BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Importation of... · BRUNEI DARUSSALAM...

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019) No Product Registration Number Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the end of the validity period as stated) 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 (B) 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 (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM 3 BRU08010001P Pharmaniaga Aciclovir Tablet 200mg Aciclovir 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 4 BRU08010002P Pharmaniaga Ketoconazole Tablet 200mg Ketoconazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 5 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 6 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 7 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 8 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 9 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 10 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 11 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 12 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 13 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 14 BRU08020020P Diprivan 10mg/ml (1%) Emulsion for Injection or Infusion (20ml Ampoule) Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05 October 2020 POM BDMCA/RMP/0319 Page 1 of 178

Transcript of BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Importation of... · BRUNEI DARUSSALAM...

Page 1: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Importation of... · BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

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 (B) 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

3 BRU08010001P Pharmaniaga Aciclovir Tablet

200mg

Aciclovir 200mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

4 BRU08010002P Pharmaniaga Ketoconazole

Tablet 200mg

Ketoconazole 200mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

5 BRU08010003P Pharmaniaga Clarithromycin

Tablet 250mg

Clarithromycin 250mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

6 BRU08010004P Pharmaniaga Fluconazole

150mg Capsules

Fluconazole 150mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

7 BRU08010005P Pharmaniaga Ciprofloxacin

Tablet 500mg

Ciprofloxacin 500mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

8 BRU08020012P Pharmaniaga Cephalexin

Capsule 500mg

Cephalexin 500mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

9 BRU08020013P Pharmaniaga Metronidazole

Tablet 200mg

Metronidazole 200mg Pharmaniaga Manufacturing

Berhad Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

10 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

11 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

12 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

13 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

14 BRU08020020P Diprivan 10mg/ml (1%)

Emulsion for Injection or

Infusion (20ml Ampoule)

Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 1 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

15 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate);

Clavulanic acid 125mg (as

Potassium Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

16 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

17 BRU08030025P Augmentin Syrup 457mg/5ml Amoxycillin 400mg/5ml (as

trihydrate); Clavulanic acid

57mg/5ml (as Potassium

Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

18 BRU08030026P Augmentin Tablet 1g Amoxycillin 875mg (as trihydrate);

Clavulanic acid 125mg (as

Potassium Clavulanate)

SmithKline Beecham Plc,

Worthing, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

19 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

20 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

21 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

22 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) GlaxoSmithKline Manufacturing

SPA, Italy.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

23 BRU08030035P Zinacef Injection 1.5g Cefuroxime (as sodium) GlaxoSmithKline Manufacturing

SPA, Italy.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

24 BRU08030036P Zinnat Tablet 125mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

25 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

26 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

27 BRU08040041P Zeffix Tablet Lamivudine 100mg GlaxoSmithKline Pharmaceuticals

S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

28 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine

300mg

GlaxoSmithKline Pharmaceuticals

S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

29 BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

120ml

BDMCA/RMP/0319 Page 2 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

30 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

31 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

32 BRU08040049P Diflucan IV Infusion 2mg/ml

(50ml)

Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

33 BRU08040050P Sulperazone IM/IV 1g Sulbactam (as Sodium) 500mg;

Cefoperazone (as Sodium) 500mg

Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

34 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

35 BRU08050053P Pharmaniaga Aciclovir Tablet

400mg

Aciclovir 400mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

36 BRU08050054P Pharmaniaga Cephalexin

Capsule 250mg

Cephalexin (as Anhydrous)

Cephalexin 250mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

37 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

38 BRU08050061P Unocef Injection 1000mg

(Vial)

Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

39 BRU08050062P Garasent 280mg Injection

(2ml Ampoule)

Gentamicin (as Sulphate BP)

280mg

Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

40 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 2015 till 05

October 2020

POM

41 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to

Gentamicin 0.3%w/w

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

42 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg

(micronised)

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

43 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 2015 till 05

October 2020

POM

44 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

45 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 2020

POM

BDMCA/RMP/0319 Page 3 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

46 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

47 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

48 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v;

Dexamethsone Phosphate

0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

49 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg;

Triamcinolone Acetonide 1mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

50 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin

125mg/5ml

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

51 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

52 BRU08060081P Betagen Eye/ Ear Drops Gentamicin Sulphate equivalent to

Gentamicin 0.3%;

Betamethasone Sodium Phosphate

0.1%

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

53 BRU08060082P Muprin Ointment Mupirocin 2.0%w/w Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

54 BRU08060083P Eryson Granules 200 Erythromycin ethylsuccinate equiv.

to eryhtromycin 200mg/5ml

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

55 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv.

to eryhtromycin 400mg/5ml

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

56 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/w Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

57 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

58 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%;

Hydrocortisone 1%

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

59 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

60 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

61 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to

Cefuroxime 250mg

Glaxo Wellcome Bernard Castle,

United Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

62 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 4 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

63 BRU08070092P Eryson Tablet 250 Erythromycin Stearate BP

equivalent to Eryhthromycin

250mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

64 BRU08070094P Ecocort Cream Econazole 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 2020

POM

65 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin

0.1%

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

66 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent

to Amoxicillin 250mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

67 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

68 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

69 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

70 BRU08070101P Zovirax Suspension

200mg/5ml

Acyclovir 200mg/5ml GlaxoSmithKline GmbH & Co

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

71 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1g GlaxoSmithKline Manufacturing

SPA, Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

72 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 2015 till 05

October 2020

POM

73 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

GSL

74 BRU08080107P Gentamicin Cream Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

75 BRU08080108P Beprogent Cream Betamethasone (as dipropionate)

0.05%, Gentamicin (as sulphate

0.1%)

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

76 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg

(Ampicillin 250mg & Sulbactam

125mg)

Pfizer Global Supply Japan Inc,

Japan

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

77 BRU08080110P Zovirax Dispersable Tablet

200mg

Aciclovir 200mg Glaxo Wellcome, S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

78 BRU08080111P Valtrex® 500mg Tablet Valciclovir (as HCl) 500mg Glaxo Wellcome SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

79 BRU08080112P Fortum® Injection 2g Ceftazidime (as pentahydrate) 2g GlaxoSmithKline Manufacturing

SPA, Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 5 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

80 BRU08080115P Vaxcel Cefuroxime 750mg

Injection

Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

81 BRU08080116P Vaxcel Ceftriaxone 1g

Injection

Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

82 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as

17-valerate) 0.1%

Kotra Pharm (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

83 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar

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

produced on VERO cell line,

inactivated and purifed

Sanofi Pasteur, France; Sanofi

Winthrop Industrie (SWI), Le Trait

– France (Diluent)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

84 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w;

Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

85 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 2020

POM

86 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w;

Hydrocortisone 1.0%w/w

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

87 BRU08090124P Ciprobay® 200 Infusion

Solution

Ciprofloxacin (as lactate) 200mg Bayer AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

88 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

91 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

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

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

GSL

93 BRU08090130P Ciprobay 100 Infusion Solution

x 50ml

Ciprofloxacin (as lactate) 100mg Bayer Pharma AG, Leverkeusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

P

94 BRU08090131P Beamoxy Capsule 500 Beamoxy Capsule 500 Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

95 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 2020

POM

BDMCA/RMP/0319 Page 6 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

96 BRU08090133NPS1;

BRU08090133NPS2

Dhamol Suspension

250mg/5ml

Paracetamol 250mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (60ml)

97 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

GSL

98 BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent

to Amoxicillin 500mg

Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

99 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 2015 till 05

October 2020

POM

100 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl

monohydrate) 500mg

Bayer Pharma AG, Leverkeusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

101 BRU08100140P Avelox Infusion Solution

0.4g/250ml

Moxifloxacin (as Hydrochloride)

400mg

Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

102 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride)

400mg

Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

103 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

GSL

104 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mg Drug Houses of Australia Pte Ltd G & H Trading Company 06 October 2015 till 05

October 2020

POM

105 BRU08100144PS1;

BRU08100144PS2

Bifen Suspension 100mg/5ml Ibuprofen BP 100mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

P

106 BRU08100145NP Dhamol Tablet 500mg Paracetamol BP 500mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P (1000's)

107 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

P

108 BRU08100147P Difenac 50 Tablet Diclofenac Sodium BP 50mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

109 BRU08100148P Erythro Ethyl Granules Erythromycin (as ethyl succinate)

200mg/5ml

Drug Houses of Australia Pte. Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

110 BRU08110150P Avaxim 160U Suspension for

Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM

strain) 160u/0.5ml

Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

111 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 7 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

112 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing

SPA Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

113 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

114 BRU08110154P Axcel Eryhthromycin ES Tablet

400mg

Erythromycin (as ethyl succinate)

400mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

115 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate)

500mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

116 BRU08110156P Axcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

117 BRU08110157PS1 ;

BRU08110157PS2

Soden Tablet 275mg Naproxen Sodium BP 275mg Drug House of Australia Pte Ltd,

Singapore ;

PT Actavis Indonesia, Indonesia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

118 BRU08110158NP Dhamol Suspension

120mg/5ml

Paracetamol BP 120mg/5ml Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (100mL)

119 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

GSL

120 BRU08110160P Malarone Tablet Atovaquone 250mg, Proguanil HCl

100mg

GlaxoSmithKline Inc Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

121 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

122 BRU08110163P CoAprovel 150/12.5mg Film-

coated Tablet

Irbesartan 150mg,

Hydrochlorothiazide 12.5mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

123 BRU08110165P;

BRU08110165PS2

Betasone Cream 0.1%w/w Betamethasone (as 17-valerate)

0.1%w/w

Drug Houses of Australia Pte Ltd;

PT Actavis Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

124 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl

monohydrate) 250mg

Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

125 BRU08120167P Axcel Cephalexin 250mg

Caspule

Cephalexin (as Monohydrate)

250mg

Kotra Pharma (M) Sdn Bhd

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

126 BRU08120168P Axcel Cephalexin 125mg

Suspension

Cephalexin (as Monohydrate)

125mg

Kotra Pharma (M) Sdn Bhd

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

127 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mg Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

128 BRU08120170P Hydrocrotisone Cream 1%

w/w

Hydrocortisone acetate BP 1%w/w Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

129 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 8 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

130 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

131 BRU08120174P;

BRU08120174PS2

Dhacopan Syrup 5mg/5ml Hyoscine (as butylbromide) BP

5mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore; PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

132 BRU08120175P;

BRU08120175PS2

Phenexpect Syrup Per 5ml - Diphenhydramine (as

HCl) 12.5mg, Ammonium Chloride

135mg

Drug Houses of Australia Pte Ltd,

Singapore; PT Actavis Indonesia,

Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

133 BRU08120176P Dhabesol Cream 0.05% Clobetasol (as propionate) 0.05%

w/v

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

134 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate)

0.05%, Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

135 BRU08120178PS1;

BRU08120178PS2

Zenmolin Syrup 2mg/5ml Salbutamol (as sulphate) BP

2mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

136 BRU08120180P Zithromax Film-coated Tablet

250mg

Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

137 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg;

Sulbactam (as sodium) 250mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

138 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg;

Sulbactam (as sodium) 1000mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

139 BRU09010183P Vaxcel Ceftriaxone-500mg

Injection

Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

140 BRU09010184PS1;

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 2020

POM

141 BRU09010185P Pacofen Tablet Paracetamol 500mg; Codeine

Phosphate 8mg; Caffeine

anhydrous 30mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

142 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate)

75mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

143 BRU09010187P Symbicort Turbuhaler

160/4.5mcg dose

Budenoside 160mcg; Formoterol

fumarate dihydrate 4.5mcg

AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 9 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

144 BRU09010188P CoAprovel 300/12.5mg film-

coated tablet

Irbesartan 300mg;

Hydrochlorothiazide 12.5mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

145 BRU09010189PS1;

BRU09010189PS2

Vasican Syrup 4mg/5ml Bromhexine HCl BP 4mg/5ml Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta

Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

146 BRU09010190P Cardium 30 tablet Diltiazem HCl 30mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

147 BRU09010191PS1 &

BRU09010191PS2

Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M)

Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

148 BRU09010194P Pulmicort turbuhaler

100mcg/dose

Budenoside 100mcg AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

149 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland,

Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

150 BRU09020196P Zovirax Cream 5% Aciclovir 5%w/w Glaxo Wellcome Opertions, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

151 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/w Jubilant HollisterStier General

Partnership, Canada

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

152 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services

Madrid S.A.U., Madrid, Spain

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

153 BRU09020201NPS1,

BRU09020201NPS2

Dhamol Suspension

500mg/5ml

Paracetamol BP 500mg/5ml Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

P (3.8L)

154 BRU09020204P Beamoxy Tablet 500 Amoxicillin (as trihydrate 575mg)

500mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

155 BRU09020205PS1 &

BRU09020205PS2

Fedac Syrup Pseudoephedrine 30mg/5ml;

Triprolidine 1.25mg/5ml

Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta

Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

POM

156 BRU09020206P Bricanyl Turbuhaler

0.5mg/dose

Terbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje,

Sweden

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 10 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

157 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate

0.064%) 0.05% & Salicylic acid 3%

w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

158 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

159 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05%

w/v

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

160 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

161 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901)

100units/ml

Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

162 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

163 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg GlaxoSmithKline Pharmaceuticals

S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

164 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

165 BRU09030215P Dhatrin Tablet Sulphamethoxazole BP 400mg;

Trimethoprim BP 80mg

Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

166 BRU09030216P Cordarone Injection

150mg/3ml

Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

167 BRU09030217PS1 &

BRU09030217PS2

Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M)

Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

168 BRU09030218P0.5gS

&

BRU09030218P0.5gA

Tetavax Suspension for

Injection (Single dose 0.5ml)

Purified Tetanus Toxoid Sanofi Pasteur, Marcy L'Etoile,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

169 BRU09030219P Cataflam 1.5% Oral Drops

Suspension

Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 11 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

170 BRU09030220P Vaxigrip Influenza Vaccine

SH2017:

Split influenza virus*, inactivated

containing antigens equivalent to

the following strains per one 0.5ml

dose:

• A/Michigan/45/2015 (H1N1)

pdm09-like strain (A

A/Michigan/45/2015, NYMC X-275

…..…………15 mcg HA**

• A/Hong Kong/4801/2014 (H3N2)-

like strain (A/Hong

Kong/4801/2014, NYMC X-

263B)…………..…...15 mcg HA**

• B/Brisbane/60/2008-like strain

(B/Brisbane/60/2008, wild

type)……………………………………………

…….15 mcg HA**

Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

171 BRU09030221P Lignocaine HCl BP Injection 1%

(5ml)

Lidocaine HCl (Lignocaine HCl) 1%

(50mg/5ml)

Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

172 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto

Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

173 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto

Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

174 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

175 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

176 BRU09030226P Benosone-N Cream Betamethasone (as Valerate

0.12%) 0.1% w/w; Neomycin

Sulphate 0.5%w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 12 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

177 BRU09030227P Pocin H Ear Drop Neomycin 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 2015 till 05

October 2020

POM

178 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

179 BRU09040229P Unasyn Powder for Oral

Suspension 250mg/5ml

Sultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc.,

Japan

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

180 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

181 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

182 BRU09040232P0.5gV

&

BRU09040232P0.5gS

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 industriel

d’Incarville, France; Sanofi

Winthrop Industrie (SWI), Le Trait

– France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

183 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

184 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride)

150mg

YSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

185 BRU09040235P Voltaren 75mg/3ml solution

for injection

Diclofenac Sodium 75mg/3ml Novartis Pharma Stein, ag,

Switzerland; Lek Pharmaceuticals

d.d, Slovenia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

186 BRU09040237P Depo-Medrol Sterile Aqueous

Suspension 40mg/ml (5ml)

Methylprednisolone Acetate

200mg/5ml

Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

187 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

188 BRU09040239P Bupivacaine Hydrochloride BP

0.5% w/v injection

Bupivacaine hydrochloride BP

0.5%w/v

Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

189 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega

Baja Puerto Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

190 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SpA, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 13 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

191 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

192 BRU09040244P Cloderm Cream Clobetasone (as butyrate)

0.05%w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading & Co 06 October 2015 till 05

October 2020

POM

193 BRU09040245P Bisacodyl Suppositories Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

P

194 BRU09040246P U-Closone Ointment Clobetasol (as propionate)

0.05%w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

195 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

196 BRU09050248NPS1;

BRU09050248NPS2

Dhactulose Syrup Lactulose 67%w/w Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (200mL) &

P(1L)

197 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride

20mg

Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

198 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg,

Indapamide 1.25mg

Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

199 BRU09050251P Methyldopa Tablet 250mg Methyldopa (as anhydrous) 250mg Drug House of Australia (Asia) Pte

Ltd, Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

200 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

201 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12%

w/w) 0.1% w/w, Neomycin

Sulphate 0.50%w/w

HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

202 BRU09050254P Benosone Ointment Betamethasone 0.1% w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

203 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

204 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0%

w/v

HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

205 BRU09050258P Lobesol Cream Clobetasol (as propionate)

0.05%w/w

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

206 BRU09060259P Vaxcel Cefuroxime 1.5g

Injection

Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 14 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

207 BRU09060260P Tetavax Suspension for

Injection (multidose)

(1 vial of 5mL – 10 doses)

Tetanus toxoid 40i.u/0.5ml dose Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

208 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn

Bhd

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

209 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Saglik, Gida ve Tarim

Urunleri San. Ve Tic. A.S. Yenisehir

Mahalledi, Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

210 BRU09060264P Voltaren 12.5mg

Suppositories

Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

211 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

212 BRU09060266P Benosone Cream Betamethasone (as valerate)

0.1%w/w

HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

213 BRU09060268P Betamethasone Cream Betamethasone (as valerate)

0.1%w/w

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

214 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

215 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium

trihydrate) 20mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

216 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

217 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega

Baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

218 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

219 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

220 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM

strain) 80u per 0.5ml

Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

221 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Recipharm Uppsala AB, Bjorkgatan

30, SE-751 82 Uppsala, Sweden.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

222 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 15 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

223 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia.

G & H Trading Company 06 October 2015 till 05

October 2020

POM

224 BRU09070282P Hydrocortisone Cream 1%

w/w

Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

225 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

226 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium

trihydrate) 40mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

227 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

228 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

229 BRU09070288P Diane-35 Tablet Cyproterone acetate 2mg;

Ethinylestradiol 0.035mg

Bayer Weimar GmbH und Co. KG,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

230 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

231 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

232 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

233 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim

Indonesia, Bogor, Indonesia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

234 BRU09080295P Pulmicort® Turbuhaler®

200mcg/dose

Budesonide (micronised) Ph Eur

200mcg/dose

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

235 BRU09080296P Epilim Intravenous 400mg/

vial

Sodium Valproate 400mg Gruppo Lepetit S.R.L. Italy Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

236 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

237 BRU09080299P Beafemic Suspension

50mg/5ml

Mefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

238 BRU09080300PS1 &

BRU09080300PS2

Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M)

Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

239 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

240 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 16 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

241 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 2020

POM

242 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

243 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd,

Malaysia

Asterix United Sdn Bhd 06 October 2015 till 05

October 2020

P (10 x 10's)

244 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

245 BRU09080308P Atrovent 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 2020

POM

246 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

247 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg;

Loratadine 5mg

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

248 BRU09090313P Typhim Vi Single Dose Purified 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

249 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

250 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

251 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Saglik, Gida ve Tarim

Urunleri San. Ve Tic. A.S. Yenisehir

Mahalledi, Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

252 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type

Plasminogen Activator (alteplase)

50mg

Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

253 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

254 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P (100x10's)

255 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 2020

POM

256 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg;

Micronised Hesperidine 50mg

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL

257 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate

6.94mg); Valsartan 80mg

Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 17 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

258 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, France ;

Sanofi Winthrop Industrie, Le Trait

(France)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

259 BRU09100331P Cloderm Ointment Clobetasol (as propionate)

0.05%w/w

HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

260 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

261 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,

Malaysia.

G & H Trading Company 06 October 2015 till 05

October 2020

POM

262 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

263 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,

Malaysia.

G & H Trading Company 06 October 2015 till 05

October 2020

POM

264 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Manufacturing Deutschland

GmbH, Germany

(Manufacturing, packaging, testing

and release.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

265 BRU09100338NP Uphamol 250 Suspension

(Fruity)

Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL (60mL and

100mL)266 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

267 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

268 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 Bhd 06 October 2015 till 05

October 2020

GSL

269 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mg Pfizer Pharmaceutical LLC, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

270 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg-

crystalline) 40mg

Pfizer pharmaceuticals LLC, vega

baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

271 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine

Citrate 35mg

Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

272 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine

250mg/5mL (Carbocisteine)

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 18 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

273 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

274 BRU09100349P Actonel® 35mg Tablet Risedronate sodium 35mg

(equivalent to 32.5mg risedronic

acid)

Norwich Pharmaceuticals Inc., USA G&H Trading Company 06 October 2015 till 05

October 2020

POM

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

GmbH, Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

276 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone

25mg

AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

277 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg -

crystalline) 10mg

Pfizer pharmaceutical LLC, vega

baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

278 BRU09110357P Atrovent Unit Dose Vial (UDV)

250mcg/2ml

Ipratropium bromide anhydrous

250mcg (as monohydrate 261mcg)

Laboratoire Unither, France (S2) Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

279 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml;

Ammonium Chloride 135mg/5ml

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

280 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P (100 x 10's)

281 BRU09110362P Carin Tablet 10mg Loratadine 10mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

282 BRU09110363P Rhinathiol 2% for Children

Syrup

Carbocisteine 100mg/5ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

283 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate)

500mg & Cilastatin Sodium 500mg

Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

284 BRU09120366PS1 &

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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

285 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Pharmaceuticals LLC, Vega

Baja, USA (Pfizer Vega Baja)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 19 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

286 BRU09120369P Oral Aid Lotion Lignocaine HCl 2.5%;

Triamcinolone Acetonide 0.1%;

Chlorhexidine HCl 0.5%

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

287 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

288 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 06 October 2015 till 05

October 2020

GSL (1 x 5's); P(10

x 10's)289 BRU09120377P Vascor 40mg Film-coated

Tablet

Simvastatin 40mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

290 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

P

291 BRU09120379P Covastin Film-coated Tablet

10mg

Simvastatin 10mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

292 BRU09120380P Metformin Tablet 500 Metformin HCl 500mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

293 BRU09120381PS2 Co-Diovan 80/12.5 Film-

coated Tablets

Valsartan 80mg;

Hydrochlorothiazide 12.5mg

Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

294 BRU09120382P Rhinathiol® Promethazine

syrup

Carbocisteine 100mg/5ml;

Promethazine HCl 2.5mg/5ml

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

295 BRU09120383P Methotrexate Injection BP

1000mg/10ml

Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

296 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

297 BRU10010385PS1 &

BRU10010385PS2

Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M)

Sdn Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

298 BRU10010386PS2 Atrovent Unit Dose Vial

0.5mg/2ml

Ipratropium bromide (as

monohydrate) 500mcg/2ml

Laboratoires Unither, Amiens

cedex, France (S2)

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

299 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

300 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate

6.94mg); Valsartan 160mg

Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

301 BRU10010390NPS3 Dulcolax 5mg Tablet Bisacodyl 5mg Delpharm Reims S.A.S., France

(S3)

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

302 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 20 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

303 BRU10010392PS2 Co-Diovan 160/25 Film-coated

Tablets

Valsartan 160mg;

Hydrochlorothiazide 25mg

Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

304 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP

4mg/5ml

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

P

305 BRU10010395P Isoket Spray Isosrobide Dinitrate 1.25mg per

actuation

Schwarz Pharma Ltd, Ireland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

306 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

307 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Fluticasone propionate 500mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

309 BRU10020402P Solu-Medrol Sterile Powder

500mg

Methyprednisolone (as Sodium

succinate) 500mg

Pfizer Manufacturing Belgium

N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

310 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

311 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

312 BRU10020406P

Combivent Unit Dose Vials

Nebuliser Solution

Per 2.5ml - Ipratropium bromide

(as monohydrate 522mcg) 500mcg;

Salbutamol 2.5mg (as sulphate

3.013mg)

Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

313 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

POM

314 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

315 BRU10020410P Etoposide 100mg/5ml

Injection

Etoposide 100mg/5ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

316 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;

Pseudoephedrine HCl 30mg

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Fluticasone propionate 100mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

318 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 2020

POM

319 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

P

BDMCA/RMP/0319 Page 21 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

320 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

321 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto

Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

322 BRU10020418P Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin

25mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

323 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

324 BRU10030423P Rhinathiol 5% Adult

Expectorant Syrup

Carbocisteine 5g/100ml Unither Liquid Manufacturing,

France

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

P

325 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., Italy Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

326 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

327 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2015 till 05

October 2020

POM

328 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

329 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

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

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

331 BRU10030432P Cisplatin CS Injection

50mg/50ml

Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

332 BRU10030433P Terramycin Ophthalmic

Ointment

Per g - Oxytetracycline 5mg;

Polymyxin B 10,000units

PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

333 BRU10030435P Adriamycin CS Injection

50mg/25ml

Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

334 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide

225mg; Magnesium hydroxide

200mg; Simethicone USP 25mg

A. Nattermann & Cie GmbH,

Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

GSL

335 BRU10030437P Seretide Evohaler 50 Salmeterol Xinafoate (micronised)

25mcg; Fluticasone Propionate

(micronised) 50mcg

Glaxo Wellcome Production,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

336 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

337 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg Daiichi Sankyo Europe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 22 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

338 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

339 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

340 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

341 BRU10040444NP Cartril-S 500mg Capsule Glucosamine HCl 472.5mg

equivalent to Glucosamine content

in Glucosamine Sulphate 500mg

Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05

October 2020

GSL

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

Fluticasone Propionate 250mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

343 BRU10040450P Seretide 125 Evohaler Salmeterol (as Xinafoate,

micronised) 25mcg; Fluticasone

Propionate 125mcg

Glaxo Wellcome Production,

France

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

344 BRU10040452P Nitroderm TTS® 10 Glyceral trinitrate/ nitroglycerin

50mg (10mg/24hr)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

345 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

346 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 2020

GSL

347 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 2020

POM

348 BRU10040457P S2 Co-Diovan 160/12.5mg

Tablets

Valsartan HCl 160mg;

Hydrochlorothiazide 12.5mg

Novartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

349 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

350 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

351 BRU10040461P Cytarabine® Injection 1000mg

in 10ml

Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

352 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen

tartrate)

Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 23 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

353 BRU10050463P Nebido 1000mg/4ml, Solution

for Injection

Testosterone undecanoate

250mg(equiv. to testosterone

157.9mg)

Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

354 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride

30mg/5ml

Delpharm Reims S.A.S., France Hongkiat Trading & Company 06 October 2015 till 05

October 2020

P

355 BRU10050466NP Uphamol Suspension 250

(Orange)

Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

GSL (60mL); P

(3.8L)356 BRU10050468P Remicade Powder for

Concentrate for Solution for

Infusion 100mg/vial

Infliximab (cA2 IgG) 100mg/vial Patheon Italia S.p.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

357 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 2020

POM

358 BRU10050471P Zyvox Infusion Bag

600mg/300ml

Linezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

359 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

360 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

361 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM P

362 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride)

150mg

Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

363 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim

Urunleri San. Ve Tic.A.S., Istanbul,

Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

364 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

365 BRU10050479P Cozaar 100mg film-coated

tablet

Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

366 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate)

10mg/Ml

Zoetis LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

367 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P

368 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 2020

POM

369 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt)

80mg

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

370 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn.

Bhd., Malaysia

G & H Trading Company 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 24 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

371 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim

Urunleri San. Ve Tic.A.S., Istanbul,

Turkey

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

372 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg Daiichi Sankyo Europe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

373 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Australia Pty. Ltd., NSW

Australia.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

374 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing,

France.

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

375 BRU10060496P Stilnox 10mg film-coated

tablet

Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

376 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide

(Scopolamine Butylbromide)

5mg/5ml

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

377 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

378 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen

tartrate 2.4mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

379 BRU10060500P Syntocinon 10IU solution for

injection

Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

380 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen

tartrate 9.6mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

381 BRU10060502P Zyvox film-coated tablet

600mg

Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto

Rico, United States

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

382 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 2020

POM

383 BRU10060505P Myfortic Gastro-Resistant

tablet 180mg

Mycophenolic Acid 180mg (as

Sodium Salt 192.4mg)

Novartis Pharma Produktions

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

384 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg;

Pholcodine 4mg; Ephedrine HCl

7.2mg

Sanofi-Aventis Pakistan Limited,

Pakistan

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

385 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Australia Pty. Ltd., NSW

Australia.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

386 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

P

387 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

GSL (6's) & P

(60's)

BDMCA/RMP/0319 Page 25 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

388 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg;

Pseudoephedrine HCl 60mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

389 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 06 October 2015 till 05

October 2020

POM

390 BRU10070513P;

BRU10070513PS2

Desferal 500mg Desferrioxamine Methane

Sulphonate

Novartis Pharma Stein AG,

Switzerland; Wasserburger

Arzneimittelwerk GmbH,

Wasserburg

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

391 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

392 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w;

Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia

Hongkiat Trading & Company 06 October 2015 till 05

October 2020

POM

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

United Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

394 BRU10070517P Singulair® Chewable Tablet

5mg

Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd.,

United Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

395 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing

SpA., Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

396 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate)

500mg

Pharmacia & Upjohn Company,

Kalamazoo, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

397 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as

Rivastigmine hydrogen tartrate

7.2mg)

Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

398 BRU10070521P Epilim Chrono 500mg Scored

Film-coated Tablet

Sodium valproate 500mg (Sodium

valproate 333mg & Valproic acid

145mg)

Sanofi Winthrop Industries, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

399 BRU10070522P Ritalin® Modified Release

Capsule 30mg

Methylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

400 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate);

Valsartan 160mg

Novartis Farmaceutica SA, Barbera

del Valles

(Barcelona) Spain

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

401 BRU10080524P Zometa 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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

402 BRU10080529P Nasacort Aqueous Nasal Spary Triamcinolone Acetonide

55mcg/actuation

Aventis Pharma UK Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 26 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

403 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride

10mg

Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

404 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin

sulphate 10mg; Hydrocortisone

5mg; Aesculin 10mg

PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

405 BRU10080532P Prostin VR Paediatric® Sterile

Solution 500mcg

Alprostadil 500mcg/ml Pharmacia & Upjohn Company,

USA

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

406 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

407 BRU10080534PS1;

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 (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

408 BRU10080535PS2 Telfast-D Extended Release

Tablet

Fexofenadine hydrochloride 60mg ;

Pseudoephedrine HCl 120mg

Sanofi Winthrop Industrie, France

(S2)

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

409 BRU10090539P Singulair Tablet 4mg Montelukast 4mg (as sodium

4.16mg)

Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

410 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

411 BRU10090541P Lanoxin Paediatric/ Geriatric

Elixir

Digoxin 0.05mg/mL Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

412 BRU10090542PS1;

BRU10090542PS2

Singulair Oral Granules 4mg Montelukast Sodium (free acid

equivalent) 4mg

Merck Sharp & Dohme Corp. USA

(S1); DSM Pharmaceuticals, Inc.,

USA (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

413 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

414 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg MSD International GmbH

(Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

415 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

416 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

417 BRU10090548P Suprefact® 1mg/ml Injection

Solution

Buserelin 1.00mg/ml (as acetate

1.05mg)

Aventis-Pharma Deutshland

GmbH, Germany

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

418 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0319 Page 27 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

419 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride

20mg

Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

420 BRU10090551P Zoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to

Goserelin 10.8mg

AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

421 BRU10090552P Harnal OCAS 400mcg Film-

coated tablet

Tamsulosin (as hydrochloride

400mcg) 367mcg

Astellas Pharma Europe BV, The

Netherlands

Medipharm Sdn Bhd 06 October 2015 till 05

October 2020

POM

422 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg MSD International GmbH (Puerto

Rico Branch) LLC., Puerto Rico,

USA.

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

423 BRU10090555PS1;

BRU10090555PS2

Elomet Cream 0.1% Mometasone Furoate 0.1% Schering-Plough Labo N.V.,

Belgium (S1); Schering-Plough

Labo N.V., Belgium (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05

October 2020

POM

424 BRU10100556P Myfortic Gastro-Resistant

tablet 360mg

Mycophenolic (as sodium) acid

360mg

Novartis Pharma Produktions

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

425 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate)

3mg

Novartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

426 BRU10100560PS2 Arcoxia 60mg Film-coated

tablet

Etoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

427 BRU10100561P Proctosedyl Ointment Cinchocaine hydrochloride 0.5%;

Framycetin sulphate 1.0%;

Hydrocortisone 0.5%; Aesculin

1.0%

Patheon UK Ltd., England Medipharm Sdn Bhd 28 October 2015 till 27

October 2020

POM

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

(9.5mg/24h)

LTS Lohmann Theraphie-System

AG, Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

429 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2

(4.6mg/24 hours)

LTS Lohmann Theraphie-System

AG, Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

430 BRU10100564P ATGAM® Sterile Solution

50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-

thymocyte globulin (equine)

250mg/5mL

Pharmacia & Upjohn Company,

USA

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

431 BRU10100565PS1;

BRU10100565PS2

Ezetrol 10mg Tablet Ezetimibe 10mg 1) MSD International GmbH

(Puerto Rico Branch) LLC, Puerto

Rico (S1); 2) MSD International

GmbH (Singapore Branch),

Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

432 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

433 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Traidng Company 28 October 2015 till 27

October 2020

POM

BDMCA/RMP/0319 Page 28 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

434 BRU10100568P Zithromax Powder For Oral

Suspension 200mg/5ml

Azithromycin (as dihydrate)

200mg/5ml

Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

435 BRU10100569P Fosamax Plus 70/2800mcg

Tablets

Alendronic (as sodium 91.37) acid

70mg & (Vitamin D3 100,000 IU/g)

Cholecalciferol 2800mcg

MSD Frosst Iberica, Spain Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

436 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

437 BRU10100572P Casprin Enteric

Microencapsulated Capsule

100mg

Aspirin 100mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia.

Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

438 BRU10100573P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia.

Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

439 BRU10100576P Albutein® Solution for Infusion

25%

Albumin (Human) 25% Grifols Biologicals Inc., USA Hongkiat Trading & Company 28 October 2015 till 27

October 2020

POM

440 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mg MSD International GmbH (Puerto

Rico Branch) LLC., Puerto Rico,

USA.

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

441 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/ml Y.S.P. Industries (M) Sdn Bhd,

Malaysia.

