157
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 2020 till 05 October 2025 POM 4 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 5 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 6 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 7 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 8 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 9 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 10 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 11 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 12 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05 October 2020 POM 13 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 14 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 15 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 BDMCA/RMP/0719 Page 1 of 157

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

  • Upload
    others

  • View
    14

  • Download
    0

Embed Size (px)

Citation preview

Page 1: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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, UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

2 BRU07100002P Augmentin Injection 600mg

Co-Amoxiclav 500/100 - Amoxicillin

500mg as sodium salt, clavulanic acid

100mg as potassium salt

SmithKline Beecham PLC, Worthing,

West Sussex, UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

3 BRU08010001PPharmaniaga Aciclovir Tablet

200mgAciclovir 200mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

4 BRU08010003PPharmaniaga Clarithromycin

Tablet 250mgClarithromycin 250mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

5 BRU08010004PPharmaniaga Fluconazole

150mg CapsulesFluconazole 150mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

6 BRU08010005PPharmaniaga Ciprofloxacin

Tablet 500mgCiprofloxacin 500mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

7 BRU08020012PPharmaniaga Cephalexin

Capsule 500mgCephalexin 500mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

8 BRU08020013PPharmaniaga Metronidazole

Tablet 200mg Metronidazole 200mg

Pharmaniaga Manufacturing Berhad

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

9BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

10BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

11BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

12BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

13 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 Bhd06 October 2015 till 05

October 2020POM

14 BRU08030023P Augmentin Tablet 625mg

Amoxycillin 500mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

15 BRU08030024P Augmentin Syrup 228mg/5ml

Amoxycillin 200mg/5ml (as trihydrate);

Clavulanic acid 28.5mg/5ml (as

Potassium Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 1 of 157

Page 2: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

16 BRU08030025P Augmentin Syrup 457mg/5ml

Amoxycillin 400mg/5ml (as trihydrate);

Clavulanic acid 57mg/5ml (as

Potassium Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

17 BRU08030026P Augmentin Tablet 1g

Amoxycillin 875mg (as trihydrate);

Clavulanic acid 125mg (as Potassium

Clavulanate)

SmithKline Beecham Plc, Worthing,

UKZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

19 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 October 2015 till 05

October 2020POM

20 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

21 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium)GlaxoSmithKline Manufacturing SPA,

Italy.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

22 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

23 BRU08040040P Retrovir Syrup Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

24 BRU08040041P Zeffix Tablet Lamivudine 100mgGlaxoSmithKline Pharmaceuticals

S.A., Poland Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

25 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mgGlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

26BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

(120ml)

27 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd06 October 2015 till 05

October 2020POM

28BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

29 BRU08040049PDiflucan IV Infusion 2mg/ml

(50ml)Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Cefoperazone (as Sodium) 500mgHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

31 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

32 BRU08050053PPharmaniaga Aciclovir Tablet

400mgAciclovir 400mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

33 BRU08050054PPharmaniaga Cephalexin

Capsule 250mg

Cephalexin (as Anhydrous) Cephalexin

250mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

06 October 2020 till 05

October 2025POM

34BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

BDMCA/RMP/0719 Page 2 of 157

Page 3: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

35BRU08050061P Unocef Injection 1000mg

(Vial)

Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

36 BRU08050062PGarasent 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 2020POM

37 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

38 BRU08050066P Beagenta Eye/ Ear DropsGentamicin Sulphate equivalent to

Gentamicin 0.3%w/wDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

39 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised)Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

40 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 Bhd06 October 2015 till 05

October 2020POM

41 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/vHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

42 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,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

43 BRU08050073P Dezor Cream Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

44 BRU08050074P Dezor Shampoo Ketoconazole 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

45BRU08060075P 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

46BRU08060077P Aecoras Ointment Econazole Nitrate 10mg; Triamcinolone

Acetonide 1mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 October 2015 till 05

October 2020

POM

47 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5mlUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

48 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

49 BRU08060081P Betagen Eye/ Ear Drops

Gentamicin Sulphate equivalent to

Gentamicin 0.3%; Betamethasone

Sodium Phosphate 0.1%

Duopharma (M) Sdn Bhd, MalaysiaHongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

50 BRU08060082P Muprin Ointment Mupirocin 2.0%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

51 BRU08060083P Eryson Granules 200Erythromycin ethylsuccinate equiv. to

eryhtromycin 200mg/5ml

Upha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020 POM

BDMCA/RMP/0719 Page 3 of 157

Page 4: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

52 BRU08060084P Eryson Granules 400Erythromycin ethylsuccinate equiv. to

eryhtromycin 400mg/5ml

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

53 BRU08060085P Neomycin Cream 0.5% Neomycin sulphate 0.5%w/wUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

55 BRU08060087P Foban Hydro OintmentSodium Fusidate 2%; Hydrocortisone

1%

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

56 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

57 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

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

Cefuroxime 250mg

Glaxo Wellcome Bernard Castle,

United KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

59 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah06 October 2015 till 05

October 2020POM

60 BRU08070092P Eryson Tablet 250Erythromycin Stearate BP equivalent to

Eryhthromycin 250mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

61 BRU08070094P Ecocort CreamEconazole Nitrate 1% w/w;

Triamcinolone Acetonide 0.1% w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

62 BRU08070095P Beprogent OintmentBetamethasone 0.05%; Gentamicin

0.1%

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

63 BRU08070096P Betamox Capsule 250mgAmoxicillin Trihydrate equivalent to

Amoxicillin 250mgDuopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

64 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

65 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

66 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

67 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1gGlaxoSmithKline Manufacturing SPA,

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

68 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

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

71 BRU08080108P Beprogent CreamBetamethasone (as dipropionate)

0.05%, Gentamicin (as sulphate 0.1%)

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 4 of 157

Page 5: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

(Ampicillin 250mg & Sulbactam 125mg)Pfizer Global Supply Japan Inc, Japan Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

73 BRU08080115PVaxcel Cefuroxime 750mg

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

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

74 BRU08080116PVaxcel Ceftriaxone 1g

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

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

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

valerate) 0.1%Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

76 BRU08090118P Verorab Injection

Inactivated rabies virus (Wistar strain

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

on VERO cell line, inactivated and

purifed

Sanofi Pasteur, Marcy l’Etoile –

France, Sanofi Pasteur, Val de Reuil –

France; Sanofi Winthrop Industrie

(SWI), Le Trait – France (Diluent)

Zuellig Pharma (B) Sdn Bhd06 October 2020 till 05

October 2025POM

77 BRU08090119P Decocort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

78 BRU08090120P Fobancort Ointment

Sodium Fusidate 2%w/w;

Betamethasone 0.05%w/w (as

Dipropionate 0.064%)

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

79 BRU08090121P Candacort CreamClotrimazole 1.0% w/w;

Hydrocortisone 1.0%w/w

Hoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

80 BRU08090124PCiprobay® 200 Infusion

SolutionCiprofloxacin (as lactate) 200mg Bayer AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

81 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

82 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

83 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

84 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

85 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020GSL

86 BRU08090130PCiprobay 100 Infusion

Solution x 50mlCiprofloxacin (as lactate) 100mg

Bayer Pharma AG, Leverkeusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020P

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

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

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

Agila Specialties Private Limited,

India; Medreich Limited Unit-1,

Bangalore, India

G & H Trading Company06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 5 of 157

Page 6: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

89BRU08090133NPS1;

BRU08090133NPS2

Dhamol Suspension

250mg/5mlParacetamol 250mg/5ml

Drug Houses of Australia Pte Ltd,

Singapore (S1); PT Actavis Indonesia,

Jakarta Indonesia (S2)

G & H Trading Company06 October 2015 till 05

October 2020GSL (60ml)

90 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

91BRU08100135P 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

92 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 2020POM

93 BRU08100139P Ciprobay® 500 TabletCiprofloxacin (as HCl monohydrate)

500mgBayer AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

94 BRU08100140PAvelox Infusion Solution

0.4g/250mlMoxifloxacin (as Hydrochloride) 400mg

Bayer AG, Leverkusen, GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

95 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

96 BRU08100142P Candazole Lotion Clotrimazole 1%w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

97 BRU08100143P Allopurinol 100mg Tablet Allopurinol 100mgDrug Houses of Australia Pte Ltd

G & H Trading Company06 October 2015 till 05

October 2020POM

98 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/wSunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020P

99 BRU08110150PAvaxim 160U Suspension for

Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM

strain) 160u/0.5mlSanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

100 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

101 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mgGlaxoSmithKline Manufacturing SPA

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

102 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

103 BRU08110154PAxcel Eryhthromycin ES Tablet

400mg

Erythromycin (as ethyl succinate)

400mgKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

104 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

105 BRU08110156PAxcel Eryhthromycin ES-200

Suspension

Erythromycin (as Ethylsuccinate)

200mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

106BRU08110157PS1 ;

BRU08110157PS2Soden Tablet 275mg Naproxen Sodium BP 275mg

Drug House of Australia Pte Ltd,

Singapore ;

PT Actavis Indonesia, Indonesia

G & H Trading Company06 October 2015 till 05

October 2020POM

107 BRU08110159P Miconazole Cream 2.0%w/w Miconazole Nitrate 2.0%w/wSunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020GSL

BDMCA/RMP/0719 Page 6 of 157

Page 7: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

108 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

109 BRU08110163PCoAprovel 150/12.5mg Film-

coated Tablet

Irbesartan 150mg, Hydrochlorothiazide

12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

110 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate)

250mg

Bayer Pharma AG, Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

111 BRU08120167PAxcel Cephalexin 250mg

CaspuleCephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

112 BRU08120168PAxcel Cephalexin 125mg

SuspensionCephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020

POM (60ml &

100ml)

113 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

114 BRU08120170PHydrocrotisone Cream 1%

w/wHydrocortisone acetate BP 1%w/w

Upha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

115 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

116 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

117 BRU08120177P Beprosalic LotionBetamethasone (as dipropionate)

0.05%, Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

118 BRU08120180PZithromax Film-coated Tablet

250mgAzithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Sulbactam (as sodium) 250mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Sulbactam (as sodium) 1000mgHaupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

121 BRU09010183PVaxcel Ceftriaxone-500mg

InjectionCeftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

122BRU09010184PS1;

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 Company06 October 2015 till 05

October 2020POM

123 BRU09010186P Plavix Tablet 75mgClopidogrel (as Hydrogen Sulphate)

75mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

124 BRU09010187PSymbicort Turbuhaler

160/4.5mcg dose

Budenoside 160mcg; Formoterol

fumarate dihydrate 4.5mcgAstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

125 BRU09010188PCoAprovel 300/12.5mg film-

coated tablet

Irbesartan 300mg; Hydrochlorothiazide

12.5mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

126BRU09010191PS1 &

BRU09010191PS2Coversyl 8mg tablet Perindopril tert-butylamine 8mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 7 of 157

Page 8: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

127 BRU09010194PPulmicort turbuhaler

100mcg/doseBudenoside 100mcg AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

128 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany Medipharm Sdn Bhd06 October 2015 till 05

October 2020POM

129 BRU09020197P Zovirax Eye Ointment 3% Aciclovir 3%w/wJubilant HollisterStier General

Partnership, CanadaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

130 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2mlFamar Health Care Services Madrid

S.A.U., Madrid, SpainMedipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

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

500mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

132 BRU09020206PBricanyl Turbuhaler

0.5mg/doseTerbutaline Sulphate 0.5mg/dose AstraZeneca AB, Sodertalje, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

133 BRU09020207P Beprosalic OintmentBetamethasone (as Dipropionate

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

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

134 BRU09020208P Beprogel Topical SolutionBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

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

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

136 BRU09020210P Declovir Cream Acyclovir 5.0% w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

137 BRU09020211PLantus 100units/ml for

OptisetInsulin Glargine (HOE 901) 100units/ml

Sanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

138 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

139 BRU09030213P 3TC Tablet 150mg Lamivudine 150mgGlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

140 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

141 BRU09030215P Dhatrin TabletSulphamethoxazole BP 400mg;

Trimethoprim BP 80mg

Drug Houses of Australia Pte Ltd,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

142 BRU09030216PCordarone Injection

150mg/3mlAmiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

143BRU09030217PS1 &

BRU09030217PS2Vastarel MR 35mg Tablet Trimetazidine HCl 35mg

Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

144

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 2020POM

BDMCA/RMP/0719 Page 8 of 157

Page 9: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

145 BRU09030219PCataflam 1.5% Oral Drops

SuspensionDiclofenac Sodium 15mg/ml Novartis Farma SpA, France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

146 BRU09030220P Vaxigrip Influenza Vaccine

SH 2018:

Split influenza virus*, inactivated

containing antigens equivalent to the

following strains per one 0.5ml dose:

-A (H1N1): an A/Michigan/45/2015

(H1N1) pdm09‐like virus

-A (H3N2): an

A/Singapore/INFIMH‐16‐0019/2016

(H3N2) ‐ like virus

‐B: a B/Phuket/3073/2013‐like virus

Sanofi Pasteur, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

147 BRU09030221PLignocaine 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 2020POM

148 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

149 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

150 BRU09030224P Beprosone OintmentBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

151 BRU09030225P Beprosone CreamBetamethasone (as Dipropionate

0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

152 BRU09030226P Benosone-N Cream

Betamethasone (as Valerate 0.12%)

0.1% w/w; Neomycin Sulphate

0.5%w/w

HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

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

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

Hydrocortisone B.P.10mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

154 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

155 BRU09040229PUnasyn Powder for Oral

Suspension 250mg/5mlSultamicillin (as tosilate) 250mg Pfizer Global Supply Japan, Inc., Japan Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

156 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

157 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 9 of 157

Page 10: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

158

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, Marcel Mérieux,

Marcy l’Etole, France & Sanofi

Pasteur, Parc industriel d’Incarville,

Val de Reuil, France; Sanofi Winthrop

Industrie (SWI), Le Trait – France

Zuellig Pharma (B) Sdn Bhd06 October 2020 till 05

October 2025POM

159 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

160 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020POM

161 BRU09040235PVoltaren 75mg/3ml solution

for injectionDiclofenac Sodium 75mg/3ml

Novartis Pharma Stein, ag,

Switzerland; Lek Pharmaceuticals d.d,

Slovenia

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

162 BRU09040237PDepo-Medrol Sterile Aqueous

Suspension 40mg/ml (5ml)

Methylprednisolone Acetate

200mg/5ml

Pfizer Manufacturing Belgium NV,

BelgiumZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

163 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 Bhd06 October 2020 till 05

October 2025POM

164 BRU09040239PBupivacaine Hydrochloride BP

0.5% w/v injectionBupivacaine hydrochloride BP 0.5%w/v Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

165 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mgPfizer Pharmaceutical LLC, Vega Baja

Puerto RicoZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

166 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SpA, Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

167 BRU09040243P T3 Mycin GelClindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

168 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading & Co

06 October 2015 till 05

October 2020POM

169 BRU09040245NP Bisacodyl Suppositories Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 October 2015 till 05

October 2020P

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

171 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

172 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

173 BRU09050250P Coversyl Plus TabletPerindopril tert-butylamine 4mg,

Indapamide 1.25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

174 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 10 of 157

Page 11: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

175 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,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

176 BRU09050254P Benosone Ointment Betamethasone 0.01% w/w 0.1% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

177 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

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

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

179 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

180 BRU09060259PVaxcel Cefuroxime 1.5g

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

Medicorp Sdn Bhd 06 October 2015 till 05

October 2020POM

181 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 2020POM

182 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mgUpha Pharmaceutical Mfg (M) Sdn

BhdK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

183 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg

Novartis Pharma SPA, Italy Novartis

Saglik, Gida ve Tarim Urunleri San. Ve

Tic. A.S. Yenisehir Mahalledi, Turkey

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

184 BRU09060264PVoltaren 12.5mg

SuppositoriesDiclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

185 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

186 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

187 BRU09060268P Betamethasone Cream Betamethasone (as valerate) 0.1%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

188 BRU09060269P Zorax Cream Aciclovir 5%w/wSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

189 BRU09060270P Nexium mups 20mgEsomeprazole (as magnesium

trihydrate) 20mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

190 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mgSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

191 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mgPfizer Pharmaceuticals LLC, Vega Baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

192 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mgGlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 11 of 157

Page 12: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

193 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 Bhd06 October 2015 till 05

October 2020POM

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

strain) 80u per 0.5mlSanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

195 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mgRecipharm Uppsala AB, Bjorkgatan

30, SE-751 82 Uppsala, Sweden.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

196 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg

Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

197 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

198 BRU09070282PHydrocortisone Cream 1%

w/wHydrocortisone acetate 1%w/w

Sunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

199 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

200 BRU09070284P Nexium mups 40mgEsomeprazole (as magnesium

trihydrate) 40mgAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

201 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

202 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

203 BRU09070288P Diane-35 TabletCyproterone acetate 2mg;

Ethinylestradiol 0.035mg

Bayer Weimar GmbH und Co. KG,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

204 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Company

06 October 2020 till 05

October 2025P

206 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/wBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

207 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mgPT Boehringer Ingelheim Indonesia,

Bogor, Indonesia

Hongkiat Trading &

Company

06 October 2020 till 05

October 2025POM

208 BRU09080295PPulmicort® Turbuhaler®

200mcg/dose

Budesonide (micronised) Ph Eur

200mcg/doseAstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

209 BRU09080296PEpilim Intravenous 400mg/

vial Sodium Valproate 400mg

Sanofi S.p.A, ItalyMedipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

210 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

211 BRU09080299PBeafemic Suspension

50mg/5mlMefenamic acid 50mg/5mL

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 12 of 157

Page 13: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

212BRU09080300PS1 &

BRU09080300PS2Diamicron MR Tablet 30mg Gliclazide 30mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

213 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

214 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

215 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

216 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia Asterix United Sdn Bhd06 October 2015 till 05

October 2020P (10 x 10's)

217 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromideDelpharm Reims S.A.S,France

Hongkiat Trading &

Company

06 October 2020 till 05

October 2025POM

218 BRU09080308PAtrovent N 20µg/ puff

Metered Dose Inhaler

Ipratropium bromide anyhdrous 20mcg

(as monohydrate 21mcg)

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

219 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

220 BRU09080311P Carinox CapsulePseudoephedrine sulphate 120mg;

Loratadine 5mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

221 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 Bhd06 October 2020 till 05

October 2025POM

222 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

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

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

224 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 Bhd06 October 2015 till 05

October 2020POM

225 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 2020POM

226 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

227 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020P (100x10's)

228 BRU09090327PMetalyse Injection

10,000unitsTenecteplase 10,000units (50mg)

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

229 BRU09090328NP Hemo RidTM TabletMiconised Diosmin 450mg; Micronised

Hesperidine 50mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

BDMCA/RMP/0719 Page 13 of 157

Page 14: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

Valsartan 80mgNovartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

231 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 2020POM

232 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

233 BRU09100332P H-Cort Cream Hydrocortisone 1%w/wHOE Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

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

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

235 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5mlGlaxoSmithKline Australia Pty Ltd,

AustraliaZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

236 BRU09100336NP Sunquadin Lozenges Dequalinium ChlorideSunward Pharmaceutical Sdn Bhd,

Malaysia.G & H Trading Company

06 October 2015 till 05

October 2020POM

237 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg

Pfizer Manufacturing Deutschland

GmbH, Germany

(Manufacturing, packaging, testing

and release.

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

238 BRU09100338NPUphamol 250 Suspension

(Fruity)Paracetamol 250mg/5mL

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL (60mL and

100mL)

239 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

240 BRU09100340P Pontalon Capsule Mefenamic acid 250mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

241 BRU09100342NP Maalox Plus Tablet

Aluminium hydroxide dried gel 200mg,

Magnesium hydroxide 200mg,

Simethicone 26.25mg (correspond to

25mg of polydiemthylsiloxane)

Sanofi S.P.A., S.S. 17 km 22, 67019

Scoppito (AQ) - Italy Medipharm Sdn Bhd06 October 2020 till 05

October 2025GSL

242 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mgPfizer Pharmaceutical LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

crystalline) 40mg

Pfizer pharmaceuticals LLC, vega baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

244 BRU09100346NP Suniton TabletParacetamol 450mg, Orphenadrine

Citrate 35mg

Sunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

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

(Carbocisteine)

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn Bhd

06 October 2015 till 05

October 2020POM

246 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 POM

BDMCA/RMP/0719 Page 14 of 157

Page 15: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

247 BRU09100349P Actonel® 35mg TabletRisedronate sodium 35mg (equivalent

to 32.5mg risedronic acid)Norwich Pharmaceuticals Inc., USA

G&H Trading Company06 October 2015 till 05

October 2020POM

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

GermanyMedipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

249 BRU09110353P Tenoretic Tablet Atenolol 100mg; Chlorthalidone 25mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

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

crystalline) 10mg

Pfizer pharmaceutical LLC, vega baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

251 BRU09110357PAtrovent 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 2020POM

252 BRU09110359P Allavin ExpectorantDiphenhydramine 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

253 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 P (100 x 10's)

254 BRU09110362P Carin Tablet 10mg Loratadine 10mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020 P

255 BRU09110363PRhinathiol 2% for Children

SyrupCarbocisteine 100mg/5ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

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

Cilastatin Sodium 500mgMerck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

257BRU09120366PS1 &

BRU09120366PS2

Opvero (Oral trivalent

poliomyelitis vaccine)

Each 0.1-mL dose (2 drops) contains:

Poliomyelitis virus type 1*, LS - c2ab

strain, (live, attenuated)

......................... at least 6.0 log† CCID‡

Poliomyelitis virus type 3*, Leon -

12a1b strain, (live, attenuated)

.................... at least 5.8 log† CCID‡

* Produced in Vero cells

† Previously expressed as "at least 10x

CCID 50"

‡ CCID50: 50% Cell Culture Infective

Doses (viral infectious units).

The vaccine may contain traces of

neomycin, streptomycin and polymyxin

B.

