2013 till 29

April 2018 POM

1020 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, GermanyHongkiat Trading &

Co

30 April 2013 till 29

April 2018 GSL

1021 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/vBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 April 2013 till 29

April 2018 GSL

BDMCA/RMP/1215 Page 74 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1022 BRU13061069PVotrient™ Film-coated tablets

200mgPazopanib (as hydrochloride) 200mg

Glaxo Operations UK Ltd,

Hertfordshire, UK

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1023 BRU13061070P

NovoMix® 30 FlexPen®

Suspension for Injection 100

U/ml

1ml contains 100u of Soluble Insulin

aspart 30% and Protamine-crystallised

Insulin aspart 70%

Novo Nordisk Producao

Farmaceutica do Brasil Ltda.,

Brazil

Medipharm Sdn Bhd04 June 2013 till 03

June 2018 POM

1024 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mgAbbott Biologicals B.V., The

Netherlands

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1025 BRU13061072NP Nutravit™ Syrup

Per 5ml - Riboflavine 1.46mg; Calcium

Pantothenate 3.25mg; Ascorbic Acid

17.5mg; Vitamin A 4000iu; Vitamin D

400iu; Nicotinamide 10.00mg; Lysine

HCl/ Monochloride 100.00mg; Thiamine

HCl/ Vit. B1 2.00mg; Cynocobalamine/

Vit B12 1.5mcg; Pyridoxine HCl/Vit B6

2.00mg

Hovid Bhd, MalaysiaG & H Trading

Company

04 June 2013 till 03

June 2018 GSL

1026 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mgBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

04 June 2013 till 03

June 2018 POM

1027 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, FranceHongkiat Trading &

Co

04 June 2013 till 03

June 2018 POM

1028 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg)Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

04 June 2013 till 03

June 2018 POM

1029 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mgProductos Roche S.A. de C.V,

Mexico

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1030 BRU13061077P Chloramphenicol Eye Ointment Chloramphenicol 10mg/g KRKA d.d., SloveniaK-Seri Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1031 BRU13061078NP Zentel Tablet 200mg Albendazole 200mgTianjin SKF Labs Ltd, Tianjin,

China

Kingston Beverage &

Creamery Sdn Bhd

04 June 2013 till 03

June 2018 GSL

1032 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-

polymaltose complex] 10mg/ml

Vifor S.A., Switzerland &

Vifor (International) Inc.,

Switzerland

Medipharm Sdn Bhd04 June 2013 till 03

June 2018 GSL

1033 BRU13061080P Noriday® Tablet Norethisterone 0.35mgPiramal Healthcare UK

Limited, United Kingdom

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1034 BRU13061081PKeppra 250mg Film-coated

TabletLevetiracetam 250mg UCB Pharma S.A., Belgium

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1035 BRU13061082PKeppra 500mg Film-coated

TabletLevetiracetam 500mg UCB Pharma S.A., Belgium

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

BDMCA/RMP/1215 Page 75 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1036

BRU13061083PS1,

BRU13061083PS2 &

BRU13061083PS3

Avastin Concentrate For

Solution For Infusion

400mg/16ml

Bevacizumab 400mg/16ml

Genetech Inc., USA; F

Hoffmann-LA Roche Ltd,

Switzerland; Roche

Diagnostics GmbH,

Germany; F. Hoffmann-La

Roche Ltd, Wurmisweg,

Switzerland

Medicare04 June 2013 till 03

June 2018 POM

1037 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mgProductos Roche S.A. de C.V,

Mexico

Zuellig Pharma Sdn

Bhd

04 June 2013 till 03

June 2018 POM

1038 BRU13061085PUripax Film-coated Tablet

200mgFlavoxate HCl 200mg

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

04 June 2013 till 03

June 2018 POM

1039 BRU13061086P Storvas Tablet 10mg Atorvastatin (as calcium) 10mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

04 June 2013 till 03

June 2018 POM

1040 BRU13061087PElonva Solution for Injection

150mcg/0.5mlCorifollitrophin alfa 150mcg/0.5ml

Vetter Pharma-Fertigung

GmbH & Co. KG, Germany

Zuellig Pharma Sdn

Bhd

27 June 2013 till 26

June 2018 POM

1041 BRU13061088P Maxitrol Eye Ointment

Per g: Neomycin Sulfate 3,500 IU;

Polymyxin B Sulfate 6,000IU;

Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

27 June 2013 till 26

June 2018 POM

1042 BRU13061089P Maxidex® Eye Ointment Dexamethasone 0.1% w/wS.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

27 June 2013 till 26

June 2018 POM

1043 BRU13061090NPCiproxol (Ciprofloxacin) 0.2%

w/v Intravenous Infusion BPCiprofloxacin 0.2% w/v

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

27 June 2013 till 26

June 2018 POM

1044 BRU13061091NPInfusol® W Intravenous

Infusion BPWater for Injection BP

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

27 June 2013 till 26

June 2018 GSL

1045 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%)EVER Pharma Jena GmbH,

Germany

Zuellig Pharma Sdn

Bhd

27 June 2013 till 26

June 2018 POM

1046 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

27 June 2013 till 26

June 2018 POM

1047 BRU13061094PPharmaniaga Simvastatin

tablet 10mgSimvastatin 10mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

27 June 2013 till 26

June 2018 POM

1048 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mgBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

27 June 2013 till 26

June 2018 POM

1049 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

27 June 2013 till 26

June 2018 POM

BDMCA/RMP/1215 Page 76 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1050 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/vICM Pharma Pte Ltd,

Singapore

Mc Quipp Technisell

Marketing Sdn Bhd

27 June 2013 till 26

June 2018 GSL

1051 BRU13071098P Cortal for Children Tablet Acetaminophen (Paracetamol) 80mgSterling Drug (Malaya) Sdn

Bhd, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2013 till 29 July

2018 GSL

1052 BRU13071099PChampix 1mg film-coated

tabletVarenicline Tartrate 1mg

Pfizer Manufacturing

Deutschland GmbH,

Germany

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1053 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine 0.9%)Perstorp Speciality

Chemicals, Sweden

Mc Quipp Technisell

Marketing Sdn Bhd

30 July 2013 till 29 July

2018 POM

1054 BRU13071101PGlucophage XR 500mg

Extended Release TabletMetformin HCl 500mg Merck Sante SAS, France

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1055 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mgSchering-Plough (Singapore)

Pte Ltd, Singapore

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1056 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mgKotra Pharma (M) Sdn Bhd,

Malaysia Medicorp Sdn Bhd

30 July 2013 till 29 July

2018 POM

1057 BRU13071104P

Gonal-F Powder and Solvent

for Solution for Injection 75IU

(5.5mcg)/ vial

Follitrophin Alfa 75 IU ( 5.5mcg)

Merck Serono S.p.A., Bari

(MSB), Italy; Merck Serono

S.A. (MSA), Swizerland

G & H Trading

Company

30 July 2013 till 29 July

2018 POM

1058 BRU13071105P Lignocaine Injection 2% x 5ml Lignocaine Hydrochloride 20mg/mlPfizer (Perth) Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1059 BRU13071106PPred Mild® Sterile Ophthalmic

Suspension 0.12%Prednisolone acetate 0.12% w/v

Allergen Pharmaceuticals

Ireland, Wesport, IrelandMedipharm Sdn Bhd

30 July 2013 till 29 July

2018 POM

1060 BRU13071107P Tamiflu Capsules 75mg Oseltamivir 75mg

Cenexi SAS, France; Catalent

Germany Schorndorf GmbH,

Germany; Roche S.p.A., Italy

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1061 BRU13071108P Revlimid® Capsules 25mg Lenalidomide 25mg

Penn Pharmaceutical

Services Limited, UK &

Celgene International Sarl,

Switzerland

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

BDMCA/RMP/1215 Page 77 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1062 BRU13071109P Revlimid® Capsules 15mg Lenalidomide 15mg

Penn Pharmaceutical

Services Limited, UK &

Celgene International Sarl,

Switzerland

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1063 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/g

Legacy Pharmaceuticals

Switzreland GmbH,

Switzerland

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1064 BRU13071111P Micosten-H CreamMiconazole Nitrate 2%; Hydrocortisone

1%

Noripharma Sdn. Bhd.,

Malaysia

K-Seri Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1065 BRU13071112PPharmaniaga Labetalol Tablet

100mgLabetalol Hydrochloride 100mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

30 July 2013 till 29 July

2018 POM

1066 BRU13071113P Hydralazine Tablet 10mg Hydralazine Hydrochloride 10mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 July 2013 till 29 July

2018 POM

1067 BRU13071114PSandimmun Neoral Capsule

25mgCiclosporin A 25mg

R.P. Scherer GmbH & Co.

KG., Germany

Zuellig Pharma Sdn

Bhd

30 July 2013 till 29 July

2018 POM

1068 BRU13081115P Champix 0.5mg & 1mg TabletVarenicline Tartrate 0.5mg & Varenicline

Tartrate 1mg

Pfizer Manufacturing

Deutschland GmbH,

Germany

Zuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 POM

1069 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2%Janssen Pharmaceutical NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 P

1070 BRU13081117P Dhasedyl DM Syrup

Per 5ml - Dextromethorphan HBr 10mg;

Promethazine HCl 3.6mg/ Ephedrine HCl

6mg

Drug House of Australia

(Asia) Pte Ltd, Singapore

G & H Trading

Company

27 August 2013 till 26

August 2018 POM

1071 BRU13081118P Daivonex® Cream Calcipotriol 50mcg/g (0.0005% w/w)LEO Laboratories Ltd (LEO

Pharma), Ireland

Zuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 POM

1072 BRU13081119P Zoral Cream Acyclovir USP 5% w/wDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

27 August 2013 till 26

August 2018 POM

1073 BRU13081120PEnbrel® 25mg solution for

injection in pre-filled syringeEtanercept 25mg/0.5ml

Pfizer Ireland

Pharmaceuticals, Ireland

Zuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 POM

1074 BRU13081121P Xenical Capsule 120mg Orlistat 120mg Roche SpA, ItalyZuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 POM

1075 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., SpainZuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 POM

1076 BRU13081123P Minazol Powder 2% Miconzaole Nitrate 2% w/wBiosis Pharmaceuticals Sdn

Bhd., Malaysia

Zuellig Pharma Sdn

Bhd

27 August 2013 till 26

August 2018 P

BDMCA/RMP/1215 Page 78 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1077 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/mlAin Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

27 August 2013 till 26

August 2018 POM

1078 BRU13081125PPharmaniaga Pyrazinamide

Tablet 500mgPyrazinamide 500mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

27 August 2013 till 26

August 2018 POM

1079 BRU13081126P Sathrocin ES Tablet 400mg Erythromycin (as ethylsuccinate) 400mgPharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

27 August 2013 till 26

August 2018 POM

1080 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, MalaysiaG & H Trading

Company

27 August 2013 till 26

August 2018 POM

1081 BRU13081128P Maxitrol Eye Drops

Per 1ml - Dexamethasone 0.1%;

Neomycin Sulphate 3,500IU; Polymyxin B

Sulphate 6,000 IU

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

27 August 2013 till 26

August 2018 POM

1082 BRU13091129P VentolinTM Syrup 2mg/5ml (T)Salbutamol Sulphate (as sulphate)

5mg/5ml

SmithKlineBeecham, Rizal,

Philippines

Zuellig Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

1083 BRU13091130PErbitux® 5mg/ml Solution for

InfusionCetuximab 5mg/ml

Boehringer Ingelheim,

Germany & Merck KGaA,

Germany (1 Artwork)

Zuellig Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

1084 BRU13091132NP Beafort Syrup

Each 5ml contains: Thiamine HCl 5mg;

Riboflavin 2.5mg; Pyridoxine HCl 2mg;

Cyanocobalamin 5mcg; Nicotinamide

20mg; Calcium Panthothenate 1.5mg

Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

28 September 2013 till

27 September 2018 GSL

1085 BRU13091133PClexane 4000/0.4ml Anti XA

Pre-filled Syringe

Enoxaprin sodium 4,000 anti-Xa IU/0.4ml

equivalent to 40mg/0.4ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

28 September 2013 till

27 September 2018 POM

1086 BRU13091134PPantaprazole Winthrop 40mg

Tablet

Pantoprazole (as sodium Sesquihydate)

40mg

Sanofi-Aventis S.P.Z.O.O.,

PolandMedipharm Sdn Bhd

28 September 2013 till

27 September 2018 POM

1087 BRU13091135P Iodosorb PowderCadexomer 99.1% w/w, with Iodine

0.9%w/w

Perstorp Speciality

Chemicals AB, Sweden

Mc Quipp Technisell

Marketing Sdn Bhd

28 September 2013 till

27 September 2018 P

1088 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mgY.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

28 September 2013 till

27 September 2018 POM

1089 BRU13091137P Effient Tablet 5mg Prasugrel HCl 5mg Eli Lilly & Co., USAZuellig Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

BDMCA/RMP/1215 Page 79 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1090 BRU13091138PClexane 6000/0.6ml Anti-Xa IU

Pre-filled Syringe

Enoxaprin sodium 6,000 anti-Xa IU/0.6ml

equivalent to 60mg/0.6ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

28 September 2013 till

27 September 2018 POM

1091 BRU13091139PSimvastatin Winthrop 40mg

TabletSimvastatin 40mg

Sanofi Aventis S.p.z.o.o,

PolandMedipharm Sdn Bhd

28 September 2013 till

27 September 2018 POM

1092 BRU13091140P Camazol Tablet 5mg Carbimazole 5mgXepa-Soul Pattinson (M) Sdn

Bhd Malaysia

Hongkiat Trading &

Co

28 September 2013 till

27 September 2018 POM

1093 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2mlYung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

28 September 2013 till

27 September 2018 POM

1094 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mgPahang Pharmacy Sdn Bhd,

Malaysia

K-Seri Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 GSL

1095 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg

Pierre Fabree Medicament

Productio (PFMP), France &

BSP Pharmaceuticals Srl

(BSP), Latina, Italy - (1

artwork)

Zuellig Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

1096 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mgNoripharma Sdn. Bhd.,

Malaysia

K-Seri Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

1097 BRU13091145NP A-Bite Cream Crotamiton 10%w/wHOE Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

28 September 2013 till

27 September 2018 GSL

1098 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

28 September 2013 till

27 September 2018 POM

1099 BRU13091147P Gynera Tablets Ethinylestradiol 0.03mg; Gestodene

0.075mg

Schering do Brasil Quimica e

Farmaceutica Ltda., Sao

Paulo, Brazil

Zuellig Pharma Sdn

Bhd

28 September 2013 till

27 September 2018 POM

1100 BRU13101148P Eumovate™ Cream Clobetasone 17-butyrate 0.05% w/wGlaxo Wellcome Opration,

UK

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1101 BRU13101149PErycin Film Coated Tablet

250mgErythromycin (as stearate) 250mg

Y.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

31 October 2013 till 31

October 2018 POM

BDMCA/RMP/1215 Page 80 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1102 BRU13101151NP ENO Fruit Salt Lemon

Per 4.3g - Sodium Bicarbonate Coarse

1.468g (34.16%w/w); Sodium

Bicarbonate Fine 0.489g (11.39%w/w);

Citric Acid Anhydrous 1.853g

(43.10%w/w); Sodium Carbonate

Anhydrous 0.43g (10.0%w/w)

Sterling Drug (Malaya) Sdn

Bhd, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

31 October 2013 till 31

October 2018 GSL

1103 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg

GlaxoSmithKline

Manufacturing S.p.A.,

Parma, Italy

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1104 BRU13101153PClexane 2000 anti-Xa IU/0.2ml

(Pre-filled Syringe for Injection)

Enoxaparin Sodium 2,000 anti-Xa

IU/0.2ml

Sanofi Winthrop Industrie,

FranceMedipharm Sdn Bhd

31 October 2013 till 31

October 2018 POM

1105 BRU13101154PAxcel Mefenamic Acid

SuspensionMefenamic Acid 125mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

31 October 2013 till 31

October 2018 POM

1106 BRU13101155P

Ovidrel Solution for Injection

250mcg/0.5ml in Pre-filled

Syringe

Choriogonadotropin alfa 250mcg/0.5ml

Merck Serono S.p.A., Italy &

Merck Serono S.A.,

Switzerland

G & H Trading

Company

31 October 2013 till 31

October 2018 POM

1107 BRU13101156PSandimmun Neoral Capsule

100mgCiclosporin 100mg

R.P Scherer GmbH & Co,

Baden, Germany

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1108 BRU13101157P Tobrex Eye Ointment Tobramycin 0.3% (3mg/g)S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

31 October 2013 till 31

October 2018 POM

1109 BRU13101158P Endoxan Tablet 50mgCyclophosphamide anhydrous (as

monohydrate) 50mg

Prasfarma Oncologicos S.L.,

Barcelona, Spain; Haupt

Pharma Amareg GmBH,

Germany

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1110 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mgSiam Bheasach Co. Ltd.,

Bangkok, Thailand

K-Seri Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1111 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg

Pfizer Ireland

Pharmaceuticals, Kildare,

Ireland

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1112BRU13101161PS1;

BRU13101161PS2Revlimid capsules 10mg Lenalidomide 10mg

Penn Pharmaceutical

Services, Gwent, UK (S1) &

Celgene International Sarl,

Boudry, Switzerlnd (S2)

Zuellig Pharma Sdn

Bhd

31 October 2013 till 31

October 2018 POM

1113 BRU13101162PPharmaniaga Cephalexin

Suspension 125mg Cephalexin (as anhydrous) 125mg/5ml

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

31 October 2013 till 31

October 2018 POM

BDMCA/RMP/1215 Page 81 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1114 BRU13101163P Tolbutamide Tablets 500mg Tolbutamide 500mgDrug Houses Australia Pte

Ltd., Singapore

G & H Trading

Company

31 October 2013 till 31

October 2018 POM

1115 BRU13101164PIsopto Homatropine 2% Sterile

Ophthalmic Solution (

Homatropine Hydrobromide 2%

(20.0mg/ml)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

31 October 2013 till 31

October 2018 POM

1116 BRU13101165NPLactacyd Feminine Hygiene

Liquid

Per 100ml - Lactic Acid 1g; Atomised

Lactoserum (spray dried) 0.93g

Sanofi Synthelabo Vietnam,

Ho Chi Minh City, Viet NamMedipharm Sdn Bhd

31 October 2013 till 31

October 2018 GSL

1117 BRU13121166P SCMC Syrup 125mg/5ml S-Carboxymethyl-cysteine 125mg/5mlUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

Hongkiat Trading &

Co

02 December 2013 till

01 December 2018 P

1118 BRU13121167PCopastin Film Coated Tablets

10mgCloperastine Hydrochloride 10mg

Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

02 December 2013 till

01 December 2018 P

1119 BRU13121168P Ucort CreamPer g – Urea 100mg; Hydrocortisone

acetate 10mg

Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

02 December 2013 till

01 December 2018 P

1120 BRU13121169PPradaxa® Hard Capsules

150mg

Dabigatran etexilate 150mg (as mesilate

172.95g)

Boehringer Ingelheim

Pharma GmbH &Co,

Ingelheim am Rhein,

Germany

Hongkiat Trading &

Co

02 December 2013 till

01 December 2018 POM

1121 BRU13121170PPradaxa® Hard Capsules

110mg

Dabigatran etexilate 110mg (as mesilate

126.83g)