Asterix United (B) Sdn Bhd 28 October 2015 till 27

October 2020

P (100ml) & POM

(4L)442 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg MSD International GmbH

(Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2015 till 27

October 2020

POM

443 BRU10110581PS1;

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 (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

444 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

445 BRU10110584P Zocor 20mg Film-coated

Tablet

Simvastatin 20mg Merck Sharp & Dohme Ltd.,

Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

446 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 2020

POM

447 BRU10110587P Metoclopramide Syrup

5mg/5ml

Metoclopramide hydrochloride

5mg/5ml

Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Traidng Company 24 November 2015 till 23

November 2020

POM

448 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 2020

GSL

BDMCA/RMP/0319 Page 29 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

449 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

450 BRU10110591P Voren Enteric Coated Tablet

25mg

Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

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

Germany

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

452 BRU10110593P Voren Enteric Coated Tablet

50mg

Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

453 BRU10110595P Zantac™ Injection 25mg/ml Ranitidine hydrochloride 25mg/ml GlaxoSmithKline Manufacturing

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

454 BRU10110596P Beconase™ Aqueous Nasal

Spray

Beclomethasone Dipropionate (as

monohydrate)

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

455 BRU10110597P Campto 40mg/2ml Injection Irinotecan hydrochloride trihydrate

40mg/2ml

Pfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 24 November 2015 till 23

November 2020

POM

456 BRU10120599PS1;

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 (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

457 BRU10120600P Ritalin® LA Modified Release

Capsule 40mg

Methylphenidate hydrochloride

40mg

Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

458 BRU10120602P Orgalutron Solution for

Injection 0.25mg/0.5ml

Ganirelix acetate 0.25mg/0.5ml Vetter Pharma-Fertigung GmbH &

Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

459 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride

0.05%

PT. Merck Sharp Dohme Pharma

Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

P

460 BRU10120605P Clarityne Tablet 10mg Loratadine 10mg PT. Merck Sharp Dohme Pharma

Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

P

461 BRU10120606P Frotin Pessaries Metronidazole 250mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

462 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

463 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The

Netherlands

Medipharm Sdn Bhd 29 December 2015 till 28

December 2020

POM

464 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

465 BRU10120612P Flixonase Aqueous Nasal

Spray 0.05%

Fluticasone propionate

(micronised) 50mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

466 BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection 50mg/5ml

(10mg/ml)

Rocuronium Bromide 50mg/5ml N.V. Organon, The Netherlands;

Hameln Pharmaceuticals GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

BDMCA/RMP/0319 Page 30 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

467 BRU10120615P FlixotideTM EvohalerTM

125mcg

Fluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

468 BRU10120616P Levitra® film-coated Tablet

5mg

Vardenafil 5mg (as

monohydrochloride trihydrate)

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

469 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28

December 2020

POM

470 BRU11010619PS1;

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 (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

471 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

472 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

473 BRU11010624P Elomet Ointment 0.1% Mometasone Furoate (as

Anhydrous) USP 0.1%

PT. Merck Sharp Dohme Pharma

Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

474 BRU11010625 Implanon® 68mg Implant Etonogestrel (Micronised)

[Org3236] 68mg

N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

475 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

P (10 x 10's), P

(100x10's &

3,000's)476 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mg Novartis Farma S.p.A., Torree

Annunziata, Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

477 BRU11010628P Oxy-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 2021

P

478 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mg Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

479 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mg Novartis Farma S.p.A., Torree

Annunziata, Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

480 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

481 BRU11010635P Zantac SyrupTM 150mg/10ml Ranitidine (as hydrochloride)

150mg/10ml

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

482 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

P

483 BRU11010637P EngerixTM-B Adult Dose

Vaccine 20mcg/ml

Purified Hepatitis B Surface

Antigen (HBsAg) 20mcg/ml

GlaxoSmithKline Biologicals SA,

Rixensart Belgium;

GlaxoSmithKline Biologicals S.A.,

Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

484 BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus

antigen (HAV), HM175 strain 720

EL.U

GlaxoSmithKline Biologicals SA,

Rixensart Belgium;

GlaxoSmithKline Biologicals S.A.,

Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

485 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; GlaxoSmithKline

Biologicals S.A., Saint-Amand-Les-

Eaux

France

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

486 BRU11010640P Microgynon® 30 Tablet Levonorgestrel 0.15mg,

Ethinylestradiol 0.03mg

Bayer Weimar GmbH und Co., KG,

Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

487 BRU11010642P Virless Tablets 200mg Acyclovir 200mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 January 2016 till 25

January 2021

POM

488 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride)

300mg

Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

489 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

490 BRU11020645P OroxineTM Tablet 100mcg Levothyroxine (as sodium)

anhydrous 100mcg

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

491 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

492 BRU11020648P Glivec® 100mg Film-coated

Tablet

Imatinib (as mesylate) 100mg Novartis Pharma Produktions

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

493 BRU11020649P Sandostatin® Ampoules

0.05mg/ml

Octreotide (as acetate) 0.05mg/ml Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

494 BRU11020650P Levitra® film-coated Tablet

20mg

Vardenafil (as monochloride

trihydrate) 20mg

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

495 BRU11020652P Urosin® Film-coated Tablet

50mg

Atenolol 50mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

496 BRU11020653P Ibuprofen Film-coated Tablet

400mg

Ibuprofen 400mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

P

497 BRU11020654P Promethazine Syrup 5mg/5ml Promethazine HCl 5mg/5ml Drug House of Australia Pte Ltd.,

Singapore

G & H Trading Company 24 February 2016 till 23

February 2021

POM

498 BRU11020655P Voren Gel Diclofenac Sodium 10mg/g (as

Diclofenac Acid Diethylamine)

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

GSL

499 BRU11020656P Atacor 20mg Film-coated

Tablets

Atorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd 24 February 2016 till 23

February 2021

POM

BDMCA/RMP/0319 Page 32 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

500 BRU11020657P Dermosol Cream Clobetasol (as propionate)

0.5%w/w

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 February 2016 till 23

February 2021

POM

501 BRU11020658P Zendhin 150 Tablet Ranitidine (as hydrochloride)

150mg

Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 24 February 2016 till 23

February 2021

POM

502 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

2021

P

503 BRU11030662P Fucon Film Coated Tablet

10mg

Hysocine-n-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

504 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

505 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

506 BRU11030667P Clarinase Syrup 5mg/5ml Per 5ml: Loratadine 5mg,

Pseudoephedrine Sulphate 60mg

Sanofi Aventis Argentina S.A.,

Argentina

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

P

507 BRU11030668P Vivaxim Suspension and

Solution for Suspension for

Injection

Inactivated Hepatitis A Virus, GBM

Strain1,2 ………………………………1603

antigen units1 produced in MRC-5 Human

Diploid Cells2 adsorbed on hydrated aluminium

hydroxide (0.3 milligrams of Al)3 in the absence of an international

standardized reference, the

antigen content is expressed using

an in-house reference.

Vi Capsular Polysaccharide of

Salmonella Typhi (Ty2 Strain)

…...25mcg

Sanofi Pasteur, Parc industriel

d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

508 BRU11030669PS1;

BRU11030669PS2

Caelyx 2mg/ml Concentrate

for Infusion

Doxorubicin HCl 2mg/ml Alza Corporation, USA (S1);

GlaxoSmithKline Manufacturing

S.P.A., Italy (S2)

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

BDMCA/RMP/0319 Page 33 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

509 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

510 BRU11030671P Hyzaar Forte Tablet 100/25mg Losartan potassium 100mg,

Hydrochlorothiazide 25mg

Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

511 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mg GlaxoSmithKline Pharmaceuticals

S.A., Poland

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

512 BRU11030673P Topistin® Solution for IV

Infusion 200mg/100ml

Ciprofloxacin (as lactate)

200mg/100ml

Elpen Pharmaceutical Co., Inc.,

Greece.

G & H Trading Company 26 March 2016 till 25 March

2021

POM

513 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production,

France

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March

2021

POM

514 BRU11040675P Puregon® 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 (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

515 BRU11040676PS1;

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 (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

516 BRU11040678P Euvax B Adult Vaccine

Recombinant

Purified HBs-Ag 20mcg LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

517 BRU11040679P TrandateTM Injection 5mg/ml x

5ml

Labetalol HCl 25mg/5ml Hsinchu Plant of UBI Pharma Inc.,

Taiwan

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

518 BRU11040680PS2 Puregon® 50IU/0.5ml Solution

for Injection

Follitrophin Beta (recombinant

follicale-stimulating hormone (FSH)

50IU/0.5ml

N.V.Organon, The Netherlands

(S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

519 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride

0.05%w/v

HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 30 April 2016 till 29 April

2021

P

520 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 30 April 2016 till 29 April

2021

POM

521 BRU11040683P Sandostatin® LAR® Injection

10mg

Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

522 BRU11040684P Vfend TM Film-Coated Tablets

200mg

Voriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

523 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

BDMCA/RMP/0319 Page 34 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

524 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

525 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mg Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

526 BRU11040690P EngerixTM-B Paediatric Vaccine

10mcg/0.5ml

Purified HBs-Ag 10mcg GlaxoSmithKline Biologicals SA.,

Rixensart Belgium;

GlaxoSmithKline Biologicals S.A.,

Wavre

Belgium

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

527 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 30 April 2016 till 29 April

2021

POM

528 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mg Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

529 BRU11040694P Stalevo® 100/25/200mg Film-

coated Tablet

Levodopa 100mg; Carbidopa

25mg; Entacapone 200mg

Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

530 BRU11040695P RevoladeTM Film-coated Tablet

25mg

Eltrombopag 25mg [as free acid]

(as olamine)

Glaxo Operations UK Ltd (trading

as Glaxo Wellcome Operations),

UK

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

531 BRU11040696P Coversyl® Film-coated Tablet

10mg

Perindopril arginine 10mg (equiv

to perindopril 6.790mg)

Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 30 April 2016 till 29 April

2021

POM

532 BRU11040697P Atorvastatin Winthrop® 20mg

Film-coated Tablet

Atorvastatin 20mg (as calcium

20.68mg)

Saneca Pharmaceuticals a.s.,

Slovak Republic

Medipharm Sdn Bhd 30 April 2016 till 29 April

2021

POM

533 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised)

27.5µg /spray

Glaxo Operations UK Ltd, United

Kingdom

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

534 BRU11050700PS1;

BRU11050700PS2

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 (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

535 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate

150mg

Pfizer Manufacturing Belgium

N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

BDMCA/RMP/0319 Page 35 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

536 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 25 May 2016 till 24 May

2021

POM

537 BRU11050703P Levitra Film-coated Tablets

10mg

Vardenafil (as monohydrochloride

trihydrate) 10mg

Bayer Pharma AG., Germany Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

538 BRU11050704P Ventolin Solution for

Intravenous Infusion 5mg/5ml

Salbutamol (as sulphate) 5mg/5ml GlaxoSmithKline Pharmaceutical

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

539 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mg Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 25 May 2016 till 24 May

2021

P (5 x 50's)

540 BRU11050706P Zofran Injection Flexi-Amp

Ampoules

Ondansetron HCl Dihydrate

8mg/4ml

GlaxoSmithKline Australia Pty

Ltd.m Australia

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

541 BRU11050707P Caverject 20mcg Powder and

solvent for injection

Alprostadil 20µg Pfizer Manufacturing Belgium

N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

542 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.,

Germany

Medipharm Sdn Bhd 25 May 2016 till 24 May

2021

GSL (50's)

543 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 (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

544 BRU11050712P Tracrium Injection

25mg/2.5ml

Atracurium besylate 25mg/2.5ml GlaxoSmithKline Manufactuirng

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 25 May 2016 till 24 May

2021

POM

545 BRU11060714P Zantac 150mg Tablet Ranitidine 150mg (as HCl 168mg) GlaxoSmithKline (Tianjin) Co. Ltd.,

PR China

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

546 BRU11060715P Oxy-Nase Paediatric Nasal

Drop 0.025%w/v

Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 02 July 2016 till 01 July 2021 POM

547 BRU11060716P Vfend 50mg film-coated

Tablet

Voriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

548 BRU11060717P Protaxos 2g Strontium Ranelate 2632mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

549 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

550 BRU11060720P Virless Tablet 800mg Acyclovir 800mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

BDMCA/RMP/0319 Page 36 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

551 BRU11060721P Atorvastatin Winthrop® 40mg

Tablet

Atorvastatin 40mg (as Calcium

41.36mg)

Saneca Pharmaceuticals a.s.,

Slovak Republic

Medipharm Sdn Bhd 02 July 2016 till 01 July 2021 POM

552 BRU11060722P Propecia 1mg Tablet Finasteride 1mg Merck Sharp & Dohme, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

553 BRU11060723P Seroquel XR Extended-Release

Tablets 50mg

Quetiapine 50mg (as fumarate

57.560mg)

AstraZeneca Pharmaeuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021 POM

554 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The

Netherlands

Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM

555 BRU11070727P SW Bena-Expectorant Per 5ml: Diphenhydramine HCl

10mg, Ammonium Chloride

102mg, Sodium Citrate 46mg

Sunward Pharmaceutical Pte Ltd.,

Singapore

G&H Trading Company 27 July 2016 till 26 July 2021 POM

556 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 (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

557 BRU11070730P Mirena® Intrauterine System

20mcg/24hr

Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

558 BRU11070732PS1;

BRU11070732PS2

Zoral 400 Tablet 400mg Acyclovir USP 400mg Drug House of Australia Pte Ltd.,

Singapore (S1); PT Actavis

Indonesia, Jakarta, Indoensia (S2)

G & H Trading Company 27 July 2016 till 26 July 2021 POM (7 x 10’s

blister pack);

(10 x 10 x 10’s

blister pack - for

DHA only)

559 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/5ml (as HCl

dihydrate)

GlaxoSmithKline Australia Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

560 BRU11070734P Syntometrine® Injection

5IU/ml Ampoule

Oxytocin 5IU/ml Novartis Pharma Steing AG.,

Switzerland

Medipharm Sdn Bhd 27 July 2016 till 26 July 2021 POM

561 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/w HOE Pharmaceuticals Sdn Bhd.,

Malaysia

G & H Trading Company 27 July 2016 till 26 July 2021 POM

562 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 (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

BDMCA/RMP/0319 Page 37 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

563 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl

dihydrate)

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

564 BRU11070738PS1;

BRU11070738PS2

Diamicron® MR 60mg Tablet Gliclazide 60mg Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M)

Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

565 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 2016 till 26 July 2021 POM

566 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml GlaxoSmithKline Manufacturing

S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

567 BRU11070741P Coralan® Tablet 7.5mg Ivabradine 7.5mg (as HCl 8.085mg) Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021 POM

568 BRU11080742P;

BRU11080742PS2

Aclasta 5mg/10ml Solution for

Infusion

Zolendranic acid (anhydrous) 5mg

(as zolendranic acid monohydrate

5.33mg)

Novartis Pharma Stein AG.,

Switzerland; Fresenius Kabi

Austria GmbH, Austria (S2)

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

569 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

570 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

571 BRU11080745P Glivec® 400mg Film-coated

Tablet

Imatinib (as mesylate) 400mg Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

572 BRU11080746P Stalevo 50/12.5/200mg film-

coated tablet

Levodopa 50mg, Carbidopa

12.5mg, Entacapone 200mg

Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

573 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 (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

BDMCA/RMP/0319 Page 38 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

574 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

575 BRU11080749P Econazine Cream Econazole 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 2016 till 24

August 2021

POM

576 BRU11080750P Frotin Film Coated 200mg

Tablet

Metronidazole 200mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

577 BRU11080751P Urosin Film Coated Tablet

100mg

Atenolol 100mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

578 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,

Rixensart, Belgium

(Responsibilities: Manufacturer of

finished products);

GlaxoSmithKline Biologicals S.A.,

Saint-Amand-Les-Eaux, France

(Responsibilities: Repacker of

finished products);

GlaxoSmithKline Biologicals S.A.,

Wavre, Belgium (Responsibilities:

Additional facility for formulation

of non-live vaccines);

GlaxoSmithKline Biologicals,

Dresden, Germany

(Responsibilities: Additional

facility for syringe filling,

packaging and labelling)

Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

579 BRU11080753P Fukole Capsule 150mg Fluconazole 150mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

580 BRU11080754P CoAprovel Tablet 300/25mg Irbesartan 300mg,

Hydrochlorothiazide 25mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 25 August 2016 till 24

August 2021

POM

581 BRU11080757P Orphenadol® Tablet Orphenadrine Citrate 50mg,

Paracetamol 325mg

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

582 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

583 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

BDMCA/RMP/0319 Page 39 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

584 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24

August 2021

POM

585 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 27 September 2016 till 26

September 2021

POM

586 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,

Rixensart Belgium;

GlaxoSmithKline Biologicals S.A.,

Saint-Amand-Les-Eaux

France; GlaxoSmithKline

Biologicals S.A., Wavre

Belgium;

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

587 BRU11090764P Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(10ml)

Oxaliplatin 50mg/10ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 27 September 2016 till 26

September 2021

POM

588 BRU11090765P Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(20ml)

Oxaliplatin 100mg/20ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 27 September 2016 till 26

September 2021

POM

BDMCA/RMP/0319 Page 40 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

589 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 (Manufacturer of finished

products); GlaxoSmithKline

Biologicals S.A. France (Repacker

of finished products, additional

facilities for formulation, filling

and quality control testing sites)

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

590 BRU11090767P Sandimmun Neoral® Oral

Solution 100mg/ml

Ciclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

591 BRU11090768P Hyzaar® Tablet 50/12.5mg Losartan Potassium 50mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

592 BRU11090769P Hyzaar® Plus Tablet

100/12.5mg

Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

593 BRU11090770P Flebogamma 5% DIF Solution

for Infusion (100mL)

Human Normal Immunoglobulin

50mg/ml

Instituo Grifols S.A., Barcelona,

Spain

Hongkiat Trading & Company 27 September 2016 till 26

September 2021

POM

594 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

595 BRU11090772P Diabetamin Film-coated

Tablet 500mg

Metformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company 27 September 2016 till 26

September 2021

POM

596 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 2016 till 26

September 2021

POM

597 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

598 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

599 BRU11090776P Virless Cream Acyclovir 50mg/g Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 27 September 2016 till 26

September 2021

POM

600 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate

6.90mg)

Hovid Bhd, Malaysia G & H Trading Company 27 September 2016 till 26

September 2021

POM

601 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan.

, Japan

MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

BDMCA/RMP/0319 Page 41 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

602 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan.

, Japan

MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

603 BRU11100781PS2 Puregon® 100IU/0.5ml

Solution for Injection

Follitropin beta (recombinant

follicle-stimulating hormone - FSH)

100IU/0.5ml

N.V. Organon, The Netherlands

(S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

604 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 (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

605 BRU11100784P Sandostatin® ampoules

0.1mg/ml

Octreotide (as acetate) 0.1mg/ml Novartis Pharma Stein A.G.,

Switzerland

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

606 BRU11100785P Atorvastatin Winthrop® 10mg

film-coated Tablets

Atorvastatin 10mg (as calsium

10.34mg)

Saneca Pharmaceuticals a.s.,

Slovak Republic

MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

607 BRU11100786P Stalevo® 150/37.5/200mg

Film-coated Tablet

Levodopa 150mg; Carbidopa

37.5mg; Entacapone 200mg

Orion Corporation Fermion,

Finland

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

608 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 (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

609 BRU11100788P Coversyl® Fim-coated Tablet

5mg

Perindopril arginine 5mg (eqv.

Perindopril 3.395mg)

Les Laboratoires Servier Industrie,

Gidy, France

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

610 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture,

Japan

MediPharm Sdn Bhd 31 October 2016 till 30

October 2021

POM

BDMCA/RMP/0319 Page 42 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

611 BRU11100790P VarilrixTM Live attenuated varicella virus

(OKA strain)

GlaxoSmithKline Biologicals SA,

Rixensart, Belgium

(Manufacturer of finished

product); (Corixa Corporation dba

GlaxoSmithKline Vaccines, USA

(formulation, filling, lyophilisation

and QC testing)

GlaxoSmithKline Biologicals SA,

Rixensart, Belgium (Manufacturing

site for Water for Injection (WFI)

diluents in syringe and ampoule);

Delpharm Tours, Chambray-lès-

Tours, France (Manufacturing site

for Water for Injection (WFI)

diluents in ampoules);

GlaxoSmithKline Biologicals S.A.,

Wavre, Belgium

& GlaxoSmithKline Biologicals,

Saint-Amand-Les-Eaux, France &

Centre de Recherche et de

Nouvelles Applications (CRNA) SA,

Belgium (Manufacturing site for

final packaging operations)

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

612 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 (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

613 BRU11100792P Voker Film Coated Tablet

20mg

Famotidine 20mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

614 BRU11100794P Clarityn-D 12HR EXTENDED

RELEASE TABLET 5mg/120mg

Loratadine 5mg, Pseudoephedrine

sulphate 120mg

Schering Plough Labo N.V.,

Belgium

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

BDMCA/RMP/0319 Page 43 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

615 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt,

Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

616 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt,

Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30

October 2021

POM

617 BRU11110797P OnglyzaTM Tablet 2.5mg Saxagliptin 2.5mg (as HCl

anhydrous 2.79mg)

Bristol-Myers Squibb Company,

Indiana, USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

618 BRU11110798P OnglyzaTM Tablet 5mg Saxagliptin 5mg (as HCl anhydrous

5.58mg)

Bristol-Myers Squibb Company,

Indiana, USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

619 BRU11110799P Sandostatin® LAR® Injection

20mg

Octreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

620 BRU11110800P Sandostatin® LAR® Injection

30mg

Octreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

621 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 (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

622 BRU11110803P Nexavar® 200mg Film-coated

Tablets

Sorafenib Tosylate 200mg Bayer Pharma AG., Leverkusen,

Germany; Bayer Healthcare

Manufacturing S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

623 BRU11110804P PEG 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 (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

624 BRU11110805P PEG Intron CLEARCLICK for

Injection 120mcg/0.5ml

Recombinant interferon alfa-2b

120mcg (pegylated to monoethoxy

polyethylene glycol)

Schering-Plough Ltd., Singapore Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

625 BRU11110806P PEG Intron CLEARCLICK for

Injection 100mcg/0.5ml

Recombinant interferon alfa-2b

100mcg (pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH

(Singapore Branch), Singapore

Singapore

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

626 BRU11110807P PEG 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 (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

BDMCA/RMP/0319 Page 44 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

627 BRU11110808P PEG 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 (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

628 BRU11110809P Dalacin CTM Sterile Solution

150mg/ml x 2ml ampoule

Clindamycin Phosphate 300mg Pfizer Manufacturing Belgium

N.V., Puurs, Belgium

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

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

Donepezil free base 4.56mg)

Eisai Taiwan Inc., Tainan Hsien,

Taiwan

MediPharm Sdn Bhd 24 November 2011 till 23

November 2016

POM

630 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt,

Germany

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

631 BRU11110813P Ketipinor Film-coated Tablet

200mg

Quetiapine 200mg (as fumarate

230.36mg)

Orion Corporation, Espoo, Finland Hongkiat Trading & Company 24 November 2016 till 23

November 2021

POM

632 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 November 2016 till 23

November 2021

POM

633 BRU11110815P Granocyte® 34 Injection Lenograstim (rHug-CSF) 33.6

million IU (equiv. to 263 mcg)/ vial

Sanofi Winthrop Industrie, France MediPharm Sdn Bhd 24 November 2016 till 23

November 2021

POM

634 BRU11120816P Euvax B Pediatric Vaccine

Recombinant (10mcg/0.5ml)

Purified HBs-Ag 10mcg/0.5ml LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

635 BRU11120817P Puregon® 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, Ravensburg

Germany

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

636 BRU11120818P Clarityn Syrup Loratadine 1mg/ml PT. Merck Sharp Dohme Pharma

Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

P

BDMCA/RMP/0319 Page 45 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

637 BRU11120819P0.5gV

&

BRU11120819P0.5gS

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

Note: 1 adsorbed on aluminium

phosphate - 0.5mg Al3+; 2

conjugated to protein D (derived

from non-typeable Haemophilus

influenza) carrier protein - 9-

16mcg; 3 conjugated to tetanus

toxoid carrier protein - 5-10mcg; 4

GlaxoSmithKline Biologicals SA,

Rixensart Belgium; Glaxo

SmithKline Biologicals SA, Saint-

Amand-Les-Eaux

France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

638 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)

100mcg

Glaxo Wellcome S.A., Burgos,

Spain

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

639 BRU11120822P RevoladeTM 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 (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

BDMCA/RMP/0319 Page 46 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

640 BRU11120823P Coversyl® Plus 5mg Perindopril arginine 5mg (as

besilate 3.395mg); Indapamide

1.25mg

Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

641 BRU11120824P Yasmin® Film-coated Tablets Drospirenone 3mg, Ethinylestradiol

0.03mg

Bayer Weimar GmbH und Co. KG

(WEIMAR PLANT), Germany

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

642 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21

December 2021

GSL

643 BRU11120827P Methycobal Injection

500mcg/ml

Mecobalamin 500mcg Bushu Pharmaceuticals Ltd, Japan MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

644 BRU11120828P Flebogamma® 5% DIF Solution

for Infusion (200ml)

Human Normal Immunoglobulin

10g/200mL (50mg/ml)

Instituto Grifols, S.A., Spain Hongkiat Trading 22 December 2016 till 21

December 2021

POM

645 BRU11120829P Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

646 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/w Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

GSL

647 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

648 BRU11120832P Clopivid Tablet 75mg Clopidogrel 75mg (as hydrogen

sulphate 97.90mg)

Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21

December 2021

POM

649 BRU11120833P Shincort Injection “Yung Shin”

10mg/ml

Triamcinolone Acetonide

50mg/5ml

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan ROC

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

650 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate

13.8mg)

Hovid Bhd, Malaysia G & H Trading Company 22 December 2016 till 21

December 2021

POM

651 BRU11120835P Indomen Capsule 25mg Indomethacin 25mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

652 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21

December 2021

POM

653 BRU11120837P Primacor® 10mg/10ml

Injection

Milrinone 10mg/10ml (as lactate) Delpharm Dijon, France MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

654 BRU11120838NP Champs D-Worms 6 Chewable

Tablet (Chocolate)

Albendazole 200mg Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading & Company 22 December 2016 till 21

December 2021

GSL (2's)

655 BRU11120839P Epilim® 200 Enteric Coated

Tablets

Sodium Valproate 200mg Sanofi-Aventis S.A., Spain MediPharm Sdn Bhd 22 December 2016 till 21

December 2021

POM

BDMCA/RMP/0319 Page 47 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

656 BRU12010840P InfanrixTM-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 (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

657 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mg Pfizer Pharmaceuticals LLC, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

658 BRU12010842P Valdoxan® 25mg film-coated

tablet

Agomelatine 25mg Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

659 BRU12010843P Zofran Tablet 4mg Ondansetron (as Hydrochloride

Dihydrate) 4mg

Aspen Bad Oldesloe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

660 BRU12010844P Flebogamma® 5% DIF Solution

for Infusion (50ml)

Human Normal Immunoglobulin

2.5g/50mL (50mg/ml)

Instituto Grifols, S.A., Spain Hongkiat Trading & Co 01 February 2017 till 31

January 2022

POM

661 BRU12010845P Coralan® Tablet 5mg Ivabradine 5mg eq. to 5.39mg

ivabradine hydrochloride

Les Laboratoires Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

662 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

663 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

664 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

BDMCA/RMP/0319 Page 48 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

665 BRU12010851NP Princi-B Fort® tablet Thiamin mononitrate 250mg,

Pyridoxine hydrochloride 250mg &

Cyanocobalamin 1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2017 till 31

January 2022

P

666 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 2017 till 31

January 2022

GSL

667 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

668 BRU12010854P Ketipinor film-coated tablet

100mg

Quetiapine (as fumarate

115.13mg) 100mg

Orion Corporation, Finland Hongkiat Trading & Co 01 February 2017 till 31

January 2022

POM

669 BRU12010855P Euthyrox® Tablet 50mcg Levothyroxine sodium 50mcg Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31

January 2022

POM

670 BRU12010856NP Panadol Suspension

250mg/5ml

Paracetamol 250mg/5ml Smithkline Beecham, Philippines Kingston Beverage &

Creamery Sdn Bhd

01 February 2017 till 31

January 2022

GSL

(60ml/120ml)671 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml

(200mg/vial)

Sanofi S.p.A, Italy MediPharm Sdn Bhd 01 February 2017 till 31

January 2022

POM

672 BRU12020858P Sebivo™ Tablet 600mg Telbivudine 600mg Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

673 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

674 BRU12020862P Ketipinor Film-coated Tablet

25mg

Quetiapine (as fumarate 28.78mg)

25mg

Orion Corporation, Finland Hongkiat Trading & Co 1 March 2017 till 28

February 2022

POM

675 BRU12020863P Taxotere 20mg/1ml

concentrate for solution for

infusion

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

GmbH, Germany

MediPharm Sdn Bhd 1 March 2017 till 28

February 2022

POM

676 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg

(eq. to 9.4mg Lercanidipine)

Recordati Industria Chimica &

Farmaceutica S.p.A, Italy

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

677 BRU12020865PS1 Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A,

Italy (S1);

G & H Trading Company 1 March 2017 till 28

February 2022

POM

678 BRU12020866P Apidra® Solostar®

100units/ml, Solution for

Injection in a Pre-filled Pen

Insulin Glulisine 100units/ml Sanofi-Aventis Deutschland

GmbH, Germany

MediPharm Sdn Bhd 1 March 2017 till 28

February 2022

POM

679 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

680 BRU12020868P Betnovate™ Cream Betamethasone 0.1%w/w (as

Betamethasone 17-Valerate BP

0.122% w/w)

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

BDMCA/RMP/0319 Page 49 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

681 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05%

w/w

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

682 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28

February 2022

POM

683 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom

25mg

Sterling Drug (Malaya) Sdn Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 March 2017 till 29 March

2022

P (12 x 10's)

684 BRU12030872NP Panaflex® 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 2017 till 29 March

2022

GSL

685 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

686 BRU12030875P DetrusitolTM SR Capsule 4mg Tolterodine L-Tartrate 4mg

(equivalent to Tolterodine 2.74mg)

Catalent Pharma Solutions LLC,

USA

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

687 BRU12030876NP Ellgy Corns & Warts

Treatment Solution

Salicylic acid 17%w/v HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 30 March 2017 till 29 March

2022

P

688 BRU12030877P Puregon® 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 (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

689 BRU12030879P Methotrexate Injection BP

50mg in 2ml

Methotrexate 50mg/2ml Pfizer (Perth) Pty Limited,

Australia

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

690 BRU12030880NP Aqua Cream Emulsifying 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 2017 till 29 March

2022

GSL

691 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mg Pfizer Pharmaceuticals LLC., vega

Baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

692 BRU12030882P Cancidas Powder for Injection

50mg/vial

Caspofungin (as acetate) 50mg/vial Laboratoires Merck Sharp &

Dohme Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March

2022

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

693 BRU12030883P Axcel Dextrozine Syrup Dextromethorphan Hydrobromide

15mg/5ml; Promethazine HCl

3.6mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 March 2017 till 29 March

2022

POM

694 BRU12040884P Dilantin Steri Vials 250mg in

5ml

Phenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

695 BRU12040885P Jevtana® 60mg Concentrate

and Solvent for Solution for

Infusion

Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 30 April 2017 till 29 April

2022

POM

696 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing

S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

697 BRU12040887NP Panadol Suspension

120mg/5ml

Paracetamol 120mg/5ml SmithKline Beecham, Cainta Rizal,

Philippines

Kingston Beverage &

Creamey Sdn Bhd

30 April 2017 till 29 April

2022

GSL (60ml

& 120ml)698 BRU12040888P Cancidas Powder for Injection

70mg/vial

Caspofungin (as acetate) 70mg/vial Laboratoires Merck Sharp &

Dohme Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

699 BRU12040889PS1 &

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 (B) Sdn Bhd 30 April 2017 till 29 April

2022

POM

700 BRU12040891P Axcel Diprodin Elixir Diphenhydramine HCl 12.5mg/5ml;

Ephedrine HCl 6mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

701 BRU12040892NP Axcel Paracetamol-120 Syrup

(Cherry)

Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

GSL (60ml &

100ml)702 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

703 BRU12040894P Axcel Tridine Syrup Triprolidine HCl 1.25mg/5ml;

Pseudoephedrine HCl 30mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

704 BRU12040895P Axcel Lignocaine Sterile Gel

2%w/w

Lignocaine HCl (Equiv. to

anhydrous HCl) 2g/100g

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022

POM

705 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company,

USA (Repacker - Fareva Amboise,

France)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

BDMCA/RMP/0319 Page 51 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

706 BRU12050898P Lamictal Dispersible Tablet

5mg

Lamotrigine 5mg GlaxoSmithKline Pharmaceuticals

SA., Poznan, Poland (Repacker -

GlaxoSmithKline Australia Pty Ltd.,

ViCtoria, Australia)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

707 BRU12050899P HycamtinTM Hard Capsule

0.25mg

Topotecan 0.25mg (as

hydrochloride)

GlaxoSmithKline Manufacturing

S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

708 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V.,

Belgium

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

709 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/w Recipharm Parets S.L., Barcelona,

Spain

Mc Quipp Technisell

Marketing Sdn Bhd

24 May 2017 till 23 May

2022

P

710 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V.,

Belgium

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

711 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg GlaxoSmithKline Dungravan Ltd,

Ireland (Repacker - Sterling Drug

(Malaya) Sdn Bhd., Malaysia

Kingston Beverage &

Creamery Sdn Bhd

24 May 2017 till 23 May

2022

P ( 48's; 80's (8

tabs per blister)

per box)

712 BRU12050904P Vaxcel Heparin Sodium

Injection 5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa)

25,000/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 24 May 2017 till 23 May

2022

POM

713 BRU12050905P Pregnyl® 5000IU Powder and

Solvent for Injection

Human chorionic gonadotrophin

5000IU/ampoule

Diluent-0.9% sodium chloride

N.V. Organon, The Netherlands;

Jubilant HolisterStier LLC, USA

(manufacturer of diluent - Sodium

chloride)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May

2022

POM

714 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd 30 June 2017 till 29 June

2022

POM

715 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg Pfizer Manufacturing Deutschland

GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

716 BRU12060910NP Panadol® Soluble Tablet

500mg

Paracetamol 500mg GlaxoSmithKline Australia Pty Ltd,

Ermington, NSW, Australia

Kingston Beverage &

Creamery Sdn Bhd

30 June 2017 till 29 June

2022

GSL

(20's) & P (144's)

717 BRU12060911NP Panadol For Children Tablets

120mg

Paracetamol 120mg Sterling Drug (Malaya) Sdn Bhd.,

Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 June 2017 till 29 June

2022

P (24's &

144's)718 BRU12060912P Canesten GYN 1 Day Therapy

Vaginal Tablet 0.5g

Clotrimazole 500mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

BDMCA/RMP/0319 Page 52 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

719 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mg Corden Pharma GmbH,

Plankstadt, Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

720 BRU12060915NP 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 2017 till 29 June

2022

GSL (55g)

721 BRU12060916P Rhewlin Gel 1%w/w Diclofenac Diethylamine equiv. to

Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading & Company 30 June 2017 till 29 June

2022

GSL

722 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg Pfizer Ireland Pharmacueticals,

Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June

2022

POM

723 BRU12070918P Beclomet Nasal Aqua

50mcg/dose Nasal Spray

Beclomethasone dipropionate

50mcg/dose

Orion Corporation, Kuopio,

Finland

Hongkiat Trading & Company 30 July 2017 till 29 July 2022 POM

724 BRU12070920NP Panadol® Biconvex Film-

coated Tablet 500mg

Paracetamol 500mg Sterling Drug (Malaya) Sdn Bhd.,

Selangor, Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2017 till 29 July 2022 P (50's, 3 x 10's &

15 x 10's)725 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 2017 till 29 July 2022 GSL

726 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 2017 till 29 July 2022 GSL

727 BRU12070923P Coversyl Plus 10mg/2.5mg

Tablet

Perindopril arginine 10mg (equiv.

to 6.79mg perindopril);

Indapamide 2.5mg

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

728 BRU12070924P RotarixTM oral Suspension Human rotavirus RIX4414 strain,

not less than 106.0 CCID50

GlaxoSmithKline Biological SA,

Belgium

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

BDMCA/RMP/0319 Page 53 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

729 BRU12070925P CutivateTM Cream Fluticasone propionate

(micronised) 0.05%w/w

Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

730 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/w GP Genzech Produktions GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 GSL