Sanofi Pasteur, Campus Merieux,

France (S1); Sanofi Pasteur, Parc

industrial d'Incarville, France (S2)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

258 BRU09120367P Dilantin 100mg Capsule Phenytoin SodiumPfizer Pharmaceuticals LLC, Vega

Baja, USA (Pfizer Vega Baja) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 15 of 157

Page 16: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

259 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 2020POM

260 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

MalaysiaAsterix United (B) Sdn Bhd

06 October 2015 till 05

October 2020GSL (1 x 5's); P(10

x 10's)

262 BRU09120377PVascor 40mg Film-coated

TabletSimvastatin 40mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

263 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020P

264 BRU09120379PCovastin Film-coated Tablet

10mgSimvastatin 10mg

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

265 BRU09120380P Metformin Tablet 500 Metformin HCl 500mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

266 BRU09120381PS2Co-Diovan 80/12.5 Film-

coated Tablets

Valsartan 80mg; Hydrochlorothiazide

12.5mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

267 BRU09120382PRhinathiol® Promethazine

syrup

Carbocisteine 100mg/5ml;

Promethazine HCl 2.5mg/5mlUnither Liquid Manufacturing, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

268 BRU09120383PMethotrexate Injection BP

1000mg/10mlMethotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

269 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg

Aspen Port Elizabeth (Pty) Ltd,

Republic of South Africa Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

270BRU10010385PS1 &

BRU10010385PS2Coversyl 4mg Tablet Perindopril tert-butylamine 4mg

Les Laboratoires Servier Industrie,

France (S1) & Kotra Pharma (M) Sdn

Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

271 BRU10010386PS2Atrovent 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 2020POM

272 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

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

Valsartan 160mgNovartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

274 BRU10010390NPS3 Dulcolax 5mg Tablet Bisacodyl 5mg Delpharm Reims S.A.S., France (S3)Hongkiat Trading &

Company

06 October 2020 till 05

October 2025P

275 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

276 BRU10010392PS2Co-Diovan 160/25 Film-coated

Tablets

Valsartan 160mg; Hydrochlorothiazide

25mgNovartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

277 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP 4mg/5mlUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020P

BDMCA/RMP/0719 Page 16 of 157

Page 17: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

278 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

279 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

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

Fluticasone propionate 500mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

281 BRU10020402PSolu-Medrol Sterile Powder

500mg

Methyprednisolone (as Sodium

succinate) 500mg

Pfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

282 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

283 BRU10020405P Vascor Tablet 20mg SimvastatinUpha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

284 BRU10020406PCombivent Unit Dose Vials

Nebuliser Solution

Per 2.5ml - Ipratropium bromide (as

monohydrate 522mcg) 500mcg;

Salbutamol 2.5mg (as sulphate

3.013mg)

Laboratorie UNITHER , FranceHongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

285 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020POM

286 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

287 BRU10020410PEtoposide CS 100mg/5ml

InjectionEtoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Pseudoephedrine HCl 30mg

Sunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

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

Fluticasone propionate 100mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

290 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

291 BRU10020414P Sunadine Syrup Loratadine 5mg/5mlSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020P

292 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

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

RicoZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Switzerland Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

295 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

296 BRU10030423PRhinathiol 5% Adult

Expectorant SyrupCarbocisteine 5g/100ml Unither Liquid Manufacturing, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025P

297 BRU10030425NP Dulcolax Suppository 5mg Bisacodyl 5mg Instituto De Angeli S.R.L., ItalyHongkiat Trading &

Company

06 October 2015 till 05

October 2020P

BDMCA/RMP/0719 Page 17 of 157

Page 18: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

298 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

299 BRU10030427P Omesec Capsule 20mg Omeprazole 20mgUpha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn Bhd

06 October 2015 till 05

October 2020POM

300 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer Pharma AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

301 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mgSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

302 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

303 BRU10030432PCisplatin CS Injection

50mg/50mlCisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

304 BRU10030433PTerramycin 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 2020POM

305 BRU10030435PAdriamycin CS Injection

50mg/25mlDoxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

306 BRU10030436NP Maalox® Plus Suspension

Per 5ml - Aluminium hydroxide 225mg;

Magnesium hydroxide 200mg;

Simethicone USP 25mg

A. Nattermann & Cie GmbH, Germany Medipharm Sdn Bhd06 October 2020 till 05

October 2025GSL

307 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HClSunward Pharmaceutical Sdn Bhd,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

308 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg

Daiichi Sankyo Europe GmbH,

Germany; Pfizer Manufacturing

Deutschland GmbH, Germany

(primary and secondary packaging

site)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

309 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

310 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

311 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

312 BRU10040444NP Cartril-S 500mg Capsule

Glucosamine HCl 472.5mg equivalent

to Glucosamine content in

Glucosamine Sulphate 500mg

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn BHd

06 October 2015 till 05

October 2020

GSL

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

Fluticasone Propionate 250mcgGlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

(10mg/24hr)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

315 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 18 of 157

Page 19: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

316 BRU10040454NP ColimixTM Syrup

Per 5ml - Simethicone (activated

dimethicone) 50mg; dicylcomine HCl

5mg

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

317 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5%Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

318 BRU10040457P S2Co-Diovan 160/12.5mg

Tablets

Valsartan HCl 160mg;

Hydrochlorothiazide 12.5mgNovartis Pharma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

319 BRU10040459P Atenolol 50mg Tablet Atenolol 50mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

320 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

06 October 2015 till 05

October 2020POM

321 BRU10040461PCytarabine® Injection 1000mg

in 10mlCytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

tartrate)Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

323 BRU10050463PNebido 1000mg/4ml, Solution

for Injection

Testosterone undecanoate

250mg(equiv. to testosterone

157.9mg)

Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

324 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Delpharm Reims S.A.S., FranceHongkiat Trading &

Company

06 October 2020 till 05

October 2025P

325 BRU10050466NPUphamol Suspension 250

(Orange)Paracetamol 250mg/5ml

Upha Pharmaceuticals Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL (60mL); P

(3.8L)

326 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 Bhd06 October 2015 till 05

October 2020POM

327 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020GSL

328 BRU10050471PZyvox Infusion Bag

600mg/300mlLinezolid 600mg/300ml Fresenius Kabi Norge As, Norway Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

329 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

330 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

331 BRU10050475P Zyrtec® Oral Solution 1mg/ml Cetrizine diHCl 1mg/ml (0.1%) Aesica Pharmaceuticals S.r.L., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020P

332 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

333 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mgNovartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, TurkeyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

334 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

BDMCA/RMP/0719 Page 19 of 157

Page 20: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

335 BRU10050479PCozaar 100mg film-coated

tabletLosartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

336 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

337 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020P

338 BRU10060487P Asmol SyrupSalbutamol 2mg/5ml (as Sulphate

2.4mg)

Sunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

339 BRU10060489P Lescol XL Tablet 80mg Fluvastatin (as the sodium salt) 80mg Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

340 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

06 October 2015 till 05

October 2020POM

341 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mgNovartis Saglik Gida ve Tarim Urunleri

San. Ve Tic.A.S., Istanbul, TurkeyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

342 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg

Daiichi Sankyo Europe GmbH,

Germany; Pfizer Manufacturing

Deutschland GmbH, Germany

(primary and secondary packaging

site)

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

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

Australia.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

344 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France. Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

345 BRU10060496PStilnox 10mg film-coated

tabletZolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

346 BRU10060497P Hyosun syrupHyoscine-N-Butylbromide

(Scopolamine Butylbromide) 5mg/5ml

Sunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

347 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

348 BRU10060499P Exelon capsule 1.5mgRivastigmine 1.5mg (as hydrogen

tartrate 2.4mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

349 BRU10060500PSyntocinon 10IU solution for

injectionSynthetic Oxytocin 10IU/ml

Novartis Pharma Stein AG,

Switzerland Medipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

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

9.6mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

351 BRU10060502PZyvox film-coated tablet

600mgLinezolid 600mg

Pfizer Pharmaceuticals LLC, Puerto

Rico, United StatesZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

352 BRU10060504P Sifrol tablet 0.125mg

Pramipexole 0.088mg (eqv. to

Pramipexole dihydrochloride

monohydrate 0.125mg)

Boehringer Ingelheim Pharma GmbH

& Co. Germany

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 20 of 157

Page 21: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU10060505PMyfortic Gastro-Resistant

tablet 180mg

Mycophenolic Acid 180mg (as Sodium

Salt 192.4mg)

Novartis Pharma Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Pholcodine 4mg; Ephedrine HCl 7.2mg

Sanofi-Aventis Pakistan Limited,

PakistanMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

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

Australia.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

356 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020P

357 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020

GSL (6's) & P

(60's)

358 BRU10070511P Decondine TabletTripolidine HCl 2.5mg;

Pseudoephedrine HCl 60mg

Sunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

359 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mgSunward Pharmaceutical Pte. Ltd.,

Singapore G & H Trading Company

06 October 2015 till 05

October 2020POM

360BRU10070513P;

BRU10070513PS2 Desferal 500mg Desferrioxamine Methane Sulphonate

Novartis Pharma Stein AG,

Switzerland; Wasserburger

Arzneimittelwerk GmbH, Wasserburg

Germany

Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

361 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

362 BRU10070515P Zaricort CreamMiconazole Nitrate 2%w/w;

Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn Bhd,

Malaysia

Hongkiat Trading &

Company

06 October 2015 till 05

October 2020POM

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

KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

364 BRU10070517PSingulair® Chewable Tablet

5mgMontelukast (as sodium) 5mg

Merck Sharp & Dohme Ltd., United

KingdomZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

365 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2mlGlaxoSmithKline Manufacturing SpA.,

ItalyZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

366 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mgPharmacia & Upjohn Company,

Kalamazoo, USAZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

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

hydrogen tartrate 7.2mg)Novartis Farmaceutica S.A., Spain Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

368 BRU10070521PEpilim Chrono 500mg Scored

Film-coated Tablet

Sodium valproate 500mg (Sodium

valproate 333mg & Valproic acid

145mg)

Sanofi Winthrop Industries, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

369 BRU10070522PRitalin® Modified Release

Capsule 30mgMethylphenidate HCl 30mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 21 of 157

Page 22: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

Valsartan 160mg

Novartis Farmaceutica SA, Barbera

del Valles

(Barcelona) SpainZuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

371 BRU10080529P Nasacort Aqueous Nasal SprayTriamcinolone Acetonide

55mcg/actuationAventis Pharma UK Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

372 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

373 BRU10080531P Proctosedyl Suppositories

Chinchocaine 5mg; Framycetin

sulphate 10mg; Hydrocortisone 5mg;

Aesculin 10mg

PT Aventis Pharma, Indonesia Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

374 BRU10080532PProstin VR Paediatric® Sterile

Solution 500mcgAlprostadil 500mcg/ml Pharmacia & Upjohn Company, USA Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

375 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

376BRU10080534PS1;

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 Bhd06 October 2015 till 05

October 2020POM

377 BRU10080535PS2 Telfast-D Extended Release

Tablet

Fexofenadine hydrochloride 60mg ;

Pseudoephedrine HCl 120mg

Sanofi Winthrop Industrie, France

(S2)Medipharm Sdn Bhd

06 October 2020 till 05

October 2025POM

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

Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

379 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

380 BRU10090541PLanoxin Paediatric/ Geriatric

ElixirDigoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

381 BRU10090542PS2 Singulair Oral Granules 4mgMontelukast Sodium (free acid

equivalent) 4mgDSM Pharmaceuticals, Inc., USA (S2) Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

382 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd06 October 2020 till 05

October 2025POM

383 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mgMSD International GmbH (Singapore

Branch), Singapore (S2)Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

384 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

385 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

386 BRU10090548PSuprefact® 1mg/ml Injection

Solution

Buserelin 1.00mg/ml (as acetate

1.05mg)

Aventis-Pharma Deutshland GmbH,

GermanyMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

387 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

BDMCA/RMP/0719 Page 22 of 157

Page 23: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Zuellig Pharma (B) Sdn Bhd06 October 2015 till 05

October 2020POM

389 BRU10090551PZoladex LA Depot Injection

10.8mg

Goserelin Acetate equivalent to

Goserelin 10.8mgAstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

390 BRU10090552PHarnal OCAS 400mcg Film-

coated tablet

Tamsulosin (as hydrochloride 400mcg)

367mcg

Astellas Pharma Europe BV, The

NetherlandsMedipharm Sdn Bhd

06 October 2015 till 05

October 2020POM

391 BRU10090554P Proscar® Tablets 5mg Finasteride 5mgMSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd

06 October 2015 till 05

October 2020POM

392BRU10090555PS1;

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 Bhd06 October 2015 till 05

October 2020POM

393 BRU10100556PMyfortic Gastro-Resistant

tablet 360mgMycophenolic (as sodium) acid 360mg

Novartis Pharma Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

394 BRU10100559P Exelon® Capsule 3mgRivastigmine (as hydrogen tartrate)

3mgNovartis Farmaceutica S.A. Spain Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

395 BRU10100560PS2Arcoxia 60mg Film-coated

tabletEtoricoxib 60mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

396 BRU10100561P Proctosedyl Ointment

Cinchocaine hydrochloride 0.5%;

Framycetin sulphate 1.0%;

Hydrocortisone 0.5%; Aesculin 1.0%

Valeant Pharmaceuticals International

Inc, CanadaMedipharm Sdn Bhd

28 October 2020 till 27

October 2025POM

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

(9.5mg/24h)

LTS Lohmann Theraphie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

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

(4.6mg/24 hours)

LTS Lohmann Theraphie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

399 BRU10100564PATGAM® Sterile Solution

50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-

thymocyte globulin (equine)

250mg/5mL

Pharmacia & Upjohn Company LLC,

USAZuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

400BRU10100565PS1;

BRU10100565PS2Ezetrol 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 Bhd28 October 2015 till 27

October 2020POM

401 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

402 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mgSunward Pharmaceutical Pte Ltd,

Singapore G & H Traidng Company

28 October 2015 till 27

October 2020POM

403 BRU10100568PZithromax Powder For Oral

Suspension 200mg/5ml

Azithromycin (as dihydrate)

200mg/5mlHaupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

BDMCA/RMP/0719 Page 23 of 157

Page 24: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

404 BRU10100569PFosamax 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 Bhd28 October 2015 till 27

October 2020POM

405 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA Zuellig Pharma (B) Sdn Bhd28 October 2015 till 27

October 2020POM

406 BRU10100572P

Casprin Enteric

Microencapsulated Capsule

100mg

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

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

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

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

408 BRU10100576PAlbutein® Solution for Infusion

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

Hongkiat Trading &

Company

28 October 2015 till 27

October 2020POM

409 BRU10100577P RebetolTM 200mg Capsule Ribavirin 200mgMSD International GmbH (Puerto Rico

Branch) LLC., Puerto Rico, USA.Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

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

Malaysia.Asterix United (B) Sdn Bhd

28 October 2015 till 27

October 2020

P (100ml) & POM

(4L)

411 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mgMSD International GmbH (Singapore

Branch), Singapore (S2) Zuellig Pharma (B) Sdn Bhd

28 October 2015 till 27

October 2020POM

412 BRU10110581PS2 JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mgMerck Sharp & Dohme Ltd, England

(S2)Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

413 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Frosst Iberica S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

414 BRU10110584PZocor 20mg Film-coated

TabletSimvastatin 20mg

Merck Sharp & Dohme Ltd.,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

415 BRU10110585P Sifrol® Tablet 1mg

Pramipexole dihydrochloride

monohydrate 1mg (equivalent to

0.7mg pramipexole)

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company

24 November 2015 till 23

November 2020POM

416 BRU10110587PMetoclopramide Syrup

5mg/5ml

Metoclopramide hydrochloride

5mg/5ml

Sunward Pharmaceutical Pte Ltd,

Singapore G & H Traidng Company

24 November 2015 till 23

November 2020POM

417 BRU10110588NP Suntacid Tablet

Aluminium Hydroxide 250mg,

Magnesium Trisilicate 250mg,

Simethicone 30mg

Sunward Pharmaceutical Pte Ltd,

Singapore G & H Traidng Company

24 November 2015 till 23

November 2020GSL

418 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

419 BRU10110591PVoren Enteric Coated Tablet

25mgDiclofenac Sodium 25mg

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

MalaysiaAsterix United (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

420 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd24 November 2015 till 23

November 2020POM

421 BRU10110593PVoren Enteric Coated Tablet

50mgDiclofenac Sodium 50mg

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

MalaysiaAsterix United (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

BDMCA/RMP/0719 Page 24 of 157

Page 25: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

422 BRU10110596PBeconase™ Aqueous Nasal

Spray

Beclomethasone Dipropionate (as

monohydrate)Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

423 BRU10110597P Campto 40mg/2ml InjectionIrinotecan hydrochloride trihydrate

40mg/2mlPfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd

24 November 2015 till 23

November 2020POM

424 BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mgMerck Sharp & Dohme Ltd, England

(S2)Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

425 BRU10120600PRitalin® LA Modified Release

Capsule 40mgMethylphenidate hydrochloride 40mg Recro Gainsville LLC, USA Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

426 BRU10120602POrgalutron Solution for

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

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

427 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05%PT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020P

428 BRU10120605P Clarityne Tablet 10mg Loratadine 10mgPT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020P

429 BRU10120606P Frotin Pessaries Metronidazole 250mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

430 BRU10120607P Allopurinol Tablet 300mg Allopurinol 300mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

431 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mgAstellas Pharma Europe B.V., The

NetherlandsMedipharm Sdn Bhd

29 December 2015 till 28

December 2020POM

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

MalaysiaAsterix United (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

433 BRU10120612PFlixonase Aqueous Nasal

Spray 0.05%

Fluticasone propionate (micronised)

50mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

434BRU10120613PS1;

BRU10120613PS2

Esmeron® Injection 50mg/5ml

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

N.V. Organon, The Netherlands;

Hameln Pharmaceuticals GmbH,

Germany

Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28

December 2020POM

435 BRU10120615PFlixotideTM EvohalerTM

125mcgFluticasone propionate 125mcg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

436 BRU10120616PLevitra® film-coated Tablet

5mg

Vardenafil 5mg (as monohydrochloride

trihydrate)Bayer AG., Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

29 December 2015 till 28

December 2020POM

437 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd29 December 2015 till 28

December 2020POM

438 BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as phosphate) 100mgMerck Sharp & Dohme Ltd, England

(S2)Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

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

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

440 BRU11010623P Allopurinol Tablet 100mg Allopurinol 100mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

441 BRU11010624P Elomet Ointment 0.1%Mometasone Furoate (as Anhydrous)

USP 0.1%

PT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

BDMCA/RMP/0719 Page 25 of 157

Page 26: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

68mgN.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021

P (10 x 10's), P

(100x10's &

3,000's)

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

Annunziata, ItalyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

445 BRU11010628POxy-Nase Paediatric Nasal

Spray 0.025%Oxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

26 January 2016 till 25

January 2021P

446 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25

January 2021POM

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

Annunziata, ItalyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

448 BRU11010632P Comtan® Tablet 200mg Entacapone 200mg Orion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd26 January 2016 till 25

January 2021POM

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

150mg/10mlAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

450 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021P

451 BRU11010637PEngerixTM-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 2021POM

452

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 2021POM

453 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 Bhd26 January 2016 till 25

January 2021POM

454 BRU11010640P Microgynon® 30 TabletLevonorgestrel 0.15mg,

Ethinylestradiol 0.03mg

Bayer Weimar GmbH und Co., KG,

GermanyZuellig Pharma (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

26 January 2016 till 25

January 2021POM

456 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

457 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

BDMCA/RMP/0719 Page 26 of 157

Page 27: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

458 BRU11020645P OroxineTM Tablet 100mcgLevothyroxine (as sodium) anhydrous

100mcgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

459 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France Zuellig Pharma (B) Sdn Bhd24 February 2016 till 23

February 2021POM

460 BRU11020648PGlivec® 100mg Film-coated

TabletImatinib (as mesylate) 100mg

Novartis Pharma Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

461 BRU11020649PSandostatin® Ampoules

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

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

462 BRU11020650PLevitra® film-coated Tablet

20mg

Vardenafil (as monochloride trihydrate)

20mg

Bayer Pharma AG., Leverkusen,

GermanyZuellig Pharma (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

463 BRU11020652PUrosin® Film-coated Tablet

50mgAtenolol 50mg

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

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

464 BRU11020653PIbuprofen Film-coated Tablet

400mgIbuprofen 400mg

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

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021P

465 BRU11020655P Voren GelDiclofenac Sodium 10mg/g (as

Diclofenac Acid Diethylamine)

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

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021GSL

466 BRU11020656PAtacor 20mg Film-coated

TabletsAtorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd

24 February 2016 till 23

February 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

24 February 2016 till 23

February 2021POM

468 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05%HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

26 March 2016 till 25

March 2021P

469 BRU11030662PFucon Film Coated Tablet

10mgHysocine-n-butylbromide 10mg

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

MalaysiaAsterix United (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

470 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

471 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

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

Pseudoephedrine Sulphate 60mg

Sanofi Aventis Argentina S.A.,

ArgentinaZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021P

BDMCA/RMP/0719 Page 27 of 157

Page 28: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

473 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, FranceZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

474BRU11030669PS1;

BRU11030669PS2

Caelyx 2mg/ml Concentrate

for InfusionDoxorubicin HCl 2mg/ml

Alza Corporation, USA (S1);

GlaxoSmithKline Manufacturing

S.P.A., Italy (S2)

Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

475 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

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

Hydrochlorothiazide 25mgMerck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

477 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mgGlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

26 March 2016 till 25

March 2021POM

478 BRU11030673PTopistin® Solution for IV

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

Elpen Pharmaceutical Co., Inc.,

Greece.G & H Trading Company

26 March 2016 till 25

March 2021POM

479 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Glaxo Wellcome Production, France Zuellig Pharma (B) Sdn Bhd26 March 2016 till 25

March 2021POM

480 BRU11040675PPuregon® 600iu/0.72ml

Solution for Injection

Recombinant follicle-stimulating

hormone (FSH) (follitrophin beta) [Org

32489] 600iu/0.72ml

Vetter Pharma-Fertigung GmbH & Co.

KG., Mooswiesen, Revensburg,

Germany and Vetter Pharma-

Fertigung GmbH & Co. KG.,

Schutzenstrasse, Ravensburg,

Germany

Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April

2021POM

481BRU11040676PS1;

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 Bhd30 April 2016 till 29 April

2021POM

BDMCA/RMP/0719 Page 28 of 157

Page 29: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

482 BRU11040678PEuvax B Adult Vaccine

RecombinantPurified HBs-Ag 20mcg LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

483 BRU11040679PTrandateTM Injection 5mg/ml x

5mlLabetalol HCl 25mg/5ml

Hsinchu Plant of UBI Pharma Inc.,

TaiwanZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

484 BRU11040680PS2 Puregon® 50IU/0.5ml Solution

for Injection

Follitrophin Beta (recombinant follicale-

stimulating hormone (FSH) 50IU/0.5mlN.V.Organon, The Netherlands (S2) Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

485 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/vHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 April 2016 till 29 April

2021P

486 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

30 April 2016 till 29 April

2021POM

487 BRU11040683PSandostatin® LAR® Injection

10mgOctreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

488 BRU11040684PVfend TM Film-Coated Tablets

200mgVoriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

490 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

492 BRU11040690PEngerixTM-B Paediatric Vaccine

10mcg/0.5mlPurified HBs-Ag 10mcg

GlaxoSmithKline Biologicals SA.,

Rixensart Belgium; GlaxoSmithKline

Biologicals S.A., Wavre

Belgium

Zuellig Pharma (B) Sdn Bhd30 April 2016 till 29 April

2021POM

493 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 April 2016 till 29 April

2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

495 BRU11040694PStalevo® 100/25/200mg Film-

coated Tablet

Levodopa 100mg; Carbidopa 25mg;

Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

496 BRU11040695PRevoladeTM Film-coated

Tablet 25mg

Eltrombopag 25mg [as free acid] (as

olamine)

Glaxo Operations UK Ltd (trading as

Glaxo Wellcome Operations), UKZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

497 BRU11040696PCoversyl® Film-coated Tablet

10mg

Perindopril arginine 10mg (equiv to

perindopril 6.790mg)

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

30 April 2016 till 29 April

2021POM

498 BRU11040697PAtorvastatin Winthrop® 20mg

Film-coated Tablet

Atorvastatin 20mg (as calcium

20.68mg)

Saneca Pharmaceuticals a.s., Slovak

Republic Medipharm Sdn Bhd30 April 2016 till 29 April

2021POM

BDMCA/RMP/0719 Page 29 of 157

Page 30: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

499 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised)

27.5µg /spray

Glaxo Operations UK Ltd, United

KingdomZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

500BRU11050700PS1;

BRU11050700PS2Tetraxim 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 Bhd25 May 2016 till 24 May

2021POM

501 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mgPfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

502 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

25 May 2016 till 24 May

2021POM

503 BRU11050703PLevitra Film-coated Tablets

10mg

Vardenafil (as monohydrochloride

trihydrate) 10mgBayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

504 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mgUpha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

25 May 2016 till 24 May

2021 P (5 x 50's)

505 BRU11050706PZofran Injection Flexi-Amp

AmpoulesOndansetron HCl Dihydrate 8mg/4ml

GlaxoSmithKline Australia Pty Ltd.m

AustraliaZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

506 BRU11050707PCaverject 20mcg Powder and

solvent for injectionAlprostadil 20µg

Pfizer Manufacturing Belgium N.V.,

BelgiumZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

507 BRU11050708NP Essentiale Forte N Capsule

Phospholipids fatty mass 392mg

(equivalent to 300mg phospholipids

from soya beans containing 76% of (3-

sn-phosphatidyl) choline)

A. Nattermann & Cie. GmbH.,

GermanyMedipharm Sdn Bhd

25 May 2016 till 24 May

2021GSL (50's)

508 BRU11050710P Coveram Tablets 5mg/5mg

Perindopril arginine 5mg (equiv. to

perindopril 3.395mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

509 BRU11050712PTracrium Injection

25mg/2.5mlAtracurium besylate 25mg/2.5ml

GlaxoSmithKline Manufactuirng

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

25 May 2016 till 24 May

2021POM

510 BRU11060715POxy-Nase Paediatric Nasal

Drop 0.025%w/vOxymetazoline HCl 0.025%

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

02 July 2016 till 01 July

2021POM

511 BRU11060716PVfend 50mg film-coated

TabletVoriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

512 BRU11060717P Protaxos 2g Strontium Ranelate 2632mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

513 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH & Co. KG, Germany Zuellig Pharma (B) Sdn Bhd02 July 2016 till 01 July

2021POM

BDMCA/RMP/0719 Page 30 of 157

Page 31: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

MalaysiaAsterix United (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

515 BRU11060721PAtorvastatin Winthrop® 40mg

Tablet

Atorvastatin 40mg (as Calcium

41.36mg)

Saneca Pharmaceuticals a.s., Slovak

Republic Medipharm Sdn Bhd02 July 2016 till 01 July

2021POM

516 BRU11060722P Propecia 1mg Tablet Finasteride 1mgMerck Sharp & Dohme, Puerto Rico,

USAZuellig Pharma (B) Sdn Bhd

02 July 2016 till 01 July

2021POM

517 BRU11060723PSeroquel 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

2021POM

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

NetherlandsMedipharm Sdn Bhd

27 July 2016 till 26 July

2021POM

519 BRU11070727P SW Bena-Expectorant

Per 5ml: Diphenhydramine HCl 10mg,

Ammonium Chloride 102mg, Sodium

Citrate 46mg

Sunward Pharmaceutical Pte Ltd.,

SingaporeG&H Trading Company

27 July 2016 till 26 July

2021POM

520 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; GSK Biologicals’ Marietta site

Corixa Corporation dba GSK

Biologicals North America, Marietta

Pennsylvania USA

Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July

2021POM

521 BRU11070730PMirena® Intrauterine System

20mcg/24hrLevonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

522BRU11070732PS1;

BRU11070732PS2Zoral 400 Tablet 400mg Acyclovir USP 400mg

Drug House of Australia Pte Ltd.,

Singapore (S1); PT Actavis Indonesia,

Jakarta, Indoensia (S2)

G & H Trading Company27 July 2016 till 26 July

2021

POM (7 x 10’s

blister pack);

(10 x 10 x 10’s

blister pack - for

DHA only)

523 BRU11070733P ZofranTM Injection 4mg/2mlOndansetron 4mg/5ml (as HCl

dihydrate)

GlaxoSmithKline Australia Pty Ltd.,

AustraliaZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

524 BRU11070734PSyntometrine® Injection

5IU/ml AmpouleOxytocin 5IU/ml

Novartis Pharma Steing AG.,

SwitzerlandMedipharm Sdn Bhd

27 July 2016 till 26 July

2021POM

525 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/wHOE Pharmaceuticals Sdn Bhd.,

MalaysiaG & H Trading Company

27 July 2016 till 26 July

2021POM

526 BRU11070736P Coveram 5/10mg Tablet

Perindopril arginine 5mg (equiv. to

3.395mg perindopril) and amlodipine

10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd,

IrelandZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

BDMCA/RMP/0719 Page 31 of 157

Page 32: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

527 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July

2021POM

528BRU11070738PS1;

BRU11070738PS2 Diamicron® MR 60mg Tablet Gliclazide 60mg

Les Laboratoires Servier Industrie,

France (S1); Kotra Pharma (M) Sdn.

Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd27 July 2016 till 26 July

2021POM

529 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5mlGlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

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

FranceZuellig Pharma (B) Sdn Bhd

27 July 2016 till 26 July

2021POM

531BRU11080742P;

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 Bhd25 August 2016 till 24

August 2021POM

532 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

533 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

534 BRU11080745PGlivec® 400mg Film-coated

TabletImatinib (as mesylate) 400mg

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

535 BRU11080746PStalevo 50/12.5/200mg film-

coated tablet

Levodopa 50mg, Carbidopa 12.5mg,

Entacapone 200mgOrion Corporation, Espoo, Finland Zuellig Pharma (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

536

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 S.p.A., Localita

Valcanello, 03012 Anagni (FR), Italy

(S3).

Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

537 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd25 August 2016 till 24

August 2021POM

538 BRU11080749P Econazine CreamEconazole nitrate 1% w/w,

Triamcinolone actonide 0.1% w/w

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

539 BRU11080750PFrotin Film Coated 200mg

Tablet Metronidazole 200mg

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

540 BRU11080751PUrosin Film Coated Tablet

100mgAtenolol 100mg

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

BDMCA/RMP/0719 Page 32 of 157

Page 33: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

541 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 Bhd25 August 2016 till 24

August 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

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

25mgSanofi Winthrop Industrie, France Medipharm Sdn Bhd

25 August 2016 till 24

August 2021POM

544 BRU11080757P Orphenadol® TabletOrphenadrine Citrate 50mg,

Paracetamol 325mg

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

25 August 2016 till 24

August 2021POM

548 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

27 September 2016 till 26

September 2021POM

BDMCA/RMP/0719 Page 33 of 157

Page 34: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

549 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 Bhd27 September 2016 till 26

September 2021POM

550 BRU11090764P

Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(10ml)

Oxaliplatin 50mg/10mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

27 September 2016 till 26

September 2021POM

551 BRU11090765P

Eloxatin 5mg/ml Concentrate

for Solution for Infusion

(20ml)

Oxaliplatin 100mg/20mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

27 September 2016 till 26

September 2021POM

552 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 Bhd27 September 2016 till 26

September 2021POM

553 BRU11090767PSandimmun Neoral® Oral

Solution 100mg/mlCiclosporin A 100mg/ml Novartis Pharma S.A.S., France Zuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

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

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

555 BRU11090769PHyzaar® Plus Tablet

100/12.5mg

Losartan Potassium 100mg,

Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme,

Northumberland, UKZuellig Pharma (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

BDMCA/RMP/0719 Page 34 of 157

Page 35: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

556 BRU11090770PFlebogamma 5% DIF Solution

for Infusion (100mL)

Human Normal Immunoglobulin

50mg/ml

Instituo Grifols S.A., Barcelona, Spain;

Grifols Biologicals LLC (GBLLC), USA

(alternative site for the preparation of

Fraction II + III)

Hongkiat Trading &

Company

27 September 2016 till 26

September 2021POM

557 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26

September 2021POM

558 BRU11090772PDiabetmin Film-coated Tablet

500mgMetformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company

27 September 2016 till 26

September 2021

POM (10 x 10's; 5

x 20's)

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

11.9mg/g)

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

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

560 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd27 September 2016 till 26

September 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

27 September 2016 till 26

September 2021POM

563 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company27 September 2016 till 26

September 2021POM

564 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mgBushu Pharmaceuticals Ltd, Japan. ,

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

565 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mgBushu Pharmaceuticals Ltd, Japan. ,

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

566 BRU11100781PS2Puregon® 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 Bhd31 October 2016 till 30

October 2021POM

567 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 Bhd31 October 2016 till 30

October 2021POM

568 BRU11100784PSandostatin® ampoules

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

Novartis Pharma Stein A.G.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

569 BRU11100785PAtorvastatin Winthrop® 10mg

film-coated Tablets

Atorvastatin 10mg (as calsium

10.34mg)

Saneca Pharmaceuticals a.s., Slovak

RepublicMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

570 BRU11100786PStalevo® 150/37.5/200mg

Film-coated Tablet

Levodopa 150mg; Carbidopa 37.5mg;

Entacapone 200mgOrion Corporation Fermion, Finland Zuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

571 BRU11100787P Coveram Tablet 10mg/5mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine 5mg

(as besilate 6.935mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

572 BRU11100788PCoversyl® Fim-coated Tablet

5mg

Perindopril arginine 5mg (eqv.

Perindopril 3.395mg)

Les Laboratoires Servier Industrie,

Gidy, FranceZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

BDMCA/RMP/0719 Page 35 of 157

Page 36: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

JapanMediPharm Sdn Bhd

31 October 2016 till 30

October 2021POM

574

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

575 BRU11100791P Coveram Tablet 10mg/10mg

Perindopril arginine 10mg (eqv. To

Perindopril 6.790mg); Amlodipine

10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd.,

IrelandZuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

576 BRU11100792PVoker Film Coated Tablet

20mgFamotidine 20mg

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

MalaysiaAsterix United (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

577 BRU11100794P Clarinase RepetabsLoratadine 5mg, Pseudoephedrine

sulphate 120mgSchering Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd

31 October 2016 till 30

October 2021POM

578 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30

October 2021POM

579 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd31 October 2016 till 30

October 2021POM

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

2.79mg)

Bristol-Myers Squibb Company,

Indiana, USAZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

BDMCA/RMP/0719 Page 36 of 157

Page 37: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

5.58mg)

Bristol-Myers Squibb Company,

Indiana, USAZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

582 BRU11110799PSandostatin® LAR® Injection

20mgOctreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

583 BRU11110800PSandostatin® LAR® Injection

30mgOctreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

584 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 Bhd24 November 2016 till 23

November 2021POM

585 BRU11110803PNexavar® 200mg Film-coated

TabletsSorafenib Tosylate 200mg

Bayer AG., Leverkusen, Germany;

Bayer Healthcare Manufacturing S.r.l.,

Italy

Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23

November 2021POM

586 BRU11110804PPEG Intron CLEARCLICK for

Injection 150mcg/0.5ml

Recombinant interferon alfa-2b

150mcg (pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

587 BRU11110805PPEG 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 Bhd24 November 2016 till 23

November 2021POM

588 BRU11110806PPEG Intron CLEARCLICK for

Injection 100mcg/0.5ml

Recombinant interferon alfa-2b

100mcg (pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

589 BRU11110807PPEG Intron CLEARCLICK for

Injection 80mcg/0.5ml

Recombinant interferon alfa-2b 80mcg

(pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

590 BRU11110808PPEG Intron CLEARCLICK for

Injection 50mcg/0.5ml

Recombinant interferon alfa-2b 50mcg

(pegylated to monoethoxy

polyethylene glycol)

MSD International GmbH (Singapore

Branch), Singapore SingaporeZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

591 BRU11110809PDalacin CTM Sterile Solution

150mg/ml x 2ml ampouleClindamycin Phosphate 300mg

Pfizer Manufacturing Belgium N.V.,

Puurs, BelgiumZuellig Pharma (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

592 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany Zuellig Pharma (B) Sdn Bhd24 November 2016 till 23

November 2021POM

593 BRU11110813PKetipinor Film-coated Tablet

200mg

Quetiapine 200mg (as fumarate

230.36mg)Orion Corporation, Espoo, Finland

Hongkiat Trading &

Company

24 November 2016 till 23

November 2021POM

594 BRU11110814P Prednisolone Tablet 5mg Prednisolone 5mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 November 2016 till 23

November 2021POM

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

(equiv. to 263 mcg)/ vialSanofi Winthrop Industrie, France MediPharm Sdn Bhd

24 November 2016 till 23

November 2021POM

BDMCA/RMP/0719 Page 37 of 157

Page 38: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

596 BRU11120816PEuvax 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 2021POM

597 BRU11120817PPuregon® 300IU/0.36 ml

Solution for Injection

Recombinant follicle-stimulating

hormone (FSH) (follitrophin beta) [Org

32489] 600iu/0.72ml

Vetter Pharm-Fertigung GmbH & Co.

KG., Schutzenstrasse, Ravensburg,

Germany: Vetter Pharm-Fertigung

GmbH & Co. KG., Mooswiesen,

Ravensburg, Germany; Vetter

Pharma-Fertigung GmbH & Co. KG,

Eisenbahnstrasse, Langenargen,

Germany and Vetter Pharma-

Fertigung GmbH & Co. KG,

Holbeinstrassee, Ravensburg

Germany

Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21

December 2021POM

598 BRU11120818P Clarityn Syrup Loratadine 1mg/mlPT. Merck Sharp Dohme Pharma Tbk,

IndonesiaZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021P

BDMCA/RMP/0719 Page 38 of 157

Page 39: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

599

BRU11120819P0.5gV

&

BRU11120819P0.5gSSynflorixTM 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

conjugated to diphtheria toxoid carrier

protein - 3-6mcg

GlaxoSmithKline Biologicals SA,

Rixensart Belgium; Glaxo SmithKline

Biologicals SA, Saint-Amand-Les-Eaux

France

Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21

December 2021POM

600 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg)

100mcgGlaxo Wellcome S.A., Burgos, Spain Zuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

601 BRU11120822PRevoladeTM Film-coated

Tablets 50mg

Eltrombopag olamine (eq. to

Eltrombopag 50mg as Eltrombopag

free acid)

Glaxo Operations UK Ltd (trading as

Glaxo Wellcome Operations) United

Kingdom

Zuellig Pharma (B) Sdn Bhd22 December 2016 till 21

December 2021POM

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

3.395mg); Indapamide 1.25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

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

0.03mg

Bayer Weimar GmbH und Co. KG

(WEIMAR PLANT), GermanyZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

BDMCA/RMP/0719 Page 39 of 157

Page 40: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

604 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mgLes Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

22 December 2016 till 21

December 2021GSL

605BRU11120827P;

BRU11120827PS2

Methycobal Injection

500mcg/mlMecobalamin 500mcg

Bushu Pharmaceuticals Ltd, Japan;

Nipro Pharma Corporation Ise Plant,

Matsusaka-shi, Mie, Japan (S2)

MediPharm Sdn Bhd22 December 2016 till 21

December 2021POM

606 BRU11120828PFlebogamma® 5% DIF Solution

for Infusion (200ml)

Human Normal Immunoglobulin

10g/200mL (50mg/ml)

Instituto Grifols, S.A., Spain; Grifols

Biologicals LLC (GBLLC), USA

(alternative site for the preparation of

Fraction II + III).

Hongkiat Trading22 December 2016 till 21

December 2021POM

607 BRU11120829P Shintamet film coated Tablet Cimetidine 400mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

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

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021GSL

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

MalaysiaAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

610 BRU11120832P Clopivid Tablet 75mgClopidogrel 75mg (as hydrogen

sulphate 97.90mg)Hovid Bhd, Malaysia G & H Trading Company

22 December 2016 till 21

December 2021POM

611 BRU11120833PShincort Injection “Yung Shin”

10mg/mlTriamcinolone Acetonide 50mg/5ml

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan ROCAsterix United (B) Sdn Bhd

22 December 2016 till 21

December 2021POM

612 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company22 December 2016 till 21

December 2021POM

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

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

December 2021POM

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

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

December 2021POM

615 BRU11120837PPrimacor® 10mg/10ml

InjectionMilrinone 10mg/10ml (as lactate) Delpharm Dijon, France MediPharm Sdn Bhd

22 December 2016 till 21

December 2021POM

616 BRU11120838NPChamps D-Worms 6 Chewable

Tablet (Chocolate)Albendazole 200mg

Upha Pharmaceutical Mfg (M) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

22 December 2016 till 21

December 2021GSL (2's)

617 BRU11120839PEpilim® 200 Enteric Coated

TabletsSodium Valproate 200mg Sanofi-Aventis S.A., Spain MediPharm Sdn Bhd

22 December 2016 till 21

December 2021POM

BDMCA/RMP/0719 Page 40 of 157

Page 41: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

618 BRU12010840PInfanrixTM-IPV+Hib Vaccine

(DTPa-IPV+Hib)

1 dose (0.5ml) contains: Diphteria

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

(TT) Min 40 I.U.; Pertussis toxoid (PT)

Min 25mcg; Filamentous

haemagglutinin (FHA) 25mcg; Pertactin

(69Kda Outer membrance protein)

8mcg; Inactivated Polio Virus Type 1

(Mahoney seed) 40DU; Inactivated

Polio Virus Type 2 (MEF-1 seed) 8DU;

Inactivated Polio Virus Type 3 (Saukett

seed) 32DU; Conjugate of purified

capsular polysaccharide (10mcg) of

Haemophilus influenza type b

covalently bound to approximately

30mcg to 50 mcg tetanus toxoid

GlaxoSmithKline Biologicals SA,

Rixensart Belgium; GlaxoSmithkline

Biologicals S.A., France

Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

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

Rico, USAZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

620 BRU12010842PValdoxan® 25mg film-coated

tabletAgomelatine 25mg

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

621 BRU12010843P Zofran Tablet 4mgOndansetron (as Hydrochloride

Dihydrate) 4mgAspen Bad Oldesloe GmbH, Germany Zuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

622 BRU12010844PFlebogamma® 5% DIF Solution

for Infusion (50ml)

Human Normal Immunoglobulin

2.5g/50mL (50mg/ml)

Instituto Grifols, S.A., Spain; Grifols

Biologicals LLC (GBLLC), USA

(alternative site for the preparation of

Fraction II + III).

Hongkiat Trading & Co 01 February 2017 till 31

January 2022POM

623 BRU12010845P Coralan® Tablet 5mgIvabradine 5mg eq. to 5.39mg

ivabradine hydrochloride

Les Laboratoires Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

624 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

625 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

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

MalaysiaAsterix United (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

627 BRU12010851NP Princi-B Fort® tablet

Thiamin mononitrate 250mg,

Pyridoxine hydrochloride 250mg &

Cyanocobalamin 1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd01 February 2017 till 31

January 2022P

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

MalaysiaAsterix United (B) Sdn Bhd

01 February 2017 till 31

January 2022GSL

629 BRU12010853P Concor® 5mg tabletBisoprolol hemifumarate 5mg

Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd01 February 2017 till 31

January 2022POM

BDMCA/RMP/0719 Page 41 of 157

Page 42: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

630 BRU12010854PKetipinor film-coated tablet

100mg

Quetiapine (as fumarate 115.13mg)

100mgOrion Corporation, Finland Hongkiat Trading & Co

01 February 2017 till 31

January 2022 POM

631 BRU12010855P Euthyrox® Tablet 50mcgLevothyroxine sodium 50mcg

Merck KGaA, Germany; Merck S.A. de

C.V., Mexico (packaging/labelling) Zuellig Pharma (B) Sdn Bhd

01 February 2017 till 31

January 2022POM

632 BRU12010856NPPanadol Suspension

250mg/5mlParacetamol 250mg/5ml

Smithkline Beecham, Philippines;

Kuehne+Nagal Sdn Bhd, Selangor,

Malaysia (secondary repacker)

Kingston Beverage &

Creamery Sdn Bhd

01 February 2017 till 31

January 2022

GSL

(60ml/120ml)

633 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Sanofi S.p.A, Italy MediPharm Sdn Bhd01 February 2017 till 31

January 2022POM

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

SwitzerlandZuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

635 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

636 BRU12020862PKetipinor Film-coated Tablet

25mg

Quetiapine (as fumarate 28.78mg)

25mgOrion Corporation, Finland Hongkiat Trading & Co

1 March 2017 till 28

February 2022 POM

637 BRU12020863P

Taxotere 20mg/1ml

concentrate for solution for

infusion

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

GermanyMediPharm Sdn Bhd

1 March 2017 till 28

February 2022 POM

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

to 9.4mg Lercanidipine)

Recordati Industria Chimica &

Farmaceutica S.p.A, ItalyZuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

639 BRU12020865PS1 Nifedipine LA Tablet 30mg Nifedipine 30mgValpharma International S.p.A, Italy

(S1)G & H Trading Company

1 March 2017 till 28

February 2022 POM

640 BRU12020866P

Apidra® Solostar®

100units/ml, Solution for

Injection in a Pre-filled Pen

Insulin Glulisine 100units/mlSanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd

1 March 2017 till 28

February 2022 POM

641 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28

February 2022 POM

642 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 Bhd1 March 2017 till 28

February 2022 POM

643 BRU12020869P Dermovate™ Cream Clobetasol (as propionate) 0.05% w/w Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd1 March 2017 till 28

February 2022 POM

644 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

1 March 2017 till 28

February 2022 POM

645 BRU12030871NP Panadol® Menstrual CapletParacetamol 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)

646 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

BDMCA/RMP/0719 Page 42 of 157

Page 43: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

647 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29

March 2022 POM

648 BRU12030875P DetrusitolTM SR Capsule 4mgTolterodine 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

649 BRU12030876NPEllgy Corns & Warts

Treatment SolutionSalicylic acid 17%w/v

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

30 March 2017 till 29

March 2022 GSL

650 BRU12030877PPuregon® 900IU/1.08ml

Solution for Injection

Follitropin Beta (Recombinant follicle-

stimulating hormone FSH) [Org 32489]

Vetter Pharma-Fertigung GmbH & Co.

KG., Schutzenstrasse, Ravensburg,

Germany; Vetter Pharma-Fertigung

GmbH & Co. KG., Mooswiesn2,

Ravensburg, Germany; Vetter Pharma-

Fertigung GmbH & Co. KG.,

Eisenbahnstrasse, Langenargen,

Germany; Vetter Pharma-Fertigung

GmbH & Co. KG., Holbeinstrasse,

Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd30 March 2017 till 29

March 2022 POM

651 BRU12030879PMethotrexate Injection BP

50mg in 2mlMethotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia Zuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

652 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

653 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mgPfizer Pharmaceuticals LLC., vega Baja

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

654 BRU12030882PCancidas Powder for Injection

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

Laboratoires Merck Sharp & Dohme

Chibret, FranceZuellig Pharma (B) Sdn Bhd

30 March 2017 till 29

March 2022 POM

655 BRU12030883P Axcel Dextrozine Syrup

Dextromethorphan Hydrobromide

15mg/5ml; Promethazine HCl

3.6mg/5ml

Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd

30 March 2017 till 29

March 2022 POM

656 BRU12040884PDilantin Steri Vials 250mg in

5mlPhenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022 POM

657 BRU12040885P

Jevtana® 60mg Concentrate

and Solvent for Solution for

Infusion

Cabazitaxel 60mg/1.5mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

30 April 2017 till 29 April

2022 POM

658 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022POM

659 BRU12040887NPPanadol Suspension

120mg/5mlParacetamol 120mg/5ml

SmithKline Beecham, Cainta Rizal,

Philippines

Kingston Beverage &

Creamey Sdn Bhd

30 April 2017 till 29 April

2022

GSL (60ml

& 120ml)

660 BRU12040888PCancidas Powder for Injection

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

Laboratoires Merck Sharp & Dohme

Chibret, FranceZuellig Pharma (B) Sdn Bhd

30 April 2017 till 29 April

2022 POM

BDMCA/RMP/0719 Page 43 of 157

Page 44: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

661BRU12040889PS1 &

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 Bhd30 April 2017 till 29 April

2022 POM

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

Ephedrine HCl 6mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

663 BRU12040892NPAxcel 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)

664 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

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

Pseudoephedrine HCl 30mg/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

666 BRU12040895PAxcel Lignocaine Sterile Gel

2%w/w

Lignocaine HCl (Equiv. to anhydrous

HCl) 2g/100gKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April

2022POM

667 BRU12050897P VfendTM IV 200mg Voriconazole 200mgPharmacia & Upjohn Company, USA

(Repacker - Fareva Amboise, France)Zuellig Pharma (B) Sdn Bhd

24 May 2017 till 23 May

2022 POM

668 BRU12050898PLamictal Dispersible Tablet

5mgLamotrigine 5mg

GlaxoSmithKline Pharmaceuticals SA.,

Poznan, Poland (Repacker -

GlaxoSmithKline Australia Pty Ltd.,

ViCtoria, Australia)

Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022 POM

669 BRU12050899PHycamtinTM Hard Capsule

0.25mgTopotecan 0.25mg (as hydrochloride)

GlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

24 May 2017 till 23 May

2022POM

670 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022POM

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

SpainMc Quipp Technisell

Marketing Sdn Bhd

24 May 2017 till 23 May

2022P

672 BRU12050902P AeriusTM Tablets 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium Zuellig Pharma (B) Sdn Bhd24 May 2017 till 23 May

2022POM

673 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)

674 BRU12050904PVaxcel Heparin Sodium

Injection 5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa)

25,000/5mlKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 24 May 2017 till 23 May

2022POM

675 BRU12050905PPregnyl® 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 Bhd24 May 2017 till 23 May

2022POM

676 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan Medipharm Sdn Bhd30 June 2017 till 29 June

2022 GSL

BDMCA/RMP/0719 Page 44 of 157

Page 45: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

677 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mgPfizer Manufacturing Deutschland

GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

678 BRU12060910NPPanadol® Soluble Tablet

500mgParacetamol 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)

679 BRU12060911NPPanadol For Children Tablets

120mgParacetamol 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)

680 BRU12060912PCanesten GYN 1 Day Therapy

Vaginal Tablet 0.5gClotrimazole 500mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

681 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mgCorden Pharma GmbH, Plankstadt,

GermanyZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

682 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)

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

Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte Ltd,

Singapore

Hongkiat Trading &

Company

30 June 2017 till 29 June

2022 GSL

684 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mgPfizer Ireland Pharmacueticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

30 June 2017 till 29 June

2022 POM

685 BRU12070918PBeclomet Nasal Aqua

50mcg/dose Nasal Spray

Beclomethasone dipropionate

50mcg/doseOrion Corporation, Kuopio, Finland

Hongkiat Trading &

Company

30 July 2017 till 29 July

2022 POM

686 BRU12070920NPPanadol® Biconvex Film-

coated Tablet 500mgParacetamol 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)

687 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

688 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

689 BRU12070923PCoversyl Plus 10mg/2.5mg

Tablet

Perindopril arginine 10mg (equiv. to

6.79mg perindopril); Indapamide

2.5mg

Servier (Ireland) Industries Ltd,

IrelandZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022POM

BDMCA/RMP/0719 Page 45 of 157

Page 46: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

690 BRU12070924P RotarixTM oral SuspensionHuman rotavirus RIX4414 strain, not

less than 106.0 CCID50

GlaxoSmithKline Biological SA,

Belgium (Manufacturer of finished

products); GlaxoSmithKline

Biologicals S.A.,Wavre, Belgium

(Additional facility for formulation&

filling)

Zuellig Pharma (B) Sdn Bhd30 July 2017 till 29 July

2022POM

691 BRU12070925P CutivateTM CreamFluticasone propionate (micronised)

0.05%w/wGlaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022POM

692 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/wGP Genzech Produktions GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

30 July 2017 till 29 July

2022GSL

693 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 July 2017 till 29 July

2022POM

694 BRU12070928PSevoflurane 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

2022POM

695 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mgPfizer Ireland Pharmaceuticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