Boehringer Ingelheim

Pharma GmbH & Co., KG,

Germany

Hongkiat Trading &

Co

02 December 2013 till

01 December 2018 POM

1122 BRU13121171P Amoxicillin Capsule 250mg Amoxicillin Trihydrate 250mgYung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

02 December 2013 till

01 December 2018 POM

1123 BRU13121172NP

Dianeal Low Calcium

(2.5mEq/L) Peritoneal Dialysis

Solution with 1.5% Dextrose (T)

Each 100ml contains: Calcium Choloride

18.3mg; Dextrose hydrous 1.5g;

Magnesium Chloride 5.08mg; Sodium

Chloride 538mg; Sodium Lactate 448mg

Baxter Healthcare SA,

SingaporeMedipharm Sdn Bhd

02 December 2013 till

01 December 2018 POM

1124 BRU13121173NPRefresh Tears Lubricant Eye

Drops 0.5%

Carboxymethylcellulose Sodium 0.5%

w/vAllergan Sales LLC, USA Medipharm Sdn Bhd

02 December 2013 till

01 December 2018 GSL

1125 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, FinlandZuellig Pharma Sdn

Bhd

02 December 2013 till

01 December 2018 POM

BDMCA/RMP/1215 Page 82 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1126 BRU13121175PBetagan® Liquifilm Ophthalmic

Solution 0.5%Levobunolol Hydrochloride 0.5% w/v

Allergan Pharmaceuticals

Ireland, IrelandMedipharm Sdn Bhd

02 December 2013 till

01 December 2018 POM

1127 BRU13121176P Dhasolone Tablet 5mg Prednisolone BP (micronized) 5mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 December 2013 till

01 December 2018 POM

1128 BRU13121177PCyclogyl® 1% Sterile

Ophthalmic Solution (T)Cyclopentolate Hydrochloride 1%

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

02 December 2013 till

01 December 2018 POM

1129 BRU13121178P Betawin Tablet 50mg (T) Metoprolol Tartrate 50mgDuopharma (M) Sdn Bhd

Malaysia

Hongkiat Trading &

Co

02 December 2013 till

01 December 2018 POM

1130 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UKZuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1131 BRU13121180P Glucovance Tablet 500mg/5mgMetformin HCl 500mg; Glibenclamide

5mgMerck Sante SAS, France

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1132 BRU13121181P

Priorix-Tetra Powder and

Diluent for Solution for

Injection

Composition of Priorix™ per dose

(0.5ml): Live attenuated measles virus

(Schwarz strain) ≥103.0 CCID50, Live

attenuated mumps virus (RIT4385 strain)

≥103.7 CCID50, Live attenuated rubella

virus (Wistar RA 27/3 strain) ≥103.0

CCID50, Live attenuated Varicella Virus

(OKA strain) ≥103.3 PFU

Glaxosmithkline Biologicals

S.A., Belgium

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1133 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mgGlaxoSmithKline

Manufacturing S.p.A., Italy

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1134 BRU13121183P Anarex TabletsParacetamol 450mg; Orphenadrine

citrate 35mg

Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 December 2013 till

29 December 2018 POM

1135 BRU13121184PAtarax Film-Coated Tablet

25mgHydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

BDMCA/RMP/1215 Page 83 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1136 BRU13121185P Propylthiouracil Tablets 50mg Propylthouracil 50mgDrug Houses of Australia Pte

Ltd., Singapore

G & H Trading

Company

30 December 2013 till

29 December 2018 POM

1137 BRU13121186P Xyzal Oral Drops 5mg/mlPer mL - Levocetitrizine Hydrochloride

5mg

Aesica Pharmaceuticals S.r.L

Pianezza, Italy

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1138 BRU13121187NP10% Glucose Intravenous

Infusion B.P.

Glucose monohydrate (as equiv. to

anhydrous glucose) 10%

B Braun Industries Sdn Bhd,

Malaysia

Hongkiat Trading &

Co

30 December 2013 till

29 December 2018 POM

1139 BRU13121188PDaivonex Scalp Solution

50mcg/mlCalcipotriol 50mcg/ml

Leo Pharmaceutical

Products Ltd., A/S (Leo

Pharma), Denmark

Zuellig Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1140 BRU13121189PHeparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa)

10i.u./ml

B Braun Industries Sdn Bhd,

Malaysia

Hongkiat Trading &

Co

30 December 2013 till

29 December 2018 POM

1141 BRU13121190P Rescuvolin Tablet 15mgCalcium Folinate (equiv. to Folinic Acid)

15mg

Teva Pharmaceutical Works

Pte Ltd Co., Debrecen Site,

Hungary

K-Seri Pharma Sdn

Bhd

30 December 2013 till

29 December 2018 POM

1142 BRU13121191PQuinax Sterile Ophthalmic

Solution

Sodium Dihydroazapentacene

Polysulfonate 0.15mg/ml

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

30 December 2013 till

29 December 2018 POM

1143 BRU13121192PNutriflex Lipid Peri Emulsion

for Infusion

1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion (For

Detailed Formulation referred to

Dossier)

B Braun Industries Sdn Bhd,

Malaysia

Hongkiat Trading &

Co

30 December 2013 till

29 December 2018 POM

1144BRU14011193PS1 &

BRU14011193PS2Alimta 500mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

500mg/vial

Eli Lilly and Company, USA

(S1); Lilly France, France (S2)

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019 POM

1145BRU14011194P

Gemzar 1G Powder for

Solution for InfusionGemcitabine 1000mg (as gemcitabine

hydrochloride)

Eli Lilly and Company, USA Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1146 BRU14011195P Imigran FD Tablets 100mgSumatriptan 100mg (as the succinate) GlaxoSmithKline

Pharmaceuticals SA, Poland

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019 POM

1147 BRU14011196P Largo Tablets 100mgChlorpromazine HCl 100mg Beacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019POM

1148 BRU14011197NP Axcel Eviline Forte Suspension

Each 5ml contains: Magnesium

Hydroxide 400mg, Aluminium Hydroxide

400mg and Simethicone 40mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd,

Malaysia

28 January 2014 till 27

January 2019 GSL

BDMCA/RMP/1215 Page 84 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1149 BRU14011198NP Bepanthen® First Aid CreamDexpanthenol 5%w/w; Chlorhexidine

hydrochloride 0.5% w/w

GP Grenzach Produktions

GmbH, Germany

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019GSL

1150 BRU14011199NPDextrose 5% and Sodium

Chloride 0.9% Injection USPDextrose 5%; Sodium Chloride 0.9% Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1151 BRU14011200NP Macgel® TabletMagnesium Hydroxide 200mg;

Aluminium Hydroxide Gel Dried 200mg;

Dimethylpolysiloxane 25mg

Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

28 January 2014 till 27

January 2019 GSL

1152 BRU14011201PPrefrin Liquifilm Eye Drops

0.12%Phenylephrine Hydrochloride 0.12% Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019P

1153 BRU14011202NPRefresh Liquigel Lubricant Eye

Drops 1%Carboxymethylcellulose Sodium 1% w/v Allergan Sales, LLC., USA MediPharm Sdn Bhd 28 January 2014 till 27

January 2019GSL

1154 BRU14011203P Betaserc 24mg TabletBetahistine dihydrochloride 24mg Abbott Healthcare SAS,

France

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1155 BRU14011204PHumalog Mix50 100 units/ml

Kwikpen

Insulin Lispro * 100U/ml (equivalent to

3.5mg) * in the proportion of 50% insulin

lispro solution and 50% insulin lispro

protamine suspension (rDNA origin)

Lilly France SAS, France Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1156 BRU14011205NP Panamol Tablet 500mgParacetamol 500mg Beacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019GSL

1157 BRU14011206PSeretide™ Evohaler™

25/50mcgFluticasone propionate 50mcg;

Salmeterol (as xinafoate) 25mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1158 BRU14011207P Tobrex® Eye Drops SolutionTobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019POM

1159 BRU14011208P PNEUMOVAX 23

Pneumococcal Polysaccharide Danish

Types 1,2,3,4,5,6B, 7F,8,9N,9V, 10A, 11A,

12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F,

23F, 33F. Each 0.5ml dose contains 25µg

of each polysaccharide type

Merck Sharp & Dohme Corp,

USA

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019

POM

1160 BRU14011209PNEUPOGEN PRE-FILLED

SYRINGE 30MU/0.5ML

Filgrastim 30mu/0.5ml F.Hoffmann-La Roche Ltd,

Kaiseraugst

Switzerland

Medipharm Sdn Bhd 28 January 2014 till 27

January 2019 POM

1161 BRU14011210P Axcel Famotidine-20 CapsuleFamotidine 20mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd,

Malaysia

28 January 2014 till 27

January 2019POM

1162 BRU14011211NPTears Naturale II Eye Drops

SolutionDextran 70 0.1% (1mg/ml); Hypromellose

0.3% (3mg/ml)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Company

28 January 2014 till 27

January 2019GSL

BDMCA/RMP/1215 Page 85 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1163 BRU14011212PAxcel Chlorpheniramine-4

SyrupChlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd,

Malaysia

28 January 2014 till 27

January 2019P

1164 BRU14011213PImojev Japanese Encephalitis

vaccine (live, attenuated) MD

Live, attenuated, recombinant Japanese

Encephalitis virus 4.0 - 5.8 log PFU*/dose

(0.5ml) *Plaque Forming Unit

Government Pharmaceutical

Organization - Meriux

Biological Products Co., Ltd.,

Thailand

Zuellig Pharma Sdn

Bhd

28 January 2014 till 27

January 2019POM

1165BRU14021214P Panaflex Extra Gel Diclofenac Sodium 10mg/1gm United Biomedical Inc., Asia,

Taiwan

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

P

1166BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen

(HAV), HM175 strain 1440 ELISA Units

(EL.U.)/ml

GlaxoSmithKline Biologicals

SA, Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1167BRU14021216P Co-Plavix® 75/100 film-coated

tablets

Clopidogrel (as hydrogen sulphate)

75mg; Acetylsalicylic acid 100mg

Sanofi Winthrop Industrie,

France

Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1168BRU14021217P VotrientTM Film-coated tablets

400mg

Pazopanib (as hydrochloride) 400mg Glaxo Operations UK

Limited, UK

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1169BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1170BRU14021219P Novorapid® Flexpen® 100IU/ml 1ml of solution contains 100U insulin

aspart (r-DNA) (equivalent to 3.5mg)

Novo Nordisk Producao

Farmaceutica do Brasil Ltda.,

Brazil

Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1171BRU14021220P Omelon Enteric

Microencapsulated capsule

20mg

Omeprazole 20mg Y.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

27 February 2014 till

26 February 2019

POM

1172BRU14021221NP Lactacyd® liquid Lactic acid (1g/100ml) and atomized

lactoserum (0.9g/100ml)

Sanofi Synthelabo Vietnam,

Ho Chi Minh City, Viet Nam

Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

GSL

1173

BRU14021222P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

25mg/0.25ml

0.25ml of solution contains Paliperidone

(as palmitate 39mg) 25mg

Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1174

BRU14021223P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

50mg/0.5ml

0.5ml of solution contains Paliperidone

(as palmitate 78mg) 50mg

Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

BDMCA/RMP/1215 Page 86 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1175

BRU14021224P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

75mg/0.75ml

0.75ml of solution contains Paliperidone

(as palmitate 117mg) 75mg

Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1176

BRU14021225P Invega® Sustenna Prolonged

Release Suspension for

Intramuscular Injection

100mg/1.0ml

1.0ml of solution contains Paliperidone

(as palmitate 156mg) 100mg

Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1177BRU14021226P Simvastatin Winthrop 20mg

tablet

Simvastatin 20mg Sanofi-Aventis S.P.Z.O.O.,

Poland

Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1178BRU14021227P LumiganTM (Bitamoprost

Ophthalmic Solution) 0.03%

Bimatoprost 0.03% w/v Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1179BRU14021228NP Refresh Plus Lubricating Eye

Drops 0.5%

Carboxymethylcellulose Sodium 0.5% Allergan Sales, LLC, USA Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1180

BRU14021229P NovoSeven® Powder and

Solvent for Solution for

Injection 2mg

Eptacog Alfa (Activated) 2mg/vial

(corresponds to 100 KIU/vial), 1mg/ml

after reconstitution.

1 KIU equals 1000 IU (International

Units)

eptacog alfa (activated) is recombinant

coagulation factor VIIa (rFVIIa) with a

molecular mass of approximately 50,000

Dalton produced in baby hamster kidney

cells (BHK Cells) by recombinant DNA

technology.

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 27 February 2014 till

26 February 2019

POM

1181BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg,

Magnesium Hydroxide 200mg,

Simethicone 20mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2014 till

26 February 2019

GSL

1182BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2014 till

26 February 2019

P

BDMCA/RMP/1215 Page 87 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1183BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Eli Lilly and Company,

Indiana, USA; Lilly del

Caribe, Inc., Puerto Rico

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1184BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate

monohydrate)

Glaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1185BRU14021234P Axcel Mefenamic Acid Capsules Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2014 till

26 February 2019

POM

1186BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1187BRU14021236NP Lactated Ringer’s Injection

USP4

Sodium Chloride 6g/L; Sodium Lactate

3.1g/L; Potassium Chloride 0.3g/L;

Calcium Chloride 0.2g/L

Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

GSL

1188BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH, Germany Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1189BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride 5mg

and Simethicone 50mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2014 till

26 February 2019

GSL

1190BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (recombinant

DNA origin) Biosynthetic

Eli Lilly an Company, USA Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1191BRU14021240NP 5% Dextrose and 0.45%

Sodium Chloride Injection, USP

Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

GSL

1192BRU14021241P Giona Easyhaler 200mcg/dose

Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading &

Co

27 February 2014 till

26 February 2019

POM

1193BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical

Ind. Co., Taiwan

Asterix United (B)

Sdn Bhd

27 February 2014 till

26 February 2019

POM

1194BRU14021243NP Neurobion tablet thiamine disulfide 100mg; Pyridoxine

hydroxide 200mg & Cyanocobalamin

200mcg

Merck KGaA & Co, Austria Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

P

1195BRU14021244P Omeprazole for Injection

(Lyophilised) 40mg/vial

Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

BDMCA/RMP/1215 Page 88 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1196BRU14021245P Keppra Concentrate for

solution for (infusion) /

intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1197

BRU14021246P Imojev Japanese Encephalitis

Vaccine (live, attenuated)

Live, attenuated, recombinant Japanese

Encephalitis virus 4.0 - 5.8 log PFU*/

dose (0.5ml) * Plaque Forming Unit

Government Pharmaceutical

organization-Meriux

Biological Products Co., Ltd.,

Thailand

Zuellig Pharma Sdn

Bhd

27 February 2014 till

26 February 2019

POM

1198BRU14021247P Pradaxa® Hard Capsules 75mg

Dabigatran etexilate 75mg (as mesilate

86.48mg)

Boehringer Ingelheim

Pharma GmbH & Co., KG,

Germany

Hongkiat Trading &

Co

27 February 2014 till

26 February 2019

POM

1199BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml;

Ammonium Chloride 130mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2014 till

26 February 2019

POM

1200BRU14031249P Tygacil 50mg Lyophilised

Powder for Intravenous

Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1201

BRU14031250PS1;B

RU14031250PS2

Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to

14.2mg

Novo Nordisk A/S, Denmark

(S1); Novo Nordisk Producao

Farmaceutica do Brasil Ltda.,

Brazil (S2)

MediPharm Sdn Bhd 27 March 2014 till 26

March 2019

POM

1202BRU14031251P Stalevo 75/18.75/200mg Film-

coated Tablet

Levodopa 75mg; Carbidopa 18.75mg;

Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1203BRU14031252P Stalevo 200/50/200mg Film-

coated Tablet

Levodopa 200mg; Carbidopa 50mg;

Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1204BRU14031253P Humulin N Injection 100iu/vial Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

BDMCA/RMP/1215 Page 89 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1205

BRU14031254NP Nutrineal PD-4 with 1.1%

Amino Acid Solution

Each 1000ml contains L-Serine 0.510g; L-

Isoleucine 0.850g; L-Leucine 1.020g; L-

Lysine (as Hydrochloride) 0.955g; L-

Methionine 0.850g; L-Phenylalanine

0.570g; L-Threonine 0.646g; L-

Tryptophan 0.270g; L-Valine 1.393g; L-

Alanine 0.951g; L-Arginine 1.071g;

Glycine 0.510g; L-Histidine 0.714g; L-

Proline 0.595g; L-Tyrosine 0.300g;

Sodium Chloride 5.380g; Calcium

Chloride Dihydrate 0.184g; Magnesium

Chloride Hexahydrate 0.051g; Sodium

Lactate 4.48g

Baxter Healthcare SA,

Singapore

Medipharm Sdn Bhd 27 March 2014 till 26

March 2019

POM

1206BRU14031255P Effient™ Tablet 10mg Prasugrel (as hydrochloride) 10mg Eli Lilly and Company, USA Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1207BRU14031256P Gonal-F 300IU/0.5ml solution

for injection in a pre-filled pen

Each pen (0.5ml) contains 300IU

follitropin alfa (eq. to 22 micrograms)

Merck Serono S.p.A, Italy G&H Trading

Company

27 March 2014 till 26

March 2019

POM

1208

BRU14031257P Gonal-F 900IU/1.5ml Solution

for Injection in a pre-filled pen

Each pen (1.5ml) contains 900IU

follitropin alfa (eq. to 66 micrograms).