731 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1%

w/w

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 July 2017 till 29 July 2022 POM

732 BRU12070928P Sevoflurane Inhalation

Anaesthetic Liquid 100%

Sevoflurane 100% (1ml/ml) Baxter Healthcare Corporation,

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022 POM

733 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg Pfizer Ireland Pharmaceuticals,

Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 29 August 2017 till 28

August 2022

POM

734 BRU12090933P Xarelto® Film-coated Tablet

10mg

Rivaroxaban 10mg Bayer Pharma AG, Leverkusen,

Germany

Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26

September 2022

POM

735 BRU12090937P Telfast 6mg/ml Oral

Suspension

Fexofenadine Hydrochloride

6mg/ml

Sanofi-Aventis Farmceutica Ltd,

Vila Areiao Suzano-SP-Brasil

Medipharm Sdn Bhd 27 September 2017 till 26

September 2022

POM

736 BRU12090938P Glucophage® XR 750mg

Extended Release Tablet

Metformin HCl 750mg Merck KGaA, Germany; Merck

Sante SAS, Semoy, France

Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26

September 2022

POM

737 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26

September 2022

POM

738 BRU12100940NP Dermoplex Calamine Cream Calamine (Fine) 4.00%; Zinc Oxide

3.00% w/w

Upha Pharmaceutical Mfg (M) Sdn

Bhd

Hongkiat Trading & Company 31 October 2018 till 30

October 2023

GSL

739 BRU12100941P;

BRU12100941PS2FragminTM Solution for

Injection 5,000IU (anti-

Xa)/0.2ml

Dalteparin Sodium 5,000IU (anti-

Xa)/0.2ml

Vetter Pharma-Fertigung GmbH &

Co., Germany; Pfizer

Manufacturing Belgium NV, Puurs,

Belgium (S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

POM

740 BRU12100942P Prostin E2TM Vaginal Tablet

3mg

Dinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

POM

741 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, Singapore Medipharm Sdn Bhd 31 October 2017 till 30

October 2022

POM

742 BRU12100944NP Potassium Chloride Tablet

600mg (Slow release)

Potassium Chloride 600mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 31 October 2017 till 30

October 2022

P (500's)

743 BRU12100945NP Anucare Suppositories Zinc Oxide 300mg; Balsam Peru

50mg; Benzyl Benzoate 33mg

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 31 October 2017 till 30

October 2022

GSL

BDMCA/RMP/0319 Page 54 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

744 BRU12100947P Illiadin Nasal Decongestant

Solution 0.01%

Oxymetazoline Hydrochloride

0.01%

Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

P

745 BRU12100948P Renvela (Sevelamer

Carbonate) Tablet 800mg

Sevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd 31 October 2017 till 30

October 2022

POM

746 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg Pfizer Manufacturing Deutschland

GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2022

POM

747 BRU12100950P QvarTM 100 Inhaler Beclomethasone dipropionate

100mcg per inhalation

3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30

October 2021

POM

748 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Medipharm Sdn Bhd 31 October 2017 till 30

October 2021

POM

749 BRU12110953P;

BRU12110953PS2FragminTM 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; Pfizer

Manufacturing Belgium NV, Puurs,

Belgium (S2)

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

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

150mg

Pfizer Ireland Pharmaceuticals,

Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

751 BRU12110955P Eprex® 4000 Prefilled Syringe

4000IU/0.4ml

Epoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

752 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

753 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 November 2017 till 26

November 2022

GSL

754 BRU12110957PS1;

BRU12110957PS2

Actrapid® 100IU/ml Solution

for Injection

Insulin Human (rDNA) 100iu/ml Novo Nordisk A/S, Denmark (S1);

Novo Nordisk Production SAS,

France (S2)

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

755 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

756 BRU12110959P Eprex® 2000 Prefilled Syringe

2000IU/0.5ml

Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

757 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

GSL

758 BRU12110962P Tenol-100 Atenolol 100mg Sunward Pharmaceutical Pte Ltd,

Singapore

G & H Trading Company 27 November 2017 till 26

November 2022

POM

BDMCA/RMP/0319 Page 55 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

759 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 2017 till 26

November 2022

GSL (200ml);

GSL (3.8L)

760 BRU12110964P Exjade 125mg Dispersible

Tablets

Deferasirox 125mg Novartis Pharmas Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

761 BRU12110965P Exjade 500mg Dispersible

Tablets

Deferasirox 500mg Novartis Pharmas Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26

November 2022

POM

762 BRU12110966P Dhamotil Tablets Diphenoxylate HCl BP 2.5mg;

Atropine Sulphate 0.025mg

Drug Houses of Australia Pte Ltd.,

Singapore

G & H Trading Company 27 November 2017 till 26

November 2022

POM

763 BRU12120967P CervarixTM 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 (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

764 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 SA, Singapore Medipharm Sdn Bhd 27 December 2017 till 26

December 2022

POM

765 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 2017 till 26

December 2022

GSL

766 BRU12120970P Clementin 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 2017 till 26

December 2022

POM

767 BRU12120971P Survanta® Beractant

Intratracheal Suspension

Beractant (as phospholipids)

25mg/ml

AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

768 BRU12120972P Humira Solution for Injection

40mg/0.8ml

Adalimumab 40mg/0.8ml Vetter-Pharma-Fertigung GmbH &

Co., KG, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

BDMCA/RMP/0319 Page 56 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

769 BRU12120973P ZyprexaTM Tablet 10mg Olanzapine 10mg Lilly del Caribe Inc, Puerto Rico,

USA & Lilly S.A., Madrid, Spain

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

770 BRU12120974P SutentTM Hard Capsules

12.5mg

Sunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno,

Italy

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

771 BRU12120975PS1 ;

BRU12120975PS2

Stelara Solution for Injection

in pre-filled syringe

45mg/0.5ml

Ustekinumab 45mg/0.5ml Baxter Pharmaceutical Solutions

LLC, Blommington, United States

(S1);

Cilag AG, Hochstrassse 201, 8200

Schaffhausen. Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

772 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

773 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

774 BRU12120978P Aerrane (Isoflurane USP)

Inhalation Liquid

Isoflurane USP 100% Baxter Healthcare Corporation,

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

775 BRU12120979P Kogenate FS for Injection

250IU/vial

Antihaemophilic Factor

(recombinant) sucrose formulated

250IU

Bayer Healthcare LLC., United

States

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

776 BRU12120980NP Potcit Mixture Per 5ml contains Potassium Citrate

1g; Citric acid anhydrous 200mg

Beacons Pharmaceutical Pte Ltd.,

Singapore

Hongkiat Trading & Company 27 December 2017 till 26

December 2022

P (3.8L)

777 BRU12120981P Garbose Tablet 100mg Acarbose 100mg Y.S.P Industries (M) Sdn Bhd.,

Selangor Darul Ehsan, Malaysia

Asterix United (B) Sdn Bhd 27 December 2017 till 26

December 2022

POM

778 BRU13010982P KombiglyzeTM XR Tablet

5/1000mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

1000mg

AstraZeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

779 BRU13010983P KombiglyzeTM XR Tablet

5/500mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

500mg

AstraZeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

780 BRU13010984P KombiglyzeTM XR Tablet

2.5/1000mg

Saxagliptin HCl 2.5mg (as

anhydrous 2.79mg); Metformin

Hydrochloride 1000mg

AstraZeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

781 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg Recordati Industria Chimica &

Farmaceutica S.p.A., Milan, Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

BDMCA/RMP/0319 Page 57 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

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

Malaysia

Asterix United (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

783 BRU13010988P Co-Trimexazole Suspension Per 5ml - Sulphamethoxazole BP

200mg; Trimethoprim 40mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & CO 26 January 2018 till 25

January 2023

POM

784 BRU13010991P Humulin 30/70 Injection

100iu/ml (vial)

Human insulin* 100IU/mL

*In the proportion of 30% Soluble

Insulin to 70% Isophane Insulin

Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

785 BRU13010993P FML® Liquifilm Sterile

Opthalmic Solution 0.1%

Fluorometholone 0.1%w/v Allergan Pharmaceuticals Ireland,

Ireland

Medipharm Sdn Bhd 26 January 2018 till 25

January 2023

POM

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

Pharma), Ireland

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

787 BRU13010996P Seretide Evohaler 25/125mcg Per actuation - Fluticasone

propionate 125mcg; Salmetarol

25mcg (as xinafoate)

Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

788 BRU13010997P Glucophage® Tablet 850mg Metformin HCl 850mg

(~Metformin 662.9mg)

Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

789 BRU13010998PS1;

BRU13010998PS2Revlimid®Capsules 5mg Lenalidomide 5mg Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

790 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 January 2018 till 25

January 2023

GSL

791 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 26 January 2018 till 25

January 2020

POM

792 BRU13011003P Nimotop Infusion Solution

0.02%

Nimodipine 0.01g/50ml Bayer Schering Pharma AG,

Leverkeusen, Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

793 BRU13011005P Zyprexa 5mg Tablet Olanzapine 5mg Lilly del Caribe Inc., Puerto Rico,

USA & Lilly, S.A., Spain

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25

January 2023

POM

794 BRU13021006P Canesten GYN 6 day 6-Day-

Therapy

Clotrimazole 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

P

795 BRU13021008P Prevenar 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

Pfizer Ireland Pharmaceuticals,

Dublin, Ireland

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

BDMCA/RMP/0319 Page 58 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

796 BRU13021009P Hemabate Sterile Solution

250mcg/ml

Carboprost (as tromethamine)

250mcg/ml

Pharmacia & Upjohn Company

LLC, USA

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

797 BRU13021011P Extraneal 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, Singapore Medipharm Sdn Bhd 26 February 2018 till 25

February 2023

POM

798 BRU13021012P Afinitor Tablet 10mg Everolimus 10mg Novartis Pharma Stein AG, Stein,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

799 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2018 till 25

February 2023

POM

800 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

801 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mg Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading & Co 26 February 2018 till 25

February 2023

POM

802 BRU13021017P Hydrogen 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 2018 till 25

February 2023

GSL

803 BRU13021018P Inpanol Tablets 40mg Propranolol BP 40mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 26 February 2018 till 25

February 2020

POM

804 BRU13021019P Stilamin 3000 for Injection

3mg/ampoule

Somatostatin (as acetate) 3mg Merck Serono SA, Aubonne,

Switzerland

G&H Trading Company 26 February 2018 till 25

February 2023

POM

805 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 2018 till 25

February 2023

P

806 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 26 February 2018 till 25

February 2023

GSL

807 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2ml Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan, ROC

Asterix United (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

808 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg Noripharma Sdn Bhd, Selangor

Darul Ehsan, Malaysia

K-Seri Pharma Sdn Bhd 26 February 2018 till 25

February 2023

POM

809 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE)

0.625mg/g

Pfizer Canada Inc., Canada Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

810 BRU13021026P Kaletra Film-coated Tablet

200mg/50mg

Lopinavir 200mg; Ritonavir 50mg AbbVie Deutschland GmbH & Co.

KG, Germany

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

BDMCA/RMP/0319 Page 59 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

811 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 (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

812 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25

February 2023

POM

813 BRU13031029NP Panadol Extend Tablet Paracetamol 665mg GlaxoSmithKline Consumer

Healthcare Australia Pty Ltd.,

Australia

Kingston Beverage &

Creamery Sdn Bhd

28 March 2018 till 27 March

2023

P (8 x 6's)

814 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March

2023

GSL

815 BRU13031033PS1;

BRU13031033PS2

Metoclopramide Tablet 10mg Metoclopramide HCl BP

(equivalent to Metoclopramide HCl

anhydrous 10mg)

Drug House of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 28 March 2018 till 27 March

2020

POM

816 BRU13031034P Loperamil Tablet 2mg Loperamide 2mg Drug House of Australia Pte Ltd,

Singapore

G & H Trading Company 28 March 2018 till 27 March

2020

POM

817 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Co 28 March 2018 till 27 March

2023

POM

818 BRU13031036P Dhacort Cream 1%w/w Hydrocortisone acetate BP

(micronised) 1% w/w

Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 28 March 2018 till 27 March

2020

POM

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

Malaysia

Asterix United (B) Sdn Bhd 28 March 2018 till 27 March

2023

POM

820 BRU13031038P Solcoseryl Dental Adhesive

Paste

Per g - Solcoseryl CMC 2.125mg;

Polidocanol 10mg

Legacy Pharmaceuticals

Switzreland GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March

2023

POM

821 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2018 till 27 March

2023

POM

822 BRU13031040P Intril SR 1.5mg Tablets Indapamide 1.5mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 28 March 2018 till 27 March

2023

POM

823 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March

2023

POM

824 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March

2023

POM

BDMCA/RMP/0319 Page 60 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

825 BRU13031045P Recormon Pre-filled Syringe

2000IU/0.3ml

Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH,

Germany

MediPharm Sdn Bhd 28 March 2018 till 27 March

2023

POM

826 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March

2023

POM

827 BRU13031047P Recormon Pre-filled Syringe

4000IU/0.3ml

Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH,

Germany

MediPharm Sdn Bhd 28 March 2018 till 27 March

2023

POM

828 BRU13031049P Saizen for Injection

3.33mg/vial

Somatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company 28 March 2018 till 27 March

2023

POM

829 BRU13031050P;

BRU13031050PS2

Isentress 400mg Tablet Raltegravir 400mg (as potassium

434.4mg)

MSD Technology Singapore Pte

Ltd., Singapore; MSD International

GmbH, Ireland (S2)

Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March

2023

POM

830 BRU13041051P Taxotere 80mg/4ml

Concentrate for Solution for

Infusion

Docetaxel trihydrate 80mg/4ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 30 April 2018 till 29 April

2023

POM

831 BRU13041052P Fosamax Plus Tablet

70mg/5600IU

Alendronic Acid 70mg (as Sodium

91.37mg); Colecalciferol 140mcg

(5,600IU)

MSD Frosst Iberica, S.A., Madrid,

Spain

Zuellig Pharma (B) Sdn Bhd 30 April 2018 till 29 April

2023

POM

832 BRU13041053P Glucovance Tablet

500mg/2.5mg

Metformin HCl 500mg,

Glibenclamide 2.5mg

Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 30 April 2018 till 29 April

2023

POM

833 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd

Malaysia

K-Seri Pharma Sdn Bhd 30 April 2018 till 29 April

2023

POM

834 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/w Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

GSL

835 BRU13041058P Pegasys Pre-filled Syringe

180mcg/0.5ml

Peginterferon alfa-2a

180mcg/0.5ml

F Hoffman-La Roche Ltd,

Switzerland; ; F Hoffman-La Roche

Ltd, Betriebsstandort Kaiseraugst

(Parenterals), Switzerland

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

POM

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

Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April

2023

POM

837 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Delpharm Milano S.r.I., Via

Carnevale 1, 20090, Segrate

(Milano), Italy

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

POM

838 BRU13041061NP Venofer® 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 2018 till 29 April

2023

POM

BDMCA/RMP/0319 Page 61 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

839 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3%

w/w

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

GSL

840 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April

2023

POM

841 BRU13041064P Lezpain film-coated tablet

135mg

Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April

2023

POM

842 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany

[Repacker: Beacons

Pharmaceuticals Pte Ltd., 21 Chin

Bee Avenue, Singapore]

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

GSL

843 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/v Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April

2023

GSL

844 BRU13061069P Votrient™ Film-coated tablets

200mg

Pazopanib (as hydrochloride)

200mg

Glaxo Operations UK Ltd,

Hertfordshire, UK

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

845 BRU13061070PS1;

BRU13061070PS2;

BRU13061070PS3

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

(S1); Novo Nordisk A/S, Bagsværd,

Denmark (S2); Novo Nordisk

Production SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

846 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The

Netherlands

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

847 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 04 June 2018 till 03 June

2023

POM

848 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2018 till 03 June

2023

POM

849 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 2018 till 03 June

2023

POM

850 BRU13061076P Xeloda™ Tablets 500mg Capecatibine 500mg Productos Roche S.A. de C.V,

Mexico

Hongkiat Trading & Co 04 June 2018 till 03 June

2023

POM

851 BRU13061077P Chloramphenicol Eye

Ointment

Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June

2018

POM

852 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, China Kingston Beverage &

Creamery Sdn Bhd

04 June 2018 till 03 June

2023

GSL (2's)

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

polymaltose complex] 10mg/ml

Vifor S.A., Switzerland Medipharm Sdn Bhd 04 June 2018 till 03 June

2023

GSL

854 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited,

United Kingdom

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

BDMCA/RMP/0319 Page 62 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

855 BRU13061081P Keppra 250mg Film-coated

Tablet

Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

856 BRU13061082P Keppra 500mg Film-coated

Tablet

Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

857 BRU13061083PS1,

BRU13061083PS2,BR

U13061083PS3,

BRU13061083PS4

Avastin Concentrate For

Solution For Infusion

400mg/16ml

Bevacizumab 400mg/16ml 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)

Hongkiat Trading & Co 04 June 2018 till 03 June

2023

POM

858 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V,

Mexico

Hongkiat Trading & Co 04 June 2018 till 03 June

2023

POM

859 BRU13061085P Uripax Film-coated Tablet

200mg

Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 04 June 2018 till 03 June

2023

POM

860 BRU13061087P Elonva Solution for Injection

150mcg/0.5ml

Corifollitrophin alfa 150mcg/0.5ml Vetter Pharma-Fertigung GmbH &

Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June

2023

POM

861 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 Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June

2023

POM

862 BRU13061090NP Ciproxol (Ciprofloxacin) 0.2%

w/v Intravenous Infusion BP

Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June

2023

POM

863 BRU13061091NP Infusol® W Intravenous

Infusion BP

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June

2023

GSL

864 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml

(0.1%)

EVER Pharma Jena GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June

2023

POM

865 BRU13061093P Invoril tablets 10mg Enalapril maleate 10mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 27 June 2018 till 26 June

2019

POM

866 BRU13061094P Pharmaniaga Simvastatin

tablet 10mg

Simvastatin 10mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 27 June 2018 till 26 June

2023

POM

867 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 27 June 2013 till 26 June

2018

POM

868 BRU13061096P Invoril tablets 20mg Enalapril maleate 20mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 27 June 2013 till 26 June

2018

POM

869 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, Singapore Mc Quipp Technisell

Marketing Sdn Bhd

27 June 2018 till 26 June

2023

p

BDMCA/RMP/0319 Page 63 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

870 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol)

80mg

Sterling Drug (Malaya) Sdn Bhd,

Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2013 till 29 July 2018 P

12 x 12's (144's)

871 BRU13071099P Champix 1mg film-coated

tablet

Varenicline Tartrate 1mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

872 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine

0.9%)

Perstorp Speciality Chemicals,

Sweden

Mc Quipp Technisell

Marketing Sdn Bhd

30 July 2018 till 29 July 2023 P

873 BRU13071101P Glucophage XR 500mg

Extended Release Tablet

Metformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

874 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mg Schering-Plough (Singapore) Pte

Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018 POM

875 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 July 2018 till 29 July 2023 POM

876 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 2018 till 29 July 2023 POM

877 BRU13071108PS1;

BRU13071108PS2

Revlimid® Capsules 25mg Lenalidomide 25mg Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

878 BRU13071109PS1;

BRU13071109PS2

Revlimid® Capsules 15mg Lenalidomide 15mg Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

879 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate

8.3mg/g

Legacy Pharmaceuticals

Switzreland GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

880 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%;

Hydrocortisone 1%

Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2018 till 29 July 2023 POM

881 BRU13071114P Sandimmun Neoral Capsule

25mg

Ciclosporin A 25mg Catalent Germany Eberbach

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023 POM

882 BRU13081115P Champix 0.5mg & 1mg Tablet Varenicline Tartrate 0.5mg &

Varenicline Tartrate 1mg

Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26

August 2023

POM

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

Belgium

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26

August 2023

P

884 BRU13081120P Enbrel® 25mg solution for

injection in pre-filled syringe

Etanercept 25mg/0.5ml Pfizer Ireland Pharmaceuticals,

Ireland

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26

August 2023

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

885 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26

August 2023

POM

886 BRU13081123P Minazol Powder 2% Miconazole Nitrate 2% w/w Biosis Pharmaceuticals Sdn Bhd.,

Malaysia

K-Seri Pharma Sdn Bhd 27 August 2018 till 26

August 2023

P

887 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine)

5,000IU/ml

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2018 till 26

August 2023

POM

888 BRU13081125P Pharmaniaga Pyrazinamide

Tablet 500mg

Pyrazinamide 500mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 27 August 2018 till 26

August 2023

POM

889 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company 27 August 2018 till 26

August 2023

POM

890 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 Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26

August 2023

POM

891 BRU13091130P Erbitux® 5mg/ml Solution for

Infusion

Cetuximab 5mg/ml Boehringer Ingelheim, Germany &

Merck KGaA, Germany (1

Artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27

September 2023

POM

892 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

893 BRU13091133P Clexane 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, France Medipharm Sdn Bhd 28 September 2018 till 27

September 2023

POM

894 BRU13091134P Pantaprazole Winthrop 40mg

Tablet

Pantoprazole (as sodium

Sesquihydate) 40mg

Sanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd 28 September 2018 till 27

September 2023

POM

895 BRU13091135P Iodosorb Powder Cadexomer 99.1% w/w, with

Iodine 0.9%w/w

Perstorp Speciality Chemicals AB,

Sweden

Mc Quipp Technisell

Marketing Sdn Bhd

28 September 2018 till 27

September 2023

P

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

Malaysia

Asterix United (B) Sdn Bhd 28 September 2018 till 27

September 2023

POM

897 BRU13091138P Clexane 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, France Medipharm Sdn Bhd 28 September 2018 till 27

September 2023

POM

898 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd

Malaysia

Hongkiat Trading & Co 28 September 2018 till 27

September 2023

POM

899 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2ml Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan

Asterix United (B) Sdn Bhd 28 September 2018 till 27

September 2023

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

900 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 28 September 2018 till 27

September 2023

GSL

901 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg Pierre Fabree Medicament

Productio (PFMP), France & BSP

Pharmaceuticals S.p.A. (BSP),

Latina, Italy - (1 artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27

September 2023

POM

902 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 28 September 2018 till 27

September 2023

POM

903 BRU13091145NP A-Bite Cream Crotamiton 10%w/w HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 28 September 2018 till 27

September 2023

GSL

904 BRU13091146P Tipidin Tablet 250mg Ticolopidine HCl BP 250mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 28 September 2013 till 27

September 2018

POM

905 BRU13101149P Erycin Film Coated Tablet

250mg

Erythromycin (as stearate) 250mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

906 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 2018 till 30

October 2023

GSL

907 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg GlaxoSmithKline Manufacturing

S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

908 BRU13101153P Clexane 2000 anti-Xa IU/0.2ml

(Pre-filled Syringe for

Injection)

Enoxaparin Sodium 2,000 anti-Xa

IU/0.2ml

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 31 October 2018 till 30

October 2023

POM

909 BRU13101154P Axcel Mefenamic Acid

Suspension

Mefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 31 October 2018 till 30

October 2023

POM

910 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 2018 till 30

October 2023

POM

911 BRU13101156P Sandimmun Neoral Capsule

100mg

Ciclosporin 100mg Catalent Germany Eberbach

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

BDMCA/RMP/0319 Page 66 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

912 BRU13101158P Endoxan Tablet 50mg Cyclophosphamide anhydrous (as

monohydrate) 50mg

Prasfarma S.L.,

Manlleu/Barcelona, Spain; Haupt

Pharma Amareg GmBH, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

913 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate)

500mg

Siam Bheasach Co. Ltd., Bangkok,

Thailand

K-Seri Pharma Sdn Bhd 31 October 2018 till 30

October 2023

POM

914 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg Pfizer Ireland Pharmaceuticals,

Kildare, Ireland

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

915 BRU13101161PS1;

BRU13101161PS2

Revlimid® Capsules 10mg Lenalidomide 10mg Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30

October 2023

POM

916 BRU13101162P Pharmaniaga Cephalexin

Suspension 125mg

Cephalexin (as anhydrous)

125mg/5ml

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 31 October 2018 till 30

October 2023

POM

917 BRU13101164P Isopto 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 30

October 2018

POM

918 BRU13101165NP Lactacyd Feminine Hygiene

Liquid

Per 100ml - Lactic Acid 1g;

Atomised Lactoserum (spray dried)

0.93g

Sanofi Synthelabo Vietnam, Ho Chi

Minh City, Viet Nam

Medipharm Sdn Bhd 31 October 2013 till 30

October 2018

GSL

919 BRU13121167P Copastin Film Coated Tablets

10mg

Cloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 02 December 2018 till 01

December 2023

P

920 BRU13121168P Ucort Cream Per g – Urea 100mg;

Hydrocortisone acetate 10mg

Y.S.P Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 02 December 2018 till 01

December 2023

POM

921 BRU13121169P Pradaxa® Hard Capsules

150mg

Dabigatran etexilate 150mg (as

mesilate 172.95g)

Boehringer Ingelheim Pharma

GmbH &Co, Ingelheim am Rhein,

Germany

Hongkiat Trading & Co 02 December 2018 till 01

December 2023

POM

922 BRU13121170P Pradaxa® Hard Capsules

110mg

Dabigatran etexilate 110mg (as

mesilate 126.83g)

Boehringer Ingelheim Pharma

GmbH & Co., KG, Germany

Hongkiat Trading & Co 02 December 2018 till 01

December 2023

POM

923 BRU13121172NP Dianeal Low Calcium

(2.5mEq/L) Peritoneal Dialysis

Solution with 1.5% Dextrose

Each 100ml contains: Calcium

Choloride 18.3mg; Dextrose

hydrous 1.5g; Magnesium Chloride

5.08mg; Sodium Chloride 538mg;

Sodium Lactate 448mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 02 December 2018 till 01

December 2023

POM

924 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2018 till 01

December 2023

POM

BDMCA/RMP/0319 Page 67 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

925 BRU13121177P Cyclogyl® 1% Sterile

Ophthalmic Solution

Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 02 December 2018 till 01

December 2023

POM

926 BRU13121178P Betawin Tablet 50mg Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co 02 December 2013 till 01

December 2018

POM

927 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29

December 2023

POM

928 BRU13121180P Glucovance Tablet

500mg/5mg

Metformin HCl 500mg;

Glibenclamide 5mg

Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29

December 2023

POM

929 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 (B) Sdn Bhd 30 December 2018 till 29

December 2023

POM

930 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mg GlaxoSmithKline Manufacturing

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29

December 2023

POM

931 BRU13121183P Anarex Tablets Paracetamol 450mg; Orphenadrine

citrate 35mg

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 December 2013 till 29

December 2018

POM

932 BRU13121184P Atarax Film-Coated Tablet

25mg

Hydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29

December 2023

POM

933 BRU13121187NP 10% Glucose Intravenous

Infusion B.P.

Glucose monohydrate (as equiv. to

anhydrous glucose) 10%

B Braun Industries Sdn Bhd,

Malaysia

Hongkiat Trading & Co 30 December 2018 till 29

December 2023

POM

934 BRU13121189P Heparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa)

10i.u./ml

B Braun Medical Industries Sdn

Bhd, Malaysia

Hongkiat Trading & Co 30 December 2018 till 29

December 2023

POM

935 BRU13121190P Rescuvolin Tablet 15mg Calcium 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

936 BRU13121192NP Nutriflex 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 2018 till 29

December 2023

POM

937 BRU14011193PS1 Alimta 500mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed

disodium) 500mg/vial

Eli Lilly and Company, USA (S1); Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

BDMCA/RMP/0319 Page 68 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

938 BRU14011194P Gemzar 1G Powder for

Solution for Infusion

Gemcitabine hydrochloride

equivalent to 1000mg gemcitabine

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

939 BRU14011196P Largo Tablets 100mg Chlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

POM

940 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 2019 till 27

January 2024

GSL

941 BRU14011198NP Bepanthen® First Aid Cream Dexpanthenol 5%w/w;

Chlorhexidine hydrochloride 0.5%

w/w

GP Grenzach Produktions GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

GSL

942 BRU14011199NP Dextrose 5% and Sodium

Chloride 0.9% Injection USP

Dextrose 5%; Sodium Chloride

0.9%

Baxter Healthcare Corporation,

USA

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

GSL

943 BRU14011200NP Macgel® Tablet Magnesium Hydroxide 200mg;

Aluminium Hydroxide Gel Dried

200mg; Dimethylpolysiloxane

25mg

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 28 January 2019 till 27

January 2024

GSL

944 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2014 till 27

January 2019

POM

945 BRU14011204P Humalog 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 S.A.S., France (S1)

(repacker - Eli Lilly And Company,

USA

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

946 BRU14011205NP Panamol Tablet 500mg Paracetamol 500mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 28 January 2014 till 27

January 2019

GSL (100 x 10's)

947 BRU14011206P Seretide™ Evohaler™

25/50mcg

Fluticasone propionate 50mcg;

Salmeterol (as xinafoate) 25mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

948 BRU14011207PS1;

BRU14011207PS2

Tobrex® Eye Drops Solution Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium

(S1); Alcon Singapore

Manufacturing Pte Ltd, Singapore

(S2)

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

BDMCA/RMP/0319 Page 69 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

949 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 (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

950 BRU14011209P NEUPOGEN 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

951 BRU14011211NPS1;

BRU14011211NPS2

Tears Naturale II Eye Drops

Solution

Dextran 70 0.1% (1mg/ml);

Hypromellose 0.3% (3mg/ml)

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

(S1); Alcon Singapore

Manufacturing Pte Ltd, Singapore

(S2)

Hongkiat Trading & Company 28 January 2019 till 27

January 2024

GSL

952 BRU14011212P Axcel Chlorpheniramine-4

Syrup

Chlorpheniramine Maleate

4mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd, Malaysia 28 January 2019 till 27

January 2024

P

953 BRU14011213P Imojev 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 (B) Sdn Bhd 28 January 2019 till 27

January 2024

POM

954 BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus

antigen (HAV), HM175 strain 1440

ELISA Units (EL.U.)/ml

GlaxoSmithKline Biologicals SA,

Rixensart Belgium (Manufacturer

of finished products);

GlaxoSmithKline Biologicals S.A.,

Wavre Belgium (Additional facility

for formulation)

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

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

tablets

Clopidogrel (as hydrogen sulphate)

75mg; Acetylsalicylic acid 100mg

Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 27 February 2019 till 26

February 2024

POM

956 BRU14021217P VotrientTM Film-coated tablets

400mg

Pazopanib (as hydrochloride)

400mg

Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

957 BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen-Cilag, Val de Reuil, France Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

BDMCA/RMP/0319 Page 70 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

958 BRU14021219PS1;

BRU14021219PS2;

BRU14021219PS3

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

(S1); Novo Nordisk A/S, Denmark

(S2); Novo Nordisk Production

SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

959 BRU14021220P Omelon Enteric

Microencapsulated capsule

20mg

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

Malaysia

Asterix United (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

960 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 (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

961 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 (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

962 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 (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

963 BRU14021227P 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

BDMCA/RMP/0319 Page 71 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

964 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 Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

965 BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg,

Magnesium Hydroxide 200mg,

Simethicone 20mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

GSL

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

Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

P

967 BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride)

30mg

Lilly del Caribe, Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

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

monohydrate)

Glaxo Operations UK Limited

(Trading as Glaxo Wellcome

Operations), UK [Repacker: Glaxo

Wellcome S.A., Burgos, Spain

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

969 BRU14021234P Axcel Mefenamic Acid

Capsules

Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

POM

970 BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

971 BRU14021236NP Lactated Ringer’s Injection

USP

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 (B) Sdn Bhd 27 February 2019 till 26

February 2024

GSL

972 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

973 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine

hydrochloride 5mg and

Simethicone 50mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

GSL

974 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin

(Recombinant DNA) 100IU/ml

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

975 BRU14021240NP 5% Dextrose and 0.45%

Sodium Chloride Injection,

USP

Dextrose 5%; Sodium Chloride

0.45%

Baxter Healthcare Corporation,

USA

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

GSL

976 BRU14021241P Giona Easyhaler 200mcg/dose

Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2014 till 26

February 2019

POM

977 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co.,

Taiwan

Asterix United (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

978 BRU14021243NP Neurobion tablet Thiamine disulfide 100mg;

Pyridoxine hydroxide 200mg &

Cyanocobalamin 200mcg

Merck KGaA & Co, Austria Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

GSL

979 BRU14021244P Omeprazole for Injection

(Lyophilised) 40mg/vial

Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2019 till 26

February 2024

POM

980 BRU14021245P Keppra Concentrate for

solution for (infusion) /

intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

981 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 (B) Sdn Bhd 27 February 2019 till 26

February 2024

POM

982 BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as

mesilate 86.48mg)

Boehringer Ingelheim Pharma

GmbH & Co., KG, Germany

Hongkiat Trading & Co 27 February 2019 till 26

February 2024

POM

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

Ammonium Chloride 130mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

POM

984 BRU14031249P Tygacil 50mg Lyophilised

Powder for Intravenous

Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

985 BRU14031250PS1;BR

U14031250PS2

BRU14031250PS3

Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml

(equivalent to 14.2mg

Novo Nordisk A/S, Bagsværd,

Denmark (S1); Novo Nordisk

Producao Farmaceutica do Brasil

Ltda., Brazil (S2); Novo Nordisk

Production SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

BDMCA/RMP/0319 Page 73 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

986 BRU14031251P Stalevo 75/18.75/200mg Film-

coated Tablet

Levodopa 75mg; Carbidopa

18.75mg; Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

987 BRU14031252P Stalevo 200/50/200mg Film-

coated Tablet

Levodopa 200mg; Carbidopa

50mg; Entacapone 200mg

Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

988 BRU14031253P Humulin N Injection 100IU/mL Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

989 BRU14031256P 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 2019 till 26 March

2024

POM

990 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 2019 till 26 March

2024

POM

991 BRU14031258P Volibris 5mg Film-coated

Tablet

Ambrisentan 5mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

992 BRU14031259P Volibris 10mg Film-coated

Tablet

Ambrisentan 10mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

993 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland MediPharm Sdn Bhd 27 March 2019 till 26 March

2024

POM

994 BRU14031262P Loperamil Syrup 1mg/5ml Loperamide HCl 1mg/5ml Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 27 March 2014 till 26 March

2019

POM

995 BRU14031263P;

BRU14031263PS2

Patanol® Eye Drops, Solution

0.1%

Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium;

Alcon Singapore Manufacturing

Pte. Ltd., Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

996 BRU14031264PS1;

BRU14031264PS2

Travatan® Eye Drops

40mcg/ml

Travoprost 40mcg/ml S.A. Alcon-Couvreur N.V., Belgium

(S1); Alcon Singapore

Manufacturing Pte Ltd, Singapore

(S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

997 BRU14031265P;

BRU14031265PS2

Chlorpheniramine tablet 4mg Chlorpheniramine Maleate 4mg Drug Houses of Australia Pte Ltd,

Singapore; PT Actavis Indonesia,

Indonesia (S2)

G&H Trading Company 27 March 2014 till 26 March

2019

POM

998 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

999 BRU14031268P Elonva Solution for Injection

100mcg/0.5ml

Corifollitropin alfa 100mcg/0.5ml Vetter Pharma-Fertigung GmbH &

Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

BDMCA/RMP/0319 Page 74 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1000 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 (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1001 BRU14031270P Enbrel® 50mg solution for