29 August 2017 till 28

August 2022 POM

696 BRU12090933PXarelto® Film-coated Tablet

10mgRivaroxaban 10mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

27 September 2017 till 26

September 2022 POM

697 BRU12090937PTelfast 6mg/ml Oral

SuspensionFexofenadine Hydrochloride 6mg/ml

Sanofi-Aventis Farmceutica Ltd, Vila

Areiao Suzano-SP-BrasilMedipharm Sdn Bhd

27 September 2017 till 26

September 2022 POM

698 BRU12090938PGlucophage® XR 750mg

Extended Release TabletMetformin HCl 750mg

Merck KGaA, Germany; Merck Sante

SAS, Semoy, FranceZuellig Pharma (B) Sdn Bhd

27 September 2017 till 26

September 2022 POM

699 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd27 September 2017 till 26

September 2022 POM

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

3.00% w/w

Upha Pharmaceutical Mfg (M) Sdn

Bhd

Hongkiat Trading &

Company

31 October 2023 till 30

October 2028GSL

701BRU12100941P;

BRU12100941PS2

FragminTM 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

702 BRU12100942PProstin E2TM Vaginal Tablet

3mgDinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2022 POM

703 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 Bhd31 October 2017 till 30

October 2022 GSL

704 BRU12100944NPPotassium 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)

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

Benzyl Benzoate 33mg

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

MalaysiaAsterix United (B) Sdn Bhd

31 October 2017 till 30

October 2022 GSL

BDMCA/RMP/0719 Page 46 of 157

Page 47: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU12100947PIlliadin 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

707 BRU12100948PRenvela (Sevelamer

Carbonate) Tablet 800mgSevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd

31 October 2017 till 30

October 2022 POM

708 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mgPfizer Manufacturing Deutschland

GmbH, Freiburg, GermanyZuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2022 POM

709 BRU12100950P QvarTM 100 InhalerBeclomethasone dipropionate 100mcg

per inhalation3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd

31 October 2017 till 30

October 2021 POM

710 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Medipharm Sdn Bhd31 October 2017 till 30

October 2021 POM

711BRU12110953P;

BRU12110953PS2

FragminTM 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 Bhd27 November 2017 till 26

November 2022 POM

712 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mgPfizer Ireland Pharmaceuticals,

Kildare, Republic of IrelandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

713 BRU12110955PEprex® 4000 Prefilled Syringe

4000IU/0.4mlEpoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

714 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd27 November 2017 till 26

November 2022 POM

715 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mgBeacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

27 November 2017 till 26

November 2022 GSL

716BRU12110957PS1;

BRU12110957PS2

Actrapid® 100IU/ml Solution

for InjectionInsulin Human (rDNA) 100iu/ml

Novo Nordisk A/S, Denmark (S1);

Novo Nordisk Production SAS, France

(S2)

Zuellig Pharma (B) Sdn Bhd27 November 2017 till 26

November 2022 POM

717 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/gY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

718 BRU12110959PEprex® 2000 Prefilled Syringe

2000IU/0.5mlEpoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

719 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mgLes Laboratories Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 GSL

720 BRU12110962P Tenol-100 Atenolol 100mgSunward Pharmaceutical Pte Ltd,

SingaporeG & H Trading Company

27 November 2017 till 26

November 2022 POM

721 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)

BDMCA/RMP/0719 Page 47 of 157

Page 48: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

722 BRU12110964PExjade 125mg Dispersible

TabletsDeferasirox 125mg

Novartis Pharmas Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

723 BRU12110965PExjade 500mg Dispersible

TabletsDeferasirox 500mg

Novartis Pharmas Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

27 November 2017 till 26

November 2022 POM

724 BRU12110966P Dhamotil TabletsDiphenoxylate HCl BP 2.5mg; Atropine

Sulphate 0.025mg

Drug Houses of Australia Pte Ltd.,

SingaporeG & H Trading Company

27 November 2017 till 26

November 2022 POM

725 BRU12120967PCervarixTM Vaccine (Prefilled

Syringe)

1 dose (0.5ml) contains: Human

Papillomavirus type 16 L1 protein

20mcg; Human Papillomavirus type 18

L1 protein 20mcg; 3-O-desacyl-4'-

monophosphoryl lipid A (MPL) 50mcg;

adsorbed on aluminium hydroxide,

hydrated (Al(OH)3) 0.5mcg Al3+

GlaxoSmithKine Biologicals S.A.,

Rixensart, BelgiumZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

726 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 Bhd27 December 2017 till 26

December 2022 POM

727 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

728 BRU12120970PClementin Film Coated Tablet

625mg

Amoxicillin (as Trihydrate) 500mg;

Clavulanic Acid (as Potassium Salt)

125mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taichung, TaiwanAsterix United (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

729 BRU12120971PSurvanta® Beractant

Intratracheal SuspensionBeractant (as phospholipids) 25mg/ml AbbVie Inc., USA Zuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

730 BRU12120972PHumira Solution for Injection

40mg/0.8mlAdalimumab 40mg/0.8ml

Vetter-Pharma-Fertigung GmbH &

Co., KG, Ravensburg, GermanyZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

731 BRU12120973P ZyprexaTM Tablet 10mg Olanzapine 10mgLilly del Caribe Inc, Puerto Rico, USA

& Lilly S.A., Madrid, SpainZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022POM

732 BRU12120974PSutentTM Hard Capsules

12.5mgSunitinib 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

733BRU12120975PS1 ;

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 Bhd27 December 2017 till 26

December 2022 POM

BDMCA/RMP/0719 Page 48 of 157

Page 49: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

734 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26

December 2022 POM

735 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd27 December 2017 till 26

December 2022 POM

736 BRU12120978PAerrane (Isoflurane USP)

Inhalation LiquidIsoflurane USP 100%

Baxter Healthcare Corporation,

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

737 BRU12120979PKogenate FS for Injection

250IU/vial

Antihaemophilic Factor (recombinant)

sucrose formulated 250IUBayer AG, Berlin Germany Zuellig Pharma (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

738 BRU12120980NP Potcit MixturePer 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)

739 BRU12120981P Garbose Tablet 100mg Acarbose 100mgY.S.P Industries (M) Sdn Bhd.,

Selangor Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd

27 December 2017 till 26

December 2022 POM

740 BRU13010982PKombiglyzeTM XR Tablet

5/1000mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

1000mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

741 BRU13010983PKombiglyzeTM XR Tablet

5/500mg

Saxagliptin HCl 5mg (as anhydrous

5.58mg); Metformin Hydrochloride

500mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

742 BRU13010984PKombiglyzeTM XR Tablet

2.5/1000mg

Saxagliptin HCl 2.5mg (as anhydrous

2.79mg); Metformin Hydrochloride

1000mg

AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

743 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mgRecordati Industria Chimica &

Farmaceutica S.p.A., Milan, ItalyZuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

744 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

745 BRU13010988P Co-Trimexazole SuspensionPer 5ml - Sulphamethoxazole BP

200mg; Trimethoprim 40mg

Beacons Pharmaceuticals Pte Ltd,

SingaporeHongkiat Trading & CO

26 January 2018 till 25

January 2023 POM

746 BRU13010991PHumulin 30/70 Injection

100iu/ml (vial)

Human insulin* 100IU/mL

*In the proportion of 30% Soluble

Insulin to 70% Isophane InsulinEli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

747 BRU13010993PFML® Liquifilm Sterile

Opthalmic Solution 0.1%Fluorometholone 0.1%w/v

Allergan Pharmaceuticals Ireland,

IrelandMedipharm Sdn Bhd

26 January 2018 till 25

January 2023 POM

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

IrelandZuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

749 BRU13010996P Seretide Evohaler 25/125mcg

Per actuation - Fluticasone propionate

125mcg; Salmetarol 25mcg (as

xinafoate)

Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

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

662.9mg)Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

BDMCA/RMP/0719 Page 49 of 157

Page 50: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

751BRU13010998PS1;

BRU13010998PS2Revlimid®Capsules 5mg Lenalidomide 5mg

Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd26 January 2018 till 25

January 2023 POM

752 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah26 January 2018 till 25

January 2023 GSL

753 BRU13011000P Inpanol Tablets 10mg Propranolol BP 10mgDrug Houses of Australia Private

Limited, SingaporeG & H Trading Company

26 January 2018 till 25

January 2020POM

754 BRU13011003PNimotop Infusion Solution

0.02%Nimodipine 0.01g/50ml Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

755 BRU13011005P Zyprexa 5mg Tablet Olanzapine 5mgLilly del Caribe Inc., Puerto Rico, USA

& Lilly, S.A., SpainZuellig Pharma (B) Sdn Bhd

26 January 2018 till 25

January 2023 POM

756 BRU13021006PCanesten 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

757 BRU13021008PPrevenar 13 Suspension for

Injection

Per 0.5ml - Pneumococcal

Polysaccharide Serotype 1, 3, 4, 5, 6A,

7F, 9V, 14, 18C, 19A, 19F, 23F - 2.2mcg;

Pneumococcal Polysaccharide Serotype

6B - 4.4mcg

Pfizer Ireland Pharmaceuticals,

Dublin, IrelandZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

758 BRU13021009PHemabate Sterile Solution

250mcg/ml

Carboprost (as tromethamine)

250mcg/ml

Pharmacia & Upjohn Company LLC,

USAZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

759 BRU13021011PExtraneal Peritoneal Dialysis

Solution 75g/L

Per 100ml: Icodextrin 7.5g; Sodium

Chloride 538mg; Sodium Lactate

448mg; Calcium Chloride 25.7mg;

Magnesium Chloride 5.08mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd26 February 2018 till 25

February 2023 POM

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

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

761 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company26 February 2018 till 25

February 2023 GSL

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

Zuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

763 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mgBeacons Pharmaceutical Pte Ltd,

SingaporeHongkiat Trading & Co

26 February 2018 till 25

February 2023 POM

764 BRU13021017PHydrogen Peroxide Solution

6%

Hydrogen Peroxide 6% w/v (equivalent

to 20 volumes of oxygen)

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaHongkiat Trading & Co

26 February 2018 till 25

February 2023 GSL

765BRU13021018P 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

766 BRU13021019PStilamin 3000 for Injection

3mg/ampouleSomatostatin (as acetate) 3mg

Merck Serono SA, Aubonne,

SwitzerlandG&H Trading Company

26 February 2018 till 25

February 2023 POM

BDMCA/RMP/0719 Page 50 of 157

Page 51: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

767 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/mlY.S.P Industries (M) Sdn Bhd, Selangor

Darul Ehsan, MalaysiaAsterix United (B) Sdn Bhd

26 February 2018 till 25

February 2023 P

768 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/wHOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

26 February 2018 till 25

February 2023 GSL

769 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2mlYung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan, ROCAsterix United (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

770 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mgNoripharma Sdn Bhd, Selangor Darul

Ehsan, MalaysiaK-Seri Pharma Sdn Bhd

26 February 2018 till 25

February 2023 POM

771 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/gPF Consumer Healthcare Canada ULC,

CanadaZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

772 BRU13021026PKaletra Film-coated Tablet

200mg/50mgLopinavir 200mg; Ritonavir 50mg

AbbVie Deutschland GmbH & Co. KG,

GermanyZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

773 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

NetherlandsZuellig Pharma (B) Sdn Bhd

26 February 2018 till 25

February 2023 POM

774 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd26 February 2018 till 25

February 2023 POM

775 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)

776 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd28 March 2018 till 27

March 2023 GSL

777BRU13031033PS1;

BRU13031033PS2Metoclopramide 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 Company28 March 2018 till 27

March 2020POM

778 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mgBeacons Pharmaceuticals Pte Ltd,

SingaporeHongkiat Trading & Co

28 March 2018 till 27

March 2023 POM

779 BRU13031036P Dhacort Cream 1%w/wHydrocortisone acetate BP

(micronised) 1% w/w

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

28 March 2018 till 27

March 2020POM

780 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 March 2018 till 27

March 2023 POM

781 BRU13031038PSolcoseryl Dental Adhesive

Paste

Per g - Solcoseryl CMC 2.125mg;

Polidocanol 10mg

Legacy Pharmaceuticals Switzreland

GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd

28 March 2018 till 27

March 2023 POM

782 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah28 March 2018 till 27

March 2023 POM

783 BRU13031040P Intril SR 1.5mg Tablets Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd28 March 2018 till 27

March 2023 POM

BDMCA/RMP/0719 Page 51 of 157

Page 52: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

784 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2018 till 27

March 2023 POM

785 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company28 March 2018 till 27

March 2023 POM

786 BRU13031045PRecormon Pre-filled Syringe

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

Roche Diagnostics GmbH, Germany

(Labeling and Secondary packaging);

F. Hoffmann-La Roche AG,

Kaiseraugst, Switzerland; Vetter

Pharma-Fertigung GmbH & Co. KG,

Ravensburg , Germany

MediPharm Sdn Bhd28 March 2018 till 27

March 2023 POM

787 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd28 March 2018 till 27

March 2023 POM

788 BRU13031047PRecormon Pre-filled Syringe

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

Roche Diagnostics GmbH, Germany

(Labeling and Secondary packaging);

F. Hoffmann-La Roche AG,

Kaiseraugst, Switzerland; Vetter

Pharma-Fertigung GmbH & Co. KG,

Ravensburg , Germany

MediPharm Sdn Bhd28 March 2018 till 27

March 2023 POM

789 BRU13031049PSaizen for Injection

3.33mg/vialSomatropin 3.33mg (10 IU) Merck Serono S.A., Switzerland G & H Trading Company

28 March 2018 till 27

March 2023 POM

790BRU13031050P;

BRU13031050PS2Isentress 400mg Tablet

Raltegravir 400mg (as potassium

434.4mg)

MSD International GmbH (Singapore

Branch) 21 Tuas South Avenue 6

Singapore 637766; MSD International

GmbH, Ireland (S2); MSD

International GmbH (Singapore

Branch), 70 Tuas West Drive,

Singapore 638414, Singapore

Zuellig Pharma (B) Sdn Bhd28 March 2018 till 27

March 2023 POM

791 BRU13041051P

Taxotere 80mg/4ml

Concentrate for Solution for

Infusion

Docetaxel trihydrate 80mg/4mlSanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

30 April 2018 till 29 April

2023 POM

792 BRU13041052PFosamax Plus Tablet

70mg/5600IU

Alendronic Acid 70mg (as Sodium

91.37mg); Colecalciferol 140mcg

(5,600IU)

MSD Frosst Iberica, S.A., Madrid,

SpainZuellig Pharma (B) Sdn Bhd

30 April 2018 till 29 April

2023 POM

793 BRU13041053PGlucovance Tablet

500mg/2.5mg

Metformin HCl 500mg, Glibenclamide

2.5mgMerck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd

30 April 2018 till 29 April

2023 POM

794 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia K-Seri Pharma Sdn Bhd30 April 2018 till 29 April

2023 POM

795 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/wBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2018 till 29 April

2023 GSL

BDMCA/RMP/0719 Page 52 of 157

Page 53: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU13041058PPegasys Pre-filled Syringe

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

F Hoffman-La Roche Ltd, Switzerland;

F Hoffman-La Roche Ltd,

Betriebsstandort Kaiseraugst

(Parenterals), Switzerland

Hongkiat Trading & Co30 April 2018 till 29 April

2023 POM

797 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd30 April 2018 till 29 April

2023 POM

798 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl)Delpharm Milano S.r.I., Via Carnevale

1, 20090, Segrate (Milano), ItalyHongkiat Trading & Co

30 April 2018 till 29 April

2023 POM

799 BRU13041061NPVenofer® Solution for

Injection 100mg/5ml

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

complex] 100mg/5ml

IDT Biologika GmbH, Germany; BIPSO

GmbH, Germany; Takeda Austria

GmbH, AustriaHongkiat Trading & Co

30 April 2018 till 29 April

2023 POM

800 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/wBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2018 till 29 April

2023 GSL

801 BRU13041063P Apuzin tablet 25mg Captopril 25mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 April 2018 till 29 April

2023 POM

802 BRU13041064PLezpain film-coated tablet

135mgMebeverine HCl 135mg

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

MalaysiaAsterix United (B) Sdn Bhd

30 April 2018 till 29 April

2023 POM

803 BRU13041067NP White Soft Paraffin White Soft Paraffin

Sasaol Wax GmbH, Germany

[Repacker: Beacons Pharmaceuticals

Pte Ltd., 21 Chin Bee Avenue,

Singapore]

Hongkiat Trading & Co30 April 2018 till 29 April

2023 GSL

804 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/vBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 April 2018 till 29 April

2023 GSL

805 BRU13061069PVotrient™ Film‐coated tablets

200mgPazopanib (as hydrochloride) 200mg

Glaxo Operations UK Ltd,

Hertfordshire, UKZuellig Pharma (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

806

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 Bhd04 June 2018 till 03 June

2023 POM

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

NetherlandsZuellig Pharma (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

808 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

04 June 2018 till 03 June

2023POM

809 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co04 June 2018 till 03 June

2023 POM

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

MalaysiaAsterix United (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

BDMCA/RMP/0719 Page 53 of 157

Page 54: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

811BRU13061076P;

BRU13061076PS2Xeloda™ Tablets 500mg Capecatibine 500mg

Productos Roche S.A. de C.V, Mexico;

Shanghai Roche Pharmaceuticals Ltd,

China (S2)

Hongkiat Trading & Co04 June 2018 till 03 June

2023 POM

812 BRU13061077PChloramphenicol Eye

OintmentChloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd

04 June 2013 till 03 June

2018 POM

813 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, ChinaKingston Beverage &

Creamery Sdn Bhd

04 June 2018 till 03 June

2023 GSL (2's)

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

polymaltose complex] 10mg/mlVifor S.A., Switzerland Medipharm Sdn Bhd

04 June 2018 till 03 June

2023 GSL

815 BRU13061080P Noriday® Tablet Norethisterone 0.35mgPiramal Healthcare UK Limited,

United KingdomZuellig Pharma (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

816 BRU13061081PKeppra 250mg Film-coated

TabletLevetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

817 BRU13061082PKeppra 500mg Film-coated

TabletLevetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

818

BRU13061083PS1,

BRU13061083PS2,BRU

13061083PS3,

BRU13061083PS4,

BRU13061083PS5

Avastin Concentrate For

Solution For Infusion

400mg/16ml

Bevacizumab 400mg/16ml

Genentech Inc., South Fransisco,

CA, USA (S1); F-Hoffman-La Roche

Ltd, Basel, Switzerland (S2); Roche

Diagnostics GmbH, Manheim,

Germany (S3); F Hoffmann-La Roche

Ltd, Kaiseraugst, Switzerland (S4);

Genentech Inc., Hillsboro, OR, USA

(S5)

Hongkiat Trading & Co04 June 2018 till 03 June

2023 POM

819 BRU13061084P Xeloda Tablet 150mg Capecatibine 150mg Productos Roche S.A. de C.V, Mexico Hongkiat Trading & Co04 June 2018 till 03 June

2023 POM

820 BRU13061085PUripax Film-coated Tablet

200mgFlavoxate HCl 200mg

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

MalaysiaAsterix United (B) Sdn Bhd

04 June 2018 till 03 June

2023 POM

821 BRU13061087PElonva Solution for Injection

150mcg/0.5mlCorifollitrophin alfa 150mcg/0.5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

27 June 2018 till 26 June

2023 POM

822 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 Bhd27 June 2018 till 26 June

2023 POM

823 BRU13061090NPCiproxol (Ciprofloxacin) 0.2%

w/v Intravenous Infusion BPCiprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah

27 June 2018 till 26 June

2023 POM

824 BRU13061091NPInfusol® W Intravenous

Infusion BPWater for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah

27 June 2018 till 26 June

2023 GSL

825 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany Zuellig Pharma (B) Sdn Bhd27 June 2018 till 26 June

2023 POM

826 BRU13061094PPharmaniaga Simvastatin

tablet 10mgSimvastatin 10mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

27 June 2018 till 26 June

2023 POM

BDMCA/RMP/0719 Page 54 of 157

Page 55: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

827 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

27 June 2013 till 26 June

2018 (extended till 31

December 2019)

POM

828 BRU13061097P Seldron Cleaning Lotion Selenium Sulphide USP 2.5% w/v ICM Pharma Pte Ltd, SingaporeMc Quipp Technisell

Marketing Sdn Bhd

27 June 2018 till 26 June

2023 p

829 BRU13071098NP Cortal for Children Tablet Acetaminophen (Paracetamol) 80mgSterling Drug (Malaya) Sdn Bhd,

Malaysia

Kingston Beverage &

Creamery Sdn Bhd

30 July 2013 till 29 July

2018

P (12 x 12's

(144's))

830 BRU13071099PChampix 1mg film-coated

tabletVarenicline Tartrate 1mg

Pfizer Manufacturing Deutschland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

30 July 2018 till 29 July

2023POM

831 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

2023P

832 BRU13071101PGlucophage XR 500mg

Extended Release TabletMetformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

30 July 2018 till 29 July

2023POM

833 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mgSchering-Plough (Singapore) Pte Ltd,

SingaporeZuellig Pharma (B) Sdn Bhd

30 July 2013 till 29 July

2018 POM

834 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, MalaysiaMedicorp Sdn Bhd

30 July 2018 till 29 July

2023 POM

835 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), SwizerlandG & H Trading Company

30 July 2018 till 29 July

2023 POM

836BRU13071108PS1;

BRU13071108PS2Revlimid® Capsules 25mg Lenalidomide 25mg

Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd30 July 2018 till 29 July

2023POM

837BRU13071109PS1;

BRU13071109PS2Revlimid® Capsules 15mg Lenalidomide 15mg

Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd30 July 2018 till 29 July

2023POM

838 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/gLegacy Pharmaceuticals Switzreland

GmbH, SwitzerlandZuellig Pharma (B) Sdn Bhd

30 July 2018 till 29 July

2023POM

839 BRU13071111P Micosten-H CreamMiconazole Nitrate 2%; Hydrocortisone

1%Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd

30 July 2018 till 29 July

2023POM

840 BRU13071114PSandimmun Neoral Capsule

25mgCiclosporin A 25mg

Catalent Germany Eberbach GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

30 July 2018 till 29 July

2023 POM

841 BRU13081115P Champix 0.5mg & 1mg TabletVarenicline Tartrate 0.5mg &

Varenicline Tartrate 1mg

Pfizer Manufacturing Deutschland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

27 August 2018 till 26

August 2023 POM

842 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium Zuellig Pharma (B) Sdn Bhd27 August 2018 till 26

August 2023 P

843 BRU13081120PEnbrel® 25mg solution for

injection in pre-filled syringeEtanercept 25mg/0.5ml

Pfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

27 August 2018 till 26

August 2023 POM

BDMCA/RMP/0719 Page 55 of 157

Page 56: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

844 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd27 August 2018 till 26

August 2023 POM

845 BRU13081123P Minazol Powder 2% Miconazole Nitrate 2% w/wBiosis Pharmaceuticals Sdn Bhd.,

MalaysiaK-Seri Pharma Sdn Bhd

27 August 2018 till 26

August 2023 P

846 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah27 August 2018 till 26

August 2023 POM

847 BRU13081125PPharmaniaga Pyrazinamide

Tablet 500mgPyrazinamide 500mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

27 August 2018 till 26

August 2023 POM

848 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company27 August 2018 till 26

August 2023 GSL

849 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., BelgiumHongkiat Trading & Co

Zuellig Pharma (B) Sdn Bhd

27 August 2018 till 26

August 2023 POM

850 BRU13091130PErbitux® 5mg/ml Solution for

InfusionCetuximab 5mg/ml

Boehringer Ingelheim, Germany &

Merck KGaA, Germany (1 Artwork)Zuellig Pharma (B) Sdn Bhd

28 September 2018 till 27

September 2023 POM

851 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,

SingaporeHongkiat Trading & Co

28 September 2013 till 27

September 2018 GSL

852 BRU13091133PClexane 4000/0.4ml Anti XA

Pre-filled Syringe

Enoxaprin sodium 4,000 anti-Xa

IU/0.4ml equivalent to 40mg/0.4mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd

28 September 2018 till 27

September 2023 POM

853 BRU13091134PPantaprazole Winthrop 40mg

Tablet

Pantoprazole (as sodium Sesquihydate)

40mgSanofi-Aventis S.P.Z.O.O., Poland Medipharm Sdn Bhd

28 September 2018 till 27

September 2023 POM

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

0.9%w/w

Perstorp Speciality Chemicals AB,

Sweden

Mc Quipp Technisell

Marketing Sdn Bhd

28 September 2018 till 27

September 2023 P

855 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd28 September 2018 till 27

September 2023 POM

856 BRU13091138PClexane 6000/0.6ml Anti-Xa

IU Pre-filled Syringe

Enoxaprin sodium 6,000 anti-Xa

IU/0.6ml equivalent to 60mg/0.6mlSanofi Winthrop Industrie, France Medipharm Sdn Bhd

28 September 2018 till 27

September 2023 POM

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

MalaysiaHongkiat Trading & Co

28 September 2018 till 27

September 2023 POM

858 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2mlYung Shin Pharmaceutical Ind. Co.