Each ml of solution contains 600IU

follitropin alfa (equivalent to 44

micrograms)

Merck Serono S.p.A, Italy G&H Trading

Company

27 March 2014 till 26

March 2019

POM

1209BRU14031258P Volibris 5mg Film-coated

TabletAmbrisentan 5mg Patheon Inc., Ontario, USA

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1210BRU14031259P Volibris 10mg Film-coated

TabletAmbrisentan 10mg Patheon Inc., Ontario, USA

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1211BRU14031260P Atarax™ Syrup 2mg/ml

Hydroxyzine hydrochloride 2mg/ml NextPharma SAS, FranceZuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1212BRU14031261P Prograf Capsule 1mg

Tacrolimus 1mg Astellas Ireland Ltd, IrelandZuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1213BRU14031262P Loperamil Syrup 1mg/5ml

Loperamide HCl 1mg/5mlDrug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company 27 March 2014 till 26

March 2019

POM

1214BRU14031263P Patanol® Eye Drops, Solution

0.1%Olopatadine (as HCl) 0.1%

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Company27 March 2014 till 26

March 2019

POM

1215BRU14031264P Travatan® Eye Drops 40mcg/ml

Travoprost 40mcg/mlS.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Company27 March 2014 till 26

March 2019

POM

BDMCA/RMP/1215 Page 90 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1216BRU14031265P Chlorpheniramine tablet 4mg

Chlorpheniramine Maleate 4mgDrug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company 27 March 2014 till 26

March 2019

POM

1217BRU14031266P Allertyn Tablet 10mg

Loratadine (micronized) 10mgDrug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company 27 March 2014 till 26

March 2019

P

1218BRU14031267P Motilium Suspension 1mg/ml

Domperidone 1mg/mlJanssen Pharmaceutica NV,

Belgium

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1219BRU14031268P Elonva Solution for Injection

100mcg/0.5mlCorifollitropin alfa 100mcg/0.5ml

Vetter Pharma-Fertigung

GmbH & Co. KG, Germany

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1220

BRU14031269P Menveo Powder & Solution for

Solution for Injection

One dose (0.5ml of the reconstituted

vaccine) contains:

Originally contained in the powder:

Meninggococcal group A oligosaccharide

10micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein 16.7 to 33.3

micrograms)

Originally contained in the solution:

Meninggococcal group C oligosaccharide

5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein…..7.1 to 12.5

micrograms); Meninggococcal group

W135 oligosaccharide 5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein 3.3 to 8.3

micrograms); Meninggococcal group Y

oligosaccharide 5micrograms

(Conjugated to Corynebacterium

diphtheria CRM197 protein….5.6 to 10.0.

micrograms)

Novartis Vaccines and

Diagnostics GmbH,

Germany; Novartis Vaccines

and Diagnostics S.r.I, Italy

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1221BRU14031270P Enbrel® 50mg solution for

Injection in a pre-filled syringe Etanercept 50.0mg/1.0mlPfizer Ireland

Pharmaceuticals, Ireland

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1222BRU14031271P Betnovate-N Cream Betamethasone (as betamethasone 17-

valerate BP) 0.1% w/w and Neomycin

sulphate BP 0.5% w/w

Glaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

BDMCA/RMP/1215 Page 91 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1223BRU14031272P Seretide Evohaler dose-

counter 25/250mcg

Salmeterol 25mcg (as the xinafoate) and

Fluticasone Propionate 250mcgGlaxo Wellcome S.A., Spain

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1224

BRU14031273PS1;

BRU14031273PS2

Galvus Met 50/500mg Film-

coated Tablet Vildagliptin 50mg; Metformin HCl

500mg(corresponding to 390mg

Metformin)

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1225

BRU14031274PS1;

BRU14031274PS2

Galvus Met 50/1000mg Film-

coated Tablet Vildagliptin 50mg; Metformin HCl

1000mg(corresponding to 780mg

Metformin)

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1226

BRU14031275PS1;

BRU14031275PS2

Galvus Met 50/850mg Film-

coated Tablet Vildagliptin 50mg; Metformin HCl

850mg(corresponding to 660mg

Metformin)

Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Pharma Produktions GmbH,

Germany (S2)

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1227BRU14031276P Galvus 50mg Tablet

Vildagliptin 50mgNovartis Farmaceutica SA,

Spain

Zuellig Pharma Sdn

Bhd27 March 2014 till 26

March 2019

POM

1228

BRU14031277P Duac Once Daily Gel Clindamycin 1% w/w (as Clindamycin

phosphate); Benzoyl Peroxide 5% w/w

(as hydrous Benzoyl Peroxide)

Glaxo Wellcome UK

Operations, UK

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1229

BRU14031278P Conazole Cream Miconazole nitrate 2.0% w/w;

Betamethasone 0.1% w/w (as valerate);

Gentamicin (as sulphate) 0.1% w/w

Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

27 March 2014 till 26

March 2019

POM

1230BRU14031279NP Axcel Paracetamol-250 Syrup

(Orange)

Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 March 2014 till 26

March 2019

GSL

1231BRU14031280P Lamictal Dispersible/Chewable

Tablet 25mg

Lamotrigine 25mg GlaxoSmithKline

Pharmaceutical SA, Poland

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1232BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine Phosphate

9mg

Beacons Pharmaceuticals

Pte Ltd, Singapore

Hongkiat Trading &

Company

27 March 2014 till 26

March 2019

POM

1233BRU14031282P Voren Injection ‘Yung Shin’

(Diclofenac)

Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical

Ind, Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

27 March 2014 till 26

March 2019

POM

1234BRU14031283P Dhasolone Syrup 3mg/5ml Prednisolone 3mg/5ml Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

27 March 2014 till 26

March 2019

POM

BDMCA/RMP/1215 Page 92 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1235BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing

Belgium NV, Belgium

Zuellig Pharma Sdn

Bhd

27 March 2014 till 26

March 2019

POM

1236

BRU14041285P Giona Easyhaler® 100mcg/dose

Inhalation Powder

Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading &

Company

26 April 2014 till 25

April 2019

POM

1237BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg; Chlorpheniramine

Maleate 4mg; Pseudoephedrine HCl

60mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 26 April 2014 till 25

April 2019

POM

1238BRU14041287P XareltoTM Film-coated tablet

15mg

Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1239BRU14041288P XareltoTM Film-coated tablet

20mg

Rivaroxaban 20mg Bayer Pharma AG, Germany Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1240BRU14041289P Metformin 500 Tablet 500mg Metformin HCl BP 500mg Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

1241BRU14041290NP Liquifilm TearsTM Ocular

Lubricant 1.4%

Polyvinyl Alcohol 1.4% Allergan Pharmaceuticals

Ireland, Ireland

Medipharm Sdn Bhd 26 April 2014 till 25

April 2019

GSL

1242BRU14041291NP Sodium Chloride Injection USP

0.9% in Mini-Bag Plus

Container

Sodium Chloride 0.9% Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

GSL

1243

BRU14041292PS1&

BRU14041292PS2

Rasilez® Film-coated Tablet

300mg

Aliskiren (as hemifumarate) 300mg Novartis Pharma Stein AG,

Switzerland (S1); Novartis

Farma S.p.A., Italy (S2)

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1244BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate

213.8mg (eq. to anhydrous

Cyclophosphamide 200mg)

Baxter Oncology GmbH,

Germany

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1245BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1246BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1247BRU14041296P Shincort IM Injection “Yung

Shin” 5ml vial

Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

26 April 2014 till 25

April 2019

POM

1248BRU14041297P DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml

(as timolol maleate)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Company

26 April 2014 till 25

April 2019

POM

1249BRU14041298P Chlormine Syrup 4mg/5ml Chlorpheniramine Maleate 4mg/5ml Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

P

1250BRU14041299P Hypernol 100 Tablets 100mg Atenolol 100mg Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

BDMCA/RMP/1215 Page 93 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1251BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

1252BRU14041301P DermovateTM Ointment Clobetasol Propionate 0.05% w/w Glaxo Wellcome Operations,

UK

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1253BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,

monohydrate) 150mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1254BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,

monohydrate) 200mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1255BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose

anhydrous 50g/L

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

26 April 2014 till 25

April 2019

POM

1256BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 April 2014 till 25

April 2019

GSL

1257BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to

Granisetron hydrochloride 1.12mg)

Cenexi SAS, France Hongkiat Trading &

Company

26 April 2014 till 25

April 2019

POM

1258BRU14041307P Alimta 100mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

100mg/vial

Eli Lilly and Company, USA Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1259BRU14041308P Decofam Cough Syrup Per 5mL contains Ephedrine HCl 4mg;

Guaiphenesin 50mg & Ammonium

Chloride 80mg

Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

P

1260BRU14041309NP RinsCap W (Sterile Water for

Injection BP)

Water for Injection BP Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

26 April 2014 till 25

April 2019

GSL

1261BRU14041310P Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

1262BRU14041311P Paradrine Tablet Paracetamol 500mg; Pseudoephedrine

HCl BP 20mg; Chlorpheniramine Maleate

BP 2mg

Drug Houses of Australia Pte

Ltd, Singapore

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

1263BRU14041312P One-Alpha® 0.25mcg Capsule Alfacalcidol 0.25mcg Leo Pharmaceutical

Products Ltd., A/S (Leo

Pharma), Denmark

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1264BRU14041313P Ibuprofen Suspension

20mg/ml

Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

26 April 2014 till 25

April 2019

P

1265BRU14041314NP Sodium Chloride Injection

0.9%, USP

Sodium Chloride 0.9% Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

GSL

1266BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate) 3mg Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1267BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate)

1.5mg

Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

26 April 2014 till 25

April 2019

POM

1268BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G&H Trading

Company

26 April 2014 till 25

April 2019

POM

BDMCA/RMP/1215 Page 94 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1269BRU14071318PS1 &

BRU14071318PS2

Rebif ® 44 Pre-filled Syringe

44mcg/0.5mlInterferon-beta-1a (12MIU) 44mcg/0.5ml Merck Serono S.p.A., Italy

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1270BRU14071319PS1 &

BRU14071319PS2Mixtard® 30 100IU/ml

Insulin Human, rDNA ( as Isophane

Insulin) 70%, Insulin Human, rDNA (as

soluble insulin) 30%

Novo Nordisk A/S,

Bagsvaerd, Denmark (S1);

Novo Nordisk Productions

SAS, France (S2)

Medipharm Sdn Bhd02 July 2014 till 01 July

2019POM

1271 BRU14071320P Protopic® Ointment 0.3% Tacrolimus 0.3mg/g (0.3%)Astellas Pharma Tech Co.,

Ltd., Japan

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1272 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5mlBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1273 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., BelgiumZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1274 BRU14071323P Nootropil 800mg Tablet Piracetam 80mg UCB Pharma S.A., BelgiumZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1275 BRU14071324PLuvox® Film-coated Tablets

50mgFluvoxamine maleate 50mg

Abbott Healthcare SAS,

France

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1276 BRU14071325PLuvox® Film-coated Tablets

100mgFluvoxamine maleate 100mg

Abbott Healthcare SAS,

France

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1277 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1%S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1278 BRU14071327PAgrippalTM S1, Suspension for

Injection in pre-filled syringe

Per 0.5ml dose: Split influenza virus*,

inactivated, containing antigens

equivalent to the following strains:

A/California/07/2009 (H1N1) pdm09–

like strain -15μg HA**

(A/California/07/2009, NYMC X-181);

A/Texas/50/2012 (H3N2) – like strain

15μg HA**, A/Texas/50/2012, NYMC X-

223-; B/Massachusetts/2/2012– like

strain 15μgHA** B/Florida/4/2006 wild

type.

Novartis Vaccines and

Diagnostic S.r.L., Italy

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1279 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH, GermanyZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

BDMCA/RMP/1215 Page 95 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1280 BRU14071329NP Axcel Papain Tablet

Papain Pure equiv. to proteolytic

enzymes from carica papaya 10,000 USP

Units

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

02 July 2014 till 01 July

2019GSL

1281 BRU14071330P Humalog Kwikpen 100units/ml Insulin Lispro 100units/ml

Lilly France S.A.S., France

(repacker - Eli Lilly And

Company, USA)

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1282 BRU14071331PShincort IM Injection "Yung

Shin" 40mg/ml ampoulesTriamcinolone acetonide 40mg

Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1283 BRU14071332PEmend IV Powder For Solution

for Infusion 150mg

Fosaprepitant 150mg (as fosaprepitant

dimeglumine)

DSM Pharmaceuticals Inc.,

USA

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1284 BRU14071333P Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. CanadaZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1285 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate)Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

02 July 2014 till 01 July

2019POM

1286 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg)Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1287 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w3M Health Care Limited,

England

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1288 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mgPfizer Ireland

Pharmaceuticals, Ireland

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1289 BRU14071338P Regro Lotion 5% Minoxidil USP 5% w/vDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019P

1290 BRU14071339P Regro Lotion 3% Minoxidil USP 3% w/vDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019P

1291 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019GSL

1292 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1293 BRU14071342PAxcel Ibuprofen Paediatric

SyrupIbuprofen 100mg/5ml

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

02 July 2014 till 01 July

2019P

1294 BRU14071343P Pharynx LozengesCetylpyridinium Chloride 1.50mg,

Benzocaine 3.33mg

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019GSL

BDMCA/RMP/1215 Page 96 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1295 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mgY.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1296 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mgY.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1297 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1%

w/w)

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1298 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1299 BRU14071348PAtropine Sulphate 1mg/1ml

InjectionAtropine Sulphate 1mg/ml

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1300 BRU14071349P Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5mlDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1301 BRU14071350P Roaccutane Capsules 20mg Isotretinion 20mgR P Scherer GmbH & Co KG.,

Germany

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1302 BRU14071351P Roaccutane Capsule 10mg Isotretinion 10mgR.P. Scherer GmbH & Co.

KG., Germany

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1303 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., CyprusHongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1304 BRU14071353P Salbutamol Injection 0.5mg/mlSalbutamol Sulphate 0.5mg/ml

(equivalent to salbutamol base)

Yung Shin Pharmaceutical

Ind., Co. Ltd., Taichong,

Taiwan

Asterix United (B)

Sdn Bhd

02 July 2014 till 01 July

2019POM

1305 BRU14071354P Glipizide Tablet 5mg Glipizide 5mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1306 BRU14071355PAxcel Dexchlorpheniramine

TabletDexchlorpheniramine 2mg

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

02 July 2014 till 01 July

2019POM

1307 BRU14071356P Phenexpect CD Syrup

Per 5 ml - Diphenhydramine HCl BP

12.5mg; Ammonium Chloride BP 135mg;

Codeine Phosphate BP 5.7mg

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1308 BRU14071357PQuinine Sulphate Tablet

300mgQuinine Sulphate BP 300mg

Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1309 BRU14071358NP20% Glucose Intravenous

Infusion BPGlucose (as monohydrate) 20%

B. Braun Medical Industries

Sdn Bhd Malaysia

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

BDMCA/RMP/1215 Page 97 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1310 BRU14071359PPharmaniaga Spironolactone

Tablet 25mgSpironolactone 25mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

02 July 2014 till 01 July

2019POM

1311 BRU14071360PMaxidex Sterile Opthalmic

SuspensionDexamethasone 0.1% ( 1mg/ml)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1312 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/mlAin Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

02 July 2014 till 01 July

2019POM

1313 BRU14071362PAlphagan Ophthalmic Solution

0.2%

Brimonidine tartrate (anhydrous basis)

2mg/ml

Allergan Pharmaceuticals

Ireland, IrelandMedipharm Sdn Bhd

02 July 2014 till 01 July

2019POM

1314 BRU14071363P Dormicum Injection 15mg/3ml Midazolam 15mg/3ml Cenexi SAS, FranceZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1315 BRU14071364P Dormicum Injection 5mg/5ml Midazolam 5mg/5ml Cenexi SAS, FranceZuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1316 BRU14071365NP

0.18% sodium Chloride and

4.3% Glucose Intravenous

Infusion

0.18% Sodium Chloride 0.18%; Glucose

4.3%

B.Braun Medical Industries

Sdn Bhd., Malaysia

Hongkiat Trading &

Co

02 July 2014 till 01 July

2019POM

1317BRU14071366PS1 &

BRU14071366PS2

Rasilez Film-coated Tablet

150mgAliskiren 150mg (as Hemifumarate)

Novartis Pharma Stein AG,

Switzerland & Novartis

Farma S.p.A., Italy

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1318 BRU14071367P

Invega Sustenna Prolonged

Release Suspension for IM

Injection 150mg/2.25ml

Paliperidone 150mg/2.25ml (as

palmitate 234mg)

Janssen Pharmaceutical NV,

Belgium

Zuellig Pharma Sdn

Bhd

02 July 2014 till 01 July

2019POM

1319 BRU14071368PYondelis® Powder for Injection

1mg/vial Trabectedin 0.05mg/ml

Baxter Oncology GmbH,

Germany

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1320 BRU14071369PTrajenta film-coated tablet

5mgLinagliptin 5mg

Boehringer Ingelhein Roxane

Inc., USA

Hongkiat Trading &

Company

24 July 2014 till 23 July

2019POM

1321 BRU14071370P

Novoseven® 1mg Powder and

Solvent for Solution for

Injection

Eptacog alfa (activated) 1mg/ml

(corresponds to 50KIU/vial) - 1mg/ml

after reconstitution

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd24 July 2014 till 23 July

2019POM

1322 BRU14071371P

NovoSeven 5mg/vial, Powder

and Solvent for Solution for

Injection

Eptacog alfa (activated) 5mg/vial

(corresponds to 250KIU/vial) - 1mg/ml

after reconstitution

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd24 July 2014 till 23 July

2019POM

1323BRU14071372PS1 &

BRU14071372PS2

Invega® Extended-Release

Tablet 9mg

Paliperidone 9mg [Layer 1 - 2.7mg; Layer

2 - 6.3mg]

ALZA Corporation, USA (S1);

Janssen Cilag Manufacturing

L.L.C., Puerto Rico (S2)

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

BDMCA/RMP/1215 Page 98 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1324BRU14071373PS1 &

BRU14071373PS2

Invega® Extended-Release

Tablet 3mg

Paliperidone 3mg [Layer 1 - 0.9mg; Layer

2 - 2.1mg]

ALZA Corporation, USA (S1);

Janssen Cilag Manufacturing

L.L.C., Puerto Rico (S2)

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1325BRU14071374PS1 &

BRU14071374PS2

Invega® Extended-Release

Tablet 6mg

Paliperidone 6mg [Layer 1 - 1.8mg; Layer

2 - 4.2mg]

ALZA Corporation, USA (S1);

Janssen Cilag Manufacturing

L.L.C., Puerto Rico (S2)

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1326 BRU14071375PLucentis 10mg/ml Solution for

InjectionRanibizumab 10mg/ml

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1327 BRU14071376P

Onbrez Breezhaler 150mcg

Inhalation Powder, Hard

Capsule

Indacterol 150mcg (as maleate 194mcg) Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1328 BRU14071377P

Onebrez Breezhaler 300mcg

Inhalation Powder Hard

Capsule

Indacterol 300mcg (as maleate 389mcg) Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1329 BRU14071378PRequip PD 24hr Prolong

Release Tablet 2mgRopinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1330 BRU14071379PDifflam Anti-Inflammatory

Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg;

Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical

Laboratories, India

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019GSL

1331 BRU14071380PVfend Powder For Oral

Suspension 40mg/mlVoriconazole 40mg/ml Pfizer PGM, France

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1332 BRU14071381P

Norditropin® Nordilet®

Solution for Injection

10mg/1.5ml

Somatropin (biosynthetic human growth

hormone) 10mg/1.5mlNovo Nordisk A/S, Denmark Medipharm Sdn Bhd

24 July 2014 till 23 July

2019POM

1333 BRU14071382PAlphagan P Ophthalmic

Solution 0.15%Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd

24 July 2014 till 23 July

2019POM

1334 BRU14071383P Mapenem® IV Injection 500mg Meropenem 500mg (as trihydrate)Siam Bheasach Co. Ltd.,

Thailand

K-Seri Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1335 BRU14071384PCuram Powder for oral

Suspension 312.5mg/5ml

Amoxycillin 250mg (as trihydrate);

Clavulanic Acid 62.5mg (as potassium

salt)

Sandoz GmbH, AustriaZuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1336 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1337 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

BDMCA/RMP/1215 Page 99 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1338 BRU14071387P Kivexa Tablets 600mg/300mgAbacavir 600mg (as sulfate); Lamivudine

300mgGlaxo Operations UK Ltd, UK

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1339 BRU14071388P Lucrin® depot 3.75mg Injection Leuproprelin acetate 3.75mgTakeda Pharmaceutical

Company Limited, Japan

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1340 BRU14071389PLucrin® depot 11.25mg

InjectionLeuproprelin acetate 11.25mg

Takeda Pharmaceutical

Company Limited, Japan

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1341 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mgKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

24 July 2014 till 23 July

2019POM

1342 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mgGlaxosmithkline

Pharmaceuticals SA, Poland

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1343 BRU14071392PInfasurf® (Calfactant)

Intrathecal Suspension

Per ml - Phospholipids 35mg (including

26mg phosphatidycholine of which 16mg

is disaturated phosphatidycholine) and

0.7mg protein (incuding 0.26mg of SP-

B0Calfactant [Calf lung Surfactant Extract

-CLSE]

ONY Inc., USA K-Seri Pharma24 July 2014 till 23 July

2019POM

1344 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin 50mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

24 July 2014 till 23 July

2019P

1345 BRU14071394PDuodart 0.5mg/0.4mg

CapsulesDutasteride 0.5mg; Tamsulosin 0.4mg

Catalent Germany

Schorndorf GmbH, Germany

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1346 BRU14071395PAxcel Metronidazole-400

TabletMetronidazole 400mg

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

24 July 2014 till 23 July

2019POM

1347 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, AustriaZuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1348

BRU14071397PS1 &

BRU14071397PS2 &

BRU14071397PS3

MABTHERA Concentrate for

Solution for Infusion

500mg/50ml

Rituximab 500mg/50ml

Genetech Inc., USA (S1); F.