Injection in a pre-filled syringe

Etanercept 50.0mg/1.0ml Pfizer Ireland Pharmaceuticals,

Ireland

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1002 BRU14031272P Seretide Evohaler dose-

counter 25/250mcg

Salmeterol 25mcg (as the

xinafoate) and Fluticasone

Propionate 250mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

BDMCA/RMP/0319 Page 75 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1003 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 (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1004 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 (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1005 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 (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1006 BRU14031276P Galvus 50mg Tablet Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1007 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

1008 BRU14031279NP Axcel Paracetamol-250

Suspension (Orange)

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

Malaysia

Medicorp Sdn Bhd 27 March 2019 till 26 March

2024

GSL (60 mL & 100

mL)1009 BRU14031280P Lamictal Dispersible/Chewable

Tablet 25mg

Lamotrigine 25mg GlaxoSmithKline Pharmaceutical

SA, Poland

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1010 BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine

Phosphate 9mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 March 2014 till 26 March

2019

POM

1011 BRU14031282P Voren Injection ‘Yung Shin’

(Diclofenac)

Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind,

Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1012 BRU14031283P 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

1013 BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March

2024

POM

1014 BRU14041285P Giona Easyhaler®

100mcg/dose Inhalation

Powder

Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading & Company 26 April 2014 till 25 April

2019

POM

1015 BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg;

Chlorpheniramine Maleate 4mg;

Pseudoephedrine HCl 60mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 26 April 2019 till 25 April

2024

P (10 x 10's)

BDMCA/RMP/0319 Page 76 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1016 BRU14041287P XareltoTM Film-coated tablet

15mg

Rivaroxaban 15mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM (14's x 2; 7's

x 1; 14's x 1)

1017 BRU14041288P XareltoTM Film-coated tablet

20mg

Rivaroxaban 20mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

(14’s x 2

14’s x 1)1018 BRU14041289P 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

1019 BRU14041291NP Sodium Chloride Injection USP

0.9% in Mini-Bag Plus

Container

Sodium Chloride 0.9% Baxter Healthcare Corporation,

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

GSL

1020 BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate

213.8mg (eq. to anhydrous

Cyclophosphamide 200mg)

Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1021 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1022 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1023 BRU14041296P 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 2019 till 25 April

2024

POM

1024 BRU14041297PS1;

BRU14041297PS2

DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol

5mg/ml (as timolol maleate)

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

(S1); Alcon Singapore

Manufacturing Pte Ltd, Singapore

(S2)

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1025 BRU14041299P 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

1026 BRU14041300P Hypernol Tablets 50mg Atenolol 50mg Drug Houses of Australia Pte Ltd,

Singapore

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1027 BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,

monohydrate) 150mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1028 BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,

monohydrate) 200mg

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1029 BRU14041304NP 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

1030 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 26 April 2019 till 25 April

2024

GSL

1031 BRU14041306P 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

BDMCA/RMP/0319 Page 77 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1032 BRU14041307P Alimta 100mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed

disodium) 100mg/vial

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

POM

1033 BRU14041308P 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

1034 BRU14041309NP 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 (500ml)

1035 BRU14041310PS1;

BRU14041310PS2

Famotin Tablet 40mg Famotidine 40mg Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis

Indonesia,

Jakarta,Indonesia (S2)

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1036 BRU14041311P 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

P (10 x 10 x 10's)

1037 BRU14041313P 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

1038 BRU14041314NP;

BRU14041314NPS2

Sodium Chloride Injection

0.9%, USP

Sodium Chloride 0.9% Baxter Healthcare Corporation,

USA (S1); Baxter Healthcare

Philippines Inc., Laguna,

Phillippines (S2)

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April

2024

GSL

1039 BRU14041315P 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

1040 BRU14041316P 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

1041 BRU14041317P Rozidal Tablet 1mg Risperidone 1mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G&H Trading Company 26 April 2014 till 25 April

2019

POM

1042 BRU14071319PS1 &

BRU14071319PS2

Mixtard® 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)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1043 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd.,

Japan

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1044 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1045 BRU14071322P Nootropil 1200mg Tablet Piracetam 1200mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1046 BRU14071323P Nootropil 800mg Tablet Piracetam 800mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

BDMCA/RMP/0319 Page 78 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1047 BRU14071324P Luvox® Film-coated Tablets

50mg

Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1048 BRU14071325P Luvox® Film-coated Tablets

100mg

Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1049 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone

0.1%

S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1050 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1051 BRU14071329NP Axcel Papain Tablet Papain Pure equiv. to proteolytic

enzymes from carica papaya

10,000 USP Units

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 GSL

1052 BRU14071330P Humalog® KwikPenTM

100units/mL

Insulin Lispro 100units/ml Lilly France S.A.S., France (S1

(repacker - Eli Lilly And Company,

USA)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1053 BRU14071331P Shincort IM Injection "Yung

Shin" 40mg/ml ampoules

Triamcinolone acetonide 40mg Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1054 BRU14071332P Emend IV Powder For Solution

for Infusion 150mg

Fosaprepitant 150mg (as

fosaprepitant dimeglumine)

DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1055 BRU14071333PS1;

BRU14071333PS2

Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. Canada (S1); Patheon

S.A.S. (Patheon-France), France

(S2)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1056 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 POM

1057 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 2019 till 01 July 2024 POM

1058 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1059 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals,

Ireland

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1060 BRU14071338PS1;

BRU14071338PS2

Regro Lotion 5% Minoxidil USP 5% w/v Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 P

BDMCA/RMP/0319 Page 79 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1061 BRU14071339PS1;

BRU14071339PS2

Regro Lotion 3% Minoxidil USP 3% w/v Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 P

1062 BRU14071340NP Dequalinium Lozenges Dequalinium Chloride 0.25mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 GSL

1063 BRU14071341P DHA-Ketozole Tablet 200mg Ketoconazole 200mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1064 BRU14071342P Axcel Ibuprofen Paediatric

Syrup

Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 P

1065 BRU14071343P Pharynx Lozenges Cetylpyridinium Chloride 1.50mg,

Benzocaine 3.33mg

Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 02 July 2014 till 01 July 2019 P

1066 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1067 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1068 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 2019 till 01 July 2024 POM

1069 BRU14071347P Invoril Tablet 5mg Enalapril Maleate 5mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1070 BRU14071348P Atropine Sulphate 1mg/1ml

Injection

Atropine Sulphate 1mg/ml Pharmaniaga Lifesciences Sdn

Bhd, Malaysia

G & H Trading Company 02 July 2019 till 01 July 2024 POM

1071 BRU14071349P;

BRU14071349PS2

Dhacodine Syrup 15mg/5ml Pholocodine 15mg/5ml Drug Houses of Australia Private

Limited, Singapore; ICM PHARMA

PTE LTD, Singapore (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1072 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2019 till 01 July 2024 POM

1073 BRU14071353P Salbutamol Injection

0.5mg/ml

Salbutamol Sulphate 0.5mg/ml

(equivalent to salbutamol base)

Yung Shin Pharmaceutical Ind., Co.

Ltd., Taichong, Taiwan

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1074 BRU14071354PS1;

BRU14071354PS2

Glipizide Tablet 5mg Glipizide 5mg Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1075 BRU14071355P Axcel Dexchlorpheniramine

Tablet

Dexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024 POM

BDMCA/RMP/0319 Page 80 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1076 BRU14071356P;

BRU14071356PS2

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; ICM PHARMA

PTE LTD, Singapore (S2)

G & H Trading Company 02 July 2014 till 01 July 2019 POM

1077 BRU14071357P Quinine Sulphate Tablet

300mg

Quinine Sulphate BP 300mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 02 July 2014 till 01 July 2019 POM

1078 BRU14071358NP 20% Glucose Intravenous

Infusion BP

Glucose (as monohydrate) 20% B. Braun Medical Industries Sdn

Bhd Malaysia

Hongkiat Trading & Co 02 July 2019 till 01 July 2024 POM

1079 BRU14071359P Pharmaniaga Spironolactone

Tablet 25mg

Spironolactone 25mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 02 July 2019 till 01 July 2024 POM

1080 BRU14071360P Maxidex Sterile Opthalmic

Suspension

Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1081 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP

1000IU/ml

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 02 July 2014 till 01 July 2019 POM

1082 BRU14071362P Alphagan Ophthalmic Solution

0.2%

Brimonidine tartrate (anhydrous

basis) 2mg/ml

Allergan Pharmaceuticals Ireland,

Ireland

Medipharm Sdn Bhd 02 July 2014 till 01 July 2019 POM

1083 BRU14071363P Dormicum Injection

15mg/3ml

Midazolam 15mg/3ml Cenexi SAS, France Hongkiat Trading & Company 02 July 2019 till 01 July 2024 POM

1084 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 2019 POM

1085 BRU14071367P Invega Sustenna Prolonged

Release Suspension for IM

Injection 150mg/1.5ml

Paliperidone 150mg/1.5ml (as

palmitate 234mg)

Janssen Pharmaceutical NV,

Belgium;

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024 POM

1086 BRU14071368P Yondelis® Powder for Injection

1mg/vial

Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1087 BRU14071369P Trajenta film-coated tablet

5mg

Linagliptin 5mg Boehringer Ingelhein Roxane Inc.,

USA

Hongkiat Trading & Company 24 July 2019 till 23 July 2024 POM

1088 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 Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1089 BRU14071372PS1 &

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 (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1090 BRU14071373PS1 &

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 (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

BDMCA/RMP/0319 Page 81 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1091 BRU14071374PS1 &

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 (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1092 BRU14071375P Lucentis 10mg/ml Solution for

Injection

Ranibizumab 10mg/ml Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1093 BRU14071376P Onbrez Breezhaler 150mcg

Inhalation Powder, Hard

Capsule

Indacterol 150mcg (as maleate

194mcg)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1094 BRU14071377P Onebrez Breezhaler 300mcg

Inhalation Powder Hard

Capsule

Indacterol 300mcg (as maleate

389mcg)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1095 BRU14071378P Requip PD 24hr Prolong

Release Tablet 2mg

Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1096 BRU14071379P Difflam Anti-Inflammatory

Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg;

Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical

Laboratories, India

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 GSL

1097 BRU14071380P Vfend Powder For Oral

Suspension 40mg/ml

Voriconazole 40mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1098 BRU14071381P Norditropin® Nordilet®

Solution for Injection

10mg/1.5ml

Somatropin (biosynthetic human

growth hormone) 10mg/1.5ml

Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1099 BRU14071382P Alphagan P Ophthalmic

Solution 0.15%

Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2019 till 23 July 2024 POM

1100 BRU14071383P Mapenem® IV Injection

500mg

Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2019 till 23 July 2024 POM

1101 BRU14071384P Curam Powder for oral

Suspension 312.5mg/5ml

Amoxycillin 250mg (as trihydrate);

Clavulanic Acid 62.5mg (as

potassium salt)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1102 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1103 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide

5mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1104 BRU14071387P Kivexa Tablets 600mg/300mg Abacavir 600mg (as sulfate);

Lamivudine 300mg

GlaxoSmithKline Pharmaceuticals

S.A, Poland [Repacker: Glaxo

Wellcome, S.A., Spain]

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1105 BRU14071388P Lucrin® depot 3.75mg

Injection

Leuproprelin acetate 3.75mg Takeda Pharmaceutical Company

Limited, Japan

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

BDMCA/RMP/0319 Page 82 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1106 BRU14071389P Lucrin® depot 11.25mg

Injection

Leuproprelin acetate 11.25mg Takeda Pharmaceutical Company

Limited, Japan

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1107 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 24 July 2019 till 23 July 2024 POM

1108 BRU14071391P Lamictal Tablet 50mg Lamotrigine 50mg Glaxosmithkline Pharmaceuticals

SA, Poland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1109 BRU14071392P Infasurf® (Calfactant)

Intratracheal 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 Biotech Inc., USA K-Seri Pharma 24 July 2019 till 23 July 2024 POM

1110 BRU14071393NP Kaolin & Pectin Mixture Per 5ml - Kaolin Light BP 1g; Pectin

50mg

Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 P

1111 BRU14071394P Duodart 0.5mg/0.4mg

Capsules

Dutasteride 0.5mg; Tamsulosin

0.4mg

Catalent Germany Schorndorf

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1112 BRU14071395P Axcel Metronidazole-400

Tablet

Metronidazole 400mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 24 July 2019 till 23 July 2024 POM

1113 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1114 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)

MediPharm Sdn Bhd 24 July 2019 till 23 July 2024 POM

1115 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 24 July 2014 till 23 July 2019 POM

1116 BRU14071399PS1 &

BRU14071397PS2

Vigamox® Ophthalmic

Solution 0.5%

Moxifloxacin 0.5% (as

hydrochloride)

ALCON LABORATORIES, INC., USA

(S1)

Alcon Singapore Manufacturing

Pte. Ltd., Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1117 BRU14071400P Cementin Tablet 200mg Cimetidene 200mg Drug Houses of Australia Pte Ltd,

Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM

BDMCA/RMP/0319 Page 83 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1118 BRU14071401PS1 &

BRU14071401PS2

Voltaren 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 (B) Sdn Bhd 24 July 2019 till 23 July 2024 GSL

1119 BRU14071402P Imexa Film-Coated Tablet

250mg

Azithromycin 250mg (as dihydrate) Xepa-Soul Pattinson (M) Sdn Bhd

Malaysia

Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

1120 BRU14071403P Cymbalta Capsule 60mg Duloxetine (as hydrochloride)

60mg

Lilly del Caribe Inc, Puerto Rico Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1121 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 2019 POM

1122 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company 24 July 2019 till 23 July 2024 POM

1123 BRU14071406P Dimenate Tablet 50mg Dimenhydrinate BP 50mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM (5 x 20 x

10's; 1000's)1124 BRU14071407P Dhatifen Tablet 1mg Ketotifen 1mg (as hydrogen

fumarate 1.38mg)

Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 24 July 2014 till 23 July 2019 POM

1125 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1126 BRU14071409P Asumalife Syrup 1.38mg/5ml Per 5ml - Ketotifen 1mg (as

hydrogen fumarate 1.38mg)

Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1127 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1128 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as

Hydrochloride)

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1129 BRU14071412NP Zoben Tablet 200mg Albendazole 200mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 24 July 2019 till 23 July 2024 P (10 x 10's)

1130 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 2019 POM

1131 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024 POM

1132 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 24 July 2014 till 23 July 2019 POM

1133 BRU14081416PS1;

BRU14081416PS2

Sevorane Inhalation Liquid Sevoflurane 100%v/v Aesica Queensborough Ltd, UK

(S1); Abbvie S.R.L, Italy (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1134 BRU14081417PS1;

BRU14081417PS2

Emend Tri-Pack Capsule Each capsule either contains

Aprepitant 80mg or 125mg

Merck Sharp & Dohme Corp., USA

(S1); Alkermes Pharma Ireland

Limited, Ireland (S2)

Repackers:

1) Merck Sharp & Dohme

(Australia) Pty. Ltd., Australia.

(Primary and secondary packaging

and release)

2) PT. Merck Sharp Dohme

Pharma Tbk., Indonesia. (Primary

and secondary packaging and

release)

3) Contract repacker: Contract

Pharmaceutical Services of

Australia Pty Ltd., Australia.

(Primary and secondary

packaging)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1135 BRU14081418P Protopic Ointment 0.1% Tacrolimus (as Tacrolimus

monohydrate) 0.1%

Astellas Pharma Tech Co., Ltd.,

Japan

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1136 BRU14081419PS2 Exforge HCT 10/160/12.5mg

Film-coated tablet

Amlodipine 10mg (as besylate);

Valsartan 160mg;

Hydrochlorothiazide 12.5mg

Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1137 BRU14081420PS2 Exforge HCT 10/160/25mg

Film-coated tablet

Amlodipine 10mg (as besylate);

Valsartan 160mg;

Hydrochlorothiazide 25mg

Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1138 BRU14081421PS2 Exforge HCT 5/160/12.5mg

Film-coated tablet

Amlodipine 5mg (as besylate);

Valsartan 160mg;

Hydrochlorothiazide 12.5mg

Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1139 BRU14081422PS2 Exforge HCT 5/160/25mg Film-

coated tablet

Amlodipine 5mg (as besylate);

Valsartan 160mg;

Hydrochlorothiazide 25mg

Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1140 BRU14081423PS2 Exforge HCT 10/320/25mg

Film-coated tablet

Amlodipine 10mg (as besylate);

Valsartan 320mg;

Hydrochlorothiazide 25mg

Novartis Farmaceutica SA,

Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1141 BRU14081424P Luveris for Injection 75IU/Vial

(Revised Formula)

Lutropin alfa 75IU (Recombinant

Human Lutenising Hormone)

Merck Serono SA., Switzerland G & H Trading Company 30 August 2019 till 29

August 2024

POM

1142 BRU14081425P Lipanthyl Penta 145 Film-

Coated tablet

Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

BDMCA/RMP/0319 Page 85 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1143 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 August 2014 till 29

August 2019

POM

1144 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1145 BRU14081428PS1

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 (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1146 BRU14081429PS1

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 (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1147 BRU14081430PS1

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 (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1148 BRU14081431P Napan Capsules 250mg Mefenamic Acid 250mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1149 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

MediPharm Sdn Bhd 30 August 2019 till 29

August 2024

POM

1150 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company

LLC, USA

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1151 BRU14081434P Moxiclav 1G Tablet Amoxycillin 875mg (as sodium);

Clavulanic Acid 125mg (as

Clavulanate potassium)

Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2019 till 29

August 2024

POM

1152 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1153 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29

August 2024

POM

1154 BRU14081440P Naphcon-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 2019

P

1155 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals

SA, Poland

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

BDMCA/RMP/0319 Page 86 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1156 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29

August 2024

P

1157 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 2019

P

1158 BRU14081444P Rhiniramine SR Tablet 6mg Dexhlorpheniramine Maleate 6mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1159 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 2019

POM

1160 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 2019

POM

1161 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29

August 2024

POM

1162 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Biosis Pharmaceuticals Sdn Bhd.,

Malaysia

K-Seri Pharma Sdn Bhd 30 August 2019 till 29

August 2024

POM

1163 BRU14081449P Mircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-

epoetin Beta 75mcg/0.3ml

Roche Diagnostics GmbH,

Germany

MediPharm Sdn Bhd 30 August 2019 till 29

August 2024

POM

1164 BRU14081450P Creobic Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd,

Malaysia

Yuh Hua Trading Company 30 August 2019 till 29

August 2024

GSL

1165 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride

5mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29

August 2024

P

1166 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 2019 till 29

August 2024

POM

1167 BRU14081455P Proluton Depot 250mg

Injection

Hydroxyprogesterone Caproate

250mg

Bayer Pharma AG, Leverkeusen,

Germany

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1168 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

P

1169 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29

August 2024

POM

1170 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1171 BRU14081459P Clamentin 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 2019 till 29

August 2024

POM

BDMCA/RMP/0319 Page 87 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1172 BRU14081460P Clarimycin Film Coated Tablet

500mg

Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1173 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol

1% w/w

HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 August 2019 till 29

August 2024

GSL

1174 BRU14081462NP Menzza Cream Methyl Salicylate 25%w/w;

Menthol 5%w/w

Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 August 2019 till 29

August 2024

GSL

1175 BRU14081463P Difnal OD Tablet 100mg Methyl Salicylate 25%w/w;

Menthol 5%w/w

Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1176 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid) PT Bayer Indonesia, Indonesia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

GSL

1177 BRU14081466P Doridone Tablet 10mg Domperidone 10mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1178 BRU14081467P Tobradex® Eye Drops

Suspension

Tobramycin 0.3%; Dexamethasone

0.1%

S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1179 BRU14081468NP Ferrous 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 2019

GSL

1180 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 2019

POM

1181 BRU14081470P Rotaqor 10mg film-coated

tablet

Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1182 BRU14081471P;

BRU14081471PS2

Zoral 200 tablet 200mg Acyclovir USP 200mg Drug Houses of Australia Private

Limited, Singapore; PT Actavis

Indonesia, Indonesia (S2)

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1183 BRU14081472P Vamlo Tablets 5mg Amlodipine 5mg (as besilate) Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 30 August 2014 till 29

August 2019

POM

1184 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29

August 2024

POM

1185 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 (B) Sdn Bhd 30 August 2019 till 29

August 2024

GSL

1186 BRU14081475P Cera-Scalp Ointment Coal Tar solution 12% w/w;

Salicylic acid 2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 August 2019 till 29

August 2024

GSL

1187 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1188 BRU14091477P Suprane Inhalation Liquid

100%

Desflurane 100% Baxter Healthcare Corporation,

Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29

August 2024

POM

1189 BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

P

1190 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 2019 till 29

September 2024

POM

1191 BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1192 BRU14091481P Xolair Powder and Solvent for

Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1193 BRU14091482P Frusemide Tablet 40mg Furosemide 40mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1194 BRU14091483P Pengesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2019 till 29

September 2024

POM

1195 BRU14091486P Crinone Progestrone Vaginal

Gel 8%

Progestrone 8% Fleet Laboratories Ltd, United

Kingdom

G & H Trading Company 30 September 2019 till 29

September 2024

POM

1196 BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd.,

Australia

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

GSL

1197 BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2019 till 29

September 2024

P

1198 BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as

Hydrochloride)

Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2019 till 29

September 2024

POM

1199 BRU14091490P Trileptal 600mg Film-coated

Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1200 BRU14091491P Binozyt 500mg film-coated

tablet

Azithromycin 500mg (as

monohydrate)

Novartis (Bangladesh) Ltd.,

Bangladesh

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1201 BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

P

1202 BRU14091494P Eprex® 10000 Prefilled

Syringes 10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1203 BRU14091495P 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

1204 BRU14091496PS1;

BRU14091496PS2

Hydrochlorothiazide Tablet

50mg

Hydrochlorothiazide BP 50mg Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 30 September 2014 till 29

September 2019

POM

BDMCA/RMP/0319 Page 89 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1205 BRU14091497PS1;

BRU14091497PS2

Famotin Tablet 20mg Famotidine USP 20mg Drug Houses of Australia Private

Limited, Singapore (S1); PT Actavis

Indonesia, Jakarta, Indonesia (S2)

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1206 BRU14091498P 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

1207 BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1208 BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

p

1209 BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1210 BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as

Hydrochloride 2.8mg)

S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1211 BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

p

1212 BRU14091506P 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

1213 BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1214 BRU14091508P Glucagen® 1mg Powder and

Solvent for Solution for

Injection

Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1215 BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate

4mg/5ml

Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2014 till 29

September 2019

p

1216 BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1217 BRU14091511NP 0.9% Sodium Chloride

Injection, B.P. (10ml)

Sodium Chloride 0.9% B. Braun Medical Industries Sdn

Bhd Malaysia

Hongkiat Trading & Co 30 September 2019 till 29

September 2024

GSL

1218 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 2019 till 29

September 2024

POM

1219 BRU14091513P HBVaxPro® 5mcg/0.5ml

Injection

Hepatitis B surface Antigen

5mcg/0.5ml

Merck Sharp & Dohme Corp.,

West Point, Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1220 BRU14091514P HBVaxPro® 10mcg/1.0ml

Injection

Hepatitis B surface Antigen

10mcg/1.0ml

Merck Sharp & Dohme Corp.,

West Point, Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1221 BRU14091515P HBvaxPro® 40mcg/1.0ml

Injection

Hepatitis B surface Antigen

40mcg/1.0ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1222 BRU14091516P 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

1223 BRU14091517P Stalevo 125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa

31.25mg, Entacapone 200mg

Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1224 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1225 BRU14091520NP 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

GSL

1226 BRU14091521P Ospexin 500mg Film-coated

Tablets

Cefalexin 500mg (as monohydrate) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1227 BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 September 2019 till 29

September 2024

GSL

1228 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

P

1229 BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2019 till 29

September 2024

POM

1230 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1231 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

P

1232 BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride

Trihydrate 300mg/15ml

Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1233 BRU14091529NP Strepsils Cool Lozenges Each lozenge contains:

Amymetacresol 0.6mg, 2,4-

Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 30 September 2019 till 29

September 2024

GSL

1234 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 Aliaa Sdn Bhd 30 September 2019 till 29

September 2024

GSL

1235 BRU14091531P Nordette 21 Tablet Levonogestrel 150mcg, Ethinyl

estradiol 30mcg

Haupt Pharma Munster GmbH.,

Germany

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1236 BRU14091533P Ansures Extended Release

Tablet 500mg

Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd.,

Taiwan

G & H Trading Company 30 September 2019 till 29

September 2024

POM

1237 BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 30 September 2014 till 29

September 2019

POM

1238 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

1239 BRU14091538P 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 2019 till 29

September 2024

POM

1240 BRU14091539P ZmaxTM Extended-Release

Granules for Oral Suspension

2g

Azithromycin 2g (as dihydrate) Pfizer Pharmaceuticals LLC Vega

Baja, Puerto Rico

Zuellig Pharma (B) Sdn Bhd 30 September 2014 till 29

September 2019

POM

1241 BRU14091540P Eturion 10mg Film Coated

Tablet

Atorvastatin 10mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1242 BRU14091541P Eturion 20mg Film Coated

Tablet

Atorvastatin 20mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1243 BRU14091542P Eturion 40mg Film Coated

Tablet

Atorvastatin 40mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceutical LLC, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1244 BRU14091543P Eturion 80mg Film Coated

Tablet

Atorvastatin 80mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1245 BRU14111544P (vial) EYLEA Solution for Injection

(vial)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc.,

New York, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1246 BRU14111545P EYLEA Solution for Injection

(pre-filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc.,

New York, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

BDMCA/RMP/0319 Page 92 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1247 BRU14111546P Binocrit Solution for Injection

2000 IU/ml in Pre-filled

Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1248 BRU14111547P Binocrit Solution for Injection

4000 IU/0.4ml in Pre-filled

Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1249 BRU14111548P Nootropil Infusion 12g/60ml Piracetam 12g/60ml Aesica Pharmaceuticals SRL., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1250 BRU14111549P Nootropil Injection 1g/5ml Piracetam 1g/5ml UCB Pharma S.P.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1251 BRU14111550P Advagraf Prolonged Release

Hard Capsule 0.5mg

Tacrolimus 0.5mg (as

monohydrate)

Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31

October 2024

POM

1252 BRU14111551P Advagraf Prolonged Release

Hard Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31

October 2024

POM

1253 BRU14111552P Advagraf Prolonged Release

Hard Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31

October 2024

POM

1254 BRU14111553P Dynastat Powder and Solvent

for Solution for Injection

40mg

Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company

LLC, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1255 BRU14111554P Invanz Powder for Injection

1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp &

Dohme-Chibret, France

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1256 BRU14111555P Humalog Mix25 100 units/ml

Kwikpen

Insulin Lispro 100IU/ml [In the

proportion of 25% Insulin Lispro &

75% Insulin Lispro Protamine

Suspension (rDNA origin)

Lilly France S.A.S., France (S1)

(repacker - Eli Lilly And Company,

USA)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1257 BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1258 BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 01 November 2019 till 31

October 2024

GSL

1259 BRU14111558P Trileptal Film-coated Tablets

300mg

Oxcarbazepine 300mg Novartis Farma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1260 BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium

Bicarbonate 1.737g; Citric Acid

(anhydrous) 1.223g.

Bayer de Mexico SA De CV, Mexico Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

GSL

1261 BRU14111560P 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 2019 till 31

October 2024

GSL

BDMCA/RMP/0319 Page 93 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1262 BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 01 November 2019 till 31

October 2024

GSL

1263 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 Aliaa Sdn Bhd 01 November 2019 till 31

October 2024

GSL

1264 BRU14111563P Loette 21 Tablet Levonorgetsrel 100mcg;

ethinylestradiol 20mcg

Haupt Pharma Munster GmbH.,

Germany

Zuellig Pharma (B) Sdn Bhd 01 November 2014 till 31

October 2019

POM

1265 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride

5mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 01 November 2019 till 31

October 2024

POM

1266 BRU14111565P NIMBEXTM Injection 2mg/ml

(5ml)

Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing

S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1267 BRU14111566P Aggrastat Concentrate for

Infusion 0.25mg/ml

Tirofibon 0.25mg/ml (as

hydrochloride monohydrate

0.281mg/ml)

Patheon Manufacturing Services

LLC, USA & Orion Corporation,

Espoo, Finland (repacker)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1268 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride

1mg/ml

Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1269 BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan

Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1270 BRU14111569P Ferinject® 50mg Iron/ml

solution for Injection/Infusion

Iron 50mg/ml (as ferric

carboxymaltose)

BIPSO GmbH, Germany K-Seri Pharma Sdn Bhd 01 November 2019 till 31

October 2024

POM

1271 BRU14111570P Olmetec Plus 20/12.5mg Film-

coated Tablet

Olmesartan Medoxomil 20mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1272 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 (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1273 BRU14111573P Eliquis Film-coated Tablets

2.5mg

Apixaban 2.5mg Bristol-Myers Squibb

Manufacturing Company, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1274 BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan

Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

BDMCA/RMP/0319 Page 94 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1275 BRU14111575P Ryzodeg Flex Touch 100

units/ml

Per 1 ml: Insulin Degludec 70%;

Insulin Aspart 30%

Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1276 BRU14111576NP 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

1277 BRU14111577NP Dettol Antiseptic Germicide

Liquid

Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2019 till 31

October 2024

GSL

1278 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1279 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 01 November 2014 till 31

October 2019

POM

1280 BRU14111580P 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

1281 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 (B) Sdn Bhd 01 November 2019 till 31

October 2024

P

1282 BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 01 November 2019 till 31

October 2024

POM

1283 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

1284 BRU14111584NP Panamol Forte Suspension

250mg/5ml

Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 01 November 2014 till 31

October 2019

P (3.8L)

BDMCA/RMP/0319 Page 95 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1285 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)

Hongkiat Trading & Co 01 November 2019 till 31

October 2024

POM

1286 BRU14111586P Zyvox 20mg/ml Granules For

Oral Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1287 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1288 BRU14111589P Resolor film-coated tablet

1mg

Prucalopride 1mg (as succinate

1.321mg)

Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1289 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

1290 BRU14111591P Pristiq 50mg Extended-

Release Tablets

Desvenlafaxine 50mg (as succinate

75.87mg)

Pfizer Ireland Pharmaceuticals,

Ireland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1291 BRU14111592P ElIquis 5mg Film-coated

Tablet

Apixaban 5mg Bristol-Myers Squibb

Manufacturing Company, Puerto

Rico, USA

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1292 BRU14111593P 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

1293 BRU14111595P Advate 250 IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII) 250 IU

1) Baxalta Manufacturing Sarl,

Switzerland (DP manufacturer); 2)

Siegfried Hameln GmbH, Germany

(Sterile Water for Injection

(Diluent) manufacturer)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1294 BRU14111596P Glibenclamide Tablet 5mg Glibenclamide 5mg Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1295 BRU14111597NP 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

GSL

BDMCA/RMP/0319 Page 96 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1296 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

1297 BRU14111599P 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

1298 BRU14111600P 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

1299 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

1300 BRU14111603P 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

1301 BRU14111604NP 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

1302 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1303 BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1304 BRU14111607NP 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

1305 BRU14111608P Binozyt 200mg/5ml Powder

for Oral Suspension

Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1306 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

GSL

BDMCA/RMP/0319 Page 97 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1307 BRU14111610NP 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

1308 BRU14111611P Kogrel 75mg Film Coated

Tablet

Clopidogrel 75mg (as bisulfate

97.875mg)

Sandoz Private Limited, Mumbai,

India

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1309 BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

P

1310 BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1311 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1312 BRU14111615P Curam 156.25mg/5ml Powder

for Oral Suspension

Per 5ml - Amoxycillin 125mg (as

trihydrate); Clavulanic acid

31.25mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1313 BRU14111617P 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

1314 BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1315 BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1316 BRU14111621P 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

1317 BRU14111622NP 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 (2 x 6's)

1318 BRU14111623P 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 2020 till 18 May

2025

POM

1319 BRU14111624P 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 2020 till 18 May

2025

POM

1320 BRU14111625P 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 2020 till 18 May

2025

POM

1321 BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1322 BRU14111627P Cellcept Tablet 500mg Mycophenolate mofetil 500mg Roche S.p.A., Italy Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 98 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1323 BRU14111628NP 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

1324 BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1325 BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1326 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1327 BRU14111633P 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

1328 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1329 BRU14111635NP 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

1330 BRU14111636P 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

1331 BRU14111637NP 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 ( 60 mL &

100 mL)1332 BRU14111638P Primovists 0.25mmol/ml

solution for injection

Gadoxetic acid, Sodium

0.25mmol/ml

Bayer Pharma AG, Leverkeusen,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1333 BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL (60mL)

1334 BRU14111642P 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

1335 BRU14111643NP Woodward's Gripe Water

(Alcohol Free)

Per 5ml - Terpeneless Dill Seed Oil

2.3mg; Sodium Bicarbonate

52.5mg

IDS Manufacturing Sdn Bhd,

Malaysia

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1336 BRU14111644P 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

1337 BRU14111645NP 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

BDMCA/RMP/0319 Page 99 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1338 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

1339 BRU14111647P 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

1340 BRU14111648P Pharmaniaga Cetirizine 10mg

tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1341 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1342 BRU14111650P Invokana Film-coated Tablet

100mg

Canagliflozin 100mg (as

hemihydrate)

JANSSEN ORTHO, LLC, Puerto Rico,

USA [Repacker: Janssen-Cilag SpA,

Italy)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1343 BRU14111651P Axcel Chlorpheniramine-2

Syrup

Chlorpheniramine maleate

2mg/5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

P

1344 BRU14111652P Binozyt Film-Coated Tablet

250mg

Azithromycin 250mg (as

monohydrate)

Novartis (Bangladesh) Ltd.,

Bangladesh

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1345 BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1346 BRU14111654NP Paracetamol Kabi Solution for

infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Deutschland

GmbH, Germany ii) Fresenius Kabi

Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1347 BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1348 BRU14121661P Kastipron Tablet 375mg S-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1349 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemic Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1350 BRU14121663P Curam 625mg Film-coated

Tablet

Amoxicillin 500mg; Clavulanic acid

as potassium salt 125mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1351 BRU14121664P Vesyca Injection 25mg/ml Ranitidine (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

1352 BRU14121666P Amoxicap 500 Capsule Amoxicillin (as trihydrate 574mg)

500mg

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1353 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w;

Menthol 2.3% w/w and Camphor

4.0% w/w

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0319 Page 100 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1354 BRU14121668NP 50% 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

1355 BRU14121670P Medoflucon Capsule 150mg Fluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1356 BRU14121671P Topamax 100 Tablets 100mg Topiramate 100mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1357 BRU14121672NP Duratears 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

1358 BRU14121673P Eprex® 40,000 Prefilled

Syringes 40,000iu/1ml

Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH &

Co. KG, Germany; Cilag AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1359 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd.,

Thailand

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1360 BRU14121675P Ziagen Oral Solution Abacavir (as Abacavir Sulfate)

20mg/ml

GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1361 BRU14121676P Minulet 21 Tablet Gestodene 75mcg; ethinylestradiol

30mcg

Haupt Pharma Munster GmbH.,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1362 BRU14121677P Pataday Olopatadine

Ophthalmic Solution 0.2%

Olopatadine hydrochloride 2.22mg

(eq. to Olopatadine 2mg (0.2%)

Alcon Laboratories, Inc., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1363 BRU14121678P Provironum Tablet 25mg Mesterolone 25mg Schering Do Brasil Quimica e

Farmaceutica Ltda., San Paulo-SP,

Brazil

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1364 BRU14121681NP Strepsils Strawberry Sugar

Free Children

Amylmetacresol 0.6mg; 2.4-

Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare

International Limited, UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1365 BRU14121682P Axcel Sodium Fusidate 250