Ltd., TaiwanAsterix United (B) Sdn Bhd

28 September 2018 till 27

September 2023 POM

859 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 September 2018 till 27

September 2023 GSL

860 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 Bhd28 September 2018 till 27

September 2023 POM

BDMCA/RMP/0719 Page 56 of 157

Page 57: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

861 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd28 September 2018 till 27

September 2023 POM

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

MalaysiaG & H Trading Company

28 September 2018 till 27

September 2023 GSL

863 BRU13101149PErycin Film Coated Tablet

250mgErythromycin (as stearate) 250mg

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

MalaysiaAsterix United (B) Sdn Bhd

31 October 2018 till 30

October 2023 POM

864 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

865 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mgGlaxoSmithKline Manufacturing

S.p.A., Parma, ItalyZuellig Pharma (B) Sdn Bhd

31 October 2018 till 30

October 2023 POM

866 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

867 BRU13101154PAxcel Mefenamic Acid

SuspensionMefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

31 October 2018 till 30

October 2023 POM

868 BRU13101155P

Ovidrel Solution for Injection

250mcg/0.5ml in Pre-filled

Syringe

Choriogonadotropin alfa 250mcg/0.5mlMerck Serono S.p.A., Italy & Merck

Serono S.A., SwitzerlandG & H Trading Company

31 October 2018 till 30

October 2023 POM

869 BRU13101156PSandimmun Neoral Capsule

100mgCiclosporin 100mg

Catalent Germany Eberbach GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

31 October 2018 till 30

October 2023 POM

870 BRU13101158P Endoxan Tablet 50mgCyclophosphamide anhydrous (as

monohydrate) 50mg

Prasfarma S.L., Manlleu/Barcelona,

Spain; Haupt Pharma Amareg GmBH,

Germany

Zuellig Pharma (B) Sdn Bhd31 October 2018 till 30

October 2023 POM

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

ThailandK-Seri Pharma Sdn Bhd

31 October 2018 till 30

October 2023 POM

872 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mgPfizer Ireland Pharmaceuticals,

Kildare, IrelandZuellig Pharma (B) Sdn Bhd

31 October 2018 till 30

October 2023 POM

873BRU13101161PS1;

BRU13101161PS2Revlimid® Capsules 10mg Lenalidomide 10mg

Penn Pharmaceutical Services

Limited, UK (S1) & Celgene

International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd31 October 2018 till 30

October 2023 POM

874 BRU13101162PPharmaniaga Cephalexin

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

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

31 October 2018 till 30

October 2023 POM

875 BRU13121167PCopastin Film Coated Tablets

10mgCloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd

02 December 2018 till 01

December 2023 P

876 BRU13121168P Ucort CreamPer g – Urea 100mg; Hydrocortisone

acetate 10mgY.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd

02 December 2018 till 01

December 2023 POM

BDMCA/RMP/0719 Page 57 of 157

Page 58: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

877 BRU13121169PPradaxa® Hard Capsules

150mg

Dabigatran etexilate 150mg (as

mesilate 172.95g)

Boehringer Ingelheim Pharma GmbH

&Co, Ingelheim am Rhein, GermanyHongkiat Trading & Co

02 December 2018 till 01

December 2023 POM

878 BRU13121170PPradaxa® Hard Capsules

110mg

Dabigatran etexilate 110mg (as

mesilate 126.83g)

Boehringer Ingelheim Pharma GmbH

& Co., KG, GermanyHongkiat Trading & Co

02 December 2018 till 01

December 2023 POM

879 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 Bhd02 December 2018 till 01

December 2023 POM

880 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd02 December 2018 till 01

December 2023 POM

881 BRU13121177PCyclogyl® 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

882 BRU13121178P Betawin Tablet 50mg Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Co02 December 2018 till 01

December 2023 POM

883 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd30 December 2018 till 29

December 2023 POM

884 BRU13121180PGlucovance Tablet

500mg/5mg

Metformin HCl 500mg; Glibenclamide

5mgMerck Sante SAS, France Zuellig Pharma (B) Sdn Bhd

30 December 2018 till 29

December 2023 POM

885 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.,

Rixensart, Belg ium; GlaxoSmithKline

Biologicals S.A., Wavre, Belgium

(Diluent: Glaxosmithkline Biologicals

S.A., Rixensart, Belg ium (WFI diluent

in ampoules and syringe); Catalent

Belgium SA, Belgium & Aspen Notre

Dame de Bondeville, France (WFI

diluent in syringe); Delpharm Tours,

France (WFI diluent in ampoules)

Zuellig Pharma (B) Sdn Bhd30 December 2018 till 29

December 2023 POM

886 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mgGlaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 December 2018 till 29

December 2023 POM

887 BRU13121183P Anarex TabletsParacetamol 450mg; Orphenadrine

citrate 35mg

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 December 2013 till 29

December 2018 (pending

renewal submission)

POM

888 BRU13121184PAtarax Film-Coated Tablet

25mgHydroxyzine Hydrochloride 25mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd

30 December 2018 till 29

December 2023 POM

889 BRU13121187NP10% Glucose Intravenous

Infusion B.P.

Glucose monohydrate (as equiv. to

anhydrous glucose) 10%B Braun Industries Sdn Bhd, Malaysia Hongkiat Trading & Co

30 December 2018 till 29

December 2023 POM

BDMCA/RMP/0719 Page 58 of 157

Page 59: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

890 BRU13121189PHeparinised Saline Injection

10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa)

10i.u./ml

B Braun Medical Industries Sdn Bhd,

MalaysiaHongkiat Trading & Co

30 December 2018 till 29

December 2023 POM

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

15mg

Teva Pharmaceutical Works Pte Ltd

Co., Debrecen Site, HungaryK-Seri Pharma Sdn Bhd

30 December 2013 till 29

December 2018 POM

892 BRU13121192NPNutriflex 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 & Co30 December 2018 till 29

December 2023 POM

893BRU14011193PS1 Alimta 500mg Powder for

Solution for InfusionPemetrexed (as Pemetrexed disodium)

500mg/vial

Eli Lilly and Company, USA (S1)Zuellig Pharma (B) Sdn Bhd

28 January 2019 till 27

January 2024POM

894 BRU14011196P Largo Tablets 100mgChlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

28 January 2019 till 27

January 2024POM

895 BRU14011197NPAxcel 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

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

hydrochloride 0.5% w/w

GP Grenzach Produktions GmbH,

Germany Zuellig Pharma (B) Sdn Bhd28 January 2019 till 27

January 2024 GSL

897 BRU14011199NPDextrose 5% and Sodium

Chloride 0.9% Injection USP

Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

28 January 2019 till 27

January 2024 GSL

898 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

899 BRU14011203P Betaserc 24mg TabletBetahistine dihydrochloride 24mg Abbott Healthcare SAS, France

Zuellig Pharma (B) Sdn Bhd28 January 2019 till 27

January 2024POM

900 BRU14011204PHumalog Mix50 100 units/ml

Kwikpen

Insulin Lispro * 100U/ml (equivalent to

3.5mg) * in the proportion of 50%

insulin lispro solution and 50% insulin

lispro protamine suspension (rDNA

origin)

Lilly France S.A.S., France (repacker

- Eli Lilly And Company, USA) Zuellig Pharma (B) Sdn Bhd

28 January 2019 till 27

January 2024

POM

901 BRU14011205NP Panamol Tablet 500mgParacetamol 500mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

28 January 2019 till 27

January 2024GSL (100 x 10's)

902 BRU14011206PSeretide™ Evohaler™

25/50mcgFluticasone propionate 50mcg;

Salmeterol (as xinafoate) 25mcg

Glaxo Wellcome S.A., SpainZuellig Pharma (B) Sdn Bhd

28 January 2019 till 27

January 2024POM

903BRU14011207PS1;

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/0719 Page 59 of 157

Page 60: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

904 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

905 BRU14011209PNEUPOGEN PRE-FILLED

SYRINGE 30MU/0.5ML

Filgrastim 30mu/0.5ml Amgen manufacturing Limited (AML),

Puerto Rico, United States

Medipharm Sdn Bhd 28 January 2019 till 27

January 2024 POM

906BRU14011211NPS1;

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

907 BRU14011212PAxcel Chlorpheniramine-4

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

Malaysia

28 January 2019 till 27

January 2024P

908 BRU14011213PImojev Japanese Encephalitis

vaccine (live, attenuated) MD

Live, attenuated, recombinant

Japanese Encephalitis virus 4.0 - 5.8 log

PFU*/dose (0.5ml) *Plaque Forming

Unit

Government Pharmaceutical

Organization - Meriux Biological

Products Co., Ltd., ThailandZuellig Pharma (B) Sdn Bhd

28 January 2019 till 27

January 2024 POM

909

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

910BRU14021216P 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

911BRU14021217P 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

912BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen-Cilag, Val de Reuil, France

Zuellig Pharma (B) Sdn Bhd27 February 2019 till 26

February 2024

POM

913

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

914BRU14021220P 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

BDMCA/RMP/0719 Page 60 of 157

Page 61: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

915

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;

Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

916

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;

Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

917

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;

Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

918

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

919

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

920BRU14021230NP 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

921BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

P

922BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Lilly del Caribe, Inc., Puerto Rico

Zuellig Pharma (B) Sdn Bhd27 February 2019 till 26

February 2024

POM

BDMCA/RMP/0719 Page 61 of 157

Page 62: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

923

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

924BRU14021234P Axcel Mefenamic Acid

Capsules

Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 27 February 2019 till 26

February 2024

POM

925BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd27 February 2019 till 26

February 2024

POM

926

BRU14021236NP;

BRU14021236NPS2

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;

Baxter Healthcare Philippines Inc.,

Laguna, Philippines (S2)Zuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

GSL (500 ml

(F8B2323);

1000ml

(F8B2324))

927BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd27 February 2019 till 26

February 2024

POM

928BRU14021238NP 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

929BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (Recombinant

DNA) 100IU/ml

Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

930BRU14021240NP 5% Dextrose and 0.45%

Sodium Chloride Injection,

USP

Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USAZuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

GSL

931BRU14021241P Giona Easyhaler 200mcg/dose

Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2019 till 26

February 2024

POM

932BRU14021242P 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

933BRU14021243NP Neurobion tablet Thiamine disulfide 100mg; Pyridoxine

hydroxide 200mg & Cyanocobalamin

200mcg

Merck KGaA & Co, AustriaZuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

GSL (30's & 90's)

934BRU14021244P 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

935BRU14021245P Keppra Concentrate for

solution for (infusion) /

intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

936

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., ThailandZuellig Pharma (B) Sdn Bhd

27 February 2019 till 26

February 2024

POM

937BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate

86.48mg)

Boehringer Ingelheim Pharma GmbH

& Co., KG, GermanyHongkiat Trading & Co 27 February 2019 till 26

February 2024

POM

BDMCA/RMP/0719 Page 62 of 157

Page 63: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

938BRU14021248P 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

939BRU14031249P Tygacil 50mg Lyophilised

Powder for Intravenous

Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, ItalyZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

940

BRU14031250PS1;BRU

14031250PS2

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

941BRU14031251P Stalevo 75/18.75/200mg Film-

coated Tablet

Levodopa 75mg; Carbidopa 18.75mg;

Entacapone 200mg

Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

942BRU14031252P Stalevo 200/50/200mg Film-

coated Tablet

Levodopa 200mg; Carbidopa 50mg;

Entacapone 200mg

Orion Corporation, FinlandZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

943BRU14031253P Humulin N Injection 100IU/mL Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA

Zuellig Pharma (B) Sdn Bhd27 March 2019 till 26

March 2024

POM

944BRU14031256P 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

945

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

946BRU14031258P Volibris 5mg Film-coated

TabletAmbrisentan 5mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

947BRU14031259P Volibris 10mg Film-coated

TabletAmbrisentan 10mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

948BRU14031261P Prograf Capsule 1mg

Tacrolimus 1mg Astellas Ireland Ltd, Ireland MediPharm Sdn Bhd27 March 2019 till 26

March 2024

POM

949BRU14031263P;

BRU14031263PS2

Patanol 0.1% Olopatadine

Hydrochloride Sterile

Ophthalmic Solution

Olopatadine (as HCl) 0.1%

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

Alcon Singapore Manufacturing Pte.

Ltd., Singapore (S2)

Zuellig Pharma (B) Sdn Bhd27 March 2019 till 26

March 2024

POM

950

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

951BRU14031267P Motilium Suspension 1mg/ml

Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium Zuellig Pharma (B) Sdn Bhd27 March 2019 till 26

March 2024

POM

952BRU14031268P Elonva Solution for Injection

100mcg/0.5mlCorifollitropin alfa 100mcg/0.5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

BDMCA/RMP/0719 Page 63 of 157

Page 64: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

953

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

954BRU14031270P Enbrel® 50mg solution for

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

IrelandZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

955BRU14031272P Seretide Evohaler dose-

counter 25/250mcgSalmeterol 25mcg (as the xinafoate)

and Fluticasone Propionate 250mcgGlaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

956

BRU14031273PS1;

BRU14031273PS2

Galvus Met 50/500mg Film-

coated TabletVildagliptin 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

957

BRU14031274PS1;

BRU14031274PS2

Galvus Met 50/1000mg Film-

coated TabletVildagliptin 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

BDMCA/RMP/0719 Page 64 of 157

Page 65: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

BRU14031275PS1;

BRU14031275PS2

Galvus Met 50/850mg Film-

coated TabletVildagliptin 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

959BRU14031276P Galvus 50mg Tablet

Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd27 March 2019 till 26

March 2024

POM

960BRU14031279NP 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)

961BRU14031280P Lamictal

Dispersible/Chewable Tablet

25mg

Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA,

Poland Zuellig Pharma (B) Sdn Bhd27 March 2019 till 26

March 2024

POM

962BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine

Phosphate 9mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

27 March 2019 till 26

March 2024

POM

963BRU14031282P 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

964BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV,

BelgiumZuellig Pharma (B) Sdn Bhd

27 March 2019 till 26

March 2024

POM

965

BRU14041285P Giona Easyhaler®

100mcg/dose Inhalation

Powder

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

Company

26 April 2019 till 25 April

2024

POM

966BRU14041286P 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)

967BRU14041287P XareltoTM Film-coated tablet

15mg

Rivaroxaban 15mg Bayer AG, Leverkusen, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM (14's x 2; 7's

x 1; 14's x 1)

968BRU14041288P XareltoTM Film-coated tablet

20mg

Rivaroxaban 20mg Bayer AG, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

(14’s x 2

14’s x 1)

969BRU14041291NP 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 Bhd26 April 2019 till 25 April

2024

GSL

970BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate

213.8mg (eq. to anhydrous

Cyclophosphamide 200mg)

Baxter Oncology GmbH, GermanyZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

971BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

972BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

973BRU14041296P 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

BDMCA/RMP/0719 Page 65 of 157

Page 66: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

974

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

975BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride,

monohydrate) 150mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

976BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride,

monohydrate) 200mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

977BRU14041304NP 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 (in process of

renewal)

POM

978BRU14041305NP 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

979BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to

Granisetron hydrochloride 1.12mg)

Cenexi SAS, France Hongkiat Trading &

Company

26 April 2019 till 25 April

2024

POM

980BRU14041307P Alimta 100mg Powder for

Solution for Infusion

Pemetrexed (as Pemetrexed disodium)

100mg/vial

Eli Lilly and Company, USAZuellig Pharma (B) Sdn Bhd

26 April 2019 till 25 April

2024

POM

981BRU14041309NP RinsCap W (Sterile Water for

Injection BP)

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2019 till 25 April

2024

GSL (500ml)

982BRU14041313P 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 (PL extended till 30

September 2019)

P

983

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

984

BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate)

3mg

Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2019 till 25 April

2024

POM (1 x 10’s

per box

4 x 7’s per box

6 x 10’s per box)

985

BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate)

1.5mg

Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 26 April 2019 till 25 April

2024

POM (1 x 10’s per

box

4 x 7’s per box

6 x 10’s per box)

986BRU14071319PS1 &

BRU14071319PS2Mixtard® 30 100IU/ml

Insulin Human, rDNA ( as Isophane

Insulin) 70%, Insulin Human, rDNA (as

soluble insulin) 30%

Novo Nordisk A/S, Bagsvaerd,

Denmark (S1); Novo Nordisk

Productions SAS, France (S2)

Zuellig Pharma (B) Sdn Bhd02 July 2019 till 01 July

2024POM

987 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd., Japan Zuellig Pharma (B) Sdn Bhd02 July 2019 till 01 July

2024POM

BDMCA/RMP/0719 Page 66 of 157

Page 67: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

988 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5mlBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

02 July 2019 till 01 July

2024POM

989 BRU14071324PLuvox® Film-coated Tablets

50mgFluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

990 BRU14071325PLuvox® Film-coated Tablets

100mgFluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

991 BRU14071326P TobraDex® Eye OintmentTobramycin 0.3%, Dexamethasone

0.1%S.A. Alcon-Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

992 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH & Co. KG., Germany Zuellig Pharma (B) Sdn Bhd02 July 2019 till 01 July

2024POM

993 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 Bhd02 July 2019 till 01 July

2024GSL

994 BRU14071330PHumalog® KwikPenTM

100units/mLInsulin Lispro 100units/ml

Lilly France S.A.S., France

(repacker - Eli Lilly And Company,

USA)

Zuellig Pharma (B) Sdn Bhd02 July 2019 till 01 July

2024POM

995 BRU14071331PShincort IM Injection "Yung

Shin" 40mg/ml ampoulesTriamcinolone acetonide 40mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., TaiwanAsterix United (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

996 BRU14071332PEmend 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

2024POM

997BRU14071333PS1;

BRU14071333PS2Zytiga 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

2024POM

998 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd02 July 2019 till 01 July

2024POM

999 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd02 July 2019 till 01 July

2024POM

1000 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd02 July 2019 till 01 July

2024POM

1001 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mgPfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

1002 BRU14071342PAxcel Ibuprofen Paediatric

SyrupIbuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

02 July 2019 till 01 July

2024P

1003 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

1004 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

1005 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1%

w/w)

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

MalaysiaAsterix United (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

BDMCA/RMP/0719 Page 67 of 157

Page 68: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1006 BRU14071348PAtropine Sulphate 1mg/1ml

InjectionAtropine Sulphate 1mg/ml

Pharmaniaga Lifesciences Sdn Bhd,

MalaysiaG & H Trading Company

02 July 2019 till 01 July

2024POM

1007 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co02 July 2019 till 01 July

2024POM

1008 BRU14071353PSalbutamol Injection

0.5mg/ml

Salbutamol Sulphate 0.5mg/ml

(equivalent to salbutamol base)

Yung Shin Pharmaceutical Ind., Co.

Ltd., Taichong, TaiwanAsterix United (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

1009 BRU14071355PAxcel Dexchlorpheniramine

TabletDexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

02 July 2019 till 01 July

2024POM

1010 BRU14071357PQuinine Sulphate Tablet

300mgQuinine Sulphate BP 300mg

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

02 July 2019 till 01 July

2024POM

1011 BRU14071358NP20% Glucose Intravenous

Infusion BPGlucose (as monohydrate) 20%

B. Braun Medical Industries Sdn Bhd

MalaysiaHongkiat Trading & Co

02 July 2019 till 01 July

2024POM

1012 BRU14071359PPharmaniaga Spironolactone

Tablet 25mgSpironolactone 25mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

02 July 2019 till 01 July

2024POM

1013 BRU14071360PMaxidex Sterile Opthalmic

SuspensionDexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium

Hongkiat Trading & Co

Zuellig Pharma (B) Sdn Bhd

02 July 2019 till 01 July

2024POM

1014 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah02 July 2019 till 01 July

2024POM

1015 BRU14071362PAlphagan Ophthalmic Solution

0.2%

Brimonidine tartrate (anhydrous basis)

2mg/ml

Allergan Pharmaceuticals Ireland,

IrelandMedipharm Sdn Bhd

02 July 2019 till 01 July

2024POM

1016 BRU14071363PDormicum Injection

15mg/3mlMidazolam 15mg/3ml Cenexi SAS, France

Hongkiat Trading &

Company

02 July 2019 till 01 July

2024POM

1017 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

2024POM

1018 BRU14071368PYondelis® Powder for

Injection 1mg/vial Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1019 BRU14071369PTrajenta film-coated tablet

5mgLinagliptin 5mg

Boehringer Ingelhein Roxane Inc.,

USA

Hongkiat Trading &

Company

24 July 2019 till 23 July

2024POM

1020 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 Bhd24 July 2019 till 23 July

2024POM

1021BRU14071372PS1 &

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 Bhd24 July 2019 till 23 July

2024POM

1022BRU14071373PS1 &

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 Bhd24 July 2019 till 23 July

2024POM

BDMCA/RMP/0719 Page 68 of 157

Page 69: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1023BRU14071374PS1 &

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 Bhd24 July 2019 till 23 July

2024POM

1024 BRU14071375PLucentis 10mg/ml Solution for

InjectionRanibizumab 10mg/ml

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1025 BRU14071376P

Onbrez Breezhaler 150mcg

Inhalation Powder, Hard

Capsule

Indacterol 150mcg (as maleate

194mcg)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1026 BRU14071377P

Onebrez Breezhaler 300mcg

Inhalation Powder Hard

Capsule

Indacterol 300mcg (as maleate

389mcg)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1027 BRU14071378PRequip PD 24hr Prolong

Release Tablet 2mgRopinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1028 BRU14071379PDifflam Anti-Inflammatory

Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg;

Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical Laboratories,

IndiaZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024GSL

1029 BRU14071380PVfend Powder For Oral

Suspension 40mg/mlVoriconazole 40mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1030 BRU14071381P

Norditropin® Nordilet®

Solution for Injection

10mg/1.5ml

Somatropin (biosynthetic human

growth hormone) 10mg/1.5mlNovo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1031 BRU14071382PAlphagan P Ophthalmic

Solution 0.15%Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd

24 July 2019 till 23 July

2024POM

1032 BRU14071383PMapenem® IV Injection

500mgMeropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd

24 July 2019 till 23 July

2024POM

1033 BRU14071384PCuram 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 Bhd24 July 2024 till 23 July

2029POM

1034 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024POM

1035 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024POM

1036 BRU14071387P Kivexa Tablets 600mg/300mgAbacavir 600mg (as sulfate);

Lamivudine 300mg

GlaxoSmithKline Pharmaceuticals S.A,

Poland [Repacker: Glaxo Wellcome,

S.A., Spain]

Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024POM

1037 BRU14071388PLucrin® depot 3.75mg

InjectionLeuproprelin acetate 3.75mg

Takeda Pharmaceutical Company

Limited, JapanZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1038 BRU14071389PLucrin® depot 11.25mg

InjectionLeuproprelin acetate 11.25mg

Takeda Pharmaceutical Company

Limited, Japan Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

BDMCA/RMP/0719 Page 69 of 157

Page 70: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1039 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd24 July 2019 till 23 July

2024POM

1040 BRU14071392PInfasurf® (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 Pharma24 July 2019 till 23 July

2024POM

1041 BRU14071393NP Kaolin & Pectin MixturePer 5ml - Kaolin Light BP 1g; Pectin

50mg

Drug Houses of Australia Private

Limited, SingaporeG & H Trading Company

24 July 2014 till 23 July

2019P

1042 BRU14071394PDuodart 0.5mg/0.4mg

CapsulesDutasteride 0.5mg; Tamsulosin 0.4mg

Catalent Germany Schorndorf GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1043 BRU14071395PAxcel Metronidazole-400

TabletMetronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

24 July 2019 till 23 July

2024POM

1044 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd24 July 2024 till 23 July

2029POM

1045

BRU14071397PS1;

BRU14071397PS3;

BRU14071397PS4

MABTHERA Concentrate for

Solution for Infusion

500mg/50ml

Rituximab 500mg/50ml

Genetech Inc., South San Francisco

CA, USA (S1); Roche Diagnostics

GmbH, Germany (S3); Genentech Inc.,

Hilsboro, OR, USA (S4)

MediPharm Sdn Bhd24 July 2019 till 23 July

2024POM

1046 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd24 July 2019 till 23 July

2024POM

1047BRU14071399PS1 &

BRU14071397PS2

Vigamox® Ophthalmic

Solution 0.5% Moxifloxacin 0.5% (as hydrochloride)

ALCON LABORATORIES, INC., USA (S1)

Alcon Singapore Manufacturing Pte.