Hoffmann-LA Roche Ltd,

Switzerland (S2); and Roche

Diagnostics GmbH, Germany

(S3)

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1349 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1350 BRU14071399PVigamox® Ophthalmic Solution

0.5% Moxifloxacin 0.5% (as hydrochloride) Alcon Laboratories, Inc., USA

Hongkiat Trading &

Co

24 July 2014 till 23 July

2019POM

1351 BRU14071400P Cementin Tablet 200mg Cimetidene 200mgDrug Houses of Australia Pte

Ltd, Singapore

G & H Trading

Company

24 July 2014 till 23 July

2019POM

BDMCA/RMP/1215 Page 100 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1352BRU14071401PS1 &

BRU14071401PS2Voltaren Emulgel 1%

Diclofenac diethylamine 1.16g/100g

(equivalent to 1g of diclofenac sodium)

Novartis Pharma

Produktions GmbH,

Germany (S1 for pack size

50g) & Novartis Consumer

Health SA, Switzerland (S2

for pack size 20g)

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019GSL

1353 BRU14071402PImexa Film-Coated Tablet

250mgAzithromycin 250mg (as dihydrate)

Xepa-Soul Pattinson (M) Sdn

Bhd Malaysia

Hongkiat Trading &

Co

24 July 2014 till 23 July

2019POM

1354 BRU14071403P Cymbalta Capsule 60mg Duloxetine 60mg (as hydrochloride)Eli Lilly and Co., USA & Lilly

del Caibe Inc, Puerto Rico

Zuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1355 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;

Ammonium Chloride BP 120mg)

Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

24 July 2014 till 23 July

2019POM

1356 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, MalaysiaG & H Trading

Company

24 July 2014 till 23 July

2019POM

1357 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

24 July 2014 till 23 July

2019POM

1358 BRU14071407P Dhatifen Tablet 1mgKetotifen 1mg (as hydrogen fumarate

1.38mg)

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

24 July 2014 till 23 July

2019POM

1359 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/gY.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 July 2014 till 23 July

2019POM

1360 BRU14071409P Asumalife Syrup 1.38mg/5mlPer 5ml - Ketotifen 1mg (as hydrogen

fumarate 1.38mg)

Y.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 July 2014 till 23 July

2019POM

1361 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mgY.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 July 2014 till 23 July

2019POM

1362 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., SpainZuellig Pharma Sdn

Bhd

24 July 2014 till 23 July

2019POM

1363 BRU14071412NP Zoben Tablet 200mg Albendazole 200mgPharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

24 July 2014 till 23 July

2019P

1364 BRU14071413P Clamentin Injection 600mg

Amoxycillin 500mg (as sodium);

Clavulanic Acid 0.1g (as Clavulanate

potassium)

Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

24 July 2014 till 23 July

2019POM

1365 BRU14071414P Garbose Tablet 50mg Acarbose 50mgY.S.P. Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

24 July 2014 till 23 July

2019POM

BDMCA/RMP/1215 Page 101 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1366 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mgBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

24 July 2014 till 23 July

2019POM

1367 BRU14081416P Sevorane Inhalation Liquid Sevoflurane 100%v/vAesica Queensborough Ltd,

UK

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1368 BRU14081417P Emend Tri-Pack CapsuleEach capsule either contains Aprepitant

80mg or 125mg

Merck Sharp & Dohme Corp.

Australia

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1369 BRU14081418P Protopic Ointment 0.1% Tacrolimus 0.1% (as monohydrate)Astellas Pharma Tech Co.,

Ltd., Japan

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1370BRU14081419PS1 &

BRU14081419PS2

Exforge HCT 10/160/12.5mg

Film-coated tablet

Amlodipine 10mg (as besylate);

Valsartan 160mg; Hydrochlorothiazide

12.5mg

Novartis Pharma Stein AG,

Switzerland (S1) & Novartis

Farmaceutica SA, Barcelona,

Spain (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1371BRU14081420PS1 &

BRU14081420PS2

Exforge HCT 10/160/25mg Film-

coated tablet

Amlodipine 10mg (as besylate);

Valsartan 160mg; Hydrochlorothiazide

25mg

Novartis Pharma Stein AG,

Switzerland (S1) & Novartis

Farmaceutica SA, Barcelona,

Spain (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1372BRU14081421PS1 &

BRU14081421PS2

Exforge HCT 5/160/12.5mg

Film-coated tablet

Amlodipine 5mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 12.5mg

Novartis Pharma Stein AG,

Switzerland (S1) & Novartis

Farmaceutica SA, Barcelona,

Spain (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1373BRU14081422PS1 &

BRU14081422PS2

Exforge HCT 5/160/25mg Film-

coated tablet

Amlodipine 5mg (as besylate); Valsartan

160mg; Hydrochlorothiazide 25mg

Novartis Pharma Stein AG,

Switzerland (S1) & Novartis

Farmaceutica SA, Barcelona,

Spain (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1374BRU14081423PS1 &

BRU14081423PS2

Exforge HCT 10/320/25mg Film-

coated tablet

Amlodipine 10mg (as besylate);

Valsartan 320mg; Hydrochlorothiazide

25mg

Novartis Pharma Stein AG,

Switzerland (S1) & Novartis

Farmaceutica SA, Barcelona,

Spain (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1375 BRU14081424PLuveris for Injection 75IU/Vial

(Revised Formula)

Lutropin alfa 75IU (Recombinant Human

Lutenising Hormone)

Merck Serono SA.,

Switzerland

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1376 BRU14081425PLipanthyl Penta 145 Film-

Coated tabletFenofibrate 145mg Recipharm Fontaine, France

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1377 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mgBeacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 August 2014 till 29

August 2019POM

1378 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mg\cg GlaxoWellcome S.A., SpainZuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

BDMCA/RMP/1215 Page 102 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1379BRU14081428PS1

BRU14081428PS2JanumetTM Tablet

50mg/850mg

Sitagliptin 50mg (as phosphate);

Metformin HCl 850mg

Patheon Puerto Rico, Inc.,

Manati, PR 00674, Puerto

Rico (S1) & Aesica

Queensborough Limited, UK

(S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1380BRU14081429PS1

BRU14081429PS2JanumetTM Tablet

50mg/500mg

Sitagliptin 50mg (as phosphate);

Metformin HCl 500mg

Patheon Puerto Rico, Inc.,

Manati, PR 00674, Puerto

Rico (S1) & Aesica

Queensborough Limited, UK

(S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1381BRU14081430PS1

BRU14081430PS2JanumetTM Tablet

50mg/1000mg

Sitagliptin 50mg (as phosphate);

Metformin HCl 1000mg

Patheon Puerto Rico Inc.,

Manati, Puerto Rico (S1) &

Aesica Queensborough

Limited, UK (S2)

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1382 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1383

BRU14081432PS1 &

BRU14081432PS2 &

BRU14081432PS3

Mabthera Concentrate for

Solution for Infusion

100mg/10ml

Rituximab 100mg/10ml

Genetech Inc., USA; F

Hoffmann-LA Roche Ltd,

Switzerland; Roche

Diagnostics GmbH, Germany

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1384 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vialPharmacia & Upjohn

Company, USA

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1385 BRU14081434P Moxiclav 1G Tablet

Amoxycillin 875mg (as sodium);

Clavulanic Acid 125mg (as Clavulanate

potassium)

Medochemie Ltd., CyprusHongkiat Trading &

Co

30 August 2014 till 29

August 2019POM

1386 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate)Lek Pharmaceuticals D.D.,

Slovenia

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1387 BRU14081436P Dilatrend Tablet 25mg Carvedilol 25mg Roche S.p.A., ItalyZuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1388 BRU14081437P Dilatrend Tablet 12.5mg Carvedilol 12.5mg Roche S.p.A., ItalyZuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1389 BRU14081438P Dilatrend Tablet 6.25mg Carvedilol 6.25mg Roche S.p.A., ItalyZuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1390 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, MalaysiaG & H Trading

Company

30 August 2014 till 29

August 2019POM

1391 BRU14081440PNaphcon-A Sterile Ophthalmic

Solution

Naphazoline Hydrochloride 0025%;

Pheniramine maleate 0.3%

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

30 August 2014 till 29

August 2019P

BDMCA/RMP/1215 Page 103 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1392 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mgGlaxosmithkline

Pharmaceuticals SA, Poland

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1393 BRU14081442P Axcel Loratadine Tablet Loratadine 10mgKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 August 2014 till 29

August 2019P

1394 BRU14081443NP Neuroxel Tablet

Thiamine Mononitrate 100mg;

Pyridoxine HCl 200mg; Cynocobalamin

200mcg

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019P

1395 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1396 BRU14081445P

Buventhol Easyhaler

100mcg/dose inhalation

powder

Salbutamol sulphate 100mcg/actuation

(delivered dose 90mcg/actuation)Orion Corporation, Finland

Hongkiat Trading &

Co

30 August 2014 till 29

August 2019POM

1397 BRU14081446P

Buventhol Easyhaler

200mcg/dose inhalation

powder

Salbutamol sulphate 300mcg/actuation

(delivered dose 180mcg/actuation)Orion Corporation, Finland

Hongkiat Trading &

Co

30 August 2014 till 29

August 2019POM

1398 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate)Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 August 2014 till 29

August 2019POM

1399 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mgBiosis Pharmaceuticals Sdn

Bhd., Malaysia

K-Seri Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1400 BRU14081449PMircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-epoetin

Beta 75mcg/0.3ml

Roche Diagnostics GmbH,

Germany

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1401 BRU14081450P Creobic (New Formula) Cream Clotrimazole 1%w/wKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 August 2014 till 29

August 2019GSL

1402 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5mlKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 August 2014 till 29

August 2019P

1403 BRU14081452P Tinacort CreamMiconazole nitrate 2%w/w;

Hydrocortisone 1.0% w/wHovid Bhd, Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1404 BRU14081453P Sunex Cough Syrup

Per 5ml - Diphenhydramine HCl 14mg;

Ammonium chloride 135mg; Sodium/

Trisodium citrate 57.5mg

Sunward Pharmaceutical

Sdn Bhd Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1405 BRU14081454P Loxof Tablets 500mg Levofloxacin 500mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1406 BRU14081455PProluton Depot 250mg

InjectionHydroxyprogesterone Caproate 250mg

Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

BDMCA/RMP/1215 Page 104 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1407 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019P

1408 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5mlKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

30 August 2014 till 29

August 2019POM

1409 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mgY.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 August 2014 till 29

August 2019POM

1410 BRU14081459PClamentin Powder for Syrup

31.25mg/ml

Per ml - Amoxycillin 25mg (as trihydrate);

Clavulanic acid 6.25mg (as potassium

salt)

Yung Shin Pharmaceutical

Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

30 August 2014 till 29

August 2019POM

1411 BRU14081460PClarimycin Film Coated Tablet

500mgClarithromycin 500mg

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 August 2014 till 29

August 2019POM

1412 BRU14081461NP Mentar ShampooCoal Tar solution 9% v/v; Menthol 1%

w/w

HOE Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019GSL

1413 BRU14081462NP Menzza CreamMethyl Salicylate 25%w/w; Menthol

5%w/w

Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019GSL

1414 BRU14081463P Difnal OD Tablet 100mg Diclofenac Sodium 100mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1415 BRU14081464PHumulin N Injection 100IU/ml

(Catridges)

Human Insulin 100IU/ml (recombinant

DNA oigin)Lilly France SAS, France

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1416 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid)PT Bayer Indonesia, East

Jakarta

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019GSL

1417 BRU14081466P Doridone Tablet 10mg Domperidone 10mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1418 BRU14081467PTobradex® Eye Drops

SuspensionTobramycin 0.3%; Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

30 August 2014 till 29

August 2019POM

1419 BRU14081468NPFerrous Fumarate Tablet

200mg

Ferrous fumarate 200mg (equivalent to

65mg of elemental iron)

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019GSL

1420 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg)Teva Pharmaceutical

Industries Ltd, Israel

K-Seri Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1421 BRU14081470PRotaqor 10mg film-coated

tabletAtorvastatin 10mg (as calcium)

Lek Pharmaceuticals D.D.,

Slovenia

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1422 BRU14081471P Zoral 200 tablet 200mg Acyclovir USP 200mgDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 August 2014 till 29

August 2019POM

BDMCA/RMP/1215 Page 105 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1423 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate)Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019POM

1424 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, MalaysiaG & H Trading

Company

30 August 2014 till 29

August 2019POM

1425 BRU14081474P Strepsils Max Plus Lozenges

2,4 Dichlorobenzyl alcohol 1.2mg;

amymetacresol 0.6mg; Lignocaine

Hydrochloride 10mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019GSL

1426 BRU14081475P Cera-Scalp OintmentCoal Tar solution 12% w/w; Salicylic acid

2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

30 August 2014 till 29

August 2019GSL

1427 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate)Lek Pharmaceuticals DD.,

Slovenia

Zuellig Pharma Sdn

Bhd

30 August 2014 till 29

August 2019POM

1428BRU14091477P Suprane Inhalation Liquid

100%

Desflurane 100% Baxter Healthcare

Corporation, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1429BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

P

1430

BRU14091479PS1;

BRU14091479PS2

Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH,

Germany (S1); Pierre Fabre

Medicament Production,

France (S2)

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1431BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline

Manufacturing S.p.A., Italy

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1432BRU14091481P Xolair Powder and Solvent for

Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1433BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1434BRU14091483P Penegesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1435BRU14091486P Crinone Progestrone Vaginal

Gel 8%

Progestrone 8% Fleet Laboratories Ltd,

United Kingdom

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

BDMCA/RMP/1215 Page 106 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1436BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty

Ltd., Australia

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

GSL

1437BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd.,

Thailand

K-Seri Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1438BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

POM

1439BRU14091490P Trileptal 600mg Film-coated

Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1440BRU14091491P Binozyt 500mg film-coated

tablet

Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd.,

Bangladesh

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1441

BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

P

1442BRU14091493P Recormon Pre-filled Syringe

30,000Iu/0.6ml

Epoetin beta 30,000 IU/0.6ml Roche Diagnostics GmbH,

Germany

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1443BRU14091494P Eprex® 10000 Prefilled Syringes

10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1444BRU14091495P Metformin Tablet 250mg Metformin Hydrochloride 250mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1445BRU14091496P Hydrochlorothiazide Tablet

50mg

Hydrochlorothiazide BP 50mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1446BRU14091497P Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1447BRU14091498P Difenac Tablet 25mg Diclofenac (as Sodium) 25mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

BDMCA/RMP/1215 Page 107 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1448BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

POM

1449BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

p

1450BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

POM

1451BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride

2.8mg)

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

POM

1452

BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

p

1453BRU14091506P Rhiniramine Syrup 2mg/5ml Dexchlorpheniramine maleate BP

2mg/5ml

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1454BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1455BRU14091508P Glucagen® 1mg Powder and

Solvent for Solution for

Injection

Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 30 September 2014 till

29 September 2019

POM

1456BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

p

1457BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1458BRU14091511NP 0.9% Sodium Chloride

Injection, B.P. (10ml)

Sodium Chloride 0.9% B. Braun Medical Industries

Sdn Bhd Malaysia

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

GSL

1459

BRU14091512NP Compound Sodium Lactate

Intravenous Infusion B.P.

(Hartmann's Solution)

Per 1000ml contains: Sodium Chloride

6g; Sodium Lactate solution 6.24g (50%

w/w); Potassium Chloride 0.40g; Calcium

Chloride dehydrate 0.27g

B. Braun Medical Industries

Sdn Bhd Malaysia

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

POM

BDMCA/RMP/1215 Page 108 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1460BRU14091513P HBVaxPro® 5mcg/0.5ml

Injection

Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme

Corp., West Point,

Pensylvania, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1461BRU14091514P HBVaxPro® 10mcg/1.0ml

Injection

Hepatitis B surface Antigen 10mcg/1.0ml Merck Sharp & Dohme

Corp., West Point,

Pensylvania, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1462BRU14091515P HBvaxPro® 40mcg/1.0ml

Injection

Hepatitis B surface Antigen 40mcg/1.0ml Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1463BRU14091516P Emthexate 2.5mg Tablet Methotrexate 2.5mg (as disodium) Teva Czech Industries S.R.O.,

Czech Republic

K-Seri Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1464BRU14091517P Stalevo 125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa 31.25mg,

Entacapone 200mg

Baxter Bioscience

Manufacturing Sarl,

Switzerland

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1465BRU14091518P Axcel Dextromethorphan-30

Syrup

Dextromethorphan Hydrobromide

30mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 September 2014 till

29 September 2019

POM

1466BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1467

BRU14091520P Renacid K8 Each 1 Litre contains: Sodium Chloride

161.43g, Potassium Chloride 5.49g,

Calcium Chloride 2H2O 6.77g,

Magnesium Chloride 6H2O 3.74g, Glacial

acetic acid 8.85g

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

30 September 2014 till

29 September 2019

POM

1468BRU14091521P Ospexin 500mg Film-coated

Tablets

Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1469BRU14091522PS1 &

BRU14091522PS2

Androcur Tablet 50mg Cyproterone acetate 50mg Delpharm Lille SAS, France Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1470BRU14091523P Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

30 September 2014 till

29 September 2019

GSL

1471BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

P

BDMCA/RMP/1215 Page 109 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1472BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc.,

Hungary

K-Seri Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1473BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

POM

1474BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

P

1475BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate

300mg/15ml

Pfizer (Perth) Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1476

BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol

0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

30 September 2014 till

29 September 2019

GSL

1477

BRU14091530NP Strepsils Sugar Free Lemon

Lozenges

Each lozenge contains: Amymetacresol

0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

30 September 2014 till

29 September 2019

GSL

1478BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl estradiol

30mcg

Haupt Pharma Munster

GmbH., Germany

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1479

BRU14091532P Primocal Solution Per Litre: Sodium 140mmol, Magnesium

0.5mmol, Lactate 3mmol, Bicarbonate

32mmol, Chloride 106mmol

Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd 30 September 2014 till

29 September 2019

POM

1480BRU14091533P Ansures Extended Release

Tablet 500mg

Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co.

Ltd., Taiwan

G & H Trading

Company

30 September 2014 till

29 September 2019

POM

1481BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

BDMCA/RMP/1215 Page 110 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1482

BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%] 857.13mg

(equivalent to Phosphatidylcholine

300mg), Di-alpha-tocopheryl acetate

10mg, Thiamine mononitrate 10mg,

Riboflavin 6mg, Pyridoxine hydrochloride

10mg, Vitamin B12 0.1% WS 15mg

(equivalent to Vitamin B12 0.015mg),

Nicotinamide 30mg.