Tablet

Sodium Fusidate (Micronized)

250mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1366 BRU14121683P Pencor 1mg tablet Doxazosin Mesylate (eq. to

Doxazosin 1mg)

Unison Laboratories Co., Ltd,

Thailand

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1367 BRU14121684P Pencor 2mg tablet Doxazosin Mesylate (eq. to

Doxazosin 2mg)

Unison Laboratories Co., Ltd,

Thailand

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1368 BRU14121685P Pencor 4 Tablet Doxazosin Mesylate (eq. to

Doxazosin 4mg)

Unison Laboratories Co., Ltd,

Thailand

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 101 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1369 BRU14121686P Decan Injection 2mg/ml Dexamethasone 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

1370 BRU14121687P Primodil-10 Tablet Amlodipine Besilate 13.87mg (eq.

to Amlodipine 10mg)

Medley Pharmaceuticals Limited,

India

Medicorp Sdn Bhd 19 May 2020 till 18 May

2025

POM

1371 BRU14121688P Cuvarlix Capsule 120mg Orlistat 120mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1372 BRU14121689NP Calcium Lactate 300mg tablet Calcium lactate 300mg Drug Houses of Australia Pte Ltd.,

Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1373 BRU14121690P Seladin 500mg tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1374 BRU14121691P Driminate 50mg Suppository Dimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

P (10 x 10's)

1375 BRU14121692NP Hurix'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

1376 BRU14121693NP Hurix Corn Rid Solution 5%

w/w

lactic 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

1377 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

1378 BRU14121695P Axcel Fungicort Cream Miconazole 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

1379 BRU14121697NP Dettol Antiseptic Wound

Wash Spray

benzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK)

Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1380 BRU14121698P Edurant Film-Coated 25mg

tablet

Rilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1381 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as

hemihydrate)

JANSSEN ORTHO, LLC, Puerto Rico,

USA [Repacker: Janssen-Cilag SpA,

Italy)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1382 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1383 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1384 BRU14121702NP Septi-Sol Solution Chlorhexidine 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

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1385 BRU14121703P Atoris Film-coated Tablet

20mg

Atorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1386 BRU14121704NP Nutrilite Glucosamine HCl

Capsule 375mg

Glucosamine HCl 375mg Pharmaniaga Manufacturing

Berhad, Malaysia

Amway Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1387 BRU14121705P Ultibro Breezhaler 110/50

mcg Inhalation Powder Hard

Capsule

Indacaterol (as maleate) 110mcg

(143 mcg); Glycopyrronium (as

bromide) 50mcg (63 mcg)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1388 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as

anhydrous)

Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1389 BRU15011711P DiSuf-B Cream Fusidic 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

1390 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

1391 BRU15011713P Binoclar® 500mg Film-coated

Tablets

Clarithromycin 500mg Novartis Bangladesh Ltd,

Bangladesh

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1392 BRU15011714P Ospamox 250mcg/5ml

granules for suspension

Amoxicillin 250mg (as trihydrate

287mg)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1393 BRU15011716P Ospamox 500mg Film-coated

Tablet

Amoxicillin 500mg (as trihydrate

574mg)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1394 BRU15011717P Salofalk® 500mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1395 BRU15011718P Salofalk® 1000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1396 BRU15011719P Vaqta® Vaccine 50U/ml Hepatitis A Virus, Purified,

Inactivated 50U/ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1397 BRU15011720P Vaqta® Vaccine 25U/0.5ml Hepatitis A Virus, Purified,

Inactivated 25U/0.5ml

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1398 BRU15011721P Salofalk® 3000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1399 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1% Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1400 BRU15011723P Clarimycin Film Coated Tablet

250mg

Clarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1401 BRU15011724P Forteo Injection 20mcg/80mcl Each ml contains 250mcg of

Teriparatide (recombinant of

human parathyroid hormone (1-

34) [rhPTH (1-34)])

Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1402 BRU15011725P Torisel Concentrate for

Injection 25mg/ml

Temsirolimus 25mg/ml Pierre Fabre Medicament

Production (PFMP), France

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1403 BRU15011726P Ursofalk 500mg Film-coated

Tablets

Ursodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1404 BRU15011727P Bactigen Eye Drops 0.3% Gentamicin 0.3% (as Gentamicin

Sulphate)

FDC Limited, India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1405 BRU15011728P Hexaxim 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1406 BRU15011730PS1;

BRU15011730PS3

Bridion Solution for Injection

100mg/ml

Sugammadex 100mg/ml N.V. Organon, The Netherlands

(S1); Patheon Manufacturing

Services LLC, USA (S3)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1407 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1408 BRU15011732NP Strepsils Soothing Honey &

Lemon

Amylmetacresol 0.6ml; 2,4-

Dichlorobenzyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0319 Page 104 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1409 BRU15011733NP Strepsils Max Blackcurrant

Lozenge

Hexylresorcinol 2.4mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1410 BRU15011734P Implanon NXT Implant 68mg Etonogestrel 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1411 BRU15011735PS2 Stocrin Tablet 200mg Efavirenz 200mg Zhejiang Huahai Pharmaceutical

Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1412 BRU15011736PS2 Stocrin Tablet 600mg Efavirenz 600mg Zhejiang Huahai Pharmaceutical

Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1413 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/v Interphill Laboratories Inc.,

Philippines

LF Asia (Borneo) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1414 BRU15011739P Nicotinell TTS 10 Nicotine 17.5mg (delivers

7mg/24hours)

LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1415 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24

hours)

LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1416 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24

hours)

LTS Lohmann Therapie-System AG,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1417 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

1418 BRU15011743P Pharmaniaga 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

1419 BRU15011744P Extraneal 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1420 BRU15011745P Seladin 250mg tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1421 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, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 105 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1422 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, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1423 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1424 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1425 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

Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1426 BRU15021751P Kogenate FS for Injection

1000IU/vial

Antihemophilic factor

(recombinant) sucrose formulated

1000IU

Bayer Healthcare LLC, United

States

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1427 BRU15021752P Kogenate FS for Injection

500IU/vial

Antihemophilic factor

(recombinant) sucrose formulated

500IU

Bayer Healthcare LLC, United

States

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1428 BRU15021753P Dimenate Syrup 15mg/5ml Dimenhydrinate 15mg/5ml Drug Houses of Australia Private

Limited, Singapore

G & H Trading Company 19 May 2015 till 18 May

2020

POM (3.8L)

BDMCA/RMP/0319 Page 106 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1429 BRU15021754P Cernevit 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, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1430 BRU15021755P Baneocin Ointment Bacitracin Zinc 250IU/1g;

Neomycin Sulphate 5000 IU

(5mg)/1g

Merck Kommanditgesellschaft Auf

Aktein & Co., Werk, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1431 BRU15021756P Ospexin 125mg/5ml granules

for oral suspension

Cephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1432 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1433 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1434 BRU15021759P Beclazone 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

1435 BRU15021760PS1 &

BRU15021760PS2

Insulatard 100IU/ml

Suspension for Injection (vial)

1ml of suspension contain 100IU

(3.5g) of insulin

Novo Nordisk A/S, Denmark (S1);

Novo Nordisk Production SAS,

France (S2)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1436 BRU15021761P Covapril Tablet 4mg Perindopril Erbumine Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1437 BRU15021762P Axcel Amlodipine 5mg Tablet Amlodipine Besylate equivalent to

Amlodipine 5mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1438 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mg Pfizer Pharmaceuticals LLC.,

Puerto Rico

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 107 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1439 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1440 BRU15021765NP 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

1441 BRU15021766P Neulastim Pre-filled Syringe

6mg/0.6ml

Pegfilgrastim 6mg/0.6ml F-Hoffman-La Roche Ltd.,

Switzerland

Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1442 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

1443 BRU15021768P Exelon Patch 15 Rivastigmine base 27mg / 15cm2

(In vivo release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme

AG, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1444 BRU15021769NP Zellox-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

1445 BRU15021770P Bonjela Gel 15g tube Choline Salicylate 8.714% &

Cetalkonium chloride 0.01%

Reckitt Benckiser Healthcare (UK)

Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1446 BRU15021771P Gilenya 0.5mg hard capsule Fingolimod 0.5mg (corresponding

to 0.56mg Fingolimod

Hydrochloride)

Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1447 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd.,

Thailand

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1448 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd.,

Thailand

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1449 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/ml Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1450 BRU15021775P Hurix Skin Ointment 5%w/w Benzoic 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

BDMCA/RMP/0319 Page 108 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1451 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1452 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1453 BRU15021779P Trajenta 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

1454 BRU15021780P Trajenta 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

1455 BRU15021781P Trajenta 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

1456 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1457 BRU15021784P Toviaz 4mg prolonged-release

tablet

Fesoterodine fumarate equivalent

to 3.1mg fesoterodine

Aesica Pharmaceuticals GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1458 BRU15021785P Toviaz 8mg prolonged-release

tablet

Fesoterodine fumarate equivalent

to 6.2mg fesoterodine

Aesica Pharmaceuticals GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1459 BRU15021786P Giotrif 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

1460 BRU15021787P Giotrif 30mg film-coated

tablets (Afatinib 30mg)

Afatinib (as dimaleate) 30mg Boehringer Ingelheim GmbH and

Co. KG., Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1461 BRU15021788P Giotrif 40mg film-coated

tablets (Afatinib 40mg)

Afatinib (as dimaleate) 40mg Boehringer Ingelheim GmbH and

Co. KG., Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1462 BRU15021789P Giotrif 50mg film-coated

tablets (Afatinib 50mg)

Afatinib (as dimaleate) 50mg Boehringer Ingelheim GmbH and

Co. KG., Germany

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1463 BRU15021790P Mikostat 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

1464 BRU15021793NP SMOFlipid 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 109 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1465 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1466 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

1467 BRU15021796P Montelair 10mg film-coated

tablet

Montelukast (as Montelukast

Sodium) 10mg

Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1468 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine

Besilate) 10mg

Lek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1469 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1470 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1471 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1472 BRU15021801NP Calactate 300mg tab Calcium Lactate pentahydrate

300mg

Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0319 Page 110 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1473 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1474 BRU15021803P Colospan 10mg sugar coated

tablet

Hyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1475 BRU15021804P Caslot 25mg tablet Carvedilol 25mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1476 BRU15021805P Serenata 50mg Tablet Sertraline hydrochloride 56mg

equivalent to Sertraline 50mg

Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1477 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G

2.5g/50ml

Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1478 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G

5g/100ml

Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1479 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G

10g/200ml

Bio Product Lab, UK Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

POM

1480 BRU15031809P Moxiclav Forte Dry Powder for

Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg &

Clavulanic acid 62.5mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1481 BRU15031810P Moxiclav 625mg Tablets Amoxicllin trihydrate (574mg)

500mg; clavulanate potassium

microcrystalline cellulose

(297.8mg) eq. to clavulanic acid

125mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1482 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1483 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

1484 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 111 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1485 BRU15031814P NimenrixTM (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.,

Rixensart, Belgium;

GlaxoSmithKline Biologicals,

Branch of SmithKline Beecham

Pharma GmbH & Co. KG., Dresden

Germany (diluent Ampoule);

Delpharm Tours, Chambray-lès-

Tours

France (Diluent ampoule);

GlaxoSmithKline Biologicals SA,

Rixensart Belgium (diluent PFS);

Catalent Belgium SA, Brussels,

Belgium (diluent PFS);

GlaxoSmithKline Biologicals S.A. ,

Wavre Belgium (Additional facility

for formulation)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1486 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1487 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1488 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd.,

Malaysia

Hongkiat Trading & Company 19 May 2015 till 18 May

2020

P (50 x 10’s)

1489 BRU15031819P Placta Film-coated Tablets

75mg

Clopidogrel (as bisulphate) 75mg Actavis Ltd., Malta G&H Trading Company 19 May 2015 till 18 May

2020

POM

1490 BRU15031820NP SmofKabiven Peripheral

Emulsion for Infusion

1 unit consists of Amino Acid

Solution; Glucose Solution; Lipid

Emulsion (For detailed formulation

referred to dossier)

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1491 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0319 Page 112 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1492 BRU15031823P ADVATE 500IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII)

1) Baxalta Manufacturing Sarl,

Switzerland (DP manufacturer);

2) Siegfried Hameln GmbH,

Germany (Sterile Water for

Injection (Diluent) manufacturer)

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1493 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., Malaysia G&H Trading Company 19 May 2015 till 18 May

2020

GSL

1494 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

1495 BRU15031826P Saizen® 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

1496 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1497 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1498 BRU15031830NP Gaviscon Liquid Sachet Each 10ml contains: Sodium

alginate 500mg, Sodium

bicarbonate 267mg and Calcium

carbonate 160mg

Reckitt Benckiser Healthcare (UK)

Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1499 BRU15031831NP Fisherman’s Friend Sugar-Free

Apple & Cinnamon Lozenges

Menthol 4.025mg IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

1500 BRU15031832NP Fisherman’s Friend Sugar-Free

Mandarin & Ginger Lozenges

Menthol 4.6mg IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

1501 BRU15031833NP Fisherman’s Friend Sugar-Free

Lemon Lozenges

Menthol 4.6mg IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0319 Page 113 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1502 BRU15041834P Rotaqor 20mg film-coated

tablet

Atorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1503 BRU15041835P Jakavi 20mg tablet Ruxolitinib (as phosphate 26.40mg)

20mg

Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1504 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg)

15mg

Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1505 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg)

5mg

Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1506 BRU15041839P Archifar 500mg powder for

injection/infusion

Meropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co. 19 May 2015 till 18 May

2020

POM

1507 BRU15041840P Ciproflo 2mg/ml solution for

IV infusion

Ciprofloxacin 2mg/ml (as

hydrochloride)

Sin Guan Chem. Ind. Co. Ltd.,

Republic of China

K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1508 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

POM

1509 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

1510 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5ml Sunward Pharmaceutical Sdn.

Bhd., Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1511 BRU15041844P Pharmaniaga Loratadine

tablet 10mg

Loratadine 10mg Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1512 BRU15041845P Curam 1000mg tablet Amoxycillin 875 (as trihydrate);

clavulanic acid 125mg (as

potassium clavulanate)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1513 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride)

500mg

Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May

2020

POM

1514 BRU15041847P Sunadine tablet 10mg Loratadine 10mg Sunward Pharmaceutical Sdn.

Bhd., Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

BDMCA/RMP/0319 Page 114 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1515 BRU15041848NP Soluvit 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 (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1516 BRU15041849NP Folic acid 5mg tablet Folic acid 5mg Sunward Pharmaceutical Sdn.

Bhd., Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

P

1517 BRU15041850P Estelle-35 tablet Cyproterone acetate 2mg;

Ethinylestradiol 0.03mg

Douglas Manufacturing Limited,

New Zealand

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1518 BRU15041851NP Cetomacragol emulsifying

ointment

Cetomacragol emulsifying wax 30%

w/w; liquid paraffin 20%; white

soft paraffin 50%

Hovid Bhd., Malaysia G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1519 BRU15041852PS1/

BRU15041852PS2

Glucophage® XR 1000mg

Extended-release tablet

Metformin (as hydrochloride

1000mg) 780mg

1. Merck Sante SAS, France;

2. Merck KGaA, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1520 BRU15041853P Duofilm Liquid Salicylic acid 16.7% w/w; lactic acid

16.7%

Stiefel Labs (Ireland) Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

P

1521 BRU15041854NP Voluven Solution for Infusion

6%

Per 1000ml: Poly (O-2-

hydroxyethyl) starch 60.0g; sodium

chloride 9.00g

Frensius Kabi Deutschland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1522 BRU15041855NP Iris eye drops Hydroxypropyl methylcellulose

3mg; dextran 70 1mg

Sam Chun Dang Pharm Co Ltd,

South Korea

Medipharm Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1523 BRU15041856P Onzapin film-coated tablet

5mg

Olanzapine 5mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May

2020

POM

1524 BRU15041857P Onzapin film-coated tablet

10mg

Olanzapine 10mg Actavis Ltd., Malta G & H Trading Company 19 May 2015 till 18 May

2020

POM

1525 BRU15041858NP Fisherman’s friend aniseed

lozenges

Menthol 5.75mg Lofthouse of Fleetwood Limited,

UK

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0319 Page 115 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1526 BRU15041859NP Fisherman’s Friend Sugar

Free Mint Lozenges

Menthol 3.45mg Lofthouse of Fleetwood Limited,

UK

Kingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18 May

2020

GSL

1527 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

1528 BRU15041861NP ChlorHex 5% Concentrate

Solution

Chlorhexidine gluconate 5% w/v;

isopropylalcohol 3.15% w/v

Pahang Pharmacy Sdn Bhd,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

GSL

1529 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mg Upha Pharmaceuticals Sdn Bhd,

Malaysia

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1530 BRU15051863NP SP Pharma Paracetamol

Tablets 500mg

Paracetamol 500mg Simpor Pharma Sendirian Berhad,

Brunei Darussalam

Simpor Pharma Sendirian

Berhad

19 May 2015 till 18 May

2020

P (200’s)

1531 BRU15051864NP Addamel™ N Concentrate for

Infusion

1 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 (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1532 BRU15051865NP 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

BDMCA/RMP/0319 Page 116 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1533 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 (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1534 BRU15051868NP Kabiven Emulsion for Infusion 1000ml of the mixture contain:

Purified soybean oil 39g; Glucose

(anhydrous) 97g; Alanine 4.7g;

Arginine 3.3g; Aspartic acid 0.99g;

Phenylalanine 2.3g; Glutamic acid

1.6g; Glycine 2.3g; Histidine 2.0g;

Isoleucine 1.6g; Leucine 2.3g;

Lysine 2.6g; Methionine 1.6g;

Proline 2.0g; Serine 1.3g;

Threonine 1.6g; Tryptophan 0.56g;

Tyrosine 0.07g; Valine 2.1g;

Sodium glycerophosphate

(anhydrous) 1.5g; Calcium chloride

0.22g; Potassium chloride 1.7g;

Magnesium sulphate 0.47g;

Sodium acetate 1.4g

Fresenius Kabi AB, Uppsala,

Sweden

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1535 BRU15051869P Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM

BDMCA/RMP/0319 Page 117 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1536 BRU15051870P Fenagesic Tablet 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July 2020 POM

1537 BRU15051871P Metta SR Tablets 500mg Metformin Hydrochloride USP

500mg

Torrent Pharmaceuticals Ltd.,

Indrad, India

K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM

1538 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 28 July 2015 till 27 July 2020 POM

1539 BRU15051873NP Calamine Lotion Calamine BP 15% w/v Royce Pharma Manufacturing Sdn

Bhd, Malaysia

SWL Biomed Sales & Services 28 July 2015 till 27 July 2020 GSL

1540 BRU15051874NP Fisherman’s Friend Original

Lozenges

Menthol 10.35mg; Eucalyptus oil

1.73mg

Lofthouse of Fleetwood Limited,

UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July 2020 GSL

1541 BRU15051875NP 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 2020 GSL

1542 BRU15051876NP Fisherman’s Friend Sugar Free

Original Lozenges

Menthol 9.2mg IDS Manufacturing Sdn Bhd,

Malaysia

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July 2020 GSL

1543 BRU15051878P Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM (100's); P

(20's)1544 BRU15051879P Candazole V Single Dose

Cream 10% w/w

Clotrimazole 10% w/w HOE Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 28 July 2015 till 27 July 2020 P

1545 BRU15061880P Keppra® Oral Solution

100mg/ml

Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1546 BRU15061881P Norditrophin Nordilet

Inejction 5mg/1.5ml Pre-filled

Pen, Solution for Injection

Somatropin (rDNA) 3.3mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1547 BRU15061882P Aceprin 10mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2015 till 27 July 2020 POM

1548 BRU15061883NP 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

1549 BRU15061884P 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

1550 BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July 2020 POM

1551 BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1552 BRU15061887NP 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

BDMCA/RMP/0319 Page 118 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1553 BRU15061888P Herceptin Powder for

Injection 440mg/vial

Trastuzumab 440mg Genentech Inc., California, USA;

Genentech Inc., Oregon, USA

MediPharm Sdn Bhd 28 July 2015 till 27 July 2020 POM

1554 BRU15061889P Azoren 20mg/5mg Film-

Coated Tablet

Olmesartan medoxomil 20mg and

Amlodipine (as

amlodipine besylate) 5mg

Daiichi Sankyo Europe GmbH,

Germany [repacker: Pfizer

Manufacturing Deutschland

GmBH, Germany]

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1555 BRU15061890P Azoren 40mg/10mg Film-

Coated Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as

amlodipine besylate) 10mg

Daiichi Sankyo Europe GmbH,

Germany [repacker: Pfizer

Manufacturing Deutschland

GmBH, Germany]

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1556 BRU15061891P Azoren 40mg/5mg Film-

Coated Tablet

Olmesartan medoxomil 40mg and

Amlodipine (as

amlodipine besylate) 5mg

Daiichi Sankyo Europe GmbH,

Germany [repacker: Pfizer

Manufacturing Deutschland

GmBH, Germany]

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1557 BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg

(eqv. to 3.338mg perindopril)

Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 POM

1558 BRU15061893NP 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

1559 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam)

Co. Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July 2020 GSL

1560 BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam)

Co. Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July 2020 GSL

1561 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd.,

Malaysia

Medicorp Sdn. Bhd. 28 July 2015 till 27 July 2020 GSL

1562 BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml

Potassium bicarbonate 100mg/5ml

Reckitt Benckiser Healthcare (UK)

Ltd., UK

Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020 GSL

1563 BRU15071899P 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

1564 BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;

Sodium bicarbonate 267mg;

Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK)

Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

BDMCA/RMP/0319 Page 119 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1565 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1566 BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D.,

Ljubljana

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1567 BRU15071903NP Chlorhex 4% antiseptic

solution

Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd.,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1568 BRU15071904P Resolor Film-coated Tablet

2mg

Prucalopride succinate 2.642mg

eqv Prucalopride 2mg

Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1569 BRU15071905P Proglutrol 500 Extended

Release Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1570 BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;

Sodium Bicarbonate 213mg;

Calcium Carbonate 325mg

Reckitt Benckiser Healthcare (UK)

Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1571 BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium

Bicarbonate 106.5mg; Calcium

Carbonate 187.5mg

Reckitt Benckiser Healthcare (UK)

Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1572 BRU15071908P Daivobet Gel Calcipotriol (as monohydrate)

50mcg/g & betamethasone (as

dipropionate) 0.5mg/g

LEO Laboratories Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1573 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam)

Co. Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL

1574 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam)

Co. Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec 2020 GSL

1575 BRU15071911P 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 GSL

1576 BRU15071912P Keppra Film-coated Tablet

1000mg

Levetiracetam 1000mg UCB Pharma SA, Belgium Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1577 BRU15081913NP Zentel Suspension

400mg/10ml

Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage &

Creamery Sdn Bhd

09 Dec 2015 till 08 Dec 2020 GSL (1's x 10ml)

1578 BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50

micrograms and timolol maleate

6.8mg (eq to 5mg timolol)

Pfizer Manufacturing Belgium NV,

Belgium

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1579 BRU15081916P 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

1580 BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

BDMCA/RMP/0319 Page 120 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1581 BRU15081918P Olanzapine Orodispersible

Tablets 5mg

Olanzapine 5mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1582 BRU15081919P Olanzapine Orodispersible

Tablets 10mg

Olanzapine 10mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1583 BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical

Laboratories, India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1584 BRU15081921P 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

1585 BRU15081922P Olmetec Plus 40/12.5mg Film-

Coated Tablet

Olmesartan Medoxomil 40mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1586 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1587 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1588 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1589 BRU15081926NP Win-Aqueous Cream Emulsifying 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 GSL

1590 BRU15091928P Acular Ophthalmic Solution

0.5%

Ketorolac Tromethamine 0.5% Allergan Pharmaceuticals Ireland,

Ireland

MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1591 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Pharmaceuticals LLC, Vega

Baja, USA (Pfizer Vega Baja)

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1592 BRU15091930P Zymar (gatifloxacin

ophthalmic solution) 0.3%

Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1593 BRU15091931P Klerimed 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 2020 POM

1594 BRU15091932P Gadovist Injection

1.0mmol/ml Prefilled syringe

5.0ml

Gadobutrol pure 604.72mg &

Calcium sodium butrol 0.513mg

Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1595 BRU15091933P Gadovist Injection

1.0mmol/ml

Gadobutrol pure 604.72mg &

Calcium sodium butrol 0.513mg

Bayer AG, MÜllerstraβe 178,

Germany

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

BDMCA/RMP/0319 Page 121 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1596 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

1597 BRU15091935P Cardiprin 100 Tablet Aspirin 100mg Reckitt Benckiser Healthcare

(UK),United Kingdom

Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1598 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

1599 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/ml Y.S.P. Industries (M) Sdn. Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1600 BRU15091938P Storvas C Tablets 10mg Atorvastatin 10mg as Atorvastatin

Calcium Trihydrate

Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1601 BRU15091939NP Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1602 BRU15091940P Pirimat Injection 10mg/ml

(1ml ampoule)

Chlorpheniramine Maleate

10mg/m

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1603 BRU15091941P Irprestan Tablet 150mg Irbesartan 150mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1604 BRU15091942P Irprestan Tablet 300mg Irbesartan 300mg Actavis ehf, Iceland G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1605 BRU15091943P Heparinol® 10 Sterile

Heparinised Saline Injection

Heparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 POM

1606 BRU15091944P Fucid Ointment 2% w/w Sodium Fusidate (Micronised)

20mg/g (2% w/w)

Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1607 BRU15091946P Axcel Bromhexine (Children)

Elixir

Bromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd.,

Malaysia

Medicorp Sdn Bhd. 09 Dec 2015 till 08 Dec 2020 POM

1608 BRU15101947P Cetyrol 10mg Film-coated

Tablet

Cetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P

1609 BRU15101948P Archifar 1g Powder for

Solution for Injection/Infusion

Meropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 POM

1610 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate

2mg/5ml

Winwa Medical Sdn Bhd.,

Malaysia

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 P

BDMCA/RMP/0319 Page 122 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1611 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1612 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1613 BRU15101952NP Flexjoint 1500mg Powder Crystalline glucosamine sulphate

1884mg (equivalent to

glucosamine sulphate 1500mg)

Winwa Medical Sdn Bhd.,

Malaysia

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 GSL

1614 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd.,

Malaysia

Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1615 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 units T.O. Chemicals (1979) Co. Ltd.,

Thailand

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1616 BRU15101955P Ezede Tablet 10mg Loratadine 10mg Xepa-Soul Pattinson (M) Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 09 Dec 2015 till 08 Dec 2020 P

1617 BRU15101956P Pred Forte Sterile Ophthalmic

Suspension 1%

Prednisolone acetate 1% w/v Allergan Pharmaceuticals Ireland,

Mayo, Ireland

Medipharm Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1618 BRU15111957P Stivarga Tablet 40mg Regorafenib

(40mg Regorafenib equivalent to

41.49mg Regorafenib

monohydrate)

Bayer Pharma AG, Germany. Zuellig Pharma (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1619 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1620 BRU15111959P Insugen-N (NPH) Insulin Injection, Isophane Ph. Eur.

(Human Insulin rDNA origin)

100IU/ml

Biocon Limited, India Hongkiat Trading & Company 09 Dec 2015 till 08 Dec 2020 POM

1621 BRU15111960P Tetradox Capsules 100mg Doxycycline Hydrochloride/Hcylate

eq to Doxycycline 100mg

Ranbaxy (Malaysia) Sdn Bhd,

Malaysia

G & H Trading Company 09 Dec 2015 till 08 Dec 2020 POM

1622 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL

1623 BRU15111962NP Infusol W (Sterilised Water for

Injection BP)

Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah 09 Dec 2015 till 08 Dec 2020 GSL (500ml)

1624 BRU15111963P Elan Forte Cream Tolnaftate 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 2020 GSL

1625 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

BDMCA/RMP/0319 Page 123 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1626 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate

(micronized) equivalent to

Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec 2020 POM

1627 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd.,

Malaysia

Yuh Hua Trading Company 09 Dec 2015 till 08 Dec 2020 GSL

1628 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

1629 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone

12.5mg

Salutas Pharma GmbH, Federal

Republic of Germany

Medicorp 09 Dec 2015 till 28 April

2019

POM

1630 BRU15111969PT Hurricaine Topical Anaesthetic

Gel – Original Wild Cherry

Benzocaine 20% Dental Technologies Inc. , United

States

L S Kai Care 09 Dec 2015 till 16 Feb 2018 POM

1631 BRU15111970PT Duocaine Cream 5% w/w Lidocaine 2.5% w/w; Prilocaine

2.5% w/w

Hoe Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Co 09 Dec 2015 till 14 Jan 2019 POM

1632 BRU15121972PS1 &

BRU15121972PS2

Varivax (refrigerated) Varicella Virus Vaccine Live (Oka /

Merck) 1350PFU / 0.5ml

Merck Sharp & Dohme Corp.,

Pennsylvania USA (S1)

ii) Merck Sharp and Dohme Corp.,

North Carolina, US (S2)

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1633 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1634 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine

Phosphate 8mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1635 BRU15121975NP Mentholatum Deep Heat

Sport Pain Relief Spray

Methyl Nicotinate 16mg/g; Glycol

Salicylate 50mg/g; Methyl

Salicylate 10mg/g; Ethyl salicylate

50mg/g

Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1636 BRU15121976NP Mentholatum Deep Cold Ice

Gel Therapy

Menthol 20g/g Mentholatum Australia Pty. Ltd.,

Australia

Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1637 BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1638 BRU15121979P Medocef 1g Powder for

Solution for Injection or

Infusion

Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

BDMCA/RMP/0319 Page 124 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1639 BRU15121980NP Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1640 BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w &

Cetylpyridinium Chloride 0.05%

w/w

Winwa Medical Sdn. Bhd.,

Malaysia

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1641 BRU16011982NP 0.9% Sodium Chloride

Injection, USP

Sodium Chloride USP 0.9% Baxter Healthcare Corporation,

USA

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1642 BRU16011983P Amlibon 5mg Tablet Amlodipine (as Amlodipine

Besilate) 5mg

Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1643 BRU16011984P Ospexin 250mg/5ml Granules

for Oral Suspension

Cephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1644 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1645 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1646 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1647 BRU16011988P Lestric Tablets 20mg Lovastatin 20mg Ranbaxy (Malaysia) Sdn Bhd.,

Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1648 BRU16011989P Potassium Chloride 10% w/v

Injection

Potassium Chloride 10% w/v Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1649 BRU16011990P Gastografin Solution 1ml contains Sodium

amidotrizoate 0.1g and Meglumine

amidotrizoate 0.66g

Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1650 BRU16011991P Rabotide Capsule 20mg (as

enteric coated pellets)

Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1651 BRU16011992P Pharmaniaga Gliclazide Tablet

80mg

Gliclazide 80mg Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1652 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1653 BRU16011994NP Betadine Feminine Wash with

Douching Apparatus 10% w/v

Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1654 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1655 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd.,

Malaysia

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL (10 x 10’s)

BDMCA/RMP/0319 Page 125 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1656 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v Hoe Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1657 BRU16021998P Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur.

(Insulin, Human of recombinant

DNA origin) 100 IU/ml

Biocon Limited, India Hongkiat Trading & Co 21 Jun 2016 till 20 Jun 2021 POM

1658 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM

1659 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM

1660 BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL

1661 BRU16022002NP Noxworm Suspension

(chocolate) 400mg

Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1662 BRU16022003P Mircera pre-filled syringe

100mcg/0.3ml

Methoxy polyethylene glycol-

epoetin beta 100mcg/0.3ml

Roche Diagnostics GmbH,

Germany

MediPharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1663 BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach

GmbH, Germany for F.Hoffmann-

La Roche Ltd., Switzerland

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1664 BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia)

Sdn Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 P

1665 BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia)

Sdn Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1666 BRU16022010P Bena

®

Expectorant

Diphenhydramine hydrochloride

14mg/5ml and ammonium

chloride 135mg/5ml

Xepa-Soul Pattinson (Malaysia)

Sdn Bhd,

Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1667 BRU16022011P Pantor 20 Pantoprazole (as sodium

sesquihydrate) 20mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1668 BRU16022012P Pantor 40 Pantoprazole (as sodium

sesquihydrate) 40mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1669 BRU16032013P Ceritec Film Coated Tablet

10mg

Cetirizine Hydrochloride 10mg Y.S.P. Industries (M) Sdn. Bhd.,

Malaysia.

Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1670 BRU16032014P Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

BDMCA/RMP/0319 Page 126 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1671 BRU16032015PS1 &

BRU16032015PS2

M-M-R II® Vaccine Live, attenuated virus derived from

Edmonston B strain of measles -

3.0 log TCID50, Live attenuated Jeryl

LynnTM strain of mumps - 4.1 log

TCID50, Live, attenuated Wistar RA

27/3 strain of rubella - 3.0 log

TCID50

1. Merck Sharp & Dohme Corp.,

Pennsylvania, USA,

2. Merck Sharp & Dohme Corp.,

North Carolina, U.S.A

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1672 BRU16032016P Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane

Ph. Eur. (Insulin, Human

recombinant DNA origin) 100

IU/ml

Biocon Limited, India Hongkiat Trading & Co. 21 Jun 2016 till 20 Jun 2021 POM

1673 BRU16032017P Natrixam 1.5mg/10mg

modified-release tablet

Indapamide 1.5mg & Amlodipine

10mg (as besilate)

Les Laboratories Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1674 BRU16032018P Natrixam 1.5mg/5mg

modified-release tablet

Indapamide 1.5mg & Amlodipine

5mg (as besilate)

Les Laboratories Servier Industrie,

France

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1675 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM

1676 BRU16032020NP Mifuko Ointment Zinc Oxide 6% (w/w) and Salicylic

acid 5% (w/w)

Winwa Medical Sdn Bhd,

Malaysia.

Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1677 BRU16032021P Primodil 5 Tablet Amlodipine Besilate 6.94mg

(equivalent to Amlodipine 5mg)

Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1678 BRU16032022P Oxair Film Coated Tablet

10mg

Montelukast Sodium 10.4mg

(equivalent to Montelukast 10mg)

Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1679 BRU16032023NP Bacidin Antiseptic Cream 1%

w/w

Chlorhexidine Gluconate 1% w/w Xepa-soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1680 BRU16032024P Axcel Oxymetazoline 0.05%

Nasal Spray

Oxymetazoline Hydrochloride

0.05% w/v

Kotra Pharma (M) Sdn Bhd.,

Malaysia.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1681 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia.

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

BDMCA/RMP/0319 Page 127 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1682 BRU16042026NP Migrate Q10 Coenzyme Q10………….100mg;

Lycopene………………….... 5mg; L-

Arginine…………….…..100mg;

Zinc Sulphate monohydrate (eq to

Elemental zinc)..22.5mg;

Piperine………………………..5mg;

Sodium selenite (eq to Elemental

selenium) ….70mcg

Goodman Pharmaceuticals, India. MediBiotech 21 Jun 2016 till 20 Jun 2021 GSL

1683 BRU16042027NP Potassium Chloride Injectable

Solution 10%

Potassium chloride 1g / 10ml DEMO SA Pharmaceutical

Industry, Greece.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1684 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg Swiss Caps AG, Switzerland,

Contract Mfg. for Douglas

Pharmaceuticals Limited, New

Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1685 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg Swiss Caps AG, Switzerland,

Contract Mfg. for Douglas

Pharmaceuticals Limited, New

Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1686 BRU16042030NP Osteoactiv 3 in 1 Joint

Formula Powder

Glucosamine Hydrochloride

1000mg, Methylsulfonylmethane

1000mg, Chondroitin Sulphate

Sodium 880.4mg (equivalent to

800mg chondroitin)

Winwa Medical Sdn. Bhd.,

Malaysia.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1687 BRU16042031NP Osteoactiv 3 in 1 Joint

Formula Tablet

Glucosamine Hydrochloride

250mg, Methylsulfonylmethane

250mg, Chondroitin Sulphate

Sodium 220mg (equivalent to

200mg chondroitin)

Winwa Medical Sdn. Bhd.,

Malaysia.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1688 BRU16042032P Sedilix-DM Linctus Dextromethorphan (as

Hydrobromide) 15mg/5mL;

Pseudoephedrine (as

Hydrochloride) 30mg/5mL;

Promethazine (as Hydrochloride)

3.125mg/5mL

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia.