Ltd., Singapore (S2)

Hongkiat Trading & Co

Zuellig Pharma (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1048BRU14071401PS1 &

BRU14071401PS2Voltaren Emulgel 1%

Diclofenac diethylamine 1.16g/100g

(equivalent to 1g of diclofenac sodium)

Novartis Pharma Produktions GmbH,

Germany (S1 for pack size 50g) &

Novartis Consumer Health SA,

Switzerland (S2 for pack size 20g)

Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024GSL

1049 BRU14071402PImexa Film-Coated Tablet

250mgAzithromycin 250mg (as dihydrate)

Xepa-Soul Pattinson (M) Sdn Bhd

MalaysiaHongkiat Trading & Co

24 July 2019 till 23 July

2024POM

1050 BRU14071403P Cymbalta Capsule 60mg Duloxetine (as hydrochloride) 60mg Lilly del Caribe Inc, Puerto Rico Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024POM

1051 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg;

Ammonium Chloride BP 120mg)

Beacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

24 July 2019 till 23 July

2024POM

BDMCA/RMP/0719 Page 70 of 157

Page 71: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1052 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company24 July 2019 till 23 July

2024POM

1053 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/gY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1054 BRU14071409P Asumalife Syrup 1.38mg/5mlPer 5ml - Ketotifen 1mg (as hydrogen

fumarate 1.38mg)

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

MalaysiaAsterix United (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1055 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mgY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1056 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd24 July 2019 till 23 July

2024POM

1057 BRU14071412NP Zoben Tablet 200mg Albendazole 200mgPharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

24 July 2019 till 23 July

2024P (10 x 10's)

1058 BRU14071414P Garbose Tablet 50mg Acarbose 50mgY.S.P. Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd

24 July 2019 till 23 July

2024POM

1059 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

24 July 2019 till 23 July

2024POM

1060BRU14081416PS1;

BRU14081416PS2Sevorane 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 2024POM

1061BRU14081417PS1;

BRU14081417PS2Emend 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 Bhd30 August 2019 till 29

August 2024POM

1062 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 2024POM

1063 BRU14081419PS2Exforge 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 2024POM

BDMCA/RMP/0719 Page 71 of 157

Page 72: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1064 BRU14081420PS2Exforge 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 2024POM

1065 BRU14081421PS2Exforge 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 2024POM

1066 BRU14081422PS2Exforge 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 2024POM

1067 BRU14081423PS2Exforge 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 2024POM

1068 BRU14081424PLuveris 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 2024POM

1069 BRU14081425PLipanthyl Penta 145 Film-

Coated tabletFenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1070 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mgBeacons Pharmaceuticals, Pte ltd,

SingaporeHongkiat Trading & Co

30 August 2019 till 29

August 2024POM

1071 BRU14081427P FlixotideTM Evohaler 50mcg Fluticasone Propionate 50mcg GlaxoWellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd30 August 2019 till 29

August 2024POM

1072BRU14081428PS1

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 Bhd30 August 2019 till 29

August 2024POM

1073BRU14081429PS1

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 Bhd30 August 2019 till 29

August 2024POM

1074BRU14081430PS1

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 Bhd30 August 2019 till 29

August 2024POM

1075

BRU14081432PS1;

BRU14081432PS3;

BRU14081432PS4

Mabthera Concentrate for

Solution for Infusion

100mg/10ml

Rituximab 100mg/10ml

Genetech Inc., South San Francisco

CA, USA (S1); Roche Diagnostics

GmbH, Germany (S3); Genentech Inc.,

Hilsboro, OR, USA (S4)

MediPharm Sdn Bhd30 August 2019 till 29

August 2024POM

1076 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vialPharmacia & Upjohn Company LLC,

USAZuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1077 BRU14081434P Moxiclav 1G Tablet

Amoxycillin 875mg (as sodium);

Clavulanic Acid 125mg (as Clavulanate

potassium)

Medochemie Ltd., Cyprus Hongkiat Trading & Co30 August 2019 till 29

August 2024POM

BDMCA/RMP/0719 Page 72 of 157

Page 73: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1078 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2024 till 29

August 2029POM

1079 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company30 August 2019 till 29

August 2024POM

1080 BRU14081440PNaphcon-A Sterile Ophthalmic

Solution

Naphazoline Hydrochloride 0025%;

Pheniramine maleate 0.3%S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co

30 August 2014 till 29

August 2019 (in process for

renewal)

P

1081 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mgGlaxosmithkline Pharmaceuticals SA,

PolandZuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1082 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2019 till 29

August 2024P

1083 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2019 till 29

August 2024POM

1084 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mgBiosis Pharmaceuticals Sdn Bhd.,

MalaysiaK-Seri Pharma Sdn Bhd

30 August 2019 till 29

August 2024POM

1085 BRU14081449PMircera Pre-filled Syringe

75mcg/0.3ml

Methoxy polyethylene glycol-epoetin

Beta 75mcg/0.3mlRoche Diagnostics GmbH, Germany MediPharm Sdn Bhd

30 August 2019 till 29

August 2024POM

1086 BRU14081450P Creobic Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia Yuh Hua Trading Company30 August 2019 till 29

August 2024GSL

1087 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2019 till 29

August 2024P

1088 BRU14081453P Sunex Cough Syrup

Per 5ml - Diphenhydramine HCl 14mg;

Ammonium chloride 135mg; Sodium/

Trisodium citrate 57.5mg

Sunward Pharmaceutical Sdn Bhd

MalaysiaG & H Trading Company

30 August 2019 till 29

August 2024POM

1089 BRU14081455PProluton Depot 250mg

InjectionHydroxyprogesterone Caproate 250mg Bayer AG, Berlin, Germany Zuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1090 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 August 2019 till 29

August 2024P

1091 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd30 August 2019 till 29

August 2024POM

1092 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mgY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1093 BRU14081459PClamentin Powder for Syrup

31.25mg/ml

Per ml - Amoxycillin 25mg (as

trihydrate); Clavulanic acid 6.25mg (as

potassium salt)

Yung Shin Pharmaceutical Ind. Co.,

Ltd, Taiwan, R.O.C.Asterix United (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1094 BRU14081460PClarimycin Film Coated Tablet

500mgClarithromycin 500mg

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

MalaysiaAsterix United (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1095 BRU14081461NP Mentar ShampooCoal Tar solution 9% v/v; Menthol 1%

w/w

HOE Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2019 till 29

August 2024GSL

1096 BRU14081462NP Menzza CreamMethyl Salicylate 25%w/w; Menthol

5%w/w

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2019 till 29

August 2024GSL

BDMCA/RMP/0719 Page 73 of 157

Page 74: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1097 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid)PT Bayer Indonesia, Indonesia

Zuellig Pharma (B) Sdn Bhd30 August 2019 till 29

August 2024GSL

1098BRU14081467P;

BRU14081467PS2

Tobradex® Eye Drops

Suspension

Tobramycin 0.3%; Dexamethasone

0.1%

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

Alcon Singapore Manufacturing Pte.

Ltd., Singapore (S2)

Hongkiat Trading & Co

Zuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1099 BRU14081469P Tamoxifen 20mg Tablet Tamoxifen 20mg (as citrate 30.4mg)Teva Pharmaceutical Industries Ltd,

IsraelK-Seri Pharma Sdn Bhd

30 August 2014 till 29

August 2019POM

1100 BRU14081470PRotaqor 10mg film-coated

tabletAtorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd

30 August 2024 till 29

August 2029POM

1101 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company30 August 2019 till 29

August 2024POM

1102 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 Bhd30 August 2019 till 29

August 2024GSL

1103 BRU14081475P Cera-Scalp OintmentCoal Tar solution 12% w/w; Salicylic

acid 2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

30 August 2019 till 29

August 2024GSL

1104 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd30 August 2024 till 29

August 2029POM

1105BRU14091477P Suprane Inhalation Liquid

100%

Desflurane 100% Baxter Healthcare Corporation,

Puerto Rico, USAZuellig Pharma (B) Sdn Bhd

30 August 2019 till 29

August 2024POM

1106BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 August 2019 till 29

August 2024P

1107BRU14091479PS1;

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

1108BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1109BRU14091481P Xolair Powder and Solvent for

Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1110BRU14091483P Pengesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2019 till 29

September 2024

POM

1111BRU14091486P Crinone Progestrone Vaginal

Gel 8%

Progestrone 8% Fleet Laboratories Ltd, United

Kingdom

G & H Trading Company 30 September 2019 till 29

September 2024

POM

1112BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd.,

AustraliaZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

GSL

1113BRU14091488P 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

1114BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2019 till 29

September 2024

POM

1115BRU14091490P Trileptal 600mg Film-coated

Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

BDMCA/RMP/0719 Page 74 of 157

Page 75: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1116BRU14091491P Binozyt 500mg film-coated

tablet

Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd.,

BangladeshZuellig Pharma (B) Sdn Bhd

30 September 2024till 29

September 2029

POM

1117BRU14091492P Nurofen 400 Caplet Ibuprofen 400mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29

September 2019

P

1118BRU14091494P Eprex® 10000 Prefilled

Syringes 10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1119BRU14091501P 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

GSL

1120BRU14091502P 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

1121BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 30 September 2019 till 29

September 2024

POM

1122BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride

2.8mg)

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co

Zuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1123BRU14091505P Nurofen Caplet 200mg Ibuprofen 200mg Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Zuellig Pharma (B) Sdn Bhd30 September 2014 till 29

September 2019

p

1124BRU14091506P 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

1125BRU14091507P Afinitor 2.5mg Tablet Everolimus 2.5mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1126BRU14091508P 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

1127BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 30 September 2019 till 29

September 2024

p

1128BRU14091510P Difnal-K Tablet 50mg Diclofenac Potassium 50mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 30 September 2014 till 29

September 2019

POM

1129BRU14091511NP 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

1130

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

1131BRU14091513P HBVaxPro® 5mcg/0.5ml

Injection

Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme Corp., West

Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1132BRU14091514P HBVaxPro® 10mcg/1.0ml

Injection

Hepatitis B surface Antigen

10mcg/1.0ml

Merck Sharp & Dohme Corp., West

Point, Pensylvania, USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

BDMCA/RMP/0719 Page 75 of 157

Page 76: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1133BRU14091515P HBvaxPro® 40mcg/1.0ml

Injection

Hepatitis B surface Antigen

40mcg/1.0ml

Merck Sharp & Dohme Corp., USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1134BRU14091516P 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

1135BRU14091517P Stalevo 125/31.25/200mg film-

coated tablet

Levodopa 125mg, Carbidopa 31.25mg,

Entacapone 200mg

Orion Corporation, Espoo, FinlandZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1136BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1137

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 2019 till 29

September 2024

GSL

1138BRU14091521P Ospexin 500mg Film-coated

Tablets

Cefalexin 500mg (as monohydrate) Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

30 September 2024 till 29

September 2029

POM

1139BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 30 September 2019 till 29

September 2024

GSL

1140BRU14091524P 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

1141BRU14091525P Calumid 50mg Film-coated Bicalutamide 50mg Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 30 September 2019 till 29

September 2024

POM

1142BRU14091526P 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

1143BRU14091527P 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

1144BRU14091528P Campto 300mg/15ml

Injection

Irinotecan Hydrochloride Trihydrate

300mg/15ml

Pfizer (Perth) Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1145BRU14091529NP 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

1146BRU14091530NP Strepsils Sugar Free Lemon

Lozenges

Each lozenge contains: Amymetacresol

0.6mg, 2,4-Dichlorobezyl alcohol

1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Rajamas Bersama

Syarikat Aliaa Sdn Bhd

30 September 2019 till 29

September 2024

GSL

1147BRU14091533P 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

1148BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 30 September 2019 till 29

September 2024

POM

BDMCA/RMP/0719 Page 76 of 157

Page 77: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1149

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 2019 till 29

September 2024

GSL

1150BRU14091538P 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

1151

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

1152BRU14091540P Eturion 10mg Film Coated

Tablet

Atorvastatin 10mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

RicoZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1153BRU14091541P Eturion 20mg Film Coated

Tablet

Atorvastatin 20mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1154BRU14091542P Eturion 40mg Film Coated

Tablet

Atorvastatin 40mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceutical LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1155BRU14091543P Eturion 80mg Film Coated

Tablet

Atorvastatin 80mg (as crystalline

atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto

Rico, USAZuellig Pharma (B) Sdn Bhd

30 September 2019 till 29

September 2024

POM

1156

BRU14111544P (vial) EYLEA Solution for Injection

(vial)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USA; Vetter Pharma-Fertigung

GmbH & Co. KG (Langenargen

Manufacturing Plant), Langenargen,

Germany and Bayer AG, Berlin,

Germany (Manufacture of filled vial

(including sterile filtration, filling –

primary packaging), In-process

testing,

Quality control testing of filled vial,

Visual inspection and interim storage

of filled vial)

Zuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

POM

1157BRU14111545P EYLEA Solution for Injection

(pre-filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New

York, USA Zuellig Pharma (B) Sdn Bhd01 November 2019 till 31

October 2024

POM

BDMCA/RMP/0719 Page 77 of 157

Page 78: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1158BRU14111546P Binocrit Solution for Injection

2000 IU/ml in Pre-filled

Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd

01 November 2024 till 31

October 2029

POM

1159BRU14111547P Binocrit Solution for Injection

4000 IU/0.4ml in Pre-filled

Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, GermanyZuellig Pharma (B) Sdn Bhd

01 November 2024 till 31

October 2029

POM

1160BRU14111550P Advagraf Prolonged Release

Hard Capsule 0.5mg

Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandMediPharm Sdn Bhd

01 November 2019 till 31

October 2024

POM

1161BRU14111551P Advagraf Prolonged Release

Hard Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., IrelandMediPharm Sdn Bhd

01 November 2019 till 31

October 2024

POM

1162BRU14111552P Advagraf Prolonged Release

Hard Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., IrelandMediPharm Sdn Bhd

01 November 2019 till 31

October 2024

POM

1163BRU14111553P Dynastat Powder and Solvent

for Solution for Injection

40mg

Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company LLC,

USA Zuellig Pharma (B) Sdn Bhd01 November 2019 till 31

October 2024

POM

1164BRU14111554P Invanz Powder for Injection

1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-

Chibret, FranceZuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

POM

1165

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

(repacker - Eli Lilly And Company,

USA)

Zuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

POM

1166BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

1167BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 01 November 2019 till 31

October 2024

GSL

1168BRU14111558P 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

1169BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium

Bicarbonate 1.737g; Citric Acid

(anhydrous) 1.223g.

Bayer de Mexico SA De CV, MexicoZuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

GSL

1170BRU14111560P 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

1171BRU14111561NP 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

1172

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

1173BRU14111564P 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

BDMCA/RMP/0719 Page 78 of 157

Page 79: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1174BRU14111565P NIMBEXTM Injection 2mg/ml

(5ml)

Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing

S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

POM

1175BRU14111566P 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 Bhd01 November 2019 till 31

October 2024

POM

1176BRU14111567P 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

1177BRU14111568P 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

1178BRU14111569P 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

1179

BRU14111570P Olmetec Plus 20/12.5mg Film-

coated Tablet

Olmesartan Medoxomil 20mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

Germany; Pfizer Manufacturing

Deutschland GmbH, Germany

(primary and secondary packaging

site)

Zuellig Pharma (B) Sdn Bhd

01 November 2019 till 31

October 2024

POM

1180

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

1181BRU14111573P Eliquis Film-coated Tablets

2.5mg

Apixaban 2.5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd01 November 2019 till 31

October 2024

POM

1182BRU14111574P 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

1183BRU14111575P 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

1184BRU14111576NP 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

1185BRU14111577NP 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

1186BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2019 till 31

October 2024

POM

1187BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 01 November 2019 till 31

October 2024

POM

1188BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31

October 2024

POM

BDMCA/RMP/0719 Page 79 of 157

Page 80: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1189

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

1190BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 01 November 2019 till 31

October 2024

POM

1191

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

1192BRU14111584NP Panamol Forte Suspension

250mg/5ml

Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 01 November 2019 till 31

October 2024

P (3.8L)

1193

BRU14111585PS1,

BRU14111585PS2,

BRU14111585PS3,

BRU14111585PS4

Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised

anti-VEGF monoclonal antibody)

Genentech Inc., South San Francisco,

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

1194BRU14111586P Zyvox 20mg/ml Granules For

Oral Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USAZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1195BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1196BRU14111589P Resolor film-coated tablet

1mg

Prucalopride 1mg (as succinate

1.321mg)

Janssen-Cilag SpA., ItalyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1197BRU14111590NP 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 2020 till 18 May

2025

GSL

1198BRU14111591P Pristiq 50mg Extended-

Release Tablets

Desvenlafaxine 50mg (as succinate

75.87mg)

Pfizer Ireland Pharmaceuticals,

IrelandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1199BRU14111592P ElIquis 5mg Film-coated

Tablet

Apixaban 5mg Bristol-Myers Squibb Manufacturing

Company, Puerto Rico, USA Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1200BRU14111593P 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

BDMCA/RMP/0719 Page 80 of 157

Page 81: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1201

BRU14111595P Advate 250 IU Powder and

Solvent for Solution for

Injection

Octocog alfa (recombinant human

coagulation factor VIII) 250 IU

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

1202BRU14111597NP 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 2020 till 18 May

2025

GSL

1203

BRU14111598PS1 &

BRU14111598PS2

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 (S1) &

Merck Serono S.A., Switzerland (S2)

G & H Trading Company 19 May 2020 till 18 May

2025

POM

1204BRU14111599P 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

1205BRU14111600P 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

1206

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

1207BRU14111603P 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

1208BRU14111604NP 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

1209BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1210BRU14111606NP 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

1211BRU14111607NP 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 2020 till 18 May

2025

POM

1212BRU14111608P Binozyt 200mg/5ml Powder

for Oral Suspension

Azithromycin 200mg Sandoz S.R.L., RomaniaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

BDMCA/RMP/0719 Page 81 of 157

Page 82: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1213

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

1214BRU14111610NP 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

GSL

1215BRU14111611P Kogrel 75mg Film Coated

Tablet

Clopidogrel 75mg (as bisulfate

97.875mg)

Sandoz Private Limited, Mumbai,

IndiaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1216BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd,

Singapore

Hongkiat Trading & Co 19 May 2015 till 18 May

2020

P

1217BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2020 till 18 May

2025

GSL

1218BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1219BRU14111615P Curam 156.25mg/5ml Powder

for Oral Suspension

Per 5ml - Amoxycillin 125mg (as

trihydrate); Clavulanic acid 31.25mg

Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1220BRU14111617P 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

1221BRU14111618NP 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

1222BRU14111620P Storvas Tablet 20mg Atorvastatin 20mg (as calcium) Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

1223BRU14111621P 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

1224BRU14111622NP 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)

1225BRU14111623P 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

1226BRU14111624P 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

1227BRU14111625P 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

1228BRU14111626P Lovir Tablets 200mg Acyclovir 200mg Ranbaxy (Malaysia) Sdn. Bhd.,

Malaysia

G & H Trading Company 19 May 2015 till 18 May

2020

POM

BDMCA/RMP/0719 Page 82 of 157

Page 83: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1229BRU14111627P;

BRU14111627PS2

Cellcept Tablet 500mg Mycophenolate mofetil 500mg Delpharm Milano S.r.I., Italy;

Recipharm Leganes, S.L.U., Spain (S2)

Hongkiat Trading & Co 19 May 2020 till 18 May

2025

POM

1230BRU14111628NP 0.45% Sodium Chloride

Intravenous Infusion B.P

Sodium Chloride 0.45% B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May

2025

P

1231BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) Sandoz GmbH, Austria; Aurobindo

Pharma Limited, IndiaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1232BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany

Sandoz GmbH, Austria; Aurobindo

Pharma Limited, India

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1233

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 Kabi Norge AS, Norway

Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1234BRU14111633P 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 2020 till 18 May

2025

POM

1235BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd 19 May 2015 till 18 May

2020

POM

1236BRU14111635NP 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 2020 till 18 May

2025

GSL

1237BRU14111636P 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

1238BRU14111637NP 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) & 4L

1239BRU14111638P Primovists 0.25mmol/ml

solution for injection

Gadoxetic acid, Sodium 0.25mmol/ml Bayer AG, Berlin, GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1240BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2020 till 18 May

2025

GSL (60mL)

1241BRU14111642P 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

1242BRU14111643NP Woodward's Gripe Water

(Alcohol Free)

Per 5ml - Terpeneless Dill Seed Oil

2.3mg; Sodium Bicarbonate 52.5mg

Olic Thailand Limited, Thailand Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1243BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd., Taiwan G & H Trading Company 19 May 2020 till 18 May

2025

POM

1244BRU14111645NP Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd

Malaysia

G & H Trading Company 19 May 2020 till 18 May

2025

GSL

BDMCA/RMP/0719 Page 83 of 157

Page 84: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1245

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

1246BRU14111647P Vesyca Film Coated Tablet

150mg

Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May

2025

POM

1247BRU14111648P Pharmaniaga Cetirizine 10mg

tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 19 May 2020 till 18 May

2025

P

1248BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May

2025

POM

1249BRU14111650P Invokana Film-coated Tablet

100mg

Canagliflozin 100mg (as hemihydrate) JANSSEN ORTHO, LLC, Puerto Rico,

USA [Repacker: Janssen-Cilag SpA,

Italy)

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1250BRU14111651P 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

1251BRU14111652P Binozyt Film-Coated Tablet

250mg

Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd.,

BangladeshZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1252

BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 19 May 2020 till 18 May

2025

POM (100 x 10's;

10 x 10's

1253BRU14111654NP Paracetamol Kabi Solution for

infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Deutschland GmbH,

Germany AB ii) Fresenius Kabi Austria

GmbH, Austria

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1254BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1255 BRU14121661P Kastipron Tablet 375mgS-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1256 BRU14121662P Ipolipid Capsules 300mgGemfibrozil 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1257 BRU14121663PCuram 625mg Film-coated

TabletAmoxicillin 500mg; Clavulanic acid as

potassium salt 125mg

Sandoz GmbH, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1258 BRU14121664P Vesyca Injection 25mg/mlRanitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical Ind. Co.,

Ltd, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1259 BRU14121666P Amoxicap 500 CapsuleAmoxicillin (as trihydrate 574mg)

500mg

Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May

2025

POM

1260 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 2020 till 18 May

2025

GSL

1261 BRU14121668NP50% Glucose Intravenous

Infusion B.P.

Glucose monohydrate (550.00g) eq. to

anhydrous glucose 500.0g/1000ml

B.Braun Medical Industries Sdn Bhd.,

Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May

2025

POM

BDMCA/RMP/0719 Page 84 of 157

Page 85: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU14121670P Medoflucon Capsule 150mgFluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2015 till 18 May

2020

POM

1263 BRU14121671P Topamax 100 Tablets 100mgTopiramate 100mg Cilag AG, Switzerland

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1264 BRU14121672NPDuratears Ocular Lubricant

Ointment

Mineral Oil 30.0mg/g, Anhydrous liquid

lanolin 30.0mg/g and white petrolatum

q.s. ad 1g

S.A. Alcon-Couvreur N.V., Belgium Hongkiat Trading & Co 19 May 2015 till 18 May

2020

GSL

1265 BRU14121673PEprex® 40,000 Prefilled

Syringes 40,000iu/1ml

Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH & Co.