Mega Lifesciences Public

Company Limited, Thailand

Hongkiat Trading &

Co

30 September 2014 till

29 September 2019

GSL

1483BRU14091536NP Pharmaniaga Aqueous Cream White Soft Paraffin 15%, Emulsifying Wax

9%, Liquid Paraffin 6%

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

30 September 2014 till

29 September 2019

GSL

1484BRU14091537P Synagis 100mg Powder and

Solvent for Solution for

Injection

Palivizumab 100mg Boehringer Ingelheim

Pharma KG, Germany

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1485BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium), Clavulanic

acid 0.2g (as clavulanate potassium)

Yung Shin Phamaceutical

Ind. Co Ltd, Taiwan, ROC

Asterix United (B)

Sdn Bhd

30 September 2014 till

29 September 2019

POM

1486

BRU14091539P ZmaxTM Extended-Release

Granules for Oral Suspension

2g

Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC

Vega Baja, Puerto Rico

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1487BRU14091540P Eturion 10mg Film Coated

Tablet

Atorvastatin 10mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC,

Puerto Rico

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1488BRU14091541P Eturion 20mg Film Coated

Tablet

Atorvastatin 20mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1489BRU14091542P Eturion 40mg Film Coated

Tablet

Atorvastatin 40mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceutical LLC,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1490BRU14091543P Eturion 80mg Film Coated

Tablet

Atorvastatin 80mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

30 September 2014 till

29 September 2019

POM

1491BRU14111544P

(vial)

EYLEA Solution for Injection

(vial)

Aflibercept 40mg/ml Regeneron Pharmaceuticals

Inc., New York, USA

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

BDMCA/RMP/1215 Page 111 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1492BRU14111545P EYLEA Solution for Injection

(pre-filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals

Inc., New York, USA

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1493BRU14111546P Binocrit Solution for Injection

2000 IU/ml in Pre-filled Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH,

Germany

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1494BRU14111547P Binocrit Solution for Injection

4000 IU/0.4ml in Pre-filled

Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH,

Germany

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1495BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL.,

Italy

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1496BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1497BRU14111550P Advagraf Prolonged Release

Hard Capsule 0.5mg

Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd.,

Ireland

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1498BRU14111551P Advagraf Prolonged Release

Hard Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd.,

Ireland

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1499BRU14111552P Advagraf Prolonged Release

Hard Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd.,

Ireland

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1500BRU14111553P Dynastat Powder and Solvent

for Solution for Injection 40mg

Parecoxib (as Sodium) 40mg Pharmacia & Upjohn

Company, USA

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1501BRU14111554P Invanz Powder for Injection

1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp &

Dohme-Chibret, France

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1502

BRU14111555P Humalog Mix25 100 units/ml

Kwikpen

Insulin Lispro 100IU/ml [In the

proportion of 25% Insulin Lisporo & 75%

Insulin Lispro Protamine Suspension

(rDNA origin)

Lilly France SAS, France Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1503BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

POM

1504BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

01 November 2014 till

31 October 2019

GSL

1505BRU14111558P Trileptal Film-coated Tablets

300mg

Oxcarbazepine 300mg Novartis Pharma S.p.A., Italy Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1506BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium

Bicarbonate 1.737g; Citric Acid

(anhydrous) 1.223g.

Bayer de Mexico SA De CV,

Mexico

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

GSL

1507BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g (1%w/w) Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

GSL

BDMCA/RMP/1215 Page 112 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1508

BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

01 November 2014 till

31 October 2019

GSL

1509

BRU14111562NP Strepsils Orange with Vitamin C

Lozenges

Amylmetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg; Ascorbic

Acid 33.5mg; Sodium Ascorbate 74.9mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

01 November 2014 till

31 October 2019

GSL

1510BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg; ethinylestradiol

20mcg

Haupt Pharma Munster

GmbH., Germany

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1511BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 01 November 2014 till

31 October 2019

POM

1512BRU14111565P NIMBEXTM Injection 2mg/ml

(5ml)

Cisatracurium Besylate 10mg/5ml GLaxoSmithKline

Manufacturing S.p.A., Italy

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1513

BRU14111566P Aggrastat Concentrate for

Infusion 0.25mg/ml

Tirofibon 0.25mg/ml (as hydrochloride

monohydrate 0.281mg/ml)

DSM Pharmaceuticals Inc.,

USA & Orion Corporation,

Espoo, Finland

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1514BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

POM

1515BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

POM

1516BRU14111569P Ferinject® 50mg Iron/ml

solution for Injection/Infusion

Iron 50mg/ml (as ferric carboxymaltose) BIPSO GmbH, Germany K-Seri Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1517BRU14111570P Olmetec Plus 20/12.5mg Film-

coated Tablet

Olmesartan Medoxomil 20mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1518BRU14111571P Norfox 400 Tablet Norfloxacin 400mg The United Drug (1966) Co.

Ltd., Thailand

K-Seri Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1519

BRU14111572P Rotateq® Rotavirus Vaccine,

Live, Oral, Pentavalent

Human-bovine Rotavirus G1 ≥ 2.2 x

106IU; Human-bovine Rotavirus G2 ≥ 2.8

x 106IU; Human-bovine Rotavirus G3 ≥

2.2 x 106IU; Human-bovine Rotavirus G4

≥ 2.0 x 106IU; Human-bovine Rotavirus

P1 ≥ 2.3 x 106IU

Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

BDMCA/RMP/1215 Page 113 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1520BRU14111573P Eliquis Film-coated Tablets

2.5mg

Apixaban 2.5mg Bristol-Myers Squibb

Manufacturing Company,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1521BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

POM

1522BRU14111575P Ryzodeg Flex Touch 100

units/ml

Per 1 ml: Insulin Degludec 70%; Insulin

Aspart 30%

Novo Nordisk A/S, Denmark Medipharm Sdn Bhd 01 November 2014 till

31 October 2019

POM

1523BRU14111576NP Folic Acid Tablets 5mg Folic Acid BP 5mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

01 November 2014 till

31 October 2019

GSL

1524BRU14111577NP Dettol Antiseptic Germicide

Liquid

Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser

Indonesia

Syarikat Aliaa Sdn

Bhd

01 November 2014 till

31 October 2019

GSL

1525BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1526BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

POM

1527BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn.

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

01 November 2014 till

31 October 2019

POM

1528

BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-Arginine

4.1g; L-Aspartic Acid 4.1g; L-Cysteine / L-

Cystine 1g; L-Glutamic Acid 7.1g; Glycine

(Amino Acetic Acid) 2.1g; L-Histidine

2.1g; L-Isoleucine3.1g; L-Leucine 7g; L-

Lysine 5.6g; L-Methionine 1.3g; L-

Phenylalanine 2.7g; L-Proline 5.6g; L-

Serine 3.8g; Taurine 300mg; L-Threonine

3.6g; L-Tryptophan 1.4g; L-Tyrosine

500mg; L-Valine 3.6g

Fresenius Kabi Austria

GmbH, Austria

Zuellig Pharma Sdn

Bhd

01 November 2014 till

31 October 2019

P

1529BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

01 November 2014 till

31 October 2019

POM

1530

BRU14111583NP Oralite Natural Oral

Rehydration Salts

Per 4.92g sachet: Glucose anhydrous

3.24g; Sodium Chloride 0.624g;

Trisodium citrate dihydrate 0.696g;

Potassium Chloride 0.36g

Royce Pharma

Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales &

Services

01 November 2014 till

31 October 2019

GSL

BDMCA/RMP/1215 Page 114 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1531BRU14111584NP Panamol Forte Suspension

250mg/5ml

Paracetamol 250mg/5ml Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

01 November 2014 till

31 October 2019

GSL

1532

BRU14111585PS1,

BRU14111585PS2,

BRU14111585PS3,

BRU14111585PS4

Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised anti-

VEGF monoclonal antibody)

Genentech Inc., USA (S1); F-

Hoffman-La Roche Ltd,

Basel, Switzerland (S2);

Roche Diagnostics GmbH,

Manheim, Germany (S3); F

Hoffmann-La Roche Ltd,

Kaiseraugst, Switzerland (S4)

Medicare 01 November 2014 till

31 October 2019

POM

1533BRU14111586P Zyvox 20mg/ml Granules For

Oral Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC,

USA

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1534BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1535BRU14111588P Humulin R Injection 100IU/ml

(Catridges)

Human Insulin (Recombinant DNA origin)

100IU/ml

Lilly France SAS, France Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1536BRU14111589P Resolor film-coated tablet 1mg Prucalopride 1mg (as succinate 1.321mg) Janssen-Cilag SpA., Italy Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1537

BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-

polymaltose Complex); Folic acid 0.35mg

Vifor S.A., Switzerland &

Iberfar-Industria

Farmacetutica S.A.,

Barcelona, Portugal

Medipharm Sdn Bhd 19 May 2015 till 18

May 2020

GSL

1538BRU14111591P Pristiq 50mg Extended-Release

Tablets

Desvenlafaxine 50mg (as succinate

75.87mg)

Pfizer Ireland

Pharmaceuticals, Ireland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1539BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb

Manufacturing Company,

Puerto Rico, USA

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1540BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as Mono HCl

10.5mg)

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1541BRU14111594P Rocephin for Injection 1g IV Ceftriaxone 1g F.Hoffmann-La Roche Ltd.,

Basel, Switzerland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1542BRU14111595P Advate 250 IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII) 250 IU

Baxter Bioscience

Manufacturing Sarl,

Switzerland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1543BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 115 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1544BRU14111597NP 0.45% Sodium Chloride and 5%

Dextrose Intravenous Infusion

B.P

Per 1L - Sodium Chloride 4.5g; Glucose

anhdyrous 50g (as monohydrate 55g)

B.Braun Medical Industries

Sdn Bhd., Malaysia

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1545

BRU14111598P Gonal-F 1050IU/1.75ml

(77mcg/1.75ml) Powder and

Solution for Injection

Per Pen (1.75ml) - Follitropin Alfa 1050IU

(equivalent 77mcg) [Per ml of solution

contains 600IU Follitropin alfa ~ 44mcg]

Merck Serono S.p.A., Italy &

Merck Serono S.A.,

Switzerland

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1546BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1547BRU14111600P Cardiol Tablet 25mg Carvedilol 25mg Yung Shin Pharmaceutical

Ind. Co. Ltd., Taiwan

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1548BRU14111601NP T3 Pimple Gel Rescorcinol 2% w/w HOE Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1549

BRU14111602NP BSS® (Balanced Salt Solution)

Sterile Irrigation Solution

Per 1L - Sodium Chloride 6.4g; Potassium

Chloride 0.75g; Calcium Chloride,

dehydrate 0.48; Magnesium Chloride,

hexahydrate 0.3; Sodium Citrate,

dehydrate 1.7; Sodium acetate,

trihydrate 3.9

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

GSL

1550BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1551BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

GSL

1552BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd.,

Thailand

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1553

BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020

GSL

1554BRU14111607NP Sodium Bicarbonate 8.4% w/v

Injection (10ml glass ampoule)

Sodium Bicarbonate 8.4%w/v (84mg/ml) Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1555BRU14111608P Binozyt 200mg/5ml Powder for

Oral Suspension

Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 116 of 143

Page 117: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1556

BRU14111609NP Renacid K4 Per Litre - Sodium Chloride BP 161.43g;

Potassium Chloride BP 5.49g; Calcium

Chloride 2H2O BP 9.75g; Magnesium

Chloride 6H2O BP 3.74g; Gacial Acetic

Acid BP 8.85g

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

19 May 2015 till 18

May 2020

POM

1557BRU14111610NP Renacarb K2 Per Litre - Sodium Chloride BP 30.5g;

Sodium Bicarbonate BP 66.0g

Ain Medicare Sdn Bhd

Malaysia

Syarikat Pakatan

Indah

19 May 2015 till 18

May 2020

POM

1558BRU14111611P Kogrel 75mg Film Coated

Tablet

Clopidogrel 75mg (as bisulfate

97.875mg)

Sandoz Private Limited,

Mumbai, India

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1559BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals,

Pte ltd, Singapore

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

P

1560BRU14111613P Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1561BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1562BRU14111615P Curam 156.25mg/5ml Powder

for Oral Suspension

Per 5ml - Amoxycillin 125mg (as

trihydrate); Clavulanic acid 31.25mg

Sandoz GmbH, Austria Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1563BRU14111616P Exjade Dispersible Tablet

250mg

Deferasirox 250mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1564BRU14111617P Nospan Tablet 30mg Dextromethorphan Hydrobromide 30mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1565

BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020

GSL

1566BRU14111619P Crixan Tablet 250mg Clarithromycin 250mg Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1567BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1568BRU14111621P Brozil Film coated Tablet

600mg

Gemfibrozil 600mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1569BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine 65mg Sterling Drug (Malaya) Sdn

Bhd, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18

May 2020

GSL

1570BRU14111623P Botox (Botulinium Toxin, Type

A) Injection 100units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex

100Units/vial

Allergan Pharmaceuticals

Ireland, Ireland

Medipharm Sdn Bhd 19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 117 of 143

Page 118: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1571BRU14111624P Botox (Botulinium Toxin, Type

A) Injection 50units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex

50Units/vial

Allergan Pharmaceuticals

Ireland, Ireland

Medipharm Sdn Bhd 19 May 2015 till 18

May 2020

POM

1572BRU14111625P Botox (Botulinium Toxin, Type

A) Injection 200units/vial

Clostridium Botulinum Toxin Type A

Purified Neurotoxin Complex

200Units/vial

Allergan Pharmaceuticals

Ireland, Ireland

Medipharm Sdn Bhd 19 May 2015 till 18

May 2020

POM

1573BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1574BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Medicare 19 May 2015 till 18

May 2020

POM

1575BRU14111628NP 0.45% Sodium Chloride

Intravenous Infusion B.P

Sodium Chloride 0.45% B.Braun Medical Industries

Sdn Bhd., Malaysia

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

P

1576BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1577BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1578

BRU14111631P Peditrace Concentrate for

Solution for Infusion

Per 1ml - Zinc Chloride 521mcg; Copper

Chloride 2H2O 53.7mcg; Manganese

Chloride 4H2O 3.60mcg; Sodium Selenite

anhydrous 4.38mcg; Sodium Fluoride

126mcg; Potassium Iodide 1.31mcg

Fresenius Kabo Nolge AS,

Norway

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1579BRU14111632P Axcel Orlistat 120 Tablet Orlistat 120mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1580BRU14111633P Pharmaniaga Salbutamol

Respirator Solution 0.5%w/v

Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1581BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1582BRU14111635NP Aqueous Cream Emulsifying wax 9.0%w/w; White Soft

Paraffin 15% w/w; Liquid Paraffin 6.0%

w/w

Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1583BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1584BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

GSL

1585BRU14111638P Primovists 0.25mmol/ml

solution for injection

Gadoxetic acid, Sodium 0.25mmol/ml Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 118 of 143

Page 119: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1586BRU14111639P Servidipine 30mg Film-coated

Tablets

Nifedipine 30mg Lek Pharmaceuticals D.D.,

Slovenia

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1587BRU14111640P Servidipine 60mg Film-coated

Tablets

Nifedipine 60mg Lek Pharmaceuticals D.D.,

Slovenia

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1588BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1589BRU14111642P Manace Injection 5mg/ml

(Haloperidol 5mg/ml)

Haloperidol 5mg/ml Duopharma (M) Sdn Bhd

Malaysia

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1590BRU14111643NP Woodward's Gripe Water

(Alcohol Free)

Per 5ml - Terpeneless Dill Seed Oil

2.3mg; Sodium Bicarbonate 52.5mg

IDS Manufacturing Sdn Bhd,

Malaysia

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020

GSL

1591BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co.

Ltd., Taiwan

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1592BRU14111645P Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1593

BRU14111646NP Oralite Orange Oral

Rehydration Salts

Per 4.95g - Glucose anhydrous 3.24g;

Sodium Chloride 0.624g; Trisodium

citrate dihydrate 0.696g; Potassium

Chloride 0.36g

Royce Pharma

Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales &

Services

19 May 2015 till 18

May 2020

GSL

1594BRU14111647P Vesyca Film Coated Tablet

150mg

Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1595BRU14111648P Pharmaniaga Cetirizine 10mg

tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

P

1596BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1597BRU14111650P Invokana Film-coated Tablet

100mg

Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1598BRU14111651P Axcel Chlorpheniramine-2

Syrup

Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

P

1599BRU14111652P Binozyt Film-Coated Tablet

250mg

Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd.,

Bangladesh

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1600BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1601BRU14111654NP Paracetamol Kabi Solution for

infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Germany

AB ii) Fresenius Kabi Austria

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1602BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV,

Belgium

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 119 of 143

Page 120: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1603BRU14111656P Visudyne Injection Verteprofin 15mg JHP Pharmaceuticals LLC,

United States

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1604 BRU14121657PRasilez® HCT 150/12.5mg Film-

Coated Tablet

Aliskiren (as hemifumarate) 150mg and

hydrochlorothiazide 12.5mg

Novartis Farma S.p.A. Via

Provinciale Schito 131 80058

Torre Annunziata Italy

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1605 BRU14121658PRasilez® HCT 300/12.5mg Film-

Coated Tablet

Aliskiren (as hemifumarate) 300mg and

hydrochlorothiazide 12.5mg

Novartis Farma S.p.A. Via

Provinciale Schito 131 80058

Torre Annunziata Italy

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1606 BRU14121659PRasilez® HCT 150/25mg Film-

Coated Tablet

Aliskiren (as hemifumarate) 150mg and

hydrochlorothiazide 25mg

Novartis Farma S.p.A. Via

Provinciale Schito 131 80058

Torre Annunziata Italy

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1607 BRU14121660PRasilez HCT 300/25mg Film-

coated Tablet

Aliskiren (as hemifumarate) 300mg and

hydrochlorothiazide 25mg

Novartis Farma S.p.A. Via

Provinciale Schito 131 80058

Torre Annunziata Italy

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1608 BRU14121661P Kastipron Tablet 375mgS-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1609 BRU14121662P Ipolipid Capsules 300mgGemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1610 BRU14121663PCuram 625mg Film-coated

TabletAmoxicillin 500mg; Clavulanic acid as

potassium salt 125mg

Sandoz GmbH, Austria Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1611 BRU14121664P Vesyca Injection 25mg/mlRanitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical

Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1612 BRU14121665PDoribax Powder for Injection

500mgDoripenem monohydrate 500mg Shionogi Kanegasaki Plant,

Japan

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1613 BRU14121666P Amoxicap 500 CapsuleAmoxicillin (as trihydrate 574mg) 500mg Hovid Bhd, Malaysia G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1614 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w; Menthol

2.3% w/w and Cmaphor 4.0% w/w

Hovid Bhd, Malaysia G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1615 BRU14121668NP50% Glucose Intravenous

Infusion B.P.

Glucose monohydrate (550.00g) eq. to

anhydrous glucose 500.0g/1000ml

B.Braun Medical Industries

Sdn Bhd., Malaysia

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 120 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1616 BRU14121669P Visanne 2mg Tablet

Dienogest 2mg Bayer Weimar GmbH und.