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1689 BRU16042033P Aloxi Solution for Injection

50mcg/ml

Palonosetron Hydrochloride 56

mcg eqv to Palonosetron 50 mcg

(0.050 mg)

Pierre-Fabre Medicament

Production, France.

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

BDMCA/RMP/0319 Page 128 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1690 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1691 BRU16042035NP Axcel B Complex Tablet Vitamin B1 10mg; Vitamin B2

3mg; Vitamin B6 1mg;

Cyanocobalamine 5mcg; Calcium

Pantothenate 1mg; Nicotinamide

25mg

Kotra Pharma (M) Sdn Bhd,

Malaysia.

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1692 BRU16042036P Pharmaniaga Allopurinol

Tablet 300mg

Allopurinol 300mg Pharmaniaga Manufacturing

Berhad, Malaysia.

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1693 BRU16042037NP Povidin Solution 10% Povidone-Iodine 10% w/v

(equivalent to 1% of Available

Iodine)

Xepa-soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 GSL

1694 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mg The Government Pharmaceutical

Organization (GPO), Thailand

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1695 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd.,

Malaysia

Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1696 BRU16052040NP Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1697 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5ml HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 P

1698 BRU16052042P Axcel Oxymetazoline 0.025%

Nasal Drop

Oxymetazoline hydrochloride

0.025% w/v

Kotra Pharma (M) Sdn. Bhd.,

Malaysia

Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 P

1699 BRU16052044P;

BRU16052044PS2

Zometa Solution for Infusion

4mg/100ml

Zoledronic Acid (anhydrous)

4mg/100ml corresponding to

4.264mg Zoledronic Acid

Monohydrate

Novartis Pharma Stein AG,

Switzerland; Fresenius Kabi

Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1700 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia.

Hongkiat Trading & Company 21 Jun 2016 till 20 Jun 2021 POM

1701 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1702 BRU16062047P Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1703 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1704 BRU16062049P Seebri Breezhaler 50mcg

Inhalation Powder Hard

Capsules

Glycopyrronium bromide 63mcg

(corresponding to 50 mcg

Glycopyrronium)

Novartis Pharma Stein AG.,

Switzerland

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

BDMCA/RMP/0319 Page 129 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1705 BRU16062050P Neotigason Capsule 10mg Acitretin 10mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07

November 2021

POM

1706 BRU16062051P Neotigason Capsule 25mg Acitretin 25mg Patheon Inc., Canada G & H Trading Company 08 November 2016 till 07

November 2021

POM

1707 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate)

150mg/ml

Yung Shin Pharmaceutical Ind. Co.

Ltd., Republic of China

Asterix United (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1708 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1709 BRU16062054P Betmiga Prolonged-Release

Tablets 25mg

Mirabegron 25mg Avara Pharma Technologies, Inc.,

USA

Medipharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1710 BRU16062055P Betmiga Prolonged-Release

Tablets 50mg

Mirabegron 50mg Avara Pharma Technologies, Inc.,

USA

Medipharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1711 BRU16062056P Axcel Mometasone 0.1%

Cream

Mometasone furoate (micronised)

0.1% w/w

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1712 BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine

200mg/ml

Frensius Kabi Austria GmbH,

Austria

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1713 BRU16072058P Noxafil 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1714 BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit

III), India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1715 BRU16072060P Pethidine-Hameln Solution for

Injection 50mg/ml

Pethidine Hydrochloride

50mg/ml

Hameln Pharmaceuticals GmbH,

Langes Feld 13, 31789 Ham

eln, Germany

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1716 BRU16072061P Axcel Clobetasol 0.05

Ointment

Clobetasol Propionate (micronized)

0.05% w/w

Kotra Pharma (M) Sdn Bhd.,

Malaysia.

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1717 BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:

Prednisolone (as salt of

prednisolone) 5mg

Beacons Pharmaceutical Pte Ltd,

Singapore

Hong Kiat Trading & Co 08 November 2016 till 07

November 2021

POM

1718 BRU16082063NP Zenalb 4.5%, Human Albumin

Solution 4.5%

Human Albumin Solution 4.5% Bio Products Laboratory Limited,

UK

MediPharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

1719 BRU16082064P Axcel Lamivudine 100mg

Tablet

Lamivudine 100mg Kotra Pharma (M) Sdn. Bhd.,

Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1720 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd.,

Malaysia

Yuh Hua Trading Company 08 November 2016 till 07

November 2021

GSL

1721 BRU16082066NP Alphanate® 250IU Factor VII 250IU and von

Willebrand Factor >400IU/1000IU

Factor VII

Grifols Bilogicals Inc., USA Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM

BDMCA/RMP/0319 Page 130 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1722 BRU16082067P Anoro Ellipta 62.5/25

micrograms inhalation

powder, pre-dispensed

Each pre-dispensed dose contains

62.5 micrograms umeclidinium

(equivalent to 74.2 micrograms of

umeclidinium bromide) and 25

micrograms vilanterol (as

trifenatate)

GlaxoSmithKline LLC, North

Carolina United States

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1723 BRU16082068NP RINS® NS Sodium Chloride

0.9% w/v Irrigation Solution

BP

Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 08 November 2016 till 07

November 2021

GSL

1724 BRU16092069P Sifrol Extended Release

0.375mg tablet

Pramipexole

Dihydrochloride

Monohydrate 0.375mg

(eq

v.

to 0.26mg

pramipexole free base)

Boehringer Ingelheim Pharma

gmbH & Co. KG, Germany

Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM

1725 BRU16092070P Sifrol Extended Release 1.5mg

tablet

Pramipexole

Dihydrochloride

Monohydrate 1.5mg

(eqv. to 1.05mg

pramipexole free base)

Boehringer Ingelheim Pharma

gmbH & Co. KG, Germany

Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM

1726 BRU16092071NP Mentholatum Deep Heating

Rub Extra Strength Cream

Methyl Salicylate 30%; Menthol

8%

The Mentholatum Co., USA. Hamitan Marketng, Brunei

Darussalam

08 November 2016 till 07

November 2021

GSL

1727 BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains:

Purified Capsular Polysaccharide

Hib

(PRP) –10mcg

(Hib Polysaccharide) (PRP) Tetanus

Toxoid (carrier protein) –19 to

33mcg

Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1728 BRU16092073P Adrenaline (Epinephrine)

Injection 1:1000

Adrenaline (Epinephrine) as acid

tartrate

Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1729 BRU16092074P Axcel Mometasone 0.1%

Ointment Mometasone Furoate

(micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

BDMCA/RMP/0319 Page 131 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1730 BRU16092075P Amphotret for Injection U.S.P.

50mg

Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd,

India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

POM

1731 BRU16092076NP Alumag Plus Tablet Per tablet:

Aluminium Hydroxide Dried Gel

250mg; Magnesium Trisilicate Light

250mg; Simethicone

30mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

HongKiat Trading Co 08 November 2016 till 07

November 2021

GSL

1732 BRU16102077PT Olanzapine Genmark 10mg

Tablet

Olanzapine 10mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading & Company 08 November 2016 till 23

Nov 2018

POM

1733 BRU16102078PT Olanzapine Genmark 5mg

Tablet

Olanzapine 5mg Glenmark Pharmaceuticals Europe

Limited, United Kingdom

Hongkiat Trading & Company 08 November 2016 till 14

Jan 2019

POM

1734 BRU16102079PT Baxter Chlorhexidine Acetate

0.1% w/v Antiseptic Solution

Chlorhexidine (as

Acetate)

Baxter Healthcare Pty Ltd,

Australia

Zuellig Pharma (B) Sdn Bhd 08 November 2019 till 26

Jan 2024

GSL

1735 BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to

doxazosin base 2

mg

Medochemie Ltd Central Factory,

Cyprus

Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1736 BRU16102081P Magurol 4mg tablet Doxazosin mesilate eq. to

doxazosin base 4

mg

Medochemie Ltd Central Factory,

Cyprus

Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1737 BRU16102082P Xyzal Film-coated tablet 5mg Levocetirizine dihydrochloride

5mg

UCB Farchim SA, Switzerland Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

P

1738 BRU16102083P Xolair 75mg powder for

solution for injection

Omalizumab 75mg.

Reconstituted Xolair contains

125mg/ml of omalizumab (75mg

in

0.6ml)

Novartis Corporation (Malaysia)

Sdn. Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1739 BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic

and Services S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07

November 2021

POM

1740 BRU16102085P Loxin Injection (5ml amp)

(Dopamine HCl)

Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 08 November 2016 till 07

November 2021

POM

1741 BRU16102086P Mycamine 50mg/vial Powder

for Solution for Infusion

Micafungin (as sodium)

50mg/via

Astellas Pharma Tech Co., Ltd.,

Japan

MediPharm Sdn Bhd 08 November 2016 till 07

November 2021

POM

BDMCA/RMP/0319 Page 132 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1742 BRU16102087P Vaxcel Fluconazole 2mg/ml IV

Infusion

Fluconazole 2mg/ml Kotra Pharma (M) Sdn.

Bhd.,Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07

November 2021

POM

1743 BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd.,

Thailand

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021

P

1744 BRU16102089NP Daily-vite multivitamin syrup

for children

Each 5mL contains:

Vitamin A: 2,000 IU

Vitamin D :400 IU

Vitamin B1 (Thiamine HCl): 1.5 mg

Vitamin B2 (Riboflavin): 1.2 mg

Vitamin B6 (Pyridoxine HCl): 1.0

mg

Vitamin B12 (cyanocobalamin): 3.0

mcg

Niacinamide: 10mg

Vitamin C (Ascorbic Acid): 50 mg

L-Lysine Monohydrochloride: 37.5

mg

Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

GSL

1745 BRU16102090NP Ubat Batuk Cap Kaki Tiga

(Solution)

Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, ,

Malaysia

Syarikat Rajamas Bersama 08 November 2016 till 07

November 2021

GSL

1746 BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride

1% (50mg/5ml)

Kotra Pharma (M) Sdn.

Bhd.,Malaysia

Medicorp Sdn. Bhd 08 November 2016 till 07

November 2021

POM

1747 BRU16112092P Risperidone Orally

Disintegrating Tablet 3mg

Risperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till

20 March 2022

POM

1748 BRU16112093P Risperidone Orally

Disintegrating Tablet 2mg

Risperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till

20 March 2022

POM

1749 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 21 March 2017 till

20 March 2022

POM

1750 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5ml Y.S.P. Industries (M) Sdn. Bhd.,

Malaysia

Asterix United (B) Sdn Bhd. 21 March 2017 till

20 March 2022

POM

1751 BRU16112096P Ospexin 1000mg Film-coated

Tablet

Cephalexin 1000mg Sandoz GmBH, Austria Zuellig Pharma (B) Sdn Bhd. 21 March 2017 till

20 March 2022

POM

1752 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mg Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd. 21 March 2017 till

20 March 2022

GSL

1753 BRU16112098NP Calamine Lotion with Menthol Calamine powder 15% w/v, zinc

oxide 5% w/v and menthol 0.4%

w/v

Beacons Pharmaceuticals Pte Ltd.,

Singapore

Hongkiat Trading & Company 21 March 2017 till

20 March 2022

GSL

BDMCA/RMP/0319 Page 133 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1754 BRU16112099P Toujeo 300 units/ml Solution

For Injection In Pre-Filled Pen

Insulin glargine 300units/ml

(10.91mg/ml)

Sanofi-Aventis Deutschland

GmbH, Germany

MediPharm Sdn Bhd. 21 March 2017 till

20 March 2022

POM

1755 BRU16112100P Apo-Levocarb Tablet

100mg/25mg

Levodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd, 21 March 2017 till

20 March 2022

POM

1756 BRU16112101P Exviera 250mg Film Coated

Tablets

Dasabuvir (as sodium

monohydrate) 250mg

AbbVie Ireland NL B.V, Ireland Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022

POM

1757 BRU16112102NP White Balsem, Three Legs

Brand

Methyl salicylate 18% w/w,

Menthol 9% w/w and Camphor 5%

w/w

Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 21 March 2017 till

20 March 2022

GSL

1758 BRU16112103NP Tinea Skin Solution, Three

Legs Brand

Salicylic acid 5% w/v and Benzoic

acid 2% w/v

Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 21 March 2017 till

20 March 2022

GSL

1759 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/v Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 21 March 2017 till

20 March 2022

GSL

1760 BRU16112105P Furosemide-hameln 10mg/ml

Injection

Furosemide 10mg/ml Hameln Pharmaceuticals

GmbH,Germany

Medicorp Sdn Bhd 21 March 2017 till

20 March 2022

POM

1761 BRU16112106NP Tolnaftate Cream Three Legs

Brand

Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 21 March 2017 till

20 March 2022

GSL

1762 BRU16112107NP Ubat Serbuk Cap Kaki Tiga

600mg/sac

Acetylsalicylic acid (Aspirin) 600mg

/ sachet

Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 21 March 2017 till

20 March 2022

GSL

1763 BRU16112108P Denkan (1) Injection i) Lignocaine HCl monohydrate eq.

to Lignocaine HCl Anhydrous 20mg

(2%w/v)

ii) Epinephrine Acid Tartrate eq. to

Epinephrine 0.01mg (1:100 000)

Duopharma (M) Sdn Bhd.,

Malaysia.

K-Seri Pharma Sdn Bhd. 21 March 2017 till

20 March 2022

POM

1764 BRU16112109NP 5% Dextrose in 0.9% Sodium

Chloride Solution for

Intravenous Infusion

Each 100ml contains: Dextrose

monohydrate 5.00g and Sodium

Chloride 900mg

Euro-Med Laboratories Phil., Inc.,

Philippines

Medicorp Sdn Bhd 21 March 2017 till

20 March 2022

POM

1765 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 March 2017 till

20 March 2022

POM

1766 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75g Yung Shin Pharmaceutical Ind. Co.

Ind., Republic of China

K-Seri Pharma Sdn. Bhd. 21 March 2017 till

20 March 2022POM

1767 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir

sulphate)

GlaxoSmithKline Pharmaceuticals

S.A., Poland

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1768 BRU16122113P Apo-Alendronate 70mg tablet Alendronate Sodium Trihydrate eq

to Alendronic acid 70mg

Apotex Inc. Canada MediPharm Sdn Bhd 21 March 2017 till

20 March 2022POM

BDMCA/RMP/0319 Page 134 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1769 BRU16122114P Tensiber Film Coated Tablet

300mg

Irbesartan 300mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1770 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5%

w/v

HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G & H Trading Company 21 March 2017 till

20 March 2022GSL

1771 BRU16122116P Apo-Quetiapine 25mg Tablet Quetiapine Fumarate equivalent to

25mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till

20 March 2022POM

1772 BRU16122117P Apo-Quetiapine 100mg Tablet Quetiapine Fumarate equivalent to

100mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till

20 March 2022POM

1773 BRU16122118P Apo-Quetiapine 200mg Tablet Quetiapine Fumarate equivalent to

200mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till

20 March 2022POM

1774 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 March 2017 till

20 March 2022GSL (10’s x 15,

10’s x 50 )1775 BRU16122120NP Betadine® Dry Powder Spray

2.5%

Povidone –Iodine 2.5% Mundipharma Pharmaceuticals

Limited, Cyprus

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till

20 March 2022GSL

1776 BRU16122121P Flanil Analgesic Cream Methyl Salicylate 10.20% w/w,

Menthol 5.44% w/w and

Eugenol1.36% w/w

Biolab Company Ltd., Thailand Hongkiat Trading & Co. 21 March 2017 till

20 March 2022GSL

1777 BRU16122122NP Betadine® Antiseptic Skin

Cleanser 7.5% w/v

Povidone-Iodine 7.5% w/v PT Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till

20 March 2022GSL

1778 BRU16122123P Oxynorm Sterile Solution for

Injection or Infusion 10mg/mL

Oxycodone hydrochloride 10mg/ml

(equivalent to 9 mg/ml

Oxycodone)

Hamol Ltd, United Kingdom Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till

20 March 2022POM

1779 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare 21 March 2017 till

20 March 2022POM

1780 BRU16122125P Vaxcel Lignocaine 2% Injection Lignocaine Hydrochloride 2%

(200mg/10ml)

Kotra Pharma (M) Sdn.

Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022POM

1781 BRU16122126P Oxynorm Oral Solution

5mg/5mL

Each 5ml contains oxycodone base

4.5mg as oxycodone hydrochloride

5mg

Mundipharma Pharmaceuticals

Limited, Cyprus

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till

20 March 2022POM

1782 BRU16122127P Shintamet Film Coated Tablet

200mg

Cimetidine 200mg Y.S.P. Industries (M) Sdn. Bhd.,

Malaysia

Asterix United (B) Sdn. Bhd. 21 March 2017 till

20 March 2022POM

1783 BRU17012128P Zaltrap™

Concentrate for Solution for

Infusion 25mg/ml (4ml

vial)

Aflibercept 25mg/ml Sanofi-Aventis Deutschland

GmbH,

Germany

Medipharm Sdn Bhd 21 March 2017 till

20 March 2022

POM

BDMCA/RMP/0319 Page 135 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1784 BRU17012129P Zaltrap™

Concentrate for Solution for

Infusion 25mg/ml (8ml

vial)

Aflibercept 25mg/ml Sanofi-Aventis Deutschland

GmbH,

Germany

Medipharm Sdn Bhd 21 March 2017 till

20 March 2022

POM

1785 BRU17012130PS2 Tarceva Tablet 100mg Erlotinib 100mg Roche SpA, Italy Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1786 BRU17012131PS2 Tarceva Tablet 150mg Erlotinib 150mg Roche SpA, Italy Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1787 BRU17012132P Apo-Gliclazide 30mr MR

tablet

Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1788 BRU17012133P Glitrol Controlled Release

Capsules 30mg

Gliclazide

30mg

Inventia Healthcare Pte Ltd, India Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1789 BRU17012134NP Orregel Choline salicylate 8.70% w/w; and

Cetylpyridinium Chloride

0.10% w/w

HOE Pharmaceuticals Sdn. Bhd.,

Malaysia

G & H Trading Company 21 March 2017 till

20 March 2022

GSL

1790 BRU17012135P Gaviscon peppermint tablets Sodium alginate 250mg

Sodium bicarbonate 133.5mg

Calcium carbonate 80mg

Reckitt Benckiser Healthcare (UK)

Limited, Dansom Lane, East Yo

rkshire, Hull HU8

7DS, United Kingdom

Syarikat Aliaa Sdn Bhd 21 March 2017 till

20 March 2022

GSL

1791 BRU17012136NP Senokot tablet Sennoside B 7.5mg Reckitt Benckiser Healthcare (UK)

Ltd., UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022

GSL

1792 BRU17012137P Tussidex Forte Linctus Dextromethorphan hydrobromide

15mg/5ml

Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

1793 BRU17012138P Floctil 250mg Capsule Azithromycin dihydrate eq. to

Azithromycin 250mg

Unison Laboratories Co. Ltd,

Thailand

Hong Kiat Trading Co 21 March 2017 till

20 March 2022

POM

1794 BRU17012139P Selegos 5mg Tablet Selegiline

Hydrochloride 5mg

Medochemie Ltd., Cyprus Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

1795 BRU17012140P Timolol-POS 0.5% Eye Drop Timolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH,

Germany

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1796 BRU17012141P Metformin Tablet 500mg Metformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd.,

Malaysia

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1797 BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn.

Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1798 BRU17012143NP UO Cream 100mg/g (10%) Carbonyldiamide (Urea)

100mg/g (10%)

Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd, 21 March 2017 till

20 March 2022

GSL

BDMCA/RMP/0319 Page 136 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1799 BRU17012144NP Axcel Vitalic Tablet Vitamin B1 (Thiamine) 100mg

Vitamin B6 (Pyridoxine) 200mg

Vitamin B12 (Cyanocobalamine)

200mcg

Kotra Pharma (M) Sdn.

Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

P

1800 BRU17012145P Iqnyde Tablet 50mg Sildenafil Citrate 70.25mg

equivalent to Sildenafil 50mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Company 21 March 2017 till

20 March 2022

POM

1801 BRU17022146P Azarga Eye Drops Suspension Brinzolamide 10mg/ml

Timolol maleate 5mg/ml

S.A. Alcon, Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1802 BRU17022147P Pharmaniaga Dermasole

Cream 0.1% w/w

Betamethasone 17-valerate 0.1%

w/w

Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Co 21 March 2017 till

20 March 2022POM

1803 BRU17022148P Jardiance 10mg Film-coated

Tablet

Empagliflozin 10mg Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Hongkiat Trading & Company 21 March 2017 till

20 March 2022POM

1804 BRU17022149P Jardiance 25mg Film-coated

Tablet

Empagliflozin 25mg Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Hongkiat Trading & Company 21 March 2017 till

20 March 2022POM

1805 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mg Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Co 21 March 2017 till

20 March 2022POM

1806 BRU17022153P Targin Prolonged Release

Tablets 5mg/2.5mg

Each tablet contains:

4.5mg of oxycodone as 5mg

oxycodone hydrochloride

2.25mg of naloxone as 2.5mg

naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1807 BRU17022154P Targin Prolonged Release

Tablets 10mg/5mg

Each tablet contains:

9mg of oxycodone as 10mg

oxycodone hydrochloride

4.5mg of naloxone as 5mg

naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1808 BRU17022155P Targin Prolonged Release

Tablets 20mg/10mg

Each tablet contains:

18mg of oxycodone as 20mg

oxycodone hydrochloride

9mg of naloxone as 10mg naloxone

hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

1809 BRU17022156P Targin Prolonged Release

Tablets 40mg/20mg

Each tablet contains:

36mg of oxycodone as 40mg

oxycodone hydrochloride

18mg of naloxone as 20mg

naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 21 March 2017 till

20 March 2022POM

BDMCA/RMP/0319 Page 137 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1810 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/w Xepa-Soul Pattinson (Malaysia)

Sdn Bhd

Hongkiat Trading & Company 21 March 2017 till

20 March 2022POM

1811 BRU17022158NP Effervescent Mouthwash

Tablets

Thymol EP 0.77mg;

Menthol EP 1.87mg

JL Bragg Ltd, UK Hongkiat Trading & Company 21 March 2017 till

20 March 2022GSL

1812 BRU17022159P Salmol Expectorant Each 5ml contains:

Salbutamol Sulfate equivalent to

Salbutamol 1.0 mg;

Guaiphenesin 50.0 mg

Biolab Co., Ltd, Thailand Hongkiat Trading & Company 21 March 2017 till

20 March 2022POM

1813 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mg Mega Lifesceinces Public Company

Limited, Thailand

G&H Trading Co 21 March 2017 till

20 March 2022POM

1814 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mg Mega Lifesceinces Public Company

Limited, Thailand

G&H Trading Co 21 March 2017 till

20 March 2022POM

1815 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/v SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Co 21 March 2017 till

20 March 2022POM

1816 BRU17022163P Axcel Glucosamine-500 Tablet Crystalline Glucosamine Sulphate

Potassium Chloride 665mg

equivalent to Glucosamine

Sulphate 500mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 21 March 2017 till

20 March 2022GSL

1817 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 21 March 2017 till

20 March 2022POM

1818 BRU17032165P Asthator 4mg Chewable

Tablet

Montelukast sodium 4.160mg eq.

to montelukast 4mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM

1819 BRU17032166P Asthator 5mg Chewable

Tablet

Montelukast sodium 5.20mg eq. to

montelukast 5mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM

1820 BRU17032167P Asthator 10mgTablet Montelukast sodium 10.40mg eq.

to montelukast 10mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM

BDMCA/RMP/0319 Page 138 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1821 BRU17032168NP OLICLINOMEL N7-1000E

EMULSION FOR INFUSION

1000ml of the mixture contain:

20% Lipid emulsion compartment

(corresponding to 20g/100ml)

(200ml); 40% Glucose solution

compartment (corresponding to

40g/100ml) (400ml); 10% Amino

acid solution compartment

(corresponding to 10g/100ml)

(400ml) (For Detailed Formulation

referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1822 BRU17032169P PHARMANIAGA ZICONAL

CREAM 2% W/W

Ketoconazole 2.0% w/w Pharmaniaga Manufacturing

Berhad, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022 POM

1823 BRU17032170P Zolennic Concentrate for

Solution for IV Infusion

Each vial (5ml) contains Zoledronic

acid monohydrate equivalent to

Zoledronic acid anhydrous 4mg

Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022 POM

1824 BRU17032171P Dynadryl Syrup Each 5ml contains:

Diphenhydramine Hydrochloride

14mg; Sodium Citrate 57mg;

Ammonium Chloride 135mg

Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

1825 BRU17032172P Depo Geston Injection

50mg/ml

Medroxyprogesterone Acetate

50mg/ml

PT. Triyasa Nagamas Farma,

Indonesia

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

1826 BRU17032173P Axcel Valacyclovir-500 Tablet Valacyclovir Hydrochloride

equivalent to Valacyclovir 500mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

1827 BRU17032174P Lidocaine Hydrochloride 2%

w/v Injection

Lidocaine Hydrochloride 2% w/v

(200mg/10mL)

Pharmaniaga LifeScience Sdn.

Bhd.,

G & H Trading Co 11 July 2017 till 10 July 2022 POM

1828 BRU17032175NP Axcel Paracetamol-250

Suspension (Strawberry)

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

Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 GSL

BDMCA/RMP/0319 Page 139 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1829 BRU17042176NP OLICLINOMEL N4-550E

EMULSION FOR INFUSION

1000ml of the mixture contain:

20% Lipid emulsion compartment

(corresponding to 20g/100ml)

(200ml); 40% Glucose solution

compartment (corresponding to

40g/100ml) (400ml); 10% Amino

acid solution compartment

(corresponding to 10g/100ml)

(400ml) (For Detailed Formulation

referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1830 BRU17042177NP HUACHI ENEMA Each 20ml enema contains:

Glycerin 30% w/v 6g;

Sodium Chloride 15% w/v 3g

Jen Sheng Pharmaceutical Co. Ltd.,

Taiwan

Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL

1831 BRU17042178P Anexate Injection 0.5mg/5ml Flumazenil 0.5mg Cenexi SAS, France Medicare 11 July 2017 till 10 July 2022 POM

1832 BRU17042179P Glumet XR Tablet 500mg Metformin Hydrochloride DC

Granules 577.36mg (equivalent to

Metformin Hydrochloride 500mg)

Pharmaniaga manufacturing

Berhad, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022 POM

1833 BRU17042180NP POVIL ANTACID MIXTURE Each 10ml contains:

Dried Aluminium Hydroxide

…400mg

Magnesium

Hydroxide………..400mg

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia

Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL

1834 BRU17042181P Zimmex 20 Tablet Simvastatin 20mg Silom Medical Co Ltd, Thailand Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

1835 BRU17042182P KOP 2.5% Gel (Ketoprofen BP) Ketoprofen 2.5% w/w Square Pharmaceuticals Ltd.,

Bangladesh

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 P

1836 BRU17042183P Dextracin Eye/Ear Drops 1. Dexamethasone Sodium

Phosphate eq. to Dexamethasone

Phosphate 0.1% w/v

2. Neomycin Sulphate 0.5% w/v

Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

BDMCA/RMP/0319 Page 140 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1837 BRU17042184P TRIPLIXAM

2.5MG/0.625MG/5MG FILM-

COATED TABLETS

Perindopril arginine 2.5mg

(corresponding to 1.6975mg of

perindopril)

Indapamide 0.625mg

Amlodipine besilate 6.935mg

(corresponding to 5mg of

amlodipine)

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1838 BRU17042185P TRIPLIXAM

5MG/1.25MG/5MG FILM-

COATED TABLETS

Perindopril arginine 5mg

(corresponding to 3.395mg of

perindopril)

Indapamide 1.25mg

Amlodipine besilate 6.935mg

(corresponding to 5mg of

amlodipine)

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1839 BRU17042186P TRIPLIXAM

5MG/1.25MG/10MG FILM-

COATED TABLETS

Perindopril arginine 5mg

(corresponding to 3.395mg of

perindopril)

Indapamide 1.25mg

Amlodipine besilate 13.870mg

(corresponding to 10mg of

amlodipine)

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1840 BRU17042187P TRIPLIXAM

10MG/2.5MG/5MG FILM-

COATED TABLETS

Perindopril arginine 10mg

(corresponding to 6.79mg of

perindopril)

Indapamide 2.5mg

Amlodipine besilate 6.935mg

(corresponding to 5mg of

amlodipine)

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1841 BRU17042188P TRIPLIXAM

10MG/2.5MG/10MG FILM-

COATED TABLETS

Perindopril arginine 10mg

(corresponding to 6.79mg of

perindopril)

Indapamide 2.5mg

Amlodipine besilate 13.870mg

(corresponding to 10mg of

amlodipine)

Servier (Ireland) Industries Ltd,

Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1842 BRU17042189P Cotren Vaginal Tablet 500mg Clotrimazole 500mg Biolab Company Ltd., Thailand Hongkiat Trading & Company 11 July 2017 till 10 July 2022 P

1843 BRU17042190P Axcel Bromhexine Tablet Bromhexine Hydrochloride 8mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

BDMCA/RMP/0319 Page 141 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1844 BRU17042191P Ameket Injection 2mL Ranitidine Hydrochloride eq. to

Ranitidine 25mg/ml

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022 POM

1845 BRU17042192P Zocol 150mg Capsule Fluconazole 150mg SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022 POM

1846 BRU17042193NP Anucare Ointment Each g contains Zinc Oxide

107.5mg (10.75% w/w); Peru

Balsam 18.8mg (1.88% w/w);

Benzyl Benzoate 12.5mg (1.25%

w/w)

Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022 GSL

1847 BRU17052194P Rani 150mg Effervescent

Granules

Ranitidine HCl (equivalent to

Ranitidine 150mg)

Techno Pharma Egypt, Egypt K-Seri Pharma 11 July 2017 till 10 July 2022 POM

1848 BRU17052195P Pamorelin 3.75mg Powder for

Suspension for Injection

Triptorelin (peptide base)

3.75mg equivalent

to triptorelin embonate

Debiopharm Research and

Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

1849 BRU17052196P Pamorelin 11.25mg Powder

for Suspension for Injection

Triptorelin (peptide base)

11.25mg equivalent

to triptorelin embonate

Debiopharm Research and

Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

1850 BRU17052197P Pamorelin 22.5mg Powder for

Suspension for Injection

Triptorelin (peptide base)

22.

5mg equivalent

to triptorelin embonate

Debiopharm Research and

Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

1851 BRU17052198NP Weng Heng Tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 11 July 2017 till 10 July 2022 GSL

1852 BRU17052199P MST CONTINUS 10MG

PROLONGED RELEASE

TABLETS

10mg

Morphine sulphate

Ph.Eur

Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1853 BRU17052200P MST CONTINUS 30MG

PROLONGED RELEASE

TABLETS

Morphine sulphate 30mg Bard Pharmaceuticals Limited, UK Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1854 BRU17052202P Viekirax 12.5mg/75mg/50mg

Tablets

Ombitasvir - 12.5mg (In the form

of Ombitasvir Extrudate)

Ritonavir - 50mg (In the form of

Ritonavir Extrudate)

Paritaprevir - 75mg (In the form of

Paritaprevir Extrudate)

Fournier Laboratories Ireland

Limited, Ireland

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

1855 BRU17052203P Maxiclear Sinus & Pain Relief

Tablet 500mg/5mg

Paracetamol 500mg and

phenylephrine hydrochloride 5mg

Sigma Laboratories Ltd, India Medipharm Sdn Bhd 11 July 2017 till 10 July 2022 P

BDMCA/RMP/0319 Page 142 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1856 BRU17052204P Oxair Chewable Tablet 5mg Montelukast sodium 5.2mg (eq. to

Montelukast 5mg)

Y.S.P Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022 POM

1857 BRU17052205P Anacaine Injection 1% Lidocaine

Hydrochloride 1%

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022 POM

1858 BRU17052206P Anacaine Injection 2% Lidocaine

Hydrochloride 2

%

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022 POM

1859 BRU17052207NP Ferromed Tablet 200mg Ferrous Fumarate BP 200mg SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022 GSL

1860 BRU17052208NP Calazite Lotion Calamine 15%w/v; Zinc oxide

5%w/v

Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 GSL

1861 BRU17052209P Acipan Injection 1mg/ml (1ml

ampoule)

Atropine Sulphate

1mg/ml

Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma 11 July 2017 till 10 July 2022 POM

1862 BRU17062210NP OLICLINOMEL N7-1000

EMULSION FOR INFUSION

1000ml of the mixture contain:

20% Lipid emulsion compartment

(corresponding to 20g/100ml)

(200ml); 40% Glucose solution

compartment (corresponding to

40g/100ml) (400ml); 10% Amino

acid solution compartment

(corresponding to 10g/100ml)

(400ml) (For Detailed Formulation

referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

1863 BRU17062211P HYOSCINE BUTYLBROMIDE

TABLET

Hyoscine N-butylbromide 10mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022 POM

1864 BRU17062212NP SMOFKABIVEN Emulsion for

Infusion

1000 ml of the mixture contain:

10% Amino acid solution with

electrolytes compartment

(corresponding to 10g/100ml)

(508ml); 42% Glucose

compartment (corresponding to

42g/100ml) (302ml); Lipid

emulsion compartment

(190ml);(For Detailed Formulation

referred to Dossier)

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

BDMCA/RMP/0319 Page 143 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1865 BRU17062213P Cosentyx 150mg Powder for

Solution for Injection

Secukinumab 150mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

1866 BRU17062214P Cosentyx 150mg Solution for

Injection in Pre-filled Syringe

Secukinumab 150mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

1867 BRU17062215P Cosentyx 150mg Solution for

Injection in Pre-filled Pen

Secukinumab 150mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 POM

1868 BRU17062216P Morphine-Hameln 10mg/ml

Injection, 1mL

Morphine Sulphate 10mg/ml Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

1869 BRU17062217P XTANDI SOFT CAPSULES

40MG

Enzalutamide 40mg Catalent Pharma Solutions LLC,

USA

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 POM

1870 BRU17062218P PRAXBIND Solution for

Injection/Infusion 50mg/ml

Idarucizumab 50mg/ml Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Hongkiat Trading & Company 11 July 2017 till 10 July 2022 POM

1871 BRU17062219NP Zam-Buk Ointment Each 100g contains: Eucalyptus oil

5.02g; Camphor 1.76g

Interthai Pharmaceutical

Manufacturing Ltd, Thailand.