KG, Germany; Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1266 BRU14121674P Milosec Capsule 20mgOmeprazole 20mg The United Drug (1966) Co. Ltd.,

Thailand

Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1267 BRU14121675P Ziagen Oral SolutionAbacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1268 BRU14121677PPataday 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 2020 till 18 May

2025

POM

1269 BRU14121678P Provironum Tablet 25mgMesterolone 25mg Schering Do Brasil Quimica e

Farmaceutica Ltda., San Paulo-SP,

Brazil

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025

POM

1270 BRU14121681NPStrepsils Strawberry Sugar

Free Children LozengeAmylmetacresol 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

1271 BRU14121682PAxcel Sodium Fusidate 250

TabletSodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1272 BRU14121683P Pencor 1mg tabletDoxazosin Mesylate (eq. to Doxazosin

1mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May

2025

POM

1273 BRU14121684P Pencor 2mg tabletDoxazosin Mesylate (eq. to Doxazosin

2mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May

2025

POM

1274 BRU14121685P Pencor 4 TabletDoxazosin Mesylate (eq. to Doxazosin

4mg)

Unison Laboratories Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May

2025

POM

1275 BRU14121686P Decan Injection 2mg/mlDexamethasone Sodium Phosphate

2.2mg (eq. to Dexamethasone

Phosphate 2mg)

Yung Shin Pharmaceutical Ind. Co.,

Ltd, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1276 BRU14121690P Seladin 500mg tabletNaproxen 500mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1277 BRU14121691P Driminate 50mg SuppositoryDimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd.,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May

2025

P (10 x 10's)

1278 BRU14121692NPHurix's Panau Salap &Gatal-

Gatal Kecil

Zinc oxide 5% w/w; Menthol 1% w/w;

Salicylic Acid/2-Hydroxybenzoic acid

5% w/w & Camphor 3% w/w

Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

1279 BRU14121693NPHurix Corn Rid Solution 5%

w/wlactic Acid 5% w/v; Salicylic Acid 17%

w/v

Dynapharm (M) Sdn Bhd, Malaysia Yuh Hua Trading Company 19 May 2015 till 18 May

2020

GSL

BDMCA/RMP/0719 Page 85 of 157

Page 86: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1280 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

1281 BRU14121695P Axcel Fungicort CreamMiconazole nitrate 2%w/w;

Hydrocortisone 1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 19 May 2015 till 18 May

2020

POM

1282 BRU14121697NPDettol Antiseptic Wound

Wash Spraybenzalkonium chloride 0.198% Reckitt Benckiser Healthcare (UK)

Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1283 BRU14121698PEdurant Film-Coated 25mg

tabletRilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1284 BRU14121699P Invokana 300mg FCTCanagliflozin 300mg (as hemihydrate) JANSSEN ORTHO, LLC, Puerto Rico,

USA [Repacker: Janssen-Cilag SpA,

Italy)

Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020

POM

1285 BRU14121700P Amlodipine Tablet 10mgAmlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1286 BRU14121701P Borymycin Capsule 100mgMinocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd,

Malaysia

Asterix United (B) Sdn Bhd 19 May 2015 till 18 May

2020

POM

1287 BRU14121702NP Septi-Sol SolutionChlorhexidine Gluconate 20% Solution -

0.5% w/v; Ethanol 94% - 77% v/v

Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May

2025

GSL

1288 BRU14121703PAtoris Film-coated Tablet

20mgAtorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May

2025

POM

1289 BRU14121704NPNutrilite Glucosamine HCl

Capsule 375mgGlucosamine HCl 375mg Pharmaniaga Manufacturing Berhad,

Malaysia

Amway Sdn Bhd 19 May 2015 till 18 May

2020

GSL

1290 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 Bhd19 May 2015 till 18 May

2020

POM

1291 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co19 May 2015 till 18 May

2020POM

1292 BRU15011711P DiSuf-B CreamFusidic acid (micronized) 2.0% w/w &

Betamethasone 0.1%w/w (as valerate)Hovid Bhd, Malaysia G & H Trading Company

19 May 2020 till 18 May

2025 POM

1293 BRU15011713PBinoclar® 500mg Film-coated

TabletsClarithromycin 500mg Novartis Bangladesh Ltd, Bangladesh Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1294 BRU15011714POspamox 250mg/5ml

granules for suspension

Amoxicillin 250mg (as trihydrate

287mg) Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1295 BRU15011716POspamox 500mg Film-coated

Tablet

Amoxicillin 500mg (as trihydrate

574mg)Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1296 BRU15011717P

Salofalk® 500mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

1297 BRU15011718P

Salofalk® 1000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 1000mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

BDMCA/RMP/0719 Page 86 of 157

Page 87: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1298 BRU15011719P Vaqta® Vaccine 50U/mlHepatitis A Virus, Purified, Inactivated

50U/mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1299 BRU15011720P Vaqta® Vaccine 25U/0.5mlHepatitis A Virus, Purified, Inactivated

25U/0.5mlMerck Sharp & Dohme Corp., USA Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1300 BRU15011721P

Salofalk® 3000mg Gastro-

Resistant Prolonged-Release

Granules

Mesalazine 3g Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd19 May 2015 till 18 May

2020 POM

1301 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1%Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025POM

1302 BRU15011723PClarimycin Film Coated Tablet

250mgClarithromycin 250mg

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

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1303 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

1304 BRU15011725PTorisel Concentrate for

Injection 25mg/mlTemsirolimus 25mg/ml

Pierre Fabre Medicament Production

(PFMP), FranceZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1305 BRU15011726PUrsofalk 500mg Film-coated

TabletsUrsodeoxycholic acid 500mg Losan Pharma GmbH, Germany LF Asia (Borneo) Sdn Bhd

19 May 2015 till 18 May

2020POM

1306 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

2020POM

1307 BRU15011728PHexaxim Suspension for

Injection

Per dose (0.5ml):

Dipththeria toxoid 30 Lf (≥ 20IU),

Tetanus toxoid 10 Lf (≥ 40IU),

Bordetella pertussis antigens: Pertussis

toxoid 25µg, Filamentous

haemagglutinin 25µg, Polio Virus

(Inactivated): Type 1 (Mahoney) 40 DU,

Type 2 (MEF-1) 8 DU, Type 3 (Saukett)

32 DU, Hepatitis B surface antigen 10

µg, Haemophilus influenzae tybe b

polysaccharide (Polyribosylribitol

phosphate) . 12µg, conjugated to

Tetanus protein (PRP-T) 22-36µg

Sanofi Pasteur Marcy I’Etoile (MLE),

France; Sanofi Pasteur Val de Reuil,

France; Sanofi Pasteur SPA, Italy

Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1308

BRU15011730PS1;

BRU15011730PS3Bridion Solution for Injection

100mg/mlSugammadex 100mg/ml

N.V. Organon, The Netherlands (S1);

Patheon Manufacturing Services LLC,

USA (S3)

Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025 POM

1309 BRU15011731P Serlift Tablets 100mg Setraline hydrochloride 100mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0719 Page 87 of 157

Page 88: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1310 BRU15011732NPStrepsils Soothing Honey &

Lemon Lozenge

Amylmetacresol 0.6ml; 2,4-

Dichlorobenzyl alcohol 1.2mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May

2020 GSL

1311 BRU15011733NPStrepsils Max Blackcurrant

LozengeHexylresorcinol 2.4mg

Reckitt Benckiser Healthcare

Manufacturing (Thailand) Limited,

Thailand

Syarikat Aliaa Sdn Bhd19 May 2015 till 18 May

2020 GSL

1312 BRU15011734P Implanon NXT Implant 68mg Etonogestrel 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025POM

1313 BRU15011735PS2 Stocrin Tablet 200mg Efavirenz 200mgZhejiang Huahai Pharmaceutical Co.

Ltd., ChinaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1314 BRU15011736PS2 Stocrin Tablet 600mg Efavirenz 600mgZhejiang Huahai Pharmaceutical Co.

Ltd., ChinaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1315 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/vInterphill Laboratories Inc.,

PhilippinesLF Asia (Borneo) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1316 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

2020GSL

1317 BRU15011740P Nicotinell TTS 20 Nicotine 35mg (delivers 14mg/24

hours)

LTS Lohmann Therapie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1318 BRU15011741P Nicotinell TTS 30 Nicotine 52.5mg (delivers 21mg/24

hours)

LTS Lohmann Therapie-System AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020GSL

1319 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, AustraliaBossom Buddies Enterprise

19 May 2015 till 18 May

2020 GSL

1320 BRU15011743PPharmaniaga Germacid Cream

2%Fusidic acid 2.0% w/w

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025POM

1321 BRU15011744PExtraneal Peritoneal Dialysis

Solution 75g/l (2L Ultrabag)

Each 100ml contains Icodextrin 7.5g,

Sodium Chloride 538mg,

Sodium lactate 448mg, Calcium

chloride dihydrate 25.7mg and

Magnesium Chloride Hexahydrate

5.08mg

Baxter Healthcare SA., Singapore

BranchZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

GSL

1322 BRU15011745P Seladin 250mg tablet Naproxen 250mgY.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1323 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 2020 till 18 May

2025

POM

BDMCA/RMP/0719 Page 88 of 157

Page 89: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1324 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 2020 till 18 May

2025

POM

1325 BRU15011748P Caslot 6.25mg tablet Carvedilol 6.25mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1326 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1327 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 2020 till 18 May

2025

GSL

1328 BRU15021751PKogenate FS for Injection

1000IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 1000IU Bayer AG, Berlin Germany Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

1329 BRU15021752PKogenate FS for Injection

500IU/vial

Antihemophilic factor (recombinant)

sucrose formulated 500IUBayer AG, Berlin Germany Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

1330 BRU15021754PCernevit Multivitamin Powder

for Injection

Each vial contains: Retinol palmitate

(VitaminA) 3500 IU, Cholecalciferol

(Vitamin D3) 220 IU, DL alpha

tocopherol (Vitamin E) 10.2 mg,

Ascorbic acid (Vitamin C) 125mg,

Cocarboxylase tetrahydrate (Vitamin

B1) 5.8mg, Riboflavin sodium

phosphate dehydrate (Vitamin B2)

5.67mg, Pyridoxine hydrochloride

(Vitamin B6) 5.5mg, Cyanocobalamin

(Vitamin B12) 0.006mg, Folic acid

0.414mg, Dexpanthenol 16.15mg,

Biotin 0.069mg, Nicotinamide 46mg

Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1331 BRU15021755P Baneocin OintmentBacitracin Zinc 250IU/1g; Neomycin

Sulphate 5000 IU (5mg)/1g

Merck Kommanditgesellschaft Auf

Aktein & Co., Werk, AustriaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

BDMCA/RMP/0719 Page 89 of 157

Page 90: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1332 BRU15021756POspexin 125mg/5ml granules

for oral suspensionCephalexin 125mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

1333 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 Bhd19 May 2015 till 18 May

2020POM

1334 BRU15021758P Histac Tablets 150mg Ranitidine Hydrochloride 150mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1335 BRU15021759PBeclazone 100micrograms

CFC-Free Inhaler

Beclomethasone Dipropionate

100micrograms/metered inhalation

Norton Waterford T/A Ivax

Pharmaceuticals IrelandG & H Trading Company

19 May 2015 till 18 May

2020 POM

1336BRU15021760PS1 &

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 Bhd19 May 2015 till 18 May

2020 POM

1337 BRU15021761P Covapril Tablet 4mg Perindopril ErbumineUpha Pharmaceutical Mfg (M) Sdn

Bhd, MalaysiaK-Seri Pharma Sdn Bhd

19 May 2020 till 18 May

2025POM

1338 BRU15021762P Axcel Amlodipine 5mg TabletAmlodipine Besylate equivalent to

Amlodipine 5mgKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

19 May 2015 till 18 May

2020POM

1339 BRU15021763P Neurontin Capsule 400mg Gabapentin 400mgPfizer Pharmaceuticals LLC., Puerto

RicoZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1340 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Laboratories Inc., USA Hongkiat Trading & Co19 May 2015 till 18 May

2020POM

1341 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 2020 till 18 May

2025 POM

1342 BRU15021766PNeulastim Pre-filled Syringe

6mg/0.6mlPegfilgrastim 6mg/0.6ml

Amgen manufacturing Limited (AML),

Puerto Rico, United States Medipharm Sdn Bhd19 May 2020 till 18 May

2025 POM

1343 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

1344 BRU15021768P Exelon Patch 15Rivastigmine base 27mg / 15cm2 (In

vivo release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme AG,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1345 BRU15021769NPZellox-II, Double Strength

Liquid Antacid

Per 10ml - Aluminium Hydroxide

800mg; Magnesium Hydroxide 800mg;

Simethicone 60mg

Hoe Pharmaceuticals Sdn Bhd

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025 GSL

1346 BRU15021770P Bonjela Gel 15g tubeCholine Salicylate 8.714% &

Cetalkonium chloride 0.01%

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

19 May 2015 till 18 May

2020GSL

BDMCA/RMP/0719 Page 90 of 157

Page 91: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1347 BRU15021771P Gilenya 0.5mg hard capsuleFingolimod 0.5mg (corresponding to

0.56mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020 POM

1348 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2020 till 18 May

2025POM

1349 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd19 May 2020 till 18 May

2025POM

1350 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/mlY.S.P. Industries (M) Sdn Bhd

MalaysiaAsterix United (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1351 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

1352 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May

2020POM

1353 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd19 May 2015 till 18 May

2020POM

1354 BRU15021779PTrajenta Duo 2.5mg/500mg

FCT tablet

Linagliptin 2.5mg; Metformin

hydrochloride 500mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1355 BRU15021780PTrajenta Duo 2.5mg/850mg

FCT

Linagliptin 2.5mg; Metformin

hydrochloride 850mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1356 BRU15021781PTrajenta Duo 2.5mg/1000mg

film-coated tablets

Linagliptin 2.5mg; Metformin

hydrochloride 1000mg

Boehringer Ingelheim GmbH and Co.

KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025 POM

1357 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd19 May 2015 till 18 May

2020POM

1358 BRU15021784PToviaz 4mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

3.1mg fesoterodine

Aesica Pharmaceuticals GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1359 BRU15021785PToviaz 8mg prolonged-release

tablet

Fesoterodine fumarate equivalent to

6.2mg fesoterodine

Aesica Pharmaceuticals GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1360 BRU15021786PGiotrif 20mg film-coated

tablets (Afatinib 20mg)Afatinib (as dimaleate) 20mg

Boehringer Ingelheim Pharma GmbH

and Co. KG., Germany Hongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1361 BRU15021787PGiotrif 30mg film-coated

tablets (Afatinib 30mg)Afatinib (as dimaleate) 30mg

Boehringer Ingelheim Pharma GmbH

and Co. KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1362 BRU15021788PGiotrif 40mg film-coated

tablets (Afatinib 40mg)Afatinib (as dimaleate) 40mg

Boehringer Ingelheim Pharma GmbH

and Co. KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1363 BRU15021789PGiotrif 50mg film-coated

tablets (Afatinib 50mg)Afatinib (as dimaleate) 50mg

Boehringer Ingelheim Pharma GmbH

and Co. KG., GermanyHongkiat Trading & Co

19 May 2020 till 18 May

2025POM

1364 BRU15021790PMikostat oral suspension 30ml

(Nystatin 100,000 IU/ml)Nystatin 100,000 IU/ml

Gulf Pharmaceutical Industries

(Julphar), United Arab EmiratesK-Seri Pharma Sdn Bhd

19 May 2015 till 18 May

2020 POM

BDMCA/RMP/0719 Page 91 of 157

Page 92: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1365 BRU15021793NPSMOFlipid 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 2020 till 18 May

2025POM

1366 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 2020 till 18 May

2025

POM

1367 BRU15021795P Ceflour CFT 250mgCefuroxime (as Cefuroxime Axetil)

250mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Republic of ChinaAsterix United (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1368 BRU15021796PMontelair 10mg film-coated

tablet

Montelukast (as Montelukast Sodium)

10mgHovid Bhd., Malaysia G & H Trading Company

19 May 2020 till 18 May

2025POM

1369 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate)

10mgLek Pharmaceuticals D.D., Solvenia Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1370 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 GSL (3L Drain Bag

/ PL146-2;

2.5L Drain Bag /

PL-19779

1371 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 GSL (3L Drain Bag

/ PL146-2;

2.5L Drain Bag /

PL-19779

1372 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

BranchZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 GSL (3L Drain Bag

/ PL146-2;

2.5L Drain Bag /

PL-19779

1373 BRU15021801NP CALACTATE TABLET 300MG Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company19 May 2020 till 18 May

2025GSL

1374 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mgPharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025POM

BDMCA/RMP/0719 Page 92 of 157

Page 93: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1375 BRU15021803PColospan 10mg sugar coated

tabletHyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company

19 May 2020 till 18 May

2025POM

1376 BRU15021804P Caslot 25mg tablet Carvedilol 25mgRanbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2015 till 18 May

2020POM

1377 BRU15021805P Serenata 50mg TabletSertraline hydrochloride 56mg

equivalent to Sertraline 50mgTorrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd

19 May 2015 till 18 May

2020POM

1378 BRU15021806P Gammaplex 5% w/v 2.5g Human Immunoglobulin G 2.5g/50ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1379 BRU15021807P Gammaplex 5% w/v 5g Human Immunoglobulin G 5g/100ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1380 BRU15021808P Gammaplex 5% w/v 10g Human Immunoglobulin G 10g/200ml Bio Product Lab, UK Medipharm Sdn Bhd19 May 2015 till 18 May

2020POM

1381 BRU15031809PMoxiclav Forte Dry Powder for

Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg &

Clavulanic acid 62.5mgMedochemie Ltd., Cyprus

Hongkiat Trading &

Company

19 May 2015 till 18 May

2020 POM

1382 BRU15031810P Moxiclav 625mg Tablets

Amoxicllin trihydrate (574mg) 500mg;

clavulanate potassium microcrystalline

cellulose (297.8mg) eq. to clavulanic

acid 125mg

Medochemie Ltd., CyprusHongkiat Trading &

Company

19 May 2015 till 18 May

2020POM

1383 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Hospira S.p.A., Italy Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025POM

1384 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18 May

2020POM

1385 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., CyprusHongkiat Trading &

Company19 May 2015 till 18 May

2020POM

BDMCA/RMP/0719 Page 93 of 157

Page 94: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1386 BRU15031814PNimenrixTM (Meningococcal

polysaccharide serogroups

A,C,W-135, Y) Vaccine

MenAAH-TT-conjugate (Mean TT/PS

ratio:3) 5mcg PSA~15mcg TT, MenCAH-

TT-conjugate (Mean TT/PS ratio:3)

5mcg PSC~15mcg TT, MenW-TT-

conjugate (Mean TT/PS ratio:1.5) 5mcg

PSW~7.5mcg TT, MenY-TT-conjugate

(Mean TT/PS ratio:1.3) 5mcg

PSY~6.5mcg TT

Glaxosmithkline Biologicals s.a.,

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); Pfizer Manufacturing

Belgium NV, Belgium (additional

secondary packaging site)

Zuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020

POM

1387 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025POM

1388 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025POM

1389 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., MalaysiaHongkiat Trading &

Company19 May 2015 till 18 May

2020P (50 x 10’s)

1390 BRU15031820NPSmofKabiven 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 2020 till 18 May

2025 POM

1391 BRU15031821P Ometec capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1392 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

2020POM

BDMCA/RMP/0719 Page 94 of 157

Page 95: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1393 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 2020 till 18 May

2025

GSL

1394 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 2020 till 18 May

2025 POM

1395 BRU15031826PSaizen® Liquid 6mg

(5.83mg/ml)

Somatropin 6mg/1.03ml (recombinant

human growth hormone)Merck Serono S.p.A., Italy G&H Trading Company

19 May 2020 till 18 May

2025 POM

1396 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1397 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1398 BRU15031830NP Gaviscon Liquid Sachet

Each 10ml contains: Sodium alginate

500mg, Sodium bicarbonate 267mg

and Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

19 May 2015 till 18 May

2020 GSL

1399 BRU15031831NPFisherman’s Friend Sugar‐Free

Apple & Cinnamon LozengesMenthol 4.025mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020 GSL

1400 BRU15031832NPFisherman’s Friend Sugar‐Free

Mandarin & Ginger LozengesMenthol 4.6mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.

19 May 2015 till 18 May

2020 GSL

1401 BRU15031833NPFisherman’s Friend Sugar‐Free

Lemon LozengesMenthol 4.6mg

IDS Manufacturing Sdn. Bhd.,

Malaysia

Kingston Beverage &

Creamery Sdn. Bhd.19 May 2015 till 18 May

2020GSL

1402 BRU15041834PRotaqor 20mg film-coated

tabletAtorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia Zuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

1403 BRU15041835P Jakavi 20mg tabletRuxolitinib (as phosphate 26.40mg)

20mg

Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1404 BRU15041836P Jakavi 15mg tabletRuxolitinib (as phosphate 19.8mg)

15mg

Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1405 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mgNovartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

19 May 2015 till 18 May

2020POM

1406 BRU15041839PArchifar 500mg powder for

injection/infusionMeropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co.

19 May 2015 till 18 May

2020POM

BDMCA/RMP/0719 Page 95 of 157

Page 96: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1407 BRU15041840PCiproflo 2mg/ml solution for

IV infusion

Ciprofloxacin 2mg/ml (as

hydrochloride)

Sin Guan Chem. Ind. Co. Ltd., Republic

of ChinaK-Seri Pharma Sdn. Bhd.

19 May 2020 till 18 May

2025POM

1408 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company19 May 2020 till 18 May

2025POM

1409 BRU15041842P B-Mycin cream

Betamethasone dipropionate 0.643mg

(eq. to 0.5mg betamethasone);

Gentamicin Sulfate 1mg (potency)

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

MalaysiaAsterix United (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

1410 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5mlSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025P

1411 BRU15041844PPharmaniaga Loratadine

tablet 10mgLoratadine 10mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025

P

1412 BRU15041845P Curam 1000mg tablet

Amoxycillin 875 (as trihydrate);

clavulanic acid 125mg (as potassium

clavulanate)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd19 May 2020 till 18 May

2025 POM

1413 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd.19 May 2015 till 18 May

2020POM

1414 BRU15041847P Sunadine tablet 10mg Loratadine 10mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025

P

1415 BRU15041848NPSoluvit N Powder for Solution

for Infusion

Thiamine mononitrate 3.1mg

(corresponding to vitamin B1 2.5mg);

Riboflavine sodium phosphate 4.9mg

(corresponding to vitamin B2

3.6mg);Nicotinamide 40mg; Pyridoxine

hydrochloride 4.9mg (corresponding to

vitamin B6 4.0mg); Sodium

panthothenate 16.5mg (corresponding

to pantothenic acid 15.0mg); Sodium

ascorbate 113mg (corresponding to

Vitamin C 100mg); Biotin 60mcg; Folic

acid 0.40mg; cyanocobalamin 5.0mcg

Sino Swed Pharmaceutical Corp. Ltd.,

ChinaZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025

POM

1416 BRU15041849NP Folic acid 5mg tablet Folic acid 5mgSunward Pharmaceutical Sdn. Bhd.,

MalaysiaG & H Trading Company

19 May 2020 till 18 May

2025P

1417 BRU15041850P Estelle-35 tabletCyproterone acetate 2mg;

Ethinylestradiol 0.03mg

Douglas Manufacturing Limited, New

ZealandG & H Trading Company

19 May 2020 till 18 May

2025POM

1418 BRU15041851NPCetomacrogol emulsifying

ointment

Cetomacragol emulsifying wax 30%

w/w; liquid paraffin 20%; white soft

paraffin 50%

Hovid Bhd., Malaysia G & H Trading Company19 May 2020 till 18 May

2025 GSL

1419BRU15041852PS1/

BRU15041852PS2

Glucophage® XR 1000mg

Extended-release tablet

Metformin (as hydrochloride 1000mg)

780mg

1. Merck Sante SAS, France;

2. Merck KGaA, GermanyZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025POM

BDMCA/RMP/0719 Page 96 of 157

Page 97: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1420 BRU15041853P Duofilm LiquidSalicylic 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

2020P

1421 BRU15041854NPVoluven Solution for Infusion

6%

Per 1000ml: Poly (O-2-hydroxyethyl)

starch 60.0g; sodium chloride 9.00g

Frensius Kabi Deutschland GmbH,

GermanyZuellig Pharma (B) Sdn Bhd

19 May 2020 till 18 May

2025 POM

1422 BRU15041855NP Iris eye dropsHydroxypropyl methylcellulose 3mg;

dextran 70 1mg

Sam Chun Dang Pharm Co Ltd, South

KoreaMedipharm Sdn Bhd

19 May 2015 till 18 May

2020GSL

1423 BRU15041858NPFisherman’s friend aniseed

lozengesMenthol 5.75mg Lofthouse of Fleetwood Limited, UK

Kingston Beverage &

Creamery Sdn Bhd19 May 2015 till 18 May

2020GSL

1424 BRU15041859NPFisherman’s Friend Sugar

Free Mint LozengesMenthol 3.45mg Lofthouse of Fleetwood Limited, UK

Kingston Beverage &

Creamery Sdn Bhd19 May 2015 till 18 May

2020GSL

1425 BRU15041860NP

Fisherman’s Friend Sugar Free

Cherry Lozenges With

Menthol 6.9mg

Menthol 6.9mg Lofthouse of Fleetwood Limited, UKKingston Beverage &

Creamery Sdn Bhd

19 May 2015 till 18 May

2020 GSL

1426 BRU15041861NPChlorHex 5% Concentrate

SolutionChlorhexidine gluconate 5% w/v Pahang Pharmacy Sdn Bhd, Malaysia G & H Trading Company

19 May 2020 till 18 May

2025GSL

1427 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mgUpha Pharmaceuticals Sdn Bhd,

MalaysiaHongkiat Trading & Co

19 May 2015 till 18 May

2020POM

1428BRU15051863NP SP Pharma Paracetamol

Tablets 500mg

Paracetamol 500mg Simpor Pharma Sendirian Berhad,

Brunei Darussalam

Simpor Pharma Sendirian

Berhad19 May 2015 till 18 May

2020 P (200’s)

1429

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 Bhd28 July 2020 till 27 July

2025

POM

1430BRU15051865NP

Dettol Moisturing Formula

Antiseptic Cream

Triclosan 0.3%; Chloroxylenol 0.3%;

Edetic acid 0.2%

Reckitt Benckiser Healthcare (UK)

Ltd., UKSyarikat Aliaa Sdn Bhd

28 July 2015 till 27 July

2020 GSL

BDMCA/RMP/0719 Page 97 of 157

Page 98: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1431

BRU15051867NP Kabiven Peripheral Emulsion

for Infusion1000ml 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 Bhd28 July 2020 till 27 July

2025

POM

1432

BRU15051868NP Kabiven Emulsion for Infusion1000ml 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 Bhd28 July 2020 till 27 July

2025

POM

1433BRU15051869P

Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company28 July 2020 till 27 July

2025POM

1434BRU15051870P

Fenagesic Tablet 250mg Mefenamic acid 250mgSunward Pharmaceutical Pte Ltd.,

SingaporeG & H Trading Company

28 July 2020 till 27 July

2025POM

1435BRU15051871P

Metta SR Tablets 500mg Metformin Hydrochloride USP 500mgTorrent Pharmaceuticals Ltd., Indrad,

IndiaK-Seri Pharma Sdn Bhd

28 July 2015 till 27 July

2020POM

1436BRU15051872P

Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd28 July 2020 till 27 July

2025POM

BDMCA/RMP/0719 Page 98 of 157

Page 99: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1437BRU15051873NP

Calamine Lotion Calamine BP 15% w/vRoyce Pharma Manufacturing Sdn

Bhd, Malaysia

SWL Biomed Sales &

Services

28 July 2015 till 27 July

2020 GSL

1438BRU15051874NP

Fisherman’s Friend Original

Lozenges

Menthol 10.35mg; Eucalyptus oil

1.73mgLofthouse of Fleetwood Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1439BRU15051875NP

Fisherman’s Friend Mint

Lozenges

Menthol 4.6mg; Peppermint oil

11.270mgLofthouse of Fleetwood Limited, UK

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1440BRU15051876NP

Fisherman’s Friend Sugar Free

Original LozengesMenthol 9.2mg IDS Manufacturing Sdn Bhd, Malaysia

Kingston beverage &

Creamary Sdn Bhd

28 July 2015 till 27 July

2020 GSL

1441BRU15051878P

Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company28 July 2020 till 27 July

2025POM (100's); P

(20's)

1442BRU15051879P

Candazole V Single Dose

Cream 10% w/wClotrimazole 10% w/w

HOE Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Company

28 July 2020 till 27 July

2025 P

1443BRU15061880P Keppra® Oral Solution

100mg/ml

Levetiracetam 10mg/ml NextPharma SAS., FranceZuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020

POM

1444

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

1445BRU15061882P Aceprin 100mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2020 till 27 July

2025

POM

1446BRU15061883NP 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

1447BRU15061884P Pharmaniaga Cephalexin

Suspension 250mg

Cephalexin (as Cephalexin Anhydrous)

250mg/5mL

Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 28 July 2020 till 27 July

2025

POM

1448BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd.,

Singapore

G & H Trading Company 28 July 2015 till 27 July

2020

POM

1449BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan

Zuellig Pharma (B) Sdn Bhd28 July 2015 till 27 July

2020

POM

1450BRU15061887NP 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

1451

BRU15061888P Herceptin Powder for

Injection 440mg/vial

Trastuzumab 440mg Genentech Inc., California, USA;

Genentech Inc., Oregon, USA; [F.