Co. KG., Dobereinesrtr. 20, D-

99427, Weimar, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1617 BRU14121670P Medoflucon Capsule 150mgFluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1618 BRU14121671P Topamax 100 Tablets 100mgTopiramate 100mg Cilag AG, Switzerland Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1619 BRU14121672NPDuratears Ocular Lubricant

Ointment

Mineral Oil 30.0mg/g, Anhydrous liquid

lanolin 30.0mg/g and white petrolatum

q.s. ad 1g

S.A. Alcon-Couvreur N.V.,

Belgium

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

GSL

1620 BRU14121673PEprex® 40,000 Prefilled

Syringes 40,000iu/1ml

Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung

GmbH & Co. KG, Germany;

Cilag AG, Switzerland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1621 BRU14121674P Milosec Capsule 20mgOmeprazole 20mg The United Drug (1966) Co.

Ltd., Thailand

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1622 BRU14121675P Ziagen Oral SolutionAbacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc.,

Canada

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1623 BRU14121676P Minulet 21 TabletGestodene 75mcg; ethinylestradiol

30mcg

Haupt Pharma Munster

GmbH., Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1624 BRU14121677PPataday Olopatadine

Ophthalmic Solution 0.2%Olopatadine hydrochloride 2.22mg (eq.

to Olopatadine 2mg (0.2%)

Alcon Laboratories, Inc., USA Hongkiat Trading &

Co

19 May 2015 till 18

May 2020

POM

1625 BRU14121678P Provironum Tablet 25mgMesterolone 25mg Schering Do Brasil Quimica e

Farmaceutica Ltda., San

Paulo-SP, Brazil

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1626 BRU14121681NPStrepsils Strawberry Sugar Free

Children

Amylmetacresol 0.6mg; 2.4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

International Limited, UK

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020

GSL

1627 BRU14121682PAxcel Sodium Fusidate 250

TabletSodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1628 BRU14121683P Pencor 1mg tabletDoxazosin Mesylate (eq. to Doxazosin

1mg)

Unison Laboratories Co.,

Ltd, Thailand

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1629 BRU14121684P Pencor 2mg tabletDoxazosin Mesylate (eq. to Doxazosin

2mg)

Unison Laboratories Co.,

Ltd, Thailand

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1630 BRU14121685P Pencor 4 TabletDoxazosin Mesylate (eq. to Doxazosin

4mg)

Unison Laboratories Co.,

Ltd, Thailand

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1631 BRU14121686P Decan Injection 2mg/mlDexamethasone Sodium Phosphate

2.2mg (eq. to Dexamethasone Phosphate

2mg)

Yung Shin Pharmaceutical

Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 121 of 143

Page 122: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1632 BRU14121687P Primodil-10 TabletAmlodipine Besilate 13.87mg (eq. to

Amlodipine 10mg)

Medley Pharmaceuticals

Limited, India

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1633 BRU14121688P Cuvarlix Capsule 120mgOrlistat 120mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1634 BRU14121689NP Calcium Lactate 300mg tabletCalcium lactate 300mg Drug Houses of Australia Pte

Ltd., Singapore

G & H Trading

Company

19 May 2015 till 18

May 2020

P

1635 BRU14121690P Seladin 500mg tabletNaproxen 500mg Y.S.P. Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1636 BRU14121691P Driminate 50mg SuppositoryDimenhydrinate 50mg Y.S.P. Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

P

1637 BRU14121692NPHurix's Panau Salap &Gatal-

Gatal Kecil

Zinc oxide 5% w/w; Menthol 1% w/w;

Salicylic Acid/2-Hydroxybenzoic acid 5%

w/w & Camphor 3% w/w

Dynapharm (M) Sdn Bhd,

Malaysia

Yuh Hua Trading

Company

19 May 2015 till 18

May 2020

GSL

1638 BRU14121693NPHurix Corn Rid Solution 5%

w/wlactic Acid 5% w/v; Salicylic Acid 17% w/v Dynapharm (M) Sdn Bhd,

Malaysia

Yuh Hua Trading

Company

19 May 2015 till 18

May 2020

GSL

1639 BRU14121694NP Hurix Corn Solution 17%Salicylic Acid 0.17g(17%w/v) Dynapharm (M) Sdn Bhd,

Malaysia

Yuh Hua Trading

Company

19 May 2015 till 18

May 2020

GSL

1640 BRU14121695P Axcel Fungicort CreamMiconazole nitrate 2%w/w;

Hydrocortisone 1% w/w

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18

May 2020

POM

1641 BRU14121696P Methacid 25mg tabletIndomethacin 25mg Sunward Pharmaceutical

Sdn Bhd, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

POM

1642 BRU14121697NPDettol Antiseptic Wound Wash

Spraybenzalkonium chloride 0.198% Reckitt Benckiser Healthcare

(UK) Ltd., UK

Syarikat Aliaa Sdn

Bhd

19 May 2015 till 18

May 2020

GSL

1643 BRU14121698PEdurant Film-Coated 25mg

tabletRilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1644 BRU14121699P Invokana 300mg FCTCanagliflozin 300mg (as hemihydrate) Janssen Ortho, LLC, Puerto

Rico

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1645 BRU14121700P Amlodipine Tablet 10mgAmlodipine Tablet 10mg Jubilant Life Sciences Ltd.,

India

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1646 BRU14121701P Borymycin Capsule 100mgMinocycline HCl 100mg Y.S.P., Industries (M) Sdn

Bhd, Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1647 BRU14121702NP Septi-Sol SolutionChlorhexidine Gluconate 20% Solution -

0.5% w/v; Ethanol 94% - 77% v/v

Pahang Pharmacy Sdn Bhd,

Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

GSL

1648 BRU14121703P Atoris Film-coated Tablet 20mgAtorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 122 of 143

Page 123: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1649 BRU14121704NPNutrilite Glucosamine HCl

Capsule 375mg

Glucosamine HCl 375mg Pharmaniaga Manufacturing

Berhad, Malaysia

Amway Sdn Bhd 19 May 2015 till 18

May 2020

GSL

1650 BRU14121705PUltibro Breehaler 40/50mcg

Inhalation Powder CapsuleIndacaterol (as maleate) 110mcg;

Glycopyrronium (as bromide) 50mcg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1651 BRU15011706PZyprexa Zydis

OrodispersibleTablet 5mgOlanzapine micronized 5mg

Catalent UK Swindon Zydis

Ltd, UK

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1652 BRU15011707PZyprexa Zydis

OrodispersibleTablet 10mgOlanzapine micronized 10mg

Catalent UK Swindon Zydis

Ltd, UK

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1653 BRU15011708PRequip PD 24hr 8mg Prolong

Release TabletRopinirole 8mg (as hydrochloride) Glaxo Wellcome SA Spain

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1654 BRU15011709P Klacid MR 500mg Tablet Clarithromycin 500mgAesica Queensborough Ltd,

UK

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1655 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., CyprusHongkiat Trading &

Co19 May 2015 till 18

May 2020POM

1656 BRU15011711P DiSuf-B CreamFusidic acid (micronized) 2.0% w/w &

Betamethasone 0.1%w/w (as valerate)Hovid Bhd, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020 POM

1657 BRU15011712NP Dhalumag Suspension

Per 5ml - Magnesium trisilicate BP

500mg, Dried Aluminium Hydroxide BP

250mg

Drug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

19 May 2015 till 18

May 2020 GSL

1658 BRU15011713PBinoclar® 500mg Film-coated

TabletsClarithromycin 500mg

Novartis Bangladesh Ltd,

Bangladesh

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1659 BRU15011714POspamox 250mcg/5ml

granules for suspensionAmoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, Austria

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1660 BRU15011715P Ospamox 250mg Capsule Amoxicillin 250mg (as trihydrate 287mg) Sandoz GmbH, AustriaZuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1661 BRU15011716POspamox 500mg Film-coated

TabletAmoxicillin 500mg (as trihydrate 574mg) Sandoz GmbH, Austria

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1662 BRU15011717P

Salofalk® 500mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 500mgLosan Pharma GmbH,

Germany

LF Asia (Borneo) Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1663 BRU15011718P

Salofalk® 1000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 1000mgLosan Pharma GmbH,

Germany

LF Asia (Borneo) Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1664 BRU15011719P Vaqta® Vaccine 50U/mlHepatitis A Virus, Purified, Inactivated

50U/ml

Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1665 BRU15011720P Vaqta® Vaccine 25U/mlHepatitis A Virus, Purified, Inactivated

25U/ml

Merck Sharp & Dohme

Corp., USA

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 123 of 143

Page 124: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1666 BRU15011721P

Salofalk® 3000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 3gLosan Pharma GmbH,

Germany

LF Asia (Borneo) Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1667 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1%Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1668 BRU15011723PClarimycin Film Coated Tablet

250mgClarithromycin 250mg

Y.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd19 May 2015 till 18

May 2020POM

1669 BRU15011724P Forteo Injection 20mcg/80mcl

Each ml contains 250mcg of Teriparatide

(recombinant of human parathyroid

hormone (1-34) [rhPTH (1-34)])

Lilly France SAS, FranceZuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1670 BRU15011725PTorisel Concentrate for

Injection 25mg/mlTemsirolimus 25mg/ml

Pierre Fabre Medicament

Production (PFMP), France

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1671 BRU15011726PUrsofalk 500mg Film-coated

TabletsUrsodeoxycholic acid 500mg

Losan Pharma GmbH,

Germany

LF Asia (Borneo) Sdn

Bhd19 May 2015 till 18

May 2020POM

1672 BRU15011727P Bactigen Eye Drops 0.3%Gentamicin 0.3% (as Gentamicin

Sulphate)FDC Limited, India

K-Seri Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1673 BRU15011728PHexaxim Suspension for

Injection

Per dose (0.5ml):

Dipththeria toxoid 30 Lf (≥ 20IU), Tetanus

toxoid 10 Lf (≥ 40IU), Bordetella pertussis

antigens: Pertussis toxoid 25µg,

Filamentous haemagglutinin 25µg, Polio

Virus (Inactivated): Type 1 (Mahoney) 40

DU, Type 2 (MEF-1) 8 DU, Type 3

(Saukett) 32 DU, Hepatitis B surface

antigen 10 µg, Haemophilus influenzae

tybe b polysaccharide (Polyribosylribitol

phosphate) . 12µg, conjugated to

Tetanus protein (PRP-T) 22-36µg

Sanofi Pasteur Marcy I’Etoile

(MLE), France; Sanofi

Pasteur Val de Reuil, France;

Sanofi Pasteur SPA, Italy

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1674 BRU15011729P Nootropil Solution 20% Piracetam 20g/100ml NextPharma SAS., FranceZuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1675 BRU15011730PBridion Solution for Injection

100mg/mlSugammadex 100mg/ml

N.V. Organon, The

Netherlands; Organon

(Ireland) Ltd., Ireland

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

BDMCA/RMP/1215 Page 124 of 143

Page 125: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1676 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1677 BRU15011732NPStrepsils Soothing Honey &

Lemon

Amylmetacresol 0.6ml; 2,4-

Dichlorobenzyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020 GSL

1678 BRU15011733NPStrepsils Max Blackcurrant

LozengeHexylresorcinol 2.4mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand)

Limited, Thailand

Syarikat Rajamas

Bersama

19 May 2015 till 18

May 2020 GSL

1679 BRU15011734P Implanon NXT Implant 68mg EtonogestrelN.V. Organon, The

Netherlands

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1680BRU15011735PS1 &

BRU15011735PS2Stocrin Tablet 200mg Efavirenz 200mg

Merck Sharp & Dohme

(Australia) Pte Ltd Australia;

Zhejian Huahai

Pharmaceutical Co. Ltd.,

China

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020POM

1681BRU15011736PS1 &

BRU15011736PS2Stocrin Tablet 600mg Efavirenz 600mg

Merck Sharp & Dohme

(Australia) Pte Ltd Australia;

Zhejian Huahai

Pharmaceutical Co. Ltd.,

China

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020POM

1682 BRU15011737P Magnevist Injection 469mg/ml

Each ml contains 0.5mmol

gadopentetate dimeglumine (eqv. to

469.01mg gadopentetate dimeglumine)

Bayer Pharma AG,

Leverkeusen, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1683 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/vInterphill Laboratories Inc.,

Philippines

LF Asia (Borneo) Sdn

Bhd19 May 2015 till 18

May 2020GSL

1684 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers 7mg/24hours)LTS Lohmann Therapie-

System AG, Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020GSL

1685 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24 hours)LTS Lohmann Therapie-

System AG, Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020GSL

1686 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24

hours)

LTS Lohmann Therapie-

System AG, Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020GSL

1687 BRU15011742NP Natzema Eczema Relief Cream

Benzoin tincture 10mg/g; Lavender

Angustifolia Oil 5mg/g; Citrus Sinensis

Peel Oil 5mg/g

Cosmetics Manufacturer

(Aust) Pty Ltd, Australia

Bossom Buddies

Enterprise

19 May 2015 till 18

May 2020 GSL

BDMCA/RMP/1215 Page 125 of 143

Page 126: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1688 BRU15011743PPharmaniaga Germacid Cream

2%Fusidic acid 2.0% w/w

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020 POM

1689 BRU15011744PExtraneal Peritoneal Dialysis

Solution 75g/l (2L Ultrabag)

Each 100ml contains Icodextrin 7.5g,

Sodium Chloride 538mg,

Sodium lactate 448mg, Calcium chloride

dihydrate 25.7mg and Magnesium

Chloride Hexahydrate 5.08mg

Baxter Healthcare SA.,

Singapore Branch

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1690 BRU15011745P Seladin 250mg tablet Naproxen 250mgY.S.P Industries (M) Sdn

Bhd., Malaysia

Asterix United (B)

Sdn Bhd19 May 2015 till 18

May 2020POM

1691 BRU15011746NP Vitalipid N Adult

1ml contains: Vitamin A 330IU (as

retinoyl palmitate 99mg), Ergocalciferol

0.5mg(»Vitamin D2 20IU), All-rac-a-

Tocopherol 0.91mg(»Vitamin E 1IU),

Phytomenadione (Vitamin K1) 15mg

Fresenius Kabi AB, SwedenZuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1692 BRU15011747NP Vitalipid N Infant

1ml contains: Vitamin A 230IU (as

retinoyl palmitate 69mg), Ergocalciferol

1.0mg(»Vitamin D2 40IU), All-rac-a-

Tocopherol 0.64mg(»Vitamin E 0.71IU),

Phytomenadione (Vitamin K1) 20mg

Fresenius Kabi AB, SwedenZuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1693 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1694 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1695 BRU15011750NP Prismasol BO

Each 1000ml contains (before

reconstitution): Calcium chloride

dihydrate 5.145g, Magnesium chloride

hexahydrate 2.033g, Lactic acid 5.4g,

Sodium chloride 6.45g & Sodium

bicarbonate 3.09g

Gambro Dasco S.p.A., Italy Medicorp Sdn Bhd

19 May 2015 till 18

May 2020

POM

1696 BRU15021751PKogenate FS for Injection

1000IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 1000IU

Vetter Pharma-Fertigung

GmbH & Co. KG, Germany;

Bayer Pharma AG, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1697 BRU15021752PKogenate FS for Injection

500IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 500IU

Bayer Healthcare LLC,

United States

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 126 of 143

Page 127: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1698 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5mlDrug Houses of Australia

Private Limited, Singapore

G & H Trading

Company

19 May 2015 till 18

May 2020 POM

1699 BRU15021754PCernevit Multivitamin Powder

for Injection

Each vial contains: Retinol palmitate

(VitaminA) 3500 IU, Cholecalciferol

(Vitamin D3) 220 IU, DL alpha tocopherol

(Vitamin E) 10.2 mg, Ascorbic acid

(Vitamin C) 125mg, Cocarboxylase

tetrahydrate (Vitamin B1) 5.8mg,

Riboflavin sodium phosphate dehydrate

(Vitamin B2) 5.67mg, Pyridoxine

hydrochloride (Vitamin B6) 5.5mg,

Cyanocobalamin (Vitamin B12) 0.006mg,

Folic acid 0.414mg, Dexpanthenol

16.15mg, Biotin 0.069mg, Nicotinamide

46mg

Baxter SA, BelgiumZuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1700 BRU15021755P Baneocin OintmentBacitracin Zinc 250IU/1g; Neomycin

Sulphate 5000 IU (5mg)/1g

Merck

Kommanditgesellschaft Auf

Aktein & Co., Werk, Austria

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1701 BRU15021756POspexin 125mg/5ml granules

for oral suspensionCephalexin 125mg/5ml Sandoz GmbH, Austria

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1702 BRU15021757P

Simponi Solution for Injection

in Pre-filled Syringe

50mg/0.5ml

Golimumab 50mg/0.5ml

Baxter Pharmaceutical

Solutions LLC, USA

(Repacker - Cilag AG,

Switzerland)

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1703 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1704 BRU15021759PBeclazone 100micrograms CFC-

Free Inhaler

Beclomethasone Dipropionate

100micrograms/metered inhalation

Norton Waterford T/A Ivax

Pharmaceuticals Ireland

G & H Trading

Company

19 May 2015 till 18

May 2020 POM

1705BRU15021760PS1 &

BRU15021760PS2

Insulatard 100IU/ml Suspnsion

for Injection (vial)

1ml of suspension contain 100IU (3.5g)

of insulinNovo Nordisk A/S, Denmark Medipharm Sdn Bhd

19 May 2015 till 18

May 2020 POM

1706 BRU15021761P Covapril Tablet 4mg Perindopril ErbumineUpha Pharmaceutical Mfg

(M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

BDMCA/RMP/1215 Page 127 of 143

Page 128: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1707 BRU15021762P Axcel Amlodipine 5mg TabletAmlodipine Besylate equivalent to

Amlodipine 5mg

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

19 May 2015 till 18

May 2020POM

1708 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mgPfizer Pharmaceuticals LLC.,

Puerto Rico

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1709 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USAHongkiat Trading &

Co19 May 2015 till 18

May 2020POM

1710 BRU15021765P NutrIflex Lipid Plus

1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion* (For

Detailed Formulation referred to

Dossier)

B.Braun Melsungen AG,

Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1711 BRU15021766PNeulastim Pre-filled Syringe

6mg/0.6mlPegfilgrastim 6mg/0.6ml

F-Hoffman-La Roche Ltd.,

SwitzerlandMedipharm Sdn Bhd

19 May 2015 till 18

May 2020POM

1712 BRU15021767P Bacitrecin-N Ointment

Bacitracin Zinc 12.5mg (potency)

(Equivalent to Bacitracin Zinc 500 units);

Polymyxin B Sulfate 0.83mg (potency)

(Equivalent to Polymyxin B Sulfate 5,000

units); Neomycin Sulfate 3.5mg (potency)

Y.s.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020

POM

1713 BRU15021768P Exelon Patch 15Rivastigmine base 27mg / 15cm2 (In vivo

release rate 13.3mg/24h)

LTS Lohmann Therapie-

Systeme AG, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020POM

1714 BRU15021769PZellox-II, Double Strength

Liquid Antacid

Per 10ml - Aluminium Hydroxide 800mg;

Magnesium Hydroxide 800mg;

Simethicone 60mg

Hoe Pharmaceuticals Sdn

Bhd Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020 GSL

1715 BRU15021770P Bonjela Gel 15g tubeCholine Salicylate 8.714% & Cetalkonium

chloride 0.01%

Reckitt Benckiser Healthcare

(UK) Ltd., UK

Syarikat Rajamas

Bersama19 May 2015 till 18

May 2020GSL

1716 BRU15021771P Gilenya 0.5mg hard capsuleFingolimod 0.5mg (corresponding to

0.56mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1717 BRU15021772P Presolin 150 tablet Irbesartan 150mgUnison Laboratories Co.