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July 2022 GSL

1872 BRU17062220P Axcel Sildenafil-100mg Tablet Sildenafil Citrate equivalent to

Sildenafil 100mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022 POM

1873 BRU17062221NP Hialid 0.3% Ophthalmic

Solution

Purified Sodium Hyaluronate 0.3% Santen Pharmaceutical Co., Ltd.,

Japan

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 POM

1874 BRU17062222NP Hialid 0.1% Ophthalmic

Solution

Purified Sodium Hyaluronate 0.1% Santen Pharmaceutical Co., Ltd.,

Japan

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022 GSL

1875 BRU17072223P Monoclox 500mg Powder for

Solution for Injection or

Infusion

Cloxacillin sodium equivalent to

cloxacillin 500mg

Medochemie Ltd., Cyprus Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

1876 BRU17072224P Simvor Tablets 10mg Simvastatin 10mg Ranbaxy (Malaysia) Sdn Bhd.,

Malaysia

Medipharm Sdn Bhd 03 October 2017 till 02

October 2022

POM

1877 BRU17072225P Gluvecron MR 30mg Tablet Gliclazide 30mg China Chemical & Pharmaceutical

Co. Ltd., Taiwan

Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

BDMCA/RMP/0319 Page 144 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1878 BRU17072226NP Restors Oral Powder i)Sodium Chloride BP 520mg

ii)Potassium Chloride BP 300mg

iii) Trisodium Citrate Dihydrate BP

580mg

iv) Glucose Anhydrous BP 2700mg

Winwa medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

GSL

1879 BRU17072227P Flumazenil-Hameln 0.1mg/ml

injection

Flumazenil 0.1mg/ml Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

1880 BRU17072228P Oxycontin® Controlled-

Release Tablets 10mg

Oxycodone hydrochloride 10mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1881 BRU17072229P Oxycontin® Controlled-

Release Tablets 20mg

Oxycodone hydrochloride 20mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1882 BRU17072230P Oxycontin® Controlled-

Release Tablets 40mg

Oxycodone hydrochloride 40mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1883 BRU17072231P Oxycontin® Controlled-

Release Tablets 80mg

Oxycodone hydrochloride 80mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1884 BRU17082232P Xeljanz Film-Coated Tablet

5mg

Tofacitinib (as citrate) 5mg Pfizer Maufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1885 BRU17082233P Amoxicap 250 capsule Amoxicillin (as trihydrate 287mg)

250mg

Hovid Bhd., Malaysia G&H Trading Company 03 October 2017 till 02

October 2022

POM

1886 BRU17082234P Forxiga 5mg Film-Coated

Tablet

Dapagliflozin 5mg AstraZeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1887 BRU17082235P Forxiga 10mg Film-Coated

Tablet

Dapagliflozin 10mg AstraZeneca Pharmaceuticals LP,

USA

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1888 BRU17082236P Motigut Suspension 1ml/1ml Domperidone 1mg/ml Square Pharmaceuticals Ltd,

Bangladesh

Hongkiat Trading Co 03 October 2017 till 02

October 2022

POM

1889 BRU17082237P Tanzaril Tablet 50mg Losartan Potassium 50mg Silom Medical Co. Ltd, Thailand Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

1890 BRU17082238P Maxiclear Sinus Relief Tablet

10mg

Phenylephrine hydrochloride 10mg Sigma Laboratories Ltd, India Medipharm Sdn Bhd 03 October 2017 till 02

October 2022

P

1891 BRU17082239P Shrizine Injection 25mg/ml Fluphenazine Decanoate BP

25mg/ml

SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 03 October 2017 till 02

October 2022

POM

1892 BRU17082240P Canesten HC Cream Clotrimazole 1% w/w;

Hydrocortisone 1% w/w

Kern Pharma S.L., Spain Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1893 BRU17082241P HOE’s Milk Of Magnesia Oral

Suspension 800mg/5ml

Magnesium Hydroxide 800mg/5ml HOE Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 03 October 2017 till 02

October 2022

GSL

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1894 BRU17082242P Losartan Hexal 50mg film-

coated tablets

Losartan potassium 50mg

equivalent to Losartan 45.76mg

Sandoz IIAC Sanayi ve Ticaret A.S.,

Turkey

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1895 BRU17082243P Losartan Hexal 100mg film-

coated tablets

Losartan potassium 100mg

equivalent to Losartan 91.52mg

Sandoz IIAC Sanayi ve Ticaret A.S.,

Turkey

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1896 BRU17092244P RELVAR ELLIPTA 100/25

MICROGRAMS INHALATION

POWDER, PRE-DISPENSED

Pre-dispensed dose of

100micrograms of fluticasone

furoate and 25 micrograms of

vilanterol (as trifenatate).

*Each inhalation of the product

provides a delivered dose of 92mcg

of fluticasone furoate and 22mcg

of vilanterol (trifenatate)

Glaxo Operations UK Ltd (trading

as Glaxo Wellcome Operations),

UK

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1897 BRU17092245P RELVAR ELLIPTA 200/25

MICROGRAMS INHALATION

POWDER, PRE-DISPENSED

Pre-dispensed dose of

200micrograms of fluticasone

furoate and 25 micrograms of

vilanterol (as trifenatate).

*Each inhalation of the product

provides a delivered dose of

184mcg of fluticasone furoate and

22mcg of vilanterol (trifenatate)

Glaxo Operations UK Ltd (trading

as Glaxo Wellcome Operations),

UK

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02

October 2022

POM

1898 BRU17092246P HIPROGIN INJECTION

250MG/ML (1 ML AMPOULE)

Hydroxyprogesterone caproate

250mg/ml

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading Co 03 October 2017 till 02

October 2022

POM

1899 BRU17092247P Phebra Magnesium Sulfate

Heptahydrate 50% 2.5g/5mL

Magnesium Sulfate Heptahydrate

500mg/Ml

Phebra Pty Ltd, Australia G&H trading Co 03 October 2017 till 02

October 2022

POM

1900 BRU17092248P Phebra Magnesium Sulfate

Heptahydrate 50% 5g/10mL

Magnesium Sulfate Heptahydrate

500mg/Ml

Phebra Pty Ltd, Australia G&H Trading Co 03 October 2017 till 02

October 2022

POM

1901 BRU17092249NP Yellow Balsem Three Legs

Brand Ointment

Methylsalicylate 13.5% w/w

Menthol 7.5% w/w

Camphor 7% w/w

Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 03 October 2017 till 02

October 2022

GSL

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1902 BRU17092251NP ORS PLUS Each sachet contains the

equivalent of:

Sodium chloride 650 mg

Potassium chloride 375 mg

Trisodium citrate 725 mg

Glucose Anhydrous 3.375 g

Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Company 03 October 2017 till 02

October 2022

GSL

1903 BRU17092252NP Axe Brand Universal Oil i) Menthol crystals 20% w/w

ii) Camphor 5% w/w

iii) Eucalyptus Oil 15% w/w

iv) Methyl salicylate 15% w/w

Leung Kai Fook Medical Co Pte

Ltd., Singapore

Yuh Hua Trading Company 03 October 2017 till 02

October 2022

GSL

1904 BRU17092253NP Vitabiotics Pregnacare breast-

feeding Tablet/Capsule

Vitamins & Minerals; Omega-3 Fish

Oil (For detailed formulation

referred to dossier)

Tablets:

Thompson and Capper, UK

Capsule:

EuroCaps Limited, UK

Rico Agencies 03 October 2017 till 02

October 2022

GSL

1905 BRU17092254P Ravimed Tablet 5mg Medroxyprogesterone acetate USP

5mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 03 October 2017 till 02

October 2022

POM

1906 BRU17092255P Prazosin 2mg Tablet Prazosin HCl 2.190mg equivalent

to Prazosin 2mg

T.O. Pharma Co., Ltd., Thailand Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

1907 BRU17092256P Vaxcel Acyclovir 250mg I.V.

for Infusion

Acyclovir Sodium equivalent to

Acyclovir 250mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 03 October 2017 till 02

October 2022

POM

1908 BRU17112257P Azithromycin Tablets 250mg Azithromycin Dihydrate equivalent

to Azithromycin 250mg

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1909 BRU17112258P Fybogel Orange Sachet Ispaghula Husk BP 3.5g Reckitt Benckiser Healthcare (UK)

Ltd., UK

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

GSL

1910 BRU17112259NP Paracetamol Osteo-Tab

Modified Release Tablets

Paracetamol 665mg Macleods Pharmaceuticals Ltd,

India

Medipharm Sdn Bhd 27 February 2018 till 26

February 2023

P

BDMCA/RMP/0319 Page 147 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1911 BRU17112260P Phenadryl Syrup Each 5ml contains:

i) Diphenhydramine Hydrochloride

14mg

ii) Ammonium Chloride

135mg

iii) Sodium Citrate

57.5mg

Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1912 BRU17112261P Dermosone Cream 0.1% Betamethasone (as Valerate) 0.1%

w/w

Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

POM

1913 BRU17112262P Regpara® TABLETS 25MG Cinacalcet hydrochloride 27.55mg

eqv to Cinacalcet 25mg

Ohara Pharmaceutical Co., Japan K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1914 BRU17112263PS1 &

BRU17112263PS2

Octagam 2.5g in 50ml Human Normal Immunoglobulin

(IVIg)* 50mg/ml

*corresponding to the total protein

content of which at least 95% is

human Immunoglobulin G

1. Octapharma S.A.S., 72 rue du

Marêchal Foch 67380 Lingolsheim,

France (Manufacturing, packaging,

batch release, storage and

distribution)

2. Octapharma Pharmazeutika

Produktionsges.m.b.H, Oberlaaer

Straβe 235 1100 Vienna, Austria

(Manufacturing, packaging testing,

batch certification)

3. Octapharma GmbH,

Niederlassung Dessau, Otto-

Reuter- Straβe 3, Gemaβ den

Lageplanen Nr. 1 bis Nr. 3, 06847

Dessau-Roβlau, Saxony-Anhalt,

Germany (Additional packaging

site)

G&H Trading Sdn Bhd 27 February 2018 till 26

February 2023

POM

1915 BRU17122264P Ceficad 1000mg injection Cefepime Hydrochloride USP eq to

Cefepime 1000mg

Cadila Pharmaceuticals Limited,

India

K-Seri Pharma 27 February 2018 till 26

February 2023

POM

1916 BRU17122265P Probitor capsule 20mg Omeprazole 20mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1917 BRU17122266P Solbid tablet 10mg Isosorbide Dinitrate 10mg SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 27 February 2018 till 26

February 2023

POM

BDMCA/RMP/0319 Page 148 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1918 BRU17122267NP Adelim Ringworm Solution Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 27 February 2018 till 26

February 2023

GSL

1919 BRU17122268P Converium 300mg Tablet Irbesartan 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 27 February 2018 till 26

February 2023

POM

1920 BRU17122269P Salazine Enteric Coated Tablet

500mg

Sulfasalazine 500mg Sriprasit Pharma Co. Ltd., Thailand Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

POM

1921 BRU17122270P Axcel Metronidazole-200

Tablet

Metronidazole 200mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

POM

1922 BRU17122271NP Dermorub Liniment Muscle &

Joint

Methyl salicylate 25% v/v Winwa Medical Sdn. Bhd.,

Malaysia

Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

GSL

1923 BRU17122272P Tenof 300mg tablet Tenofovir Disoproxil Fumarate

300mg eq. to Tenofovir Disoproxil

245mg

Hetero Labs Limited,India K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1924 BRU17122273NP Bisacodyl Tablets 5mg Bisacodyl 5mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 27 February 2018 till 26

February 2023

P (as discussed in

the Meeting). All

Bisacodyl tablet

to change from

POM to P. If

already GSL

retain as GSL

(refer to minute

of 119th Mtg

Item 4.1 & 26TH

BDMCA Mtg

1925 BRU17122274P Alfutor ER Tablets 10mg Alfuzosin Hydrochloride 10mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1926 BRU17122275P Venlift ER 37.5mg Capsule Venlafaxine Hydrochloride

equivalent to Venlafaxine 37.5mg

Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1927 BRU17122276P Venlift ER 75mg Capsule Venlafaxine Hydrochloride

equivalent to Venlafaxine 75mg

Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1928 BRU17122277P Venlift ER 150mg Capsule Venlafaxine Hydrochloride

equivalent to Venlafaxine 150mg

Torrent Pharmaceuticals Ltd.,

India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

BDMCA/RMP/0319 Page 149 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1929 BRU17122278NP Rohto C Cube Eye Drops Per 100mL contains: Potassium

Chloride 0.08g; Sodium Chloride

0.44g; Hydroxyethylcellulose 0.07g

Rohto Pharmaceutical Co., Ltd.,

Japan

Hamitan Marketing 27 February 2018 till 26

February 2023

GSL

1930 BRU17122279P Medaxonum (Ceftriaxone) 1G

Powder for Injection for

Infusion

Ceftriaxone sodium eq. to

ceftriaxone 1G

Medochemie Ltd., Cyprus Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

POM

1931 BRU17122281NP Konsyl Original Formula

Psyllium Fiber

Psyllium Hydrophilic Mucilloid

Husk 6g/dose

Konsyl Pharmaceuticals, Inc., USA MediPharm Sdn Bhd 27 February 2018 till 26

February 2023

GSL

1932 BRU17122282P VAXCEL CEFOBACTAM-1G

INJECTION

Cefoperazone sodium eq. to

cefoperazone 500mg; Sulbactam

sodium eq. to Sulbactam 500mg

Kotra Pharma (M) Sdn Bhd.,

Malaysia

Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

POM

1933 BRU17122283P Ibuspan Tablet 200mg Ibuprofen 200mg SM Pharmacetuicals Sdn Bhd,

Malaysia

G & H Trading Company 27 February 2018 till 26

February 2023

P

1934 BRU17122284NP Ubat Sembelit Cap Kaki Tiga Per 5ml: Magnesium sulphate

1.77g

Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 27 February 2018 till 26

February 2023

GSL

1935 BRU17122285P Fucithalmic Eye Drops 1% Fusidic acid 10mg/g LEO Laboratories Limited, Ireland LF Asia (Borneo) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1936 BRU17122286NP Calamine Lotion BP 15% w/v i) Calamine 15%w/v; ii) Zinc

Oxide 5% w/v

SM Pharmacetuicals Sdn Bhd,

Malaysia

G & H Trading Company 27 February 2018 till 26

February 2023

GSL

1937 BRU17122287P Pivakan 0.5% w/v (plain)

Injection (20ml Vial)

Bupivacaine HCl Monohydrate

equivalent to Bupivacaine HCl

5mg/ml

Duophrma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1938 BRU18012288P Irbesartan Tablets 150mg Irbesartan 150mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1939 BRU18012289P Irbesartan Tablets 300mg Irbesartan 300mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1940 BRU18012290P Travocort Cream Isoconazole nitrate (10mg/g):

Diflucortolone valerate (1mg/1g)

Bayer Healthcare Manufacturing

S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1941 BRU18012291P Spiolto Respimat Inhalation

Solution 2.5μg/2.5μg per

actuation

Per actuation: 2.5mg Tiotropium

(as bromide monohydrate) and

2.5mg Olodaterol (as

hydrochloride)

Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Hongkiat Trading & Company 27 February 2018 till 26

February 2023

POM

1942 BRU18012292P Zykadia™ 150mg Hard Capsule Ceritinib 150mg Novartis Pharma AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1943 BRU18012293P Synagis 100mg/ml Solution for

Injection

Palivizumab 100mg/ml Boehringer Ingelheim Pharma

GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

BDMCA/RMP/0319 Page 150 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1944 BRU18012294NP Ketosteril Film-Coated Tablet Calcium-3-methyl-2-oxo-valerate

(α–Ketoanologue to Isoleucine,

calcium salt) 67 mg;

Calcium-4-methyl-2-oxo-valerate

(α–Ketoanologue to Leucine,

calcium salt) 101 mg;

Calcium-2--oxo-3-phenyl-

propionate (α–Ketoanologue to

Phenylalanine, calcium salt) 68 mg;

Calcium-3-methyl-2-oxo-butyrate

(α–Hydroxyanalogue to Valine,

calcium salt) 86 mg;

Calcium-DL-2-hydroxyl-4-(methyl-

thio)butyrate (α–Hydroxyanalogue

to Methionine, calcium salt) 59 mg;

L-Lysine acetate (= 75mg L-Lysine)

105 mg;

L-Threonine 53 mg;

L-Tryptophan 23 mg;

L-Histidine 38 mg;

L-Tyrosine 30 mg;

Labesfal-Laboratorios Almiro S.A.,

Portugal

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1945 BRU18012295PS1;

BRU18012295PS2

Kadcyla Powder for

Coencentrate for Solution for

Infusion 100mg/vial

Trastuzumab emtansine 100mg Patheon, Manufacturing Services,

LLC, USA (S1); F. Hoffmann-La

Roche Ltd, Switzerland (S2)

MediPharm Sdn Bhd 27 February 2018 till 26

February 2023

POM

1946 BRU18012296PS1;

BRU18012296PS2

Kadcyla Powder for

Coencentrate for Solution for

Infusion 160mg/vial

Trastuzumab emtansine 160mg Patheon, Manufacturing Services,

LLC, USA (S1); F. Hoffmann-La

Roche Ltd, Switzerland (S2)

MediPharm Sdn Bhd 27 February 2018 till 26

February 2023

POM

1947 BRU18012297NP 5% DEXTROSE IN WATER

SOLUTION FOR INTRAVENOUS

INFUSION

Dextrose monohydrate 5% Euro-Med Laboratories Phil Inc,

Philippines

Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

GSL

BDMCA/RMP/0319 Page 151 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1948 BRU18012298NP 10% DEXTROSE IN WATER

SOLUTION FOR INTRAVENOUS

INFUSION

Dextrose monohydrate 10% Euro-Med Laboratories Phil Inc,

Philippines

Medicorp Sdn Bhd 27 February 2018 till 26

February 2023

GSL

1949 BRU18012299P THREE LEGS TINEA-KARE ANTI-

FUNGAL CREAM 1%W/W

Clotrimazole 1% w/w Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 27 February 2018 till 26

February 2023

GSL

1950 BRU18012300P Airlukast Chewable Tablets

5mg

Montelukast sodium 5.187mg (eq.

to Montelukast 5mg)

Ranbaxy (Malaysia) Sdn Bhd,

Malaysia

MediPharm Sdn Bhd 27 February 2018 till 26

February 2023

POM

1951 BRU18012301NP Gascoal Tablet 50mg Dimethylpolysiloxane 50mg Y.S.P. Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

GSL

BDMCA/RMP/0319 Page 152 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1952 BRU18012302NP Vitabiotics Pregnacare

Original Tablet

Natural Mixed Carotenoids (as

Natural Betacarotene 20% CWD

Powder 10.0 mg) 2.00 mg;

Thiamin (Vitamin B1) (as Thiamine

Mononitrate 3.7 mg) 3.00 mg;

Riboflavin (Vitamin B2) (as

Riboflavin 2.0 mg) 2.00 mg;

Vitamin D3 (as Vitamin D3 100

IU/mg EC 4.0 mg) 10.00 µg;

Folacin (Folic Acid) (as Folic Acid

400.0 µg) 400.00 µg;

Vitamin K (as Vitamin K1 5% GFT

(BASF) 1.4 mg) 70.00 µg;

Vitamin B12 (as Cyanocobalamin

0.1% DCP Prep. 6.0 mg) 6.00 µg;

Vitamin B6 (as Pyridoxine

Hydrochloride 12.2 mg) 10.00 mg;

Pantothenic Acid (as Calcium D-

Pantothenate 6.5 mg) 6.00 mg;

Biotin (as D-Biotin 150.0 µg)

150.00 µg;

Vitamin C (as Ascorbic Acid HPMC

(97%) 72.2 mg) 70.00 mg;

Vitamin E (as D alphaTocopheryl

Acid Succinate 24.6 mg) 20.00 mg;

Niacin (Vitamin B3) (as

Nicotinamide 20.0 mg) 20.00 mg;

Zinc (as Zinc Sulphate

Monohydrate 41.2 mg) 15.00 mg;

Iron (as Ferrous Fumarate 51.7 mg)

17.00 mg;

Brunel Healthcare Manufacturing

Limited, UK

Rico Agencies 27 February 2018 till 26

February 2023

GSL

1953 BRU18022303NP Glycophos Concentrate for

Solution for Infusion

Sodium glycerophosphate

pentahydrate 306.1mg/ml

corresponds to 216mg sodium

glycerophosphate

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

P

BDMCA/RMP/0319 Page 153 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1954 BRU18022304NP Nutrilite Daily Tablet

Nutrilite concentrate 527.84mg;

Dicalcium phosphate 447.58mg;

Ascorbic acid 125.96mg; Ferrous

fumarate 57.37mg; d-alpha-

tocopheryl acid succinate 32.21mg;

Niacinamide 23.99mg; Zinc oxide

21.55mg; Copper gluconate

16.44mg; Calcium stearate

20.48mg; Corn starch 15.34mg;

Talc 15.00mg; D-calcium

panthothenate 13.88mg; Sucrose

13.12mg; Fish gelatin 10.80mg;

Sodium carboxymethylcellulose

10.39mg; Lactose 9.8mg;

Magnesium oxide 8.62mg;

Hydroxypropyl methylcellulose

8.01mg; PolyvInylpyrrolidone

5.28mg; Vitamin A Palmitate

5.00mg; Pyridoxine Hydrochloride

3.64mg; Riboflavin 2.99mg;

Thiamine mononitrate 2.79mg;

Glycerin 0.80mg; Folic acid 0.64mg;

Potassium iodide 0.27mg;

Carnauba wax 0.08mg; Vitamin D3

0.02mg ; Cyanocobalamin 0.002mg

Access Business Group LLC, USA Amway (B) Sdn Bhd 06 June 2018 till 05 June

2023

GSL

BDMCA/RMP/0319 Page 154 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1955 BRU18022305P Flutiform 50 microgram/5

microgram Per Actuation

Pressurised Inhalation

Suspension

Each metered dose (ex-valve)

contains:

50mcg of fluticasone propionate

and 5mcg of formeterol fumarate

dihydrate,

This is equivalent to a delivered

dose (ex-actuator) of

approximately 46 mcg of

fluticasone propionate/ 4.5mcg of

formoterol fumarate dihydrate.

Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1956 BRU18022306P Flutiform 250 microgram/10

microgram Per Actuation

Pressurised Inhalation

Suspension

Each metered dose (ex-valve)

contains:

250mcg of fluticasone propionate

and 10mcg of formeterol fumarate

dihydrate,

This is equivalent to a delivered

dose (ex-actuator) of

approximately 230 mcg of

fluticasone propionate/ 9.0mcg of

formoterol fumarate dihydrate.

Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

BDMCA/RMP/0319 Page 155 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1957 BRU18022307P Flutiform 125 microgram/5

microgram Per Actuation

Pressurised Inhalation

Suspension

Each metered dose (ex-valve)

contains:

125mcg of fluticasone propionate

and 5mcg of formeterol fumarate

dihydrate,

This is equivalent to a delivered

dose (ex-actuator) of

approximately 115 mcg of

fluticasone propionate/ 4.5mcg of

formoterol fumarate dihydrate.

Fisons Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1958 BRU18022308P Jakavi 10mg tablet Ruxolitinib phosphate 13.2mg eq.

to 10mg Ruxolitinib

Novartis Pharma Stein, AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1959 BRU18022309P HYDROCORTISONE INJECTION

100MG

Each vial contains Hydrocortisone

Sodium Succinate BP equivalent to

Hydrocortisone 100mg

SM Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

POM

1960 BRU18022310P Opsumit 10mg Film-coated

Tablet

Macitentan 10mg Patheon Italia S.p.A., Italy Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

1961 BRU18022311P URACTONUM 25MG TABLET Spironolactone 25mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 06 June 2018 till 05 June

2023

POM

1962 BRU18022312P Perjeta Concentrate for

Solution for Infusion

420mg/14ml

Pertuzumab 420mg Roche Diagnostics GmbH,

Germany

Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

1963 BRU18022313P Cefepime-AFT Powder for

Injection 1G

Cefepime Hydrochloride equivalent

to Cefepime 1G

Qilu Pharmaceutical Co. Ltd., P.R.

China

Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

BDMCA/RMP/0319 Page 156 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1964 BRU18022314NP Renal-Sol® A1 Each litre of concentrate contains:

Sodium Chloride BP 161.43g

Potassium Chloride BP 5.50g

Calcium Chloride 2H2O BP 9.74g

Magnesium Chloride 6H2O BP

3.74g

Glacial Acetic Acid BP 8.84g

Highly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

GSL

1965 BRU18022315NP Renal-Sol® A3 Each litre of concentrate contains:

Sodium Chloride BP 161.43g

Potassium Chloride BP 5.50g

Calcium Chloride 2H2O BP 6.75g

Magnesium Chloride 6H2O BP

3.74g

Glacial Acetic Acid BP 8.84g

Highly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

GSL

1966 BRU18022316P Celecoxib Sandoz Capsule

200mg

Celecoxib 200mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1967 BRU18022317NP Microshield® 2 Chlorhexidine

Skin Cleanser

Chlorhexidine Gluconate 2% w/v Ensign Laboratories Pty Ltd.,

Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

GSL

1968 BRU18022318NP Sangobion Capsule Each capsule contains:

Ferrous Gluconate 250mg

Manganese sulphate 0.2mg

Copper sulphate 0.2mg

Vitamin C 50.0mg

Folic acid 1.0mg

Vitamin B12 7.5mcg

PT. Merck Tbk, Indonesia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

GSL

1969 BRU18022319P Talgesil Injection 0.1mg/2ml

(Amp)

Fentanyl 0.1mg/2ml Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

POM

BDMCA/RMP/0319 Page 157 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1970 BRU18032320P Norfox tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd.,

Thailand

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1971 BRU18032321P Domil Suspension 5mg/5ml Domperidone 5mg/5ml Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1972 BRU18032322P Latanostill 50mcg/ml Eye

Drops Solution

Latanoprost 50 mcg/ml Bruschettini s.r.I., Italy Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1973 BRU18032323P Gardasil 9, suspension for

injection

Each 0.5mL dose contains:

HPV Type 6 L1 Protein….. 30 μg

HPV Type 11 L1 Protein….40 μg

HPV Type 16 L1 Protei.…. 60 μg

HPV Type 18 L1 Protein….40 μg

HPV Type 31 L1 Protein.... 20 μg

HPV Type 33 L1 Protein… 20 μg

HPV Type 45 L1 Protein… 20 μg

HPV Type 52 L1 Protein… 20 μg

HPV Type 58 L1 Protein… 20 μg

Merck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1974 BRU18032324P Entresto 50mg Film-coated

Tablets

Sacubitril 24.3 mg & Valsartan 25.7

mg

Novartis Singapore

Pharmaceutical Manufacturing Pte

Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1975 BRU18032325P Entresto 100mg Film-coated

Tablets

Sacubitril 48.6 mg & Valsartan 51.4

mg

Novartis Singapore

Pharmaceutical Manufacturing Pte

Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1976 BRU18032326P Entresto 200mg Film-coated

Tablets

Sacubitril 97.2 mg & Valsartan

102.8 mg

Novartis Singapore

Pharmaceutical Manufacturing Pte

Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1977 BRU18032327P Dyna Amoxycillin 125mg/5ml Amoxycillin (as trihydrate)

125mg/5ml

Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1978 BRU18032328P Winofen suspension 2% w/v Ibuprofen 100mg/5ml Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

P

1979 BRU18032329P Wincort 1% cream Hydrocortisone acetate 1% w/w Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1980 BRU18032330P Acugesic Tablet 50mg Tramadol HCl 50mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

POM

1981 BRU18032331NP Microshield® Handrub

Solution

Chlorhexidine Gluconate 0.5% w/v

in Ethanol 70% v/v

Ensign Laboratories Pty Ltd.,

Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

GSL

BDMCA/RMP/0319 Page 158 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1982 BRU18032332P Defuzin Cream 2% w/w Fusidic acid 2% w/w Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 June 2018 till 05 June

2023

POM

1983 BRU18032333P Hydrochlorzide-50 Tablet Hydrochlorothiazide 50mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 June 2018 till 05 June

2023

POM

1984 BRU18032334P SIMBRINZA* 10 mg/ml + 2

mg/ml eye drops, suspension

1 ml of suspension contains 10 mg

of Brinzolamide and 2 mg of

Brimonidine tartrate equivalent to

1.3 mg of Brimonidine

Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1985 BRU18032335NP Hexidin Cream 1% Chlorhexidine Gluconate 1% w/w Noripharma Sdn Bhd, Malaysia G&H Trading Company 06 June 2018 till 05 June

2023

GSL

1986 BRU18032336NP Green Balsem, Three Legs

Brand

Menthol........... 10% w/w

Camphor......... 4% w/w

Syarikat Wen Ken Drug Sdn Bhd.,

Malaysia

Syarikat Rajamas Bersama 06 June 2018 till 05 June

2023

GSL

1987 BRU18042337P DUAVIVE 20MG/0.45MG

MODIFIED-RELEASE TABLETS Bazedoxifene acetate equivalent to

20mg bazedoxifene; and

Conjugated estrogens 0.45mg.

Pfizer Ireland Pharmaceuticals,

Ireland

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1988 BRU18042338P Novatretin™ 25mg Capsules Acitretin 25mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

POM

1989 BRU18042339P Novatretin™ 10mg Capsules Acitretin 10mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

POM

1990 BRU18042340P Axcel Metoclopramide Tablet Metoclopramide Hydrochloride

equivalent to Anhydrous

Metoclopramide Hydrochloride

10mg

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1991 BRU18042341P TADIM Colistimethate Sodium

1 Million IU Powder for

Nebuliser Solution Vial

Colistimethate Sodium 1 Million IU Xellia Pharmaceuticals ApS,

Denmark

G&H Trading Company 06 June 2018 till 05 June

2023

POM

1992 BRU18042342P Clovix 75mg tablet Clopidogrel hydrogen sulphate

97.875mg (eq. to clopidogrel

75mg)

China Chemical & Pharmaceutical

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

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1993 BRU18042343P AXCEL CETIRIZINE TABLET Cetirizine dihydrochloride 10mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

P

BDMCA/RMP/0319 Page 159 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

1994 BRU18042344P Zarzio 30 MU/0.5ml Solution

for Injection or Infusion in Pre-

filled Syringe

30 million units (equivalent to

300mcg) filgrastim in 0.5ml

IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1995 BRU18042345P Ibrance Capsules 75mg Palbociclib 75mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1996 BRU18042346P Ibrance Capsules 100mg Palbociclib 100mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1997 BRU18042347P Ibrance Capsules 125mg Palbociclib 125mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1998 BRU18042348P TULIP® 40MG FILM-COATED

TABLET

Atorvastatin (as Atorvastatin

calcium) 40mg

Lek Pharmaceuticals d.d , Solvenia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

1999 BRU18062349P Victoza® 6mg/ml, Solution for

Injeciton in Pre-filled Pen

Liraglutide 6mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June

2023

POM

2000 BRU18062350P AXCEL CLINDAMYCIN TOPICAL

SOLUTION 1% W/V

Clindamycin Phosphate 1% Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

2001 BRU18062351P Flucon Solution for IV Infusion

2mg/ml

Fluconazole 2mg/ml Siu Guan Chem. Ind., Taiwan K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

POM

2002 BRU18062352P ANALPAN INJECTION

75MG/3ML

Diclofenac Sodium 75mg/3ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 June 2018 till 05 June

2023

POM

2003 BRU18062353P ELIGARD® Powder and Solvent

for Solution for Injection

7.5mg

Leuprorelin Acetate 7.5 mg

(equivalent to 6.96 mg leuprorelin)

(syringe B)

Solvent (Syringe A):

Poly(DL-lactic-co-glycolic-acid)

(50:50) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

2004 BRU18062354P ELIGARD® Powder and Solvent

for Solution for Injection

22.5mg

Leuprorelin Acetate 22.5 mg

(equivalent to 20.87 mg

leuprorelin) (syringe B)

Solvent (Syringe A):

Poly(DL-lactic-co-glycolic-acid)

(75:25) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

BDMCA/RMP/0319 Page 160 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2005 BRU18062355P ELIGARD® Powder and Solvent

for Solution for Injection

45mg

Leuprorelin Acetate 45 mg

(equivalent to 41.7 mg leuprorelin)

(syringe B)

Solvent (Syringe A):

Poly(DL-lactic-co-glycolic-acid)

(85:15) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June

2023

POM

2006 BRU18062356P THREE LEGS TINEA-KARE ANTI-

FUNGAL SPRAY 1% W/V

Clotrimazole 1% w/v Syarikat Wen Ken Drug Sdn. Bhd.,

Malaysia

Syarikat Rajamas Bersama 06 June 2018 till 05 June

2023

GSL

2007 BRU18062357NP Potrelease TR Tablet 600mg Potassium Chloride 600mg SM Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

P

2008 BRU18062358NP Renal-Sol® A3 + G Each litre of concentrate contains:

Sodium Chloride BP 161.43g

Potassium Chloride BP 5.50g

Calcium Chloride 2H2O BP 6.75g

Magnesium Chloride 6H2O BP

3.74g

Glacial Acetic Acid BP 8.84g

Dextrose H20 73.00g

Highly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd,

Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June

2023

GSL

2009 BRU18062359P Encardil Tablet 10mg Enalapril Maleate 10mg SM Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

POM

2010 BRU18062360NP Microshield® 4 Chlorhexidine

Surgical Handwash

Chlorhexidine Gluconate 4% w/v

(equivalent to Chlorhexidine

22.5g/L)

Ensign Laboratories Pty Ltd.,

Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

GSL

2011 BRU18062361P Pharmaniaga Ranitidine

Tablet 150mg

Ranitidine (as hydrochloride)

150mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

POM

2012 BRU18062362P Apo-Carvedilol 6.25mg Tablet Carvedilol 6.25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

2013 BRU18062363P Apo-Carvedilol 25mg Tablet Carvedilol 25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

BDMCA/RMP/0319 Page 161 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2014 BRU18062364P Cef-3 Injection IM (500mg) Powder - Ceftriaxone (as disodium)

500mg

Diluent – Lidocaine HCl 1%

Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

2015 BRU18062365P Simponi Solution for Injection

100mg/1.0ml

Golimumab 100mg/1.0ml Baxter Pharmaceutical Solutions

LLC, United States

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2016 BRU18062366P Apo-Atorvastatin 20mg tablet Atorvastatin calcium propylene

glycol solvate USP 22mg eq. to

20mg atorvastatin

Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2017 BRU18062367P Apo-Atorvastatin 40mg tablet Atorvastatin calcium propylene

glycol solvate USP 42mg eq. to

40mg atorvastatin

Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2018 BRU18062368NP Sodium Chloride Parenteral

Solution 0.9%

Each 100ml contains Sodium

Chloride 900mg

Euro-Med Laboratories Phil.,

Philippines

Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

GSL

2019 BRU18062369NP Lactated Ringer’s Solution Each 100ml contains:

Sodium Chloride

600mg

Sodium Lactate Anhydrous

310mg

Potassium Chloride

30mg

Calcium Chloride Dihydrate

20mg

Euro-Med Laboratories Phil.,

Philippines

Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

GSL

2020 BRU18062370NP Optrex Refreshing Eye Drops Hamamelis Water (Witch Hazel)

13.0% v/v

Reckitt Beckinser Healthcare

International Ltd, UK

Syarikat Aliaa Sdn Bhd 05 September 2018 till 04

September 2023

GSL

2021 BRU18062371P Codipront Capsules Codeine base 30mg (as Codeine

phosphate hemihydrate);

Phenyltoloxamine base 10mg (as

Phenyltoloxamine citrate)

CTS Chemical Industries Ltd, Israel Hongkiat Trading & Company 05 September 2018 till 04