Ltd., Thailand

K-Seri Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1718 BRU15021773P Presolin 300 tablet Irbesartan 300mgUnison Laboratories Co.

Ltd., Thailand

K-Seri Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1719 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/mlY.S.P. Industries (M) Sdn

Bhd Malaysia

Asterix United (B)

Sdn Bhd19 May 2015 till 18

May 2020POM

1720 BRU15021775P Hurix Skin Ointment 5%w/wBenzoic acid 5%; Sulphur 25; Salicyllic

acid 5%; Camphor 3%; Menthol 1% w/w

Dynapharm (M) Sdn Bhd,

Malaysia

Yuh Hua Trading

Company

19 May 2015 till 18

May 2020 GSL

1721 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 128 of 143

Page 129: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1722 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18

May 2020POM

1723 BRU15021778P Olapine 5mg FCT Olanzapine 5mgSalutas Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1724 BRU15021779PTrajenta Duo 2.5mg/500mg

FCT tablet

Linagliptin 2.5mg; Metformin

hydrochloride 500mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1725 BRU15021780PTrajenta Duo 2.5mg/850mg

FCT

Linagliptin 2.5mg; Metformin

hydrochloride 850mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1726 BRU15021781PTrajenta Duo 2.5mg/1000mg

film-coated tablets

Linagliptin 2.5mg; Metformin

hydrochloride 1000mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1727 BRU15021782P Humalog 100u/ml (Catridge) Insulin Lispro 100 units/ml Lillly France, FranceZuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1728 BRU15021783P Acustop Cataplasma Flurbiprofen 40mgGreen Cross Corporation,

Korea

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1729 BRU15021784PToviaz 4mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

3.1mg fesoterodine

Aesica Pharmaceuticals

GmbH, Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1730 BRU15021785PToviaz 8mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

6.2mg fesoterodine

Aesica Pharmaceuticals

GmbH, Germany

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1731 BRU15021786PGiotrif 20mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1732 BRU15021787PGiotrif 30mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 30mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1733 BRU15021788PGiotrif 40mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 40mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1734 BRU15021789PGiotrif 50mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 50mg

Boehringer Ingelheim GmbH

and Co. KG., Germany

Hongkiat Trading &

Co

19 May 2015 till 18

May 2020 POM

1735 BRU15021790PMikostat oral suspension 30ml

(Nystatin 100,000 IU/ml)Nystatin 100,000 IU/ml

Gulf Pharmaceutical

Industries (Julphar), United

Arab Emirates

K-Seri Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1736 BRU15021791P Losartan Winthrop 50mg tablet Losartan Potassium 50mgZentiva, a.as., Slovak

RepublicMedipharm Sdn Bhd

19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 129 of 143

Page 130: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1737 BRU15021792PLosartan Winthrop 100mg

tabletLosartan Potassium 100mg

Zentiva, a.as., Slovak

RepublicMedipharm Sdn Bhd

19 May 2015 till 18

May 2020POM

1738 BRU15021793PSMOFlipid 20% Emulsion for

Infusion

1000ml contain: Soya-bean oil, refined

60 g, Medium-chain triglycerides 60 g,

Olive oil, refined 50 g, Fish oil, rich in

omega-2- acids 30 g

Fresenius Kabi Austria

GmbH, Austria

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020POM

1739 BRU15021794NP Aminoven 10%

Isoleucine 5.00g/L; Leucine 7.4g/L; Lysine

acetate= Lysine 9.31g/L; Methionine

4.3g/L; Phenylalanine 5.1g/L; Threonine

4.4g/L; Tryptophan 2.0 g/L; Valine 6.2

g/L; Arginine 12.0g/L; Histidine 3.0 g/L,

Alanine 14.0 g/L, Glycine 11.0 g/L;

Proline 11.2 g/L; Serine 6.5g/L; Tyrosine

0.4g/L; Taurine 1.0g/L.

Fresenius Kabi Austria

GmbH, Austria

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1740 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil) 250mg

Yung Shin Pharmaceutical

Ind. Co. Ltd., Republic of

China

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020 POM

1741 BRU15021796PMontelair 10mg film-coated

tablet

Montelukast (as Montelukast Sodium)

10mgHovid Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1742 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate)

10mg

Lek Pharmaceuticals D.D.,

Solvenia

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1743 BRU15021798NP

Dianeal Low Calcium

(2.5MEq/L) Peritoneal Dialysis

Solution with 4.25% Dextrose

(2L Ultrabag)

Each 100ml contains: Dextrose Hydrous

4.25g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride

dihydrate 18.3mg; and Magnesium

Chloride Hexhydrate 5.08mg

Baxter Healthcare SA.,

Singapore Branch

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1744 BRU15021799NP

Dianeal Low Calcium

(2.5MEq/L) Peritoneal Dialysis

Solution 2.5% Dextrose (2L

Ultrabag and 2.5L Ultrabag)

Each 100ml contains: Dextrose Hydrous

2.5g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride

dihydrate 18.3mg; and Magnesium

Chloride Hexhydrate 5.08mg

Baxter Healthcare SA.,

Singapore Branch

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

BDMCA/RMP/1215 Page 130 of 143

Page 131: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1745 BRU15021800NP

Dianeal Low Calcium

(2.5MEq/L) Peritoneal Dialysis

Solution 1.5% Dextrose (2L

Ultrabag and 2.5L Ultrabag)

Each 100ml contains: Dextrose Hydrous

1.5g; Sodium Chloride 538mg; Sodium

Lactate 448mg; Calcium Chloride

dihydrate 18.3mg; and Magnesium

Chloride Hexhydrate 5.08mg

Baxter Healthcare SA.,

Singapore Branch

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1746 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate 300mg Hovid Bhd, MalaysiaG & H Trading

Company19 May 2015 till 18

May 2020GSL

1747 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mgPharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020 POM

1748 BRU15021803PColospan 10mg sugar coated

tabletHyoscine Butylbromide 10mg Hovid Bhd, Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1749 BRU15021804P Caslot 25mg tablet Carvedilol 25mgRanbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020POM

1750 BRU15021805P Serenata 50mg TabletSertraline hydrochloride 56mg

equivalent to Sertraline 50mg

Torrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1751 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18

May 2020POM

1752 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18

May 2020POM

1753 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18

May 2020POM

1754 BRU15031809PMoxiclav Forte Dry Powder for

Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg &

Clavulanic acid 62.5mgMedochemie Ltd., Cyprus

Hongkiat Trading &

Company

19 May 2015 till 18

May 2020 POM

1755 BRU15031810P Moxiclav 625mg Tablets

Amoxicllin trihydrate (574mg) 500mg;

clavulanate potassium microcrystalline

cellulose (297.8mg) eq. to clavulanic acid

125mg

Medochemie Ltd., CyprusHongkiat Trading &

Company

19 May 2015 till 18

May 2020 POM

1756 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., ItalyZuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1757 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18

May 2020POM

1758 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 131 of 143

Page 132: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1759 BRU15031814PNimenrixTM (Meningococcal

polysaccharide serogroups

A,C,W-135, Y) Vaccine

MenAAH-TT-conjugate (Mean TT/PS

ratio:3) 5mcg PSA~15mcg TT, MenCAH-TT-

conjugate (Mean TT/PS ratio:3) 5mcg

PSC~15mcg TT, MenW-TT-conjugate

(Mean TT/PS ratio:1.5) 5mcg

PSW~7.5mcg TT, MenY-TT-conjugate

(Mean TT/PS ratio:1.3) 5mcg PSY~6.5mcg

TT

Glaxosmithkline Biologicals

s.a., Belgium

Zuellig Pharma Sdn.

Bhd.

19 May 2015 till 18

May 2020

POM

1760 BRU15031815P Cialis 2.5mg Tablet Tadalafil 2.5mgLily del Caribe Inc., Puerto

Rico

Zuellig Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1761 BRU15031816P Cialis 5mg Tablet Tadalafil 5mgLily del Caribe Inc., Puerto

Rico

Zuellig Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1762 BRU15031817P Cialis 20mg Tablet Tadalafil 20mgLily del Caribe Inc., Puerto

Rico

Zuellig Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1763 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mgDuopharma (M) Sdn. Bhd.,

Malaysia

Hongkiat Trading &

Company19 May 2015 till 18

May 2020P (50 x 10’s)

1764 BRU15031819PPlacta Film-coated Tablets

75mgClopidogrel (as bisulphate) 75mg Actavis Ltd., Malta

G&H Trading

Company19 May 2015 till 18

May 2020POM

1765 BRU15031820PSmofKabiven Peripheral

Emulsion for Infusion

1 unit consists of Amino Acid Solution;

Glucose Solution; Lipid Emulsion (For

detailed formulation referred to dossier)

Fresenius Kabi AB, SwedenZuellig Pharma Sdn.

Bhd

19 May 2015 till 18

May 2020 POM

1766 BRU15031821P Ometec capsule 20mg Omeprazole 20mgNoripharma Sdn. Bhd.,

Malaysia

K-Seri Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1767 BRU15031822PElantan® long sustained-

release capsuleIsosorbide-5-mononitrate 50mg

GlaxoSmithKline

Pharmaceuticals Sdn. Bhd.,

Malaysia

Zuellig Pharma Sdn.

Bhd

19 May 2015 till 18

May 2020 POM

1768 BRU15031823P

ADVATE 500IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII)

Baxter BioScience

Manufacturing Sàrl,

Switzerland

Zuellig Pharma Sdn.

Bhd

19 May 2015 till 18

May 2020 POM

1769 BRU15031824NP Livovid Forte Capsule

Lecithin soya bean (300mg phosphatidyl

choline) 858.0mg, Thiamine

hydrochloride (4.7mg vitamin B1) 6mg,

Riboflavin 6mg, Pyridoxine hydrochloride

(4.93mg of vitamin B6) 6mg,

Cyanocobalamin 0.006mg, Nicotinamide

30mg, dl-alpha-tocopherol acetate 6IU

Hovid Bhd., MalaysiaG&H Trading

Company

19 May 2015 till 18

May 2020

GSL

BDMCA/RMP/1215 Page 132 of 143

Page 133: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1770 BRU15031825P Saizen® Liquid 12mg (8mg/ml)Somatropin 12mg/1.5ml (recombinant

human growth hormone)Merck Serono S.p.A., Italy

G&H Trading

Company

19 May 2015 till 18

May 2020 POM

1771 BRU15031826PSaizen® Liquid 6mg

(5.83mg/ml)

Somatropin 6mg/1.03ml (recombinant

human growth hormone)Merck Serono S.p.A., Italy

G&H Trading

Company

19 May 2015 till 18

May 2020 POM

1772 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1773 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1774 BRU15031829NP BrevoxylTM 4% creamHydrous Benzoyl Peroxide (eq. to

benzoyl peroxide 4%)

Glaxo Operations UK

Limited, UK

Zuellig Pharma Sdn.

Bhd19 May 2015 till 18

May 2020GSL

1775 BRU15031830NP Gaviscon Liquid Sachet

Each 10ml contains: Sodium alginate

500mg, Sodium bicarbonate 267mg and

Calcium carbonate 160mg

Reckitt Benckiser Healthcare

(UK) Ltd., UK

Zuellig Pharma Sdn.

Bhd

19 May 2015 till 18

May 2020 GSL

1776 BRU15031831NPFisherman’s Friend Sugar-Free

Apple & Cinnamon LozengesMenthol 4.025mg

IDS Manufacturing Sdn.

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18

May 2020 GSL

1777 BRU15031832NPFisherman’s Friend Sugar-Free

Mandarin & Ginger LozengesMenthol 4.6mg

IDS Manufacturing Sdn.

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18

May 2020 GSL

1778 BRU15031833NPFisherman’s Friend Sugar-Free

Lemon LozengesMenthol 4.6mg

IDS Manufacturing Sdn.

Bhd., Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18

May 2020 GSL

1779 BRU15041834PRotaqor 20mg film-coated

tabletAtorvastatin Calcium 20mg

Lek Pharmaceuticals D.D.,

Slovenia

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1780 BRU15041835P Jakavi 20mg tabletRuxolitinib (as phosphate 26.40mg)

20mg

Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1781 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg) 15mgNovartis Pharma Stein, AG,

Switzerland

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1782 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mgNovartis Pharma Stein, AG,

Switzerland

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1783 BRU15041838PRocephin for Injection 250mg

IM

Ceftriaxone sodium (eq. to ceftriaxone

250mg/vial)

F.Hoffman-La Roche Ltd.,

France

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020POM

1784 BRU15041839PArchifar 500mg powder for

injection/infusionMeropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus

Hong Kiat Trading &

Co.19 May 2015 till 18

May 2020POM

1785 BRU15041840PCiproflo 2mg/ml solution for IV

infusionCiprofloxacin 2mg/ml (as hydrochloride)

Sin Guan Chem. Ind. Co.

Ltd., Republic of China

K-Seri Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

BDMCA/RMP/1215 Page 133 of 143

Page 134: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1786 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., MalaysiaG & H Trading

Company19 May 2015 till 18

May 2020POM

1787 BRU15041842P B-Mycin cream

Betamethasone dipropionate 0.643mg

(eq. to 0.5mg betamethasone);

Gentamicin Sulfate 1mg (potency)

Y.S.P. Industries (M) Sdn.

Bhd., Malaysia

Asterix United (B)

Sdn Bhd

19 May 2015 till 18

May 2020 POM

1788 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5mlSunward Pharmaceutical

Sdn. Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020P

1789 BRU15041844PPharmaniaga Loratadine tablet

10mgLoratadine 10mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

19 May 2015 till 18

May 2020

P

1790 BRU15041845P Curam 1000mg tablet

Amoxycillin 875 (as trihydrate);

clavulanic acid 125mg (as potassium

clavulanate)

Sandoz GmbH, AustriaZuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1791 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., ItalyK-Seri Pharma Sdn.

Bhd.19 May 2015 till 18

May 2020POM

1792 BRU15041847P Sunadine tablet 10mg Loratadine 10mgSunward Pharmaceutical

Sdn. Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020

P

1793 BRU15041848NPSoluvit N Powder for Solution

for Infusion

Thiamine mononitrate 3.1mg

(corresponding to vitamin B1 2.5mg);

Riboflavine sodium phosphate 4.9mg

(corresponding to vitamin B2

3.6mg);Nicotinamide 40mg; Pyridoxine

hydrochloride 4.9mg (corresponding to

vitamin B6 4.0mg); Sodium

panthothenate 16.5mg (corresponding

to pantothenic acid 15.0mg); Sodium

ascorbate 113mg (corresponding to

Vitamin C 100mg); Biotin 60mcg; Folic

acid 0.40mg; cyanocobalamin 5.0mcg

Sino Swed Pharmaceutical

Corp. Ltd., China

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020

POM

1794 BRU15041849NP Folic acid 5mg tablet Folic acid 5mgSunward Pharmaceutical

Sdn. Bhd., Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020P

1795 BRU15041850P Estelle-35 tabletCyproterone acetate 2mg;

Ethinylestradiol 0.03mg

Douglas Manufacturing

Limited, New Zealand

G & H Trading

Company19 May 2015 till 18

May 2020POM

1796 BRU15041851NPCetomacragol emulsifying

ointment

Cetomacragol emulsifying wax 30% w/w;

liquid paraffin 20%; white soft paraffin

50%

Hovid Bhd., MalaysiaG & H Trading

Company

19 May 2015 till 18

May 2020 GSL

BDMCA/RMP/1215 Page 134 of 143

Page 135: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1797BRU15041852PS1/

BRU15041852PS2

Glucophage® XR 1000mg

Extended-release tablet

Metformin (as hydrochloride 1000mg)

780mg

1. Merck Sante SAS, France;

2. Merck KGaA, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1798 BRU15041853P Duofilm LiquidSalicylic acid 16.7% w/w; lactic acid

16.7%

Stiefel Labs (Ireland) Ltd.,

Ireland

Zuellig Pharma Sdn

Bhd19 May 2015 till 18

May 2020P

1799 BRU15041854NPVoluven Solution for Infusion

6%

Per 1000ml: Poly (O-2-hydroxyethyl)

starch 60.0g; sodium chloride 9.00g

Frensius Kabi Deutschland

GmbH, Germany

Zuellig Pharma Sdn

Bhd

19 May 2015 till 18

May 2020 POM

1800 BRU15041855NP Iris eye dropsHydroxypropyl methylcellulose 3mg;

dextran 70 1mg

Sam Chun Dang Pharm Co

Ltd, South KoreaMedipharm Sdn Bhd

19 May 2015 till 18

May 2020GSL

1801 BRU15041856POnzapin film-coated tablet

5mgOlanzapine 5mg Actavis Ltd., Malta

G & H Trading

Company19 May 2015 till 18

May 2020POM

1802 BRU15041857POnzapin film-coated tablet

10mgOlanzapine 10mg Actavis Ltd., Malta

G & H Trading

Company19 May 2015 till 18

May 2020POM

1803 BRU15041858NPFisherman’s friend aniseed

lozengesMenthol 5.75mg

Lofthouse of Fleetwood

Limited, UK

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18

May 2020 GSL

1804 BRU15041859NPFisherman’s Friend Sugar Free

Mint LozengesMenthol 3.45mg

Lofthouse of Fleetwood

Limited, UK

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18

May 2020 GSL

1805 BRU15041860NP

Fisherman’s Friend Sugar Free

Cherry Lozenges With

Menthol 6.9mg

Menthol 6.9mg Lofthouse of Fleetwood

Limited, UK

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18

May 2020 GSL

1806 BRU15041861NPChlorHex 5% Concentrate

Solution

Chlorhexidine gluconate 5% w/v;

isopropylaocohol 3.15% w/v

Pahang Pharmacy Sdn Bhd,

Malaysia

G & H Trading

Company19 May 2015 till 18

May 2020GSL

1807 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mgUpha Pharmaceuticals Sdn

Bhd, Malaysia

Hongkiat Trading &

Co19 May 2015 till 18

May 2020POM

1808BRU15051863NP SP Pharma Paracetamol

Tablets 500mg

Paracetamol 500mgSimpor Pharma Sendirian

Berhad, Brunei Darussalam

Simpor Pharma

Sendirian Berhad

19 May 2015 till 18

May 2020P (200’s)

1809

BRU15051864NP Addamel™ N Concentrate for

Infusion1 mL contains: Chromic chloride 6 H2O

5.33 µg; Copper chloride 2 H2O 340 µg;

Ferric chloride 6 H2O 540 µg; Manganese

chloride 4 H2O 99 µg; Potassium iodide

16.6 µg; Sodium fluoride 210 µg; Sodium

molybdate 2 H2O 4.85 µg; Sodium

selenite anhydrous 6.90 µg; Zinc chloride

1.36 mg

Fresenius Kabi Norge AS,

Norway

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

BDMCA/RMP/1215 Page 135 of 143

Page 136: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1810BRU15051865NP

Dettol Moisturing Formula

Antiseptic Cream

Triclosan 0.3%; Chloroxylenol 0.3%;

Edetic acid 0.2%

Reckitt Benckiser Healthcare

(UK) Ltd., UK

Syarikat Aliaa Sdn

Bhd

28 July 2015 till 27 July

2020 GSL

1811BRU15051866P

Dophilin Tablets 2mg Doxazosin (as mesylate) 2mgTaiwan Biotech Co. Ltd.,

Taiwan R.O.C.

K-Seri Pharma Sdn

Bhd

28 July 2015 till 27 July

2020 POM

1812

BRU15051867NP

Kabiven Peripheral Emulsion

for Infusion

1000ml of the mixture contain: Purified

soybean oil 35g; Glucose (anhydrous)

68g; Alanine 3.3g; Arginine 2.4g; Aspartic

acid 0.71g; Phenylalanine 1.6g; Glutamic

acid 1.2g; Glycine 1.6g; Histidine 1.4g;

Isoleucine 1.2g; Leucine 1.6g; Lysine

1.9g; Methionine 1.2g; Proline 1.4g;

Serine 0.94g; Threonine 1.2g;

Tryptophan 0.40g; Tyrosine 0.05g; Valine

1.5g; Sodium glycerophosphate

(anhydrous) 1.0g; Calcium chloride

0.15g; Potassium chloride 1.2g;

Magnesium sulphate 0.33g; Sodium

acetate 1.0g

Fresenius Kabi AB, Uppsala,

Sweden

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1813BRU15051868NP

Kabiven Emulsion for InfusionFresenius Kabi AB, Uppsala,

Sweden

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020POM

1814BRU15051869P

Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., MalaysiaG & H Trading

Company

28 July 2015 till 27 July

2020POM

1815BRU15051870P

Fenagesic Tablet 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte

Ltd., Singapore

G & H Trading

Company

28 July 2015 till 27 July

2020POM

1816BRU15051871P

Metta SR Tablets 500mg Metformin Hydrochloride USP 500mgTorrent Pharmaceuticals

Ltd., Indrad, India

K-Seri Pharma Sdn

Bhd

28 July 2015 till 27 July

2020POM

1817BRU15051872P

Diamitex Tablet 80mg Gliclazide 80mgDuopharma (M) Sdn Bhd,

Malaysia

K-Seri Pharma Sdn

Bhd

28 July 2015 till 27 July

2020POM

1818BRU15051873NP

Calamine Lotion Calamine BP 15% w/v

Royce Pharma

Manufacturing Sdn Bhd,

Malaysia

SWL Biomed Sales &

Services

28 July 2015 till 27 July

2020GSL

1819BRU15051874NP

Fisherman’s Friend Original

LozengesMenthol 10.35mg; Eucalyptus oil 1.73mg

Lofthouse of Fleetwood

Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020GSL

1820BRU15051875NP

Fisherman’s Friend Mint

Lozenges

Menthol 4.6mg; Peppermint oil

11.270mg

Lofthouse of Fleetwood

Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020GSL

BDMCA/RMP/1215 Page 136 of 143

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1821BRU15051876NP

Fisherman’s Friend Sugar Free

Original LozengesMenthol 9.2mg

IDS Manufacturing Sdn Bhd,

Malaysia

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020GSL

1822

BRU15051877P

Progyluton Tablet

Estradiol Valerate (in brown tablet) 2mg;

Estradiol Valerate (in white tablet) 2mg;

Norgestrel (in brown tablet) 0.5mg

Bayer Weimar GmbH und

Co. KG., Germany

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020POM

1823BRU15051878P

Loratyn-10 Loratadine 10mg Hovid Bhd., MalaysiaG & H Trading

Company

28 July 2015 till 27 July

2020POM (100's);

P (20's)

1824BRU15051879P

Candazole V Single Dose Cream

10% w/wClotrimazole 10% w/w

HOE Pharmaceuticals Sdn

Bhd, Malaysia

G & H Trading

Company

28 July 2015 till 27 July

2020 POM

1825BRU15061880P Keppra® Oral Solution

100mg/ml

Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1826

BRU15061881P Norditrophin Nordilet Inejction

5mg/1.5ml Pre-filled Pen,

Solution for Injection

Somatropin (rDNA) 3.3mg/ml Nove Nordisk A/A, Denmark Medipharm Sdn Bhd 28 July 2015 till 27 July

2020

POM

1827BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading

Company

28 July 2015 till 27 July

2020

POM

1828BRU15061883P Povidone Iodine solution 10%

w/v

Povidone Iodine 10% w/v Royce Pharma

Manufacturing Sdn. Bhd.,

Malaysia

SWL Biomed Sales &

Services

28 July 2015 till 27 July

2020

GSL

1829BRU15061884P Pharmaniaga Cephalexin

Suspension 250mg

Cephalexin (as Cephalexin Anhydrous)

250mg/5mL

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

28 July 2015 till 27 July

2020

POM

1830BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical

Pte. Ltd., Singapore

G & H Trading

Company

28 July 2015 till 27 July

2020

POM

1831BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1832BRU15061887P PVP Iodine Solution Povidone-Iodine 10% w/v (equivalent to

1% available Iodine)

Dynapharm (M) Sdn. Bhd.,

Malaysia

Medicorp Sdn Bhd 28 July 2015 till 27 July

2020

GSL

1833

BRU15061888P Herceptin Powder for Injection

440mg/vial

Trastuzumab 440mg Genentech Inc., California,

USA; Genentech Inc.,

Oregon, USA

Medicare 28 July 2015 till 27 July

2020

POM

1834BRU15061889P Azoren 20mg/5mg Film-Coated

Tablet

Olmesartan medoxomil 20mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

BDMCA/RMP/1215 Page 137 of 143

Page 138: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1835BRU15061890P Azoren 40mg/10mg Film-

Coated Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 10mg

Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1836BRU15061891P Azoren 40mg/5mg Film-Coated

Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as amlodipine

besylate) 5mg

Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1837BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv. to

3.338mg perindopril)

Lek Pharmaceuticals DD.,

Slovenia

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

POM

1838BRU15061893NP Mentholatum Deep Heating

Rub

Methyl Salicylate 12.7% & Menthol 5.8% The Mentholatum Co., Inc.,

USA

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1839BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum

(Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1840BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum

(Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1841BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd.,

Malaysia

Medicorp Sdn. Bhd. 28 July 2015 till 27 July

2020

GSL

1842BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml

Potassium bicarbonate 100mg/5ml

Reckitt Benckiser Healthcare

(UK) Ltd., UK

Zuellig Pharma Sdn

Bhd

28 July 2015 till 27 July

2020

GSL

1843BRU15071898P Celluvisc Lubricating Eye Drops

1%

Carboxymethylcellulose sodium 1% Allergan Sales, LLC, USA Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec

2020

GSL

1844BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg;

Clavulanic acid (as potassium salt) 125mg

Siam Bheasach Co. Ltd.,

Thailand

K-Seri Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1845BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;

Sodium bicarbonate 267mg; Calcium

carbonate 160mg

Reckitt Benckiser Healthcare

(UK) Ltd, UK

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

GSL

1846BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd,

Taiwan

G & H Trading

Company

09 Dec 2015 till 08 Dec

2020

POM

1847BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D.,

Ljubljana

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1848BRU15071903NP Chlorhex 4% antiseptic solution Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd.,

Malaysia

G & H Trading

Company

09 Dec 2015 till 08 Dec

2020

GSL

1849BRU15071904P Resolor Film-coated Tablet

2mg

Prucalopride succinate 2.642mg eqv

Prucalopride 2mg

Janssen-Cilag S.p.A., Italy Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1850BRU15071905P Proglutrol 500 Extended

Release Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd.,

India

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

BDMCA/RMP/1215 Page 138 of 143

Page 139: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1851BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;

Sodium Bicarbonate 213mg; Calcium

Carbonate 325mg

Reckitt Benckiser Healthcare

(UK) Ltd, UK

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

GSL

1852BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium

Bicarbonate 106.5mg; Calcium

Carbonate 187.5mg

Reckitt Benckiser Healthcare

(UK) Ltd, UK

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

GSL

1853BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g &

betamethasone (as dipropionate)

0.5mg/g

LEO Laboratories Ltd.,

Ireland

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1854BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum

(Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec

2020

GSL

1855BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum

(Vietnam) Co. Ltd., Vietnam

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

GSL

1856BRU15071911P Hydrogen Peroxide Solution

(6%)

Hydrogen Peroxide 6% w/v (equivalent

to 20 volumes of available oxygen)

The Government

Pharmaceutical

Organization, Thailand

SWL Biomed Sales &

Services

09 Dec 2015 till 08 Dec

2020

P

1857BRU15071912P Keppra Film-coated Tablet

1000mg

Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1858BRU15081913NP Zentel Suspension

400mg/10ml

Albendazole 400mg/10ml Smithkline Beecham,

Philippines

Kingston Beverage &

Creamery Sdn Bhd

09 Dec 2015 till 08 Dec

2020

GSL

1859BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50 micrograms

and timolol maleate 6.8mg (eq to 5mg

timolol)

Pfizer Manufacturing

Belgium NV, Belgium

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1860BRU15081915P Dormicum Tablet 15mg Midazolam Maleate 20.40mg eqv. to

Midazolam 15mg

Productos Roche S.A. de C.V.

Via Isidro Fabela Nte., Edo

de Mexico.

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1861BRU15081916P Unihepa 5000IU/ml Injection

(5ml vial)

Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd.,

Malaysia

K-Seri Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1862BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1863BRU15081918P Olanzapine Orodispersible

Tablets 5mg

Olanzapine 5mg Jubilant Life Sciences Ltd.,

India

Asterix United (B)

Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1864BRU15081919P Olanzapine Orodispersible

Tablets 10mg

Olanzapine 10mg Jubilant Life Sciences Ltd.,

India

Asterix United (B)

Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1865BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical

Laboratories, India

K-Seri Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

BDMCA/RMP/1215 Page 139 of 143

Page 140: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1866BRU15081921P Pharmaniaga Dermapro

Ointment 0.05% w/w

Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading

Company

09 Dec 2015 till 08 Dec

2020

POM

1867BRU15081922P Olmetec Plus 40/12.5mg Film-

Coated Tablet

Olmesartan Medoxomil 40mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe

GmbH, Germany

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1868BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1869BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1870BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1871

BRU15081926NP Win-Aqueous CreamEmulsifying Wax 8%w/w; Liquid Paraffin

5% w/w; White Soft Paraffin 13% w/w

Winwa Medical Sdn Bhd.,

Pulau Pinang, Malaysia

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1872 BRU15091927P Axcel Piroxicam-10 Capsule Piroxicam 10mgKotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1873 BRU15091928PAcular Ophthalmic Solution

0.5%Ketorolac Trometamol 0.50% w/v

Allergan Pharmaceuticals

Ireland, IrelandMediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1874 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mgPfizer Australia Pty Ltd,

Australia

Zuellig Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1875 BRU15091930PZymar® (gatifloxacin opthalmic

solution) 0.3%Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1876 BRU15091931PKlerimed 500mg Film-Coated

Tablets

Clarithromycin 515mg (equivalent to

anhydrous clarithromycin 500mg)

1. Medochmie Ltd (Factory

AZ), Cyprus

2. Medochmie Ltd (Central

Factory), Cyprus

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020POM

1877 BRU15091932PGadovist Injection 1.0mmol/ml

Prefilled syringe 5.0ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mgBayer Pharma AG, Germany

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020 POM

1878 BRU15091933P Gadovist Injection 1.0mmol/mlGadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mgBayer Pharma AG, Germany

Zuellig Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1879 BRU15091934P

Neostigmine Methysulphate –

Fresenius 2.5mg/1ml

(Ampoules)

Neostigmine methylsulphate 2.5mg/ml

Fresenius Kabi

Manufacturing SA (Pty) Ltd.,

Republic of South Africa.

K-Seri Pharma Sdn.

Bhd.

09 Dec 2015 till 08 Dec

2020 POM

BDMCA/RMP/1215 Page 140 of 143

Page 141: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1880 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare

(UK),United Kingdom

Zuellig Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020 POM

1881 BRU15091936P Calact 300mg Tablets

Calcium Lactate USP Eq. to Calcium

Lactate Pentahydrate 300mg.

Elemental Calcium 39mg (from Calcium

lactate pentahydrate 300mg).

Unique Pharmaceutical

Laboratories (A Division of

J.B. Chemicals &

Pharmaceuticals Limited),

India.

K-Seri Pharma Sdn

Bhd

09 Dec 2015 till 08 Dec

2020

POM

1882 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/mlY.S.P. Industries (M) Sdn.

Bhd., Malaysia

Asterix United (B)

Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1883 BRU15091938P Storvas C Tablets 10mgAtorvastatin 10mg as Atorvastatin

Calcium Trihydrate

Ranbaxy (Malaysia) Sdn.

Bhd., Malaysia

G & H Trading

Company09 Dec 2015 till 08 Dec

2020POM

1884 BRU15091939NP Zinc Cream Zinc Oxide 32% w/wHOE Pharmaceuticals Sdn.

Bhd., Malaysia

G & H Trading

Company09 Dec 2015 till 08 Dec

2020GSL

1885 BRU15091940PPirimat Injection 10mg/ml (1ml

ampoule)Chlorpheniramine Maleate 10mg/m

Duopharma (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company09 Dec 2015 till 08 Dec

2020POM

1886 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, IcelandG & H Trading

Company09 Dec 2015 till 08 Dec

2020POM

1887 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, IcelandG & H Trading

Company09 Dec 2015 till 08 Dec

2020POM

1888 BRU15091943PHeparinol® 10 Sterile

Heparinised Saline InjectionHeparin Sodium (Bovine) 10 IU/ml

Ain Medicare Sdn Bhd,

Malaysia

Syarikat Pakatan

Indah

09 Dec 2015 till 08 Dec

2020 POM

1889 BRU15091944P Fucid Ointment 2% w/wSodium Fusidate (Micronised) 20mg/g

(2% w/w)

Noripharma Sdn Bhd,

Malaysia

Asterix United (B)

Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1890 BRU15091945PActemra Concentrate for

Solution for Infusion 20mg/mlTocilizumab 20mg/ml

Chugai Pharma

Manufacturing Co., Ltd,

Japan

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020 POM

1891 BRU15091946PAxcel Bromhexine (Children)

ElixirBromhexine Hydrochloride 4mg

Kotra Pharma (M) Sdn Bhd.,

MalaysiaMedicorp Sdn Bhd.

09 Dec 2015 till 08 Dec

2020POM

1892 BRU15101947PCetyrol 10mg Film-coated

TabletCetirizine dihydrochloride 10mg

Salutas Pharma GmbH,

Germany

Zuellig Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1893 BRU15101948PArchifar 1g Powder for

Solution for Injection/InfusionMeropenem (as trihydrate) 1g Medochemie Ltd., Cyprus

Hongkiat Trading &

Co

09 Dec 2015 till 08 Dec

2020 POM

1894 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5mlWinwa Medical Sdn Bhd.,

MalaysiaMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020P

BDMCA/RMP/1215 Page 141 of 143

Page 142: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1895 BRU15101950P Respidon 2mg Tablets Risperidone 2mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1896 BRU15101951P Respidon 1mg Tablets Risperidone 1mgTorrent Pharmaceuticals

Ltd., India

K-Seri Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1897 BRU15101952NP Flexjoint 1500mg Powder

Crystalline glucosamine sulphate 1884mg

(equivalent to glucosamine sulphate

1500mg)

Winwa Medical Sdn Bhd.,

MalaysiaMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020 GSL

1898 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5mlWinwa Medical Sdn Bhd.,

Malaysia

Yuh Hua Trading

Company09 Dec 2015 till 08 Dec

2020GSL

1899 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 unitsT.O. Chemicals (1979) Co.

Ltd., ThailandMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1900 BRU15101955P Ezede Tablet 10mg Loratadine 10mgXepa-Soul Pattinson (M) Sdn

Bhd., Malaysia

Hongkiat Trading &

Co09 Dec 2015 till 08 Dec

2020P

1901 BRU15101956PPred Forte Sterile Ophthalmic

Suspension 1%Prednisolone acetate 1% w/v

Allergan Pharmaceuticals

Ireland, Mayo, Ireland

Zuellig Pharma Sdn

Bhd09 Dec 2015 till 08 Dec

2020POM

1902 BRU15111957P Stivarga Tablet 40mg

Regorafenib

(40mg Regorafenib equivalent to

41.49mg Regorafenib monohydrate)

Bayer Pharma AG, Germany.Zuellig Pharma Sdn

Bhd,

09 Dec 2015 till 08 Dec

2020 POM

1903 BRU15111958P A Scabs Lotion Permethrin 5.0% w/vHOE Pharmaceuticals Sdn.

Bhd., Malaysia

G & H Trading

Company09 Dec 2015 till 08 Dec

2020GSL

1904 BRU15111959P Insugen-N (NPH)Insulin Injection, Isophane Ph. Eur.

(Human Insulin rDNA origin) 100IU/mlBiocon Limited, India

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020 POM

1905 BRU15111960P Tetradox Capsules 100mgDoxycycline Hydrochloride/Hcylate eq to

Doxycycline 100mg

Ranbaxy (Malaysia) Sdn Bhd,

Malaysia

G & H Trading

Company09 Dec 2015 till 08 Dec

2020POM

1906 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/vAIN Medicare Sdn. Bhd.,

Malaysia

Syarikat Pakatan

Indah09 Dec 2015 till 08 Dec

2020GSL

1907 BRU15111962NPInfusol W (Sterilised Water for

Injection BP)Water for injection BP

AIN Medicare Sdn. Bhd.,

Malaysia

Syarikat Pakatan

Indah09 Dec 2015 till 08 Dec

2020GSL

1908 BRU15111963P Elan Forte CreamTolnaftate 10mg/g; Chlorhexidine HCl

2mg/g

Y.S.P. Industries (M) Sdn.

Bhd.,Malaysia

Asterix United (B)

Sdn Bhd.09 Dec 2015 till 08 Dec

2020GSL

1909 BRU15111964P Valparin XR 500mg Tablet

i) Sodium Valproate 333mg

ii) Valproic Acid 145mg

(Both together correspond to sodium

valproate 500mg)

Torrent Pharmaceuticals

Limited, India

K-Seri Pharma Sdn

Bhd.,

09 Dec 2015 till 08 Dec

2020 POM

1910 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate (micronized)

equivalent to Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

BDMCA/RMP/1215 Page 142 of 143

Page 143: BRUNEI DARUSSALAM MEDICINES CONTROL ... DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015) No Product

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DEC 2015)

1911 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd.,

Malaysia

Yuh Hua Trading

Company 09 Dec 2015 till 08 Dec

2020GSL

1912 BRU15111967P Cough-En Linctus

Dextromethorphan Hydrobromide

15mg/5ml;

Tripolidine Hydrochloride 1.25mg/5ml;

Pseudoephedrine Hydrochloride

30mg/5ml

Xepa-Soul Pattinson

(Malaysia) Sdn. Bhd.,

Malaysia

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020

POM

1913 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mgSalutas Pharma GmbH,

Federal Republic of

Germany

Medicorp09 Dec 2015 till 28

April 2019POM

1914 BRU15111969PTHurricane Topical Anaesthetic

Gel – Original Wild CherryBenzocaine 20%

Dental Technologies Inc. ,

United States L S Kai Care09 Dec 2015 till 16 Feb

2018POM

1915 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine 2.5% w/wHoe Pharmaceuticals Sdn

Bhd, MalaysiaG & H Trading Co

09 Dec 2015 till 14 Jan

2019POM

1916 BRU15111971PTSOLIRIS Concentrate for

Solution for Infusion 300mgEculizumab 300mg

DSM Pharmaceuticals Inc,

USAMedipharm Sdn Bhd

09 Dec 2015 till

23/11/2018POM

BDMCA/RMP/1215 Page 143 of 143