September 2023

POM

2022 BRU18062372PS1,

BRU18062372PS2 &

BRU18062372PS3

Mixtard® 30 Penfill® 100

IU/ml, 3ml Cartridge

Suspension for Injeciton

1ml suspension contains 100 IU

(3.5 mg) of insulin human (rDNA)

(30% as soluble insulin and 70% as

isophane insulin)

1.       Novo Nordisk A/S, Denmark

(S1)

2.       Novo Nordisk Production

SAS, France (S2)

3.       Novo Nordisk Producão,

Brazil (S3)

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

BDMCA/RMP/0319 Page 162 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2023 BRU18072373P Apo-Ranitidine 150mg Tablet Ranitidine 150mg Apotex Inc, Canada MediPharm Sdn Bhd 05 September 2018 till 04

September 2023

POM

2024 BRU18072374P Axcel Iridin Linctus Pholcodine 10mg/5ml Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2025 BRU18072375P Dynalexin Dry Syrup

125mg/5ml

Cephalexin monohydrate 130mg

eq to 125mg cephalexin per 5ml

Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2026 BRU18072376P Aspira Tablet 10mg Montelukast sodium 10.40mg

equivalent to montelukast 10mg

Pharmaniaga Manufacturing

Berhad, Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

POM

2027 BRU18072377P Terbin Cream 1% Terbinafine Hydrochloride 10mg/g SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

GSL

2028 BRU18072378NP Eagle Brand Medicated Oil

Aromatic, Lavender &

Eucalyptus

i) Menthol 16.0%

w/w

ii) Methyl Salicylate 35.0%

w/w

iii) Eucalyptus Oil 17.5%

w/w

iv) Camphor 7.0%

w/w

Borden Company (Private)

Limited, Singapore

SP Setia Sdn Bhd 05 September 2018 till 04

September 2023

GSL

2029 BRU18072379P Eye Glo Plus Eye Drops i) Boric Acid 1.3% w/v

ii) Borax 0.3% w/v

iii) Distilled Witch Hazel 5%

w/v

Duopharma (M) Sdn Bhd, Malaysia Bintang Ria Sdn Bhd 05 September 2018 till 04

September 2023

GSL

2030 BRU18072380NP Crotamiton Cream 10% w/w Crotamiton 10% w/w SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

GSL

2031 BRU18072381P MabThera® Solution for

Subcutaneous Injection

1400mg

Rituximab 120mg/mL F. Hoffmann-LA Roche Ltd,

Switzerland

MediPharm Sdn Bhd 05 September 2018 till 04

September 2023

POM

2032 BRU18082382P Tolanz ODT Tablets 5mg Olanzapine 5mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

2033 BRU18082383P Tolanz ODT Tablets 10mg Olanzapine 10mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

2034 BRU18082384NP BETADINE Gargle and

Mouthwash

Povidone-Iodine 1% w/v PT Mahakam Beta Farma,

Indonesia

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

GSL

BDMCA/RMP/0319 Page 163 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2035 BRU18082385P Midazolam-Hameln 5mg/ml

Injection, 1ml

Midazolam (as hydrochloride)

5mg/ml

Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2036 BRU18082386P Optimol Eye Drops 0.5% Timolol Maleate 0.5% Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

2037 BRU18082387P Niferin SR 30mg tablet Nifedipine 30mg China Chemical & Pharmaceutical

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

Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2038 BRU18082388P Pethidine hydrochloride

50mg/1ml

Pethidine hydrochloride 50mg/ml Pharmaniaga Lifescience Sdn Bhd,

Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

POM

2039 BRU18082389P Pethidine hydrochloride

100mg/2ml

Pethidine hydrochloride

100mg/2ml

Pharmaniaga Lifescience Sdn Bhd,

Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

POM

2040 BRU18082390P TAGRISSO 40MG FILM-

COATED TABLETS

Osimertinib 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2041 BRU18082391P TAGRISSO 80MG FILM-

COATED TABLETS

Osimertinib 80mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2042 BRU18082392P Adezio Tablet 10mg Cetirizine Hydrohloride 10mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04

September 2023

P

2043 BRU18082393P Enapril Tablet 20mg Enalapril Maleate 20mg Y.S.P. Industries (M) Sdn Bhd Asterix United (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2044 BRU18082394P XALKORI 200MG HARD

CAPSULES

Crizotinib 200mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2045 BRU18082395P XALKORI 250MG HARD

CAPSULES

Crizotinib 250mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2046 BRU18082396P Normaten Tablet 100mg Atenolol 100mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04

September 2023

POM

2047 BRU18082397P Brilinta 60mg Film-coated

Tablet

Ticagrelor 60mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

2048 BRU18082398P Atswift 10 Film Coated Tablets Atorvastatin Calcium Trihydrate

equivalent to Atorvastatin 10mg

Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2049 BRU18082399P Atswift 20 Film Coated Tablets Atorvastatin Calcium Trihydrate

equivalent to Atorvastatin 20mg

Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

2050 BRU18082400P Normaten Tablet 50mg Atenolol 50mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04

September 2023

POM

2051 BRU18082401P Adroten Tablet 5mg Bisoprolol Fumarate 5mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04

September 2023

POM

BDMCA/RMP/0319 Page 164 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2052 BRU18092402P Mapenem (1G Injection) Meropenem trihydrate and sodium

carbonate 1.28g (equivalent to

Meropenem 1g)

Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn. Bhd 11 December 2018 till 10

December 2023

POM

2053 BRU18092403P (With

condition the porcine

information is stated

on the label)

Zostavax (Refrigerator Stable

Formulation) Injection

Live attenuated Oka/Merck

Varicella-Zoster Virus

Drug product

Merck Sharp & Dohme, USA

Diluent

Vetter Pharma-Fertigung GmbH &

Co. KG., Germany.

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2054 BRU18092404P Apo-Fluvoxamine 50mg tablet Fluvoxamine maleate 50mg Apotex Inc. Canada, Canada Medicorp Sdn. Bhd 11 December 2018 till 10

December 2023

POM

2055 BRU18092405P Ultiva Injection 5mg Each single use vial contains 5mg

remifentanil (as hydrochloride).

GlaxoSmithKline Manufacturing,

S.P.A., Italy.

Zuellig Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2056 BRU18092406P Ultravist 300 Injection

300mg/Ml

1ml contains 623mg iopromide

(equivalent to 300mg iodine)

Bayer Pharma AG, Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2057 BRU18092407P Ultravist 370 Injection

370mg/Ml

1ml contains 769mg iopromide

(equivalent to 370mg iodine)

Bayer Pharma AG, Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2058 BRU18092408P Halaven 0.5mg/ml Solution

for Injection

Eribulin mesilate Biogen U.S. Corporation, USA. Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2059 BRU18092409P Sivkort® Sterile Suspension for

injection 40mg/1ml

Triamcinolone acetonide 40mg /

1ml

Siu Guan Chem. Ind. Co. Ltd.,

Taiwan

K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10

December 2023

POM

2060 BRU18092410P Dotarem 0.5 mmol/mL,

Solution for Injection

Per 100 mL of solution:

Gadoteric acid ……27.932 g

Corresponding to:

DOTA ……………20.246 g

Gadolinium oxide...9.062g

Contrast agent concentration:

0.5mmol/mL

Guerbet, France Manning Jaya Trading (B) Sdn

Bhd

11 December 2018 till 10

December 2023

POM

2061 BRU18092411P Polytet Eye Ointment Each gram contains:

Polymyxin B sulphate 6900 unit eq

to Polymyxin B 6000 units

Oxytetracycline hydrochloride

5.94mg eq to Oxytetracycline 5mg

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 165 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2062 BRU18092412P Latanoprost eye drops

solution 0.005%w/v

Latanoprost 0.05mg/ml FDC Limited, India K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10

December 2023

POM

2063 BRU18092413NP Eye Glo Relief Eye Drops

0.25% w/v

Zinc Sulphate 0.25% w/v Duopharma (M) Sdn Bhd,

Malaysia

Bintang Ria Sdn Bhd 11 December 2018 till 10

December 2023

GSL

2064 BRU18092414NP Aqueous Cream Cetomacrogol 1000 2.75%w/w

White Soft Paraffin 17.85%w/w

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 11 December 2018 till 10

December 2023

GSL

2065 BRU18092415P Axcel Cefuroxime-125 for Oral

Suspension (125mg/5ml)

Each 5ml contains:

Cefuroxime Axetil equivalent to

Cefuroxime 125mg

Kotra Pharma (M) Sdn. Bhd.,

NMalaysia

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2066 BRU18092416P

(Applicant to be

informed to remove

label "to be dispensed

on physician's

prescription")

Horf Lozenges Chlorhexidine Hydrochloride

5mg; Benzocaine 2mg

Y.S.P Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 11 December 2018 till 10

December 2023

P

2067 BRU18092417NP Salap Putih Tiger Balm Dementholised Mint Oil 16.0%

w/w; Cajuput Oil 13.0% w/w;

Camphor 11.0% w/w; Levomenthol

(Menthol) BP 8.0% w/w; Clove Oil

1.5% w/w

Haw Par Healthcare Ltd, Singapore Hamitan Marketing 11 December 2018 till 10

December 2023

GSL

2068 BRU18092418P Prolia Solution for Injection

60mg/mL (Prefilled Syringe)

Denosumab 60mg/mL Amgen Manufacturing Limited,

United States

MediPharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2069 BRU18102419PS1 &

BRU18102419PS2

Zient® 10mg Tablet Ezetimibe 10mg 1.       MSD Internaitonal GmbH

(Singapore Branch), Singapore

2.       MSD International GmbH

(Puerto Rico Branch) LLC, Puerto

Rico

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2070 BRU18102420P Simulect Lyophilisate for

Injection 20mg per vial

Basiliximab 20mg Novartis Pharma Stein AG,

Switzerland

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2071 BRU18102421NP Calcium Lactate Tablet 300mg Calcium Lactate 300mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G&H Trading Company 11 December 2018 till 10

December 2023

GSL

2072 BRU18102422P Sulpin F.C. Tablets 200mg Sulpiride 200mg Taiwan Biotech Co. Ltd., Taiwan,

Republic of China

K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2073 BRU18102423P Quetiapine Fumarate Tablets

25mg

Quetiapine 25mg (as Quetiapine

Fumarate 28.78mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 166 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2074 BRU18102424P Quetiapine Fumarate Tablets

200mg

Quetiapine 200mg (as Quetiapine

Fumarate 230.26mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2075 BRU18102425P Quetiapine Fumarate Tablets

100mg

Quetiapine 100mg (as Quetiapine

Fumarate 115.13mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2076 BRU18102426NP Volulyte 6% Solution for

Infusion

Active ingredient (per 1000 ml)

Poly (O-2-hydroxylethyl) starch

60.0 g

Sodium acetate trihydrate 4.63 g

Sodium chloride 6.02 g

Potassium chloride 0.30 g

Magnesium chloride hexahydrate

0.30 g

Fresenius Kabi Deutchland GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2077 BRU18102427P Hydrogen Peroxide Solution

6% w/v

Hydrogen Peroxide 6% w/v Royce Pharma Manufacturing Sdn

Bhd, Malaysia

SWL Biomed Sales & Services 11 December 2018 till 10

December 2023

GSL

2078 BRU18102428P Axcel Prednisolone-5mg EC

Tablets

Prednisolone 5mg Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2079 BRU18102429P Praluent 75mg Solution for

Injection in Pre-filled Pen

Alirocumab 75mg/ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2080 BRU18102430P Praluent 150mg Solution for

Injection in Pre-filled Pen

Alirocumab 150mg/ml Sanofi-Aventis Deutschland

GmbH, Germany

Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2081 BRU18102431P Praluent 75mg Solution for

Injection in Pre-filled Syringe

Alirocumab 75mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2082 BRU18102432P Praluent 150mg Solution for

Injection in Pre-filled Syringe

Alirocumab 150mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2083 BRU18102433P Udoxan Injection (1 ml

amp)

Oxytocin (synthetic) 10 I.U. /ml Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2084 BRU18102434P Lignopad®medicated plaster

5%w/w

Lidocaine 5% w/w Teikoku Seiyaku Co Ltd, Japan K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2085 BRU18102435P CEFTREX INJECTION 1G IV

CEFTRIAXONE

Ceftriaxone sodium equivalent to

Ceftriaxone 1G

Biolab Co Ltd, Thailand Hongkiat Trading & Company 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 167 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2086 BRU18102436P Doxymycin-100 Capsules Doxycycline Hyclate BP equivalent

to Doxycycline 100mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 11 December 2018 till 10

December 2023

POM

2087 BRU18102437NP Optrex Multi Action Eye Wash Hamamelis Water (Witch Hazel)

13.0% v/v

Reckitt Beckinser Healthcare

International Ltd, UK

Syarikat Aliaa Sdn Bhd 11 December 2018 till 10

December 2023

GSL

2088 BRU18102438NP Optrex Rehydrating Eye Drops Sodium Hyaluronate 0.165%w/w Reckitt Beckinser Healthcare

International Ltd, UK

Syarikat Aliaa Sdn Bhd 11 December 2018 till 10

December 2023

GSL

2089 BRU18102439P Candesartan Sandoz tablet

8mg

Candesartan cilexetil 8mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2090 BRU18102440P Keytruda 25mg/mL Pembrolizumab 25mg/mL MSD Ireland (Carlow), Ireland Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2091 BRU18112441NP African Sea Coconut Brand

Cough MIxture

Tolutanus Syrup BP 4.48% v/v;

Tincture of Ipecacuanha BP 1953

2.24% v/v; Solution for Making

Squill Elixir BP 1980 2.24% v/v;

Liquorice Liquid Extract BP 2.24%

v/v

Luen Fook Medicine (M) Sdn Bhd,

Malaysia

Yuh Hua Trading Company 11 December 2018 till 10

December 2023

GSL

2092 BRU18112442P FRESOFOL 2% MCT/LCT

EMULSION FOR INJECTION OR

INFUSION

Propofol 20mg/ml Fresenius Kabi Austria GMBH

(Plant Graz), Austria

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2093 BRU18112443P FRESOFOL 1% MCT/LCT

EMULSION FOR INJECTION OR

INFUSION

Propofol 10mg/ml Fresenius Kabi Austria GMBH

(Plant Graz), Austria

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2094 BRU18112444NP SURGICAL SPIRIT Methylated spirit 98.8% v/v Sanchuan Medical Sdn BHd,

Malaysia

SWL Biomed Sales & Services 11 December 2018 till 10

December 2023

GSL

2095 BRU18112445P ANDROZ 100 TABLET 100mg Sildenafil (as Sildenafil

citrate 140.485mg)

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2096 BRU18112446P ANDROZ 50 TABLET 50mg Sildenafil (as Sildenafil

citrate 70.243mg)

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2097 BRU18112447P VERAPIME POWDER FOR

SOLUTION FOR INJECTION

1G/VIAL

Cefepime Hydrochloride

Monohydrate equivalent to

Cefepime 1g

DEMO S.A. Pharmaceutical

Industry, Greece

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 168 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2098 BRU18112448PS1;

BRU18112448PS2

REBIF SOLUTION FOR

INJECTION IN PRE-FILLED PEN

22MCG/0.5ML

Each Rebif 22 micrograms solution

for injection in pre-filled pen

contains 22 micrograms (6MIU*) of

interferon beta-1a** in 0.5ml

solution

* Million International Units,

measured by cytopathic effect

(CPE) bioassay against the in-house

IFN beta-1a standard which is

calibrated against the current

international NIH standard (GB-23-

902-531).

** produced in Chinese hamster

ovary Cells (CHO-K1) by

recombinant DNA technology

1) Merck Serono S.p.A., Italy

2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10

December 2023

POM

2099 BRU18112449PS1;

BRU18112449PS2

REBIF SOLUTION FOR

INJECTION IN PRE-FILLED PEN

44MCG/0.5ML

Each Rebif 44 micrograms solution

for injection in pre-filled pen

contains 44 micrograms (12MIU*)

of interferon beta-1a** in 0.5ml

solution

* Million International Units,

measured by cytopathic effect

(CPE) bioassay against the in-house

IFN beta-1a standard which is

calibrated against the current

international NIH standard (GB-23-

902-531).

** produced in Chinese hamster

ovary Cells (CHO-K1) by

recombinant DNA technology

1) Merck Serono S.p.A., Italy

2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10

December 2023

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2100 BRU18112450PS1;

BRU18112450PS2

REBIF SOLUTION FOR

INJECTION IN PRE-FILLED

CARTRIDGE 22MCG/0.5ML

Each pre-filled cartridge contains

66 micrograms (18 MIU*) of

interferon beta-1 a** in 1.5mL

solution, corresponding to 44

micrograms/rnl.

* Million International Units,

measured by cytopathic effect

(CPE) bioassay against the in-house

IFN beta-1a standard which is

calibrated against the current

international NIH standard (GB-23-

902-531).

** produced in Chinese hamster

ovary Cells (CHO-K1) by

recombinant DNA technology.

1) Merck Serono S.p.A., Italy

2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10

December 2023

POM

2101 BRU18112451PS1;

BRU18112451PS2

REBIF SOLUTION FOR

INJECTION IN PRE-FILLED

CARTRIDGE 44 MCG/0.5ML

Each pre-filled cartridge contains

132 micrograms (36 MIU*) of

interferon beta-1 a** in 1.5mL

solution, corresponding to 88

micrograms/rnl.

* Million International Units,

measured by cytopathic effect

(CPE) bioassay against the in-house

IFN beta-1a standard which is

calibrated against the current

international NIH standard (GB-23-

902-531).

** produced in Chinese hamster

ovary Cells (CHO-K1) by

recombinant DNA technology.

1) Merck Serono S.p.A., Italy

2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10

December 2023

POM

2102 BRU18112452P Nelin 150mg/1.5mL Injection Netilmicin Sulfate USP Eq. to

Netilmicin 150mg/1.5mL

Biolab Company Ltd, Thailand K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 170 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2103 BRU18112453P Midazolam-Hameln 5mg/ml

Injection, 3ml

Midazolam (as hydrochloride)

15mg/3ml

Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2104 BRU18112454P APO-ATENIDONE TABLETS

100/25MG

Atenolol 100mg and

Chlorthalidone 25mg

Apotex Inc, Canada Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2105 BRU18112455P Torio Tablet Simvastatin 10mg Unison Laboratories Co. Ltd.,

Thailand

K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2106 BRU18112456P Arvastatil 10mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq.

to Atorvastatin 10mg

One-Pharma Industrial

Pharmaceutical Company S.A.,

Greece

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2107 BRU18112457P Arvastatil 20mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq.

to Atorvastatin 20mg

One-Pharma Industrial

Pharmaceutical Company S.A.,

Greece

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2108 BRU18112458P Arvastatil 40mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq.

to Atorvastatin 40mg

One-Pharma Industrial

Pharmaceutical Company S.A.,

Greece

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

POM

2109 BRU18112459P Ificipro 250mg Tablets Ciprofloxacin Hydrochloride USP

eq. to Ciprofloxacin 250mg

Unique Pharmaceutical

Laboratories (A Division of JB

Chemicals & Pharmaceuticals

Limited), India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023

POM

2110 BRU18112460P Humira 40mg/0.4ml Solution

for Injection

Adalimumab 40mg/0.4ml Vetter Pharma-Fertigung,

Germany

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2111 BRU18112461P IMACH INJECTION 1ML Chlorpheniramine maleate

10mg/1ml

SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 11 December 2018 till 10

December 2023

POM

2112 BRU18112462NP Silverderm cream Silver Sulfadiazine 1% w/w T.O. Chemicals (1979) Ltd,

Thailand

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023

P

2113 BRU18112463P Granisetron-AFT Solution for

Injection 1mg/ml

Granisetron hydrochloride

equivalent to Granisetron 1mg/ml

Qilu Pharmaceutical Co. Ltd., P.R.

China

Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2114 BRU18112464P Lenvima 4mg Hard Capsule Lenvatinib 4mg (equivalent to

4.90mg levatinib mesilate)

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2115 BRU18112465P Lenvima 10mg Hard Capsule Lenvatinib 10mg (equivalent to

12.25mg levatinib mesilate

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10

December 2023

POM

2116 BRU18112466P KISQALI 200MG FILM-COATED

TABLET

Ribociclib succinate equivalent to

200mg ribociclib

Novartis Singapore

Pharmaceutical Manufacturing Pte

Ltd., Singapore

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10

December 2023

POM

2117 BRU18112467P Zylovaa Tablet 50mg Losartan Potassium 50mg Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Company 11 December 2018 till 10

December 2023

POM

BDMCA/RMP/0319 Page 171 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2118 BRU18122468P CLOXABIOTIC INJECTION

500MG

Cloxacillin sodium BP equivalent to

cloxacillin 500mg

Karnataka Antibiotics &

Pharmaceuticals Limited (A. Govt

of India Enterprise), India

K-Seri Pharma Sdn. Bhd 04 March 2019 till 03 March

2024

POM

2119 BRU18122469P Losartan Potassium Tablet

50mg

Losartan Potassium 50mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March

2024

POM

2120 BRU18122470P Losartan Potassium Tablet

100mg

Losartan Potassium 100mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March

2024

POM

2121 BRU18122471P Injecsol LIG2 (Lignocaine

Hydrochloride Injection 2%

w/v)

Lignocaine Hydrochloride 20mg

/mL

Ain Medicare Sdn. Bhd, Malaysia. Syarikat Pakatan Indah 04 March 2019 till 03 March

2024

POM

2122 BRU18122472NP Injecsol S20 (Sodium Chloride

20% w/v Injection BP)

Each 10ml contains Sodium

chloride 2g (Na+ 34.2mmol, CL-

34.2mmol)

Ain Medicare Sdn. Bhd., Malaysia. Syarikat Pakatan Indah 04 March 2019 till 03 March

2024

POM

2123 BRU18122473P Dyna Ferrous Fumarate Tablet Ferrous Fumarate 200mg Dynapharm (M) Sdn Bhd (65683-

V), Pulau Pinang, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

GSL

2124 BRU18122474P OXYNORM 5MG CAPSULES Each capsule contains:

4.5mg oxycodone as 5mg

oxycodone hydrochloride.

Bard Pharmaceuticals Limited,

United Kingdom.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2125 BRU18122475P OXYNORM 10MG CAPSULES Each capsule contains:

9mg oxycodone as 10mg

oxycodone hydrochloride.

Bard Pharmaceuticals Limited,

United Kingdom.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2126 BRU18122476P OXYNORM 20MG CAPSULES Each capsule contains:

18mg oxycodone as 20mg

oxycodone hydrochloride.

Bard Pharmaceuticals Limited,

United Kingdom.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2127 BRU18122477P Signifor LAR 20mg Powder

and Solvent for Suspension for

Injection

Pasireotide 20mg (as pamoate) Powder

Novartis Pharma AG, Switzerland

Sandoz GmbH, Austria

Solvent

Abbott Biologicals B.V., The

Netherlands

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 172 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2128 BRU18122478P Signifor LAR 40mg Powder

and Solvent for Suspension for

Injection

Pasireotide 40mg (as pamoate) Powder

Novartis Pharma AG, Switzerland

Sandoz GmbH, Austria

Solvent

Abbott Biologicals B.V., The

Netherlands.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2129 BRU18122479P Signifor LAR 60mg Powder

and Solvent for Suspension for

Injection

Pasireotide 60mg (as pamoate) Powder

Novartis Pharma AG, Switzerland

Sandoz GmbH, Austria

Solvent

Abbott Biologicals B.V., The

Netherlands.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2130 BRU18122480PS1 &

BRU18122480PS2

MUCODIN TABLET 375MG Carbocysteine 375mg 1. Sunward Pharmaceutical Sdn

Bhd, Malaysia;

2. Sunward Pharmaceutical Pte

Ltd, Singapore,

Note: Both sites conducts their

batch releases and share the same

package insert and label artwork

G & H Trading Company 04 March 2019 till 03 March

2024

P

2131 BRU18122481P Kary Uni® Ophthalmic

Suspension (Pirenoxine

0.005%)

Pirenoxine 0.05mg/ mL Santen Pharmaceutical Co., Japan MediPharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 173 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2132 BRU18122482NP Belcid Suspension Each 15ml contains:

Aluminum Hydroxide Gel USP eq.

to Aluminium Hydroxide 918mg

Magnesium Hydroxide USP

300mg

Simethicone USP 60mg

Biolab Company Ltd., Thailand. Hongkiat Trading & Company 04 March 2019 till 03 March

2024

GSL

2133 BRU18122483NP Eye Glo Moist Eye Drops Hydroxypropyl methylcellulose

0.3% w/v

Duopharma (M) Sdn Bhd,

Malaysia.

Bintang Ria Sdn Bhd 04 March 2019 till 03 March

2024

GSL

2134 BRU18122484NP Mifulin lotion Salicylic acid 12% Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 04 March 2019 till 03 March

2024

GSL

2135 BRU18122485P Ketazon shampoo Ketoconazole 2g/100ml Siam Bheasach Co Ltd, Thailand K-Seri Pharma Sdn. Bhd. 04 March 2019 till 03 March

2024

P

2136 BRU18122486P DURATOCIN® 100mcg/ml

Injection

Carbetocin 100mcg/ml Ferring GmbH, Germany

Repacker: Zuellig Pharma Specialty

Solutions Group Pte. Ltd.,

Singapore

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2137 BRU18122487NP Alucid Suspension Each 10ml contains:

Aluminium Hydroxide 800mg,

Magnesium Hydroxide 800mg,

Simethicone 60mg

Upha Pharmaceutical

Manufacturing (M) Sdn Bhd,

Malaysia

Bintang Ria Sdn Bhd 04 March 2019 till 03 March

2024

GSL

2138 BRU19012488P BENZAPEN 2.4MIU INJECTION Sterile Penicillin G Benzathine 1.8G

(2.4 MU)

Karnataka Antibiotics &

Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March

2024

POM

2139 BRU19012489NP VITBION FORTE TABLET Vitamin B1 HCl (Thiamine HCl)

100mg

Vitamin B6 HCL (Pyridoxine HCl)

200mg

Vitamin B12 HCL (Cyanocobalamin)

200mcg

Dynapharm (M) Sdn Bhd,

Malaysia.

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

GSL

2140 BRU19012490NP MENTHOLATUM DEEP

HEATING PLASTER

L-Menthol 4.26% Teh Seng Pharmaceutical Mfg. Co.,

Ltd., Taiwan, R.O.C

Hamitan Marketing 04 March 2019 till 03 March

2024

GSL

2141 BRU19012491P FENTANYL-HAMELN 50

MCG/ML INJECTION

Fentanyl citrate (0.157mg) eq. to

fentanyl 0.1mg/2ml

Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2142 BRU19012492P AXINOL TABLET 20MG Trimetazidine dihydrochloride

20mg

T.O Chemicals (1970) Co. Ltd.,

Thailand.

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 174 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2143 BRU19012493P HCQS

(HYDROXYCHLOROQUINE

TABLETS BP 200MG)

Hydroxychloroquine Sulfate BP

200mg

Ipca Laboratories Limited, India. K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March

2024

POM

2144 BRU19012494P VAXCEL CEFEPIME 1G

INJECTION

Cefepime Hydrochloride buffered

with L-Arginine equivalent to

Cefepime 1g

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2145 BRU19012495NP POVIDONE IODINE, THREE

LEGS BRAND

Povidone Iodine 10% w/v Syarikat Wen Ken Drug Sdn Bhd,

Malaysia

Syarikat Rajamas Bersama 04 March 2019 till 03 March

2024

GSL

2146 BRU19012496P ALTRATM TABLET 10MG Montelukast 10mg (as

montelukast sodium 10.66mg)

Xepa-Soul Pattinson (Malaysia)

Sdn Bhd, Malaysia

Hongkiat Trading & Co. 04 March 2019 till 03 March

2024

POM

2147 BRU19012497P AXCEL DIPHENHYDRAMINE

PAEDIATRIC SYRUP

Diphenhydramine hydrochloride

7mg / 5ml

Ammonium chloride 67.5mg / 5ml

Kotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2148 BRU19012498NP VISIPAQUE 320 MG I/ML,

SOLUTION FOR INJECTION

Iodixanol 652 mg/ml eq to 320 mg

I/ml

GE Healthcare (Shanghai) Co., Ltd,

China

Medipharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2149 BRU19012499PS1 &

BRU19012499PS2

ALBUNORM 20%, 200G/L,

SOLUTION FOR INFUSION

200g/l of total protein of which at

least 96% is human albumin

i) Octapharma Pharmazeutika

Produktionsges.m.b.H, Austria

ii) Octapharma

Produktionsgesellschaft

Deutschland mbH, Germany

G&H Trading Company 04 March 2019 till 03 March

2024

POM

2150 BRU19012500PS1 &

BRU19012500PS2

ALBUNORM 5%, 50G/L,

SOLUTION FOR INFUSION

50g/l of total protein of which at

least 96% is human albumin

i) Octapharma Pharmazeutika

Produktionsges.m.b.H, Austria

ii) Octapharma

Produktionsgesellschaft

Deutschland mbH, Germany

G&H Trading Company 04 March 2019 till 03 March

2024

POM

2151 BRU19012501PS1 &

BRU19012501PS2

ALBUNORM 25%, 250G/L,

SOLUTION FOR INFUSION

250g/l of total protein of which at

least 96% is human albumin

i) Octapharma Pharmazeutika

Produktionsges.m.b.H, Austria

ii) Octapharma S.A.S., Lingolsheim,

France.

G&H Trading Company 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 175 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2152 BRU19012502P VAXIGRIP TETRA SUSPENSION

FOR INJECTION IN PREFILLED

SYRINGE

A/Michigan/45/2015

(H1N1)pdm09 – like strain

(A/Michigan/45/2015, NYMC X-

275)….....

15 mcg HA**

A/Switzerland/8060/2017 (H3N2)

– like train (A/Brisbane/1/2018,

NYMC X-311)........

15 mcg HA**

B/Colorado/06/2017 like strain

(B/Maryland/15/216, NYMC BX-

69A)…………

15 mcg HA**

B/Phuket/3073/2013 – like strain

(B/Phuket/3073/2013, wild

type)………

15 mcg HA**

For one 0.5ml dose

*propagated in fertilised hen’s

eggs from healthy chicken flocks

**haemagglutinin

Sanofi Pasteur, Val De Reuil,

France

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2153 BRU19012503NP REGIOCIT SOLUTION FOR

HAEMOFILTRATION

Sodium chloride 5.03 g/L

Sodium citrate 5.29 g/L

Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2154 BRU19012504P PYRONIUM INJECTION

200MCG/ML

Glycopyrrolate 200mcg/ml SM Pharmaceuticals Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2155 BRU19012505P HERCEPTIN SOLUTION FOR

INJECTION 600MG/5ML

Trastuzumab 600mg/5ml F.Hoffmann-La Roche Ltd.,

Kaiseraugst, Switzerland

Medipharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2156 BRU19012506P EZETIMIBE SANDOZ TABLET

10MG

Ezetimibe 10mg Lek Pharmaceuticals, Ljubljana,

Slovenia

Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 176 of 178

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2157 BRU19022507P APO-FLUCONAZOLE 100MG

TABLETS

FLUCONAZOLE 100MG Apotex Inc., Canada Medipharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2158 BRU19022508NP NUTRILITE IRON FOLIC TABLET IRON 10MG

FOLATE (FOLIC ACID) 0.133MG

Access Business Group LLC, USA Amway (B) Sdn Bhd 04 March 2019 till 03 March

2024

GSL

2159 BRU19022509P CEFATUM INJECTION 1G CEFTAZIDIME 1GM Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 04 March 2019 till 03 March

2024

POM

2160 BRU19022510NP Folic Acid Tablets 5mg FOLIC ACID 5MG HOVID Bhd., Malaysia G&H Trading Company 04 March 2019 till 03 March

2024

GSL

2161 BRU19022511P Clopine 100MG Tablet Clozapine 100mg Douglas Manufacturing Ltd., New

Zealand

K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March

2024

POM

2162 BRU19022512P Vaxcel Omeprazole 40mg

Injection

Omeprazole Sodium equivalent to

Omeprazole 40mgKotra Pharma (M) Sdn Bhd,

Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2163 BRU19022513NP Medon 500 capsule Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 04 March 2019 till 03 March

2024

GSL

2164 BRU19022514P Bufencon Injection Betamethasone (as dipropionate) 5mg

& Betamethasone (as phosphate

disodium) 2mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan, Republic of China

Asterix (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2165 BRU19022515NP PARACETAMOL-AFT

SOLUTION FOR INFUSION

10MG/ML

Paracetamol 10mg/ml S.M. Farmaceutici SRL, Italy MediPharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2166 BRU19022516P Domi Injection 15mg (3ml

Amp)

Midazolam HCl equivalent to

Midazolam 15mg/3mlDuopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March

2024

POM

2167 BRU19022517P Baraclude® 0.5mg Tablets Entecavir 0.5mg Bristol-Myers Squibb Company,

USA

Medipharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2168 BRU19022518NP Tricera Cleanser 1.6% w/w Pine Tar 1.6% HOE Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 04 March 2019 till 03 March

2024

GSL

2169 BRU19022519P Chloroquine Tablets 250mg Chloroquine Phosphate BP 250mg

equivalent to Chloroquine Base

150mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading & Company 04 March 2019 till 03 March

2024

POM

2170 BRU19022520P KENO ORAL PASTE Triamcinolone acetonide 1 mg/g T.O. CHEMICALS (1979) LTD.,

Thailand

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2171 BRU19022521P ATRACURIUM-HAMELN

10MG/ML INJECTION, 2.5ML

Atracurium besilate 25mg in 2.5ml

(10mg/ml)

Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

POM

2172 BRU19022522NP Kidz PCM 250 Suspension

(Strawberry)

Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia

Yuh Hua Trading Company 04 March 2019 till 03 March

2024

GSL

2173 BRU19022523NP Povil Antacid Tablet Dried Aluminium Hydroxide 250 mg,

Magnesium Hydroxide 250 mg,

Simethicone 50 mg

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March

2024

GSL

BDMCA/RMP/0319 Page 177 of 178

Page 178: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Importation of... · BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED MARCH 2019)

No Product Registration

Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of

current and until the end of

the validity period as

stated)

Product

Classification

2174 BRU19022524P Inlyta® 1mg Film-Coated

Tablet

Axitinib 1mg Pfizer manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March

2024

POM

2175 BRU19022525P Inlyta® 5mg Film-Coated

Tablet

Axitinib 5mg Pfizer manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

2176 BRU19022526P Taflotan Ophthalmic Solution

0.0015%

Tafluprost 0.00015% Santen Pharmaceutical Co., Ltd.,

Shiga Plant, Japan

MediPharm Sdn Bhd 04 March 2019 till 03 March

2024

POM

2177 BRU19022527NP Paracil suspension 250mg/5ml Paracetamol 250mg/5ml SM Pharmaceuticals Sdn Bhd,

Malaysia

G& H Trading Company 04 March 2019 till 03 March

2024

GSL

2178 BRU19022528P DTI for Injection 200mg Dacarbazine 200mg Korea United Pharm, Inc., Republic

of Korea

Kingsley Medical Supplies

Sdn Bhd

04 March 2019 till 03 March

2024

POM

2179 BRU19022529P Sildegra 100mgTablets Sildenafil Citrate 140.4mg

equivalent to Sildenafil 100mg

Sandoz Private Limited, India Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March

2024

POM

BDMCA/RMP/0319 Page 178 of 178