Hoffmann-La Roche Ltd, Kaiseraugst,

Switzerland (Manufacturer and

packaging site for Solvent); F.

Hoffmann-La Roche Ltd, Kaiseraugst,

Switzerland (Secondary packaging of

finished product)]

MediPharm Sdn Bhd 28 July 2015 till 27 July

2020

POM

BDMCA/RMP/0719 Page 99 of 157

Page 100: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1452

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

1453

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

1454

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

1455BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv.

to 3.338mg perindopril)

Lek Pharmaceuticals DD., SloveniaZuellig Pharma (B) Sdn Bhd

28 July 2015 till 27 July

2020

POM

1456BRU15061893NP 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

1457BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1458BRU15061895NP Oxy Acne Wash Triclosan 0.30% Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 28 July 2015 till 27 July

2020

GSL

1459BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia Medicorp Sdn. Bhd. 28 July 2015 till 27 July

2020

GSL

1460BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5ml

Potassium bicarbonate 100mg/5ml

Reckitt Benckiser Healthcare (UK)

Ltd., UK Zuellig Pharma (B) Sdn Bhd28 July 2020 till 27 July

2025

GSL

1461BRU15071899P 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

1462BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg;

Sodium bicarbonate 267mg; Calcium

carbonate 160mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1463BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2015 till 08 Dec

2020

POM

1464BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1465BRU15071903NP Chlorhex 4% antiseptic

solution

Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia G & H Trading Company 09 Dec 2015 till 08 Dec

2020

GSL

1466BRU15071904P Resolor Film-coated Tablet

2mg

Prucalopride succinate 2.642mg eqv

Prucalopride 2mg

Janssen-Cilag S.p.A., ItalyZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1467BRU15071905P Proglutrol 500 Extended

Release Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Pvt. Ltd., India Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

BDMCA/RMP/0719 Page 100 of 157

Page 101: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1468BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg;

Sodium Bicarbonate 213mg; Calcium

Carbonate 325mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1469BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium

Bicarbonate 106.5mg; Calcium

Carbonate 187.5mg

Reckitt Benckiser Healthcare (UK) Ltd,

UK Syarikat Aliaa Sdn Bhd09 Dec 2015 till 08 Dec

2020

GSL

1470BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g

& betamethasone (as dipropionate)

0.5mg/g

LEO Laboratories Ltd., IrelandZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1471BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec

2020

GSL

1472BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co.

Ltd., Vietnam

Hamitan Marketing 09 Dec 2015 till 08 Dec

2020

GSL

1473BRU15071911P 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

1474BRU15081913NP 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)

1475BRU15081914P 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 Bhd09 Dec 2015 till 08 Dec

2020

POM

1476BRU15081916P 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

1477

BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH,

Germany; Pfizer Manufacturing

Deutschland GmbH, Germany

(primary and secondary packaging

site)

Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1478BRU15081918P Olanzapine Orodispersible

Tablets 5mg

Olanzapine 5mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1479BRU15081919P Olanzapine Orodispersible

Tablets 10mg

Olanzapine 10mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1480BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories,

India

K-Seri Pharma Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1481BRU15081921P Pharmaniaga Dermapro

Ointment 0.05% w/w

Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing Berhad,

Malaysia

G & H Trading Company 09 Dec 2020 till 08 Dec

2025

POM

1482

BRU15081922P Olmetec Plus 40/12.5mg Film-

Coated Tablet

Olmesartan Medoxomil 40mg;

Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH,

Germany; Pfizer Manufacturing

Deutschland GmbH, Germany

(primary and secondary packaging

site)

Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

BDMCA/RMP/0719 Page 101 of 157

Page 102: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1483BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1484BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020

POM

1485BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2015 till 08 Dec

2020

POM

1486

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

1487 BRU15091928PAcular Ophthalmic Solution

0.5%Ketorolac Tromethamine 0.5%

Allergan Pharmaceuticals Ireland,

IrelandMediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1488 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mgPfizer Pharmaceuticals LLC, Vega

Baja, USA (Pfizer Vega Baja) Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1489 BRU15091930PZymar (gatifloxacin

ophthalmic solution) 0.3%Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1490 BRU15091931PKlerimed 500mg Film-Coated

Tablets

Clarithromycin 515mg (equivalent to

anhydrous clarithromycin 500mg)

1. Medochmie Ltd (Factory AZ),

Cyprus

2. Medochmie Ltd (Central Factory),

Cyprus

Hongkiat Trading &

Company

09 Dec 2015 till 08 Dec

2020POM

1491 BRU15091932P

Gadovist Injection

1.0mmol/ml Prefilled syringe

5.0ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mgBayer AG, Berlin, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020

POM

1492 BRU15091933PGadovist Injection

1.0mmol/ml

Gadobutrol pure 604.72mg & Calcium

sodium butrol 0.513mg

Bayer Pharma AG, MÜllerstr. 178

Bayer AG, MÜllerstraβe 178,

Germany

Zuellig Pharma (B) Sdn Bhd09 Dec 2015 till 08 Dec

2020 POM

1493 BRU15091934P

Neostigmine Methysulphate –

Fresenius 2.5mg/1ml

(Ampoules)

Neostigmine methylsulphate 2.5mg/mlFresenius Kabi Manufacturing SA

(Pty) Ltd., Republic of South Africa.K-Seri Pharma Sdn. Bhd.

09 Dec 2015 till 08 Dec

2020 POM

1494 BRU15091935P Cardiprin 100 Tablet Aspirin 100mgReckitt Benckiser Healthcare

(UK),United KingdomZuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1495 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

1496 BRU15091937P Guafensin Syrup 20mg/ml Guaifenesin 20mg/mlY.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1497 BRU15091938P Storvas C Tablets 10mgAtorvastatin 10mg as Atorvastatin

Calcium Trihydrate

Ranbaxy (Malaysia) Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020POM

BDMCA/RMP/0719 Page 102 of 157

Page 103: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1498 BRU15091939NP Hoe Zinc Cream Zinc Oxide 32% w/wHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020GSL

1499 BRU15091940PPirimat Injection 10mg/ml

(1ml ampoule)Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading &

Company09 Dec 2015 till 08 Dec

2020POM

1500 BRU15091943PHeparinol® 10 Sterile

Heparinised Saline InjectionHeparin Sodium (Bovine) 10 IU/ml Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah

09 Dec 2015 till 08 Dec

2020 POM

1501 BRU15091944P Fucid Ointment 2% w/wSodium Fusidate (Micronised) 20mg/g

(2% w/w)Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1502 BRU15091946PAxcel Bromhexine (Children)

ElixirBromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia Medicorp Sdn Bhd.

09 Dec 2015 till 08 Dec

2020POM

1503 BRU15101947PCetyrol 10mg Film-coated

TabletCetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020P

1504 BRU15101948PArchifar 1g Powder for

Solution for Injection/InfusionMeropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co

09 Dec 2015 till 08 Dec

2020 POM

1505 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020P

1506 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1507 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd09 Dec 2015 till 08 Dec

2020POM

1508 BRU15101952NP Flexjoint 1500mg Powder

Crystalline glucosamine sulphate

1884mg (equivalent to glucosamine

sulphate 1500mg)

Winwa Medical Sdn Bhd., Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020 GSL

1509 BRU15101953NP Colin Cough Syrup 100mg Guaiphenesin 100mg/5ml Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company09 Dec 2015 till 08 Dec

2020GSL

1510 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 unitsT.O. Chemicals (1979) Co. Ltd.,

ThailandMedicorp Sdn Bhd

09 Dec 2015 till 08 Dec

2020POM

1511 BRU15101955P Ezede Tablet 10mg Loratadine 10mgXepa-Soul Pattinson (M) Sdn Bhd.,

MalaysiaHongkiat Trading & Co

09 Dec 2015 till 08 Dec

2020P

1512 BRU15101956PPred Forte Sterile Ophthalmic

Suspension 1%Prednisolone acetate 1% w/v

Allergan Pharmaceuticals Ireland,

Mayo, IrelandMedipharm Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

1513 BRU15111957P Stivarga Tablet 40mg

Regorafenib

(40mg Regorafenib equivalent to

41.49mg Regorafenib monohydrate)

Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

1514 BRU15111958P A Scabs Lotion Permethrin 5.0% w/vHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020GSL

BDMCA/RMP/0719 Page 103 of 157

Page 104: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1515BRU15111959P;

BRU15111959PS2Insugen-N (NPH)

Insulin Injection, Isophane Ph. Eur.

(Human Insulin rDNA origin) 100IU/ml

Biocon Limited, India; Biocon Sdn

Bhd, Malaysia (S2)K-Seri Pharma Sdn Bhd

09 Dec 2015 till 08 Dec

2020 POM

1516 BRU15111960P Tetradox Capsules 100mgDoxycycline Hydrochloride/Hcylate eq

to Doxycycline 100mg

Ranbaxy (Malaysia) Sdn Bhd,

MalaysiaG & H Trading Company

09 Dec 2015 till 08 Dec

2020POM

1517 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah09 Dec 2015 till 08 Dec

2020GSL

1518 BRU15111962NPInfusol W (Sterilised Water for

Injection BP)Water for injection BP AIN Medicare Sdn. Bhd., Malaysia Syarikat Pakatan Indah

09 Dec 2015 till 08 Dec

2020GSL (500ml)

1519 BRU15111963P Elan Forte CreamTolnaftate 10mg/g; Chlorhexidine HCl

2mg/g

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

Bhd.,MalaysiaAsterix United (B) Sdn Bhd.

09 Dec 2015 till 08 Dec

2020GSL

1520 BRU15111964P Valparin XR 500mg Tablet

i) Sodium Valproate 333mg

ii) Valproic Acid 145mg

(Both together correspond to sodium

valproate 500mg)

Torrent Pharmaceuticals Limited,

IndiaK-Seri Pharma Sdn Bhd.,

09 Dec 2015 till 08 Dec

2020 POM

1521 BRU15111965P Axcel Betamethasone Cream

Betamethasone 17-Valerate

(micronized) equivalent to

Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd09 Dec 2015 till 08 Dec

2020 POM

1522 BRU15111966P Freederm Gel Terbinafine HCl 1%w/w Winwa Medical Sdn Bhd., Malaysia Yuh Hua Trading Company 09 Dec 2015 till 08 Dec

2020GSL

1523 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

1524 BRU15111968PT Atehexal Comp Mite Tablet Atenolol 50mg; Chlorthalidone 12.5mgSalutas Pharma GmbH, Federal

Republic of Germany Medicorp

09 Dec 2015 till 28 April

2019POM

1525 BRU15111969PTHurricaine Topical Anaesthetic

Gel – Original Wild CherryBenzocaine 20%

Dental Technologies Inc. , United

States L S Kai Care09 Dec 2015 till 16 Feb

2018POM

1526 BRU15111970PT Duocaine Cream 5% w/wLidocaine 2.5% w/w; Prilocaine 2.5%

w/wHoe Pharmaceuticals Sdn Bhd,

MalaysiaG & H Trading Co 09 Dec 2015 till 14 Jan 2019 POM

1527

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

1528BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd.,

Singapore

G & H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1529BRU15121974P 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

BDMCA/RMP/0719 Page 104 of 157

Page 105: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1530

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

1531BRU15121976NP Mentholatum Deep Cold Ice

Gel Therapy

Menthol 20g/g Mentholatum Australia Pty. Ltd.,

Australia

Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1532BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1533BRU15121979P 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

1534BRU15121980NP Axcel Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1535BRU15121981P 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

1536 BRU16011982NP0.9% Sodium Chloride

Injection, USPSodium Chloride USP 0.9% Baxter Healthcare Corporation, USA Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021GSL

1537 BRU16011983P Amlibon 5mg TabletAmlodipine (as Amlodipine Besilate)

5mgLek Pharmaceuticals DD., Slovenia Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1538 BRU16011984POspexin 250mg/5ml Granules

for Oral SuspensionCephalexin 250mg/5ml Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1539 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun 2021

POM

1540 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd21 Jun 2016 till 20 Jun 2021

POM

1541 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd21 Jun 2016 till 20 Jun 2021

POM

1542 BRU16011988P Lestric Tablets 20mg Lovastatin 20mgRanbaxy (Malaysia) Sdn Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun 2021POM

1543 BRU16011989PPotassium Chloride 10% w/v

InjectionPotassium Chloride 10% w/v

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun 2021POM

1544 BRU16011990P Gastografin Solution

1ml contains Sodium amidotrizoate

0.1g and Meglumine amidotrizoate

0.66g

Belimed SA, Spain Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun 2021

POM

1545 BRU16011991PRabotide Capsule 20mg (as

enteric coated pellets)Rabeprazole Sodium 20mg Inventia Healthcare Pvt Ltd., India Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1546 BRU16011992PPharmaniaga Gliclazide Tablet

80mgGliclazide 80mg

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun 2021POM

1547 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun 2021

GSL

BDMCA/RMP/0719 Page 105 of 157

Page 106: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1548 BRU16011994NPBetadine Feminine Wash with

Douching Apparatus 10% w/vPovidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021GSL

1549 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun 2021

GSL

1550 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mgPrime Pharmaceuticals Sdn Bhd.,

MalaysiaMedicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021GSL (10 x 10’s)

1551 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/vHoe Pharmaceuticals Sdn Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun 2021GSL

1552BRU16021998P;

BRU16021998PS2

Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur.

(Insulin, Human of recombinant DNA

origin) 100 IU/ml

Biocon Limited, India; Biocon Sdn

Bhd, Malaysia (S2)

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1553BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM

1554BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 POM

1555BRU16022001NP Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2016 till 20 Jun 2021 GSL

1556BRU16022002NP Noxworm Suspension

(chocolate) 400mg

Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1557BRU16022003P Mircera pre-filled syringe

100mcg/0.3ml

Methoxy polyethylene glycol-epoetin

beta 100mcg/0.3ml

Roche Diagnostics GmbH, GermanyMediPharm Sdn Bhd

21 Jun 2016 till 20 Jun 2021 POM

1558BRU16022006P 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

1559BRU16022007P 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

1560BRU16022008P 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

1561BRU16022010P 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

1562BRU16022011P

Pantor 20Pantoprazole (as sodium

sesquihydrate) 20mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1563BRU16022012P Pantor 40 Pantoprazole (as sodium

sesquihydrate) 40mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1564BRU16032013P Ceritec Film Coated Tablet

10mgCetirizine Hydrochloride 10mg

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

Malaysia.Asterix United (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021P

1565BRU16032014P

Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company21 Jun 2016 till 20 Jun 2021

GSL

BDMCA/RMP/0719 Page 106 of 157

Page 107: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1566

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

1567BRU16032016P;

BRU16032016PS2 Insugen-30/70 (Biphasic)

Insulin Injection, Biphasic Isophane Ph.

Eur. (Insulin, Human recombinant DNA

origin) 100 IU/ml

Biocon Limited, India; Biocon Sdn

Bhd, Malaysia (S2)K-Seri Pharma Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1568BRU16032017P Natrixam 1.5mg/10mg

modified-release tablet

Indapamide 1.5mg & Amlodipine 10mg

(as besilate)

Les Laboratories Servier Industrie,

FranceZuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1569

BRU16032018PNatrixam 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

1570BRU16032019P

Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd.,21 Jun 2016 till 20 Jun 2021

POM

1571BRU16032020NP

Mifuko OintmentZinc 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 2021GSL

1572BRU16032021P

Primodil 5 Tablet Amlodipine Besilate 6.94mg

(equivalent to Amlodipine 5mg)Medley Pharmaceuticals Ltd, India Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1573BRU16032022P Oxair Film Coated Tablet

10mg

Montelukast Sodium 10.4mg

(equivalent to Montelukast 10mg)

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

MalaysiaAsterix United (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1574BRU16032023NP Bacidin Antiseptic Cream 1%

w/wChlorhexidine Gluconate 1% w/w

Xepa-soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company21 Jun 2016 till 20 Jun 2021

GSL

1575BRU16032024P Axcel Oxymetazoline 0.05%

Nasal Spray

Oxymetazoline Hydrochloride 0.05%

w/vKotra Pharma (M) Sdn Bhd., Malaysia. Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021P

1576 BRU16042025P Romesec 20mg Capsules Omeprazole USP 20mgRanbaxy (Malaysia) Sdn. Bhd.,

Malaysia.G & H Trading Company

21 Jun 2016 till 20 Jun 2021POM

1577

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

1578 BRU16042027NPPotassium Chloride Injectable

Solution 10%Potassium chloride 1g / 10ml

DEMO SA Pharmaceutical Industry,

Greece. Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

BDMCA/RMP/0719 Page 107 of 157

Page 108: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1579 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

1580 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

1581 BRU16042030NPOsteoactiv 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

1582 BRU16042031NPOsteoactiv 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

1583 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

1584 BRU16042033PAloxi 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 2021POM

1585 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., Cyprus. Medicorp Sdn Bhd 21 Jun 2016 till 20 Jun 2021

POM

1586 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

1587 BRU16042036PPharmaniaga Allopurinol

Tablet 300mgAllopurinol 300mg

Pharmaniaga Manufacturing Berhad,

Malaysia.G & H Trading Company

21 Jun 2016 till 20 Jun 2021POM

1588 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 2021GSL

1589 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mgThe Government Pharmaceutical

Organization (GPO), ThailandK-Seri Pharma Sdn Bhd

21 Jun 2016 till 20 Jun 2021POM

1590 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company21 Jun 2016 till 20 Jun 2021

GSL

BDMCA/RMP/0719 Page 108 of 157

Page 109: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1591 BRU16052040NP Betadine® Antiseptic Solution Povidone-Iodine 10% w/v PT Mahakam Beta Farma, Indonesia Zuellig Pharma (B) Sdn Bhd21 Jun 2016 till 20 Jun 2021

GSL

1592 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5mlHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG&H Trading Company

21 Jun 2016 till 20 Jun 2021P

1593 BRU16052042PAxcel Oxymetazoline 0.025%

Nasal Drop

Oxymetazoline hydrochloride 0.025%

w/vKotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd

21 Jun 2016 till 20 Jun 2021P

1594BRU16052044P;

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 (S2)

Zuellig Pharma (B) Sdn Bhd

21 Jun 2016 till 20 Jun 2021

POM

1595 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia.

Hongkiat Trading &

Company21 Jun 2016 till 20 Jun 2021

POM

1596 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07

November 2021POM

1597BRU16062047P

Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India K-Seri Pharma Sdn. Bhd08 November 2016 till 07

November 2021POM

1598 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma Sdn Bhd08 November 2016 till 07

November 2021POM

1599 BRU16062049P

Seebri Breezhaler 50mcg

Inhalation Powder Hard

Capsules

Glycopyrronium bromide 63mcg

(corresponding to 50 mcg

Glycopyrronium)

Novartis Pharma Stein AG.,

SwitzerlandZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1600 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/mlYung Shin Pharmaceutical Ind. Co.

Ltd., Republic of ChinaAsterix United (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1601 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd08 November 2016 till 07

November 2021POM

1602 BRU16062054PBetmiga Prolonged-Release

Tablets 25mgMirabegron 25mg Avara Pharma Technologies, Inc., USA Medipharm Sdn Bhd

08 November 2016 till 07

November 2021POM

1603 BRU16062055PBetmiga Prolonged-Release

Tablets 50mgMirabegron 50mg Avara Pharma Technologies, Inc., USA Medipharm Sdn Bhd

08 November 2016 till 07

November 2021POM

1604 BRU16062056PAxcel Mometasone 0.1%

Cream

Mometasone furoate (micronised)

0.1% w/wKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

08 November 2016 till 07

November 2021POM

1605BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07

November 2021POM

1606

BRU16072058P Noxafil 100mg tablet Posaconazole 100mg N.V Organon, Netherlan

Zuellig Pharma (B) Sdn Bhd08 November 2016 till 07

November 2021

POM (12

tablets/blister x 2

blisters/carton

12 tablets/blister

x 8

blisters/carton

BDMCA/RMP/0719 Page 109 of 157

Page 110: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1607BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit

III), India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07

November 2021POM

1608BRU16072060P Pethidine-Hameln Solution for

Injection 50mg/ml

Pethidine Hydrochloride

50mg/ml

Hameln Pharmaceuticals GmbH,

Langes Feld 13, 31789 Ham

eln, Germany

Medicorp Sdn Bhd08 November 2016 till 07

November 2021

POM

1609BRU16072061P 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 2021POM

1610BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains:

Prednisolone (as salt of

prednisolone) 5mg

Beacons Pharmaceutical Pte Ltd,

Singapore

Hong Kiat Trading & Co08 November 2016 till 07

November 2021

POM

1611 BRU16082063NPZenalb 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 2021POM

1612 BRU16082064PAxcel Lamivudine 100mg

TabletLamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia Medicorp Sdn Bhd

08 November 2016 till 07

November 2021POM

1613 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia Yuh Hua Trading Company08 November 2016 till 07

November 2021GSL

1614 BRU16082066NP Alphanate® 250IUFactor VII 250IU and von Willebrand

Factor >400IU/1000IU Factor VIIGrifols Biologicals LLC, USA

Hongkiat Trading &

Company

08 November 2016 till 07

November 2021POM

1615 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 StatesZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021POM

1616 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 Indah08 November 2016 till 07

November 2021GSL

1617

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

1618

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

1619BRU16092071NP 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 2021GSL

BDMCA/RMP/0719 Page 110 of 157

Page 111: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1620

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

1621BRU16092073P Adrenaline (Epinephrine)

Injection 1:1000

Adrenaline (Epinephrine) as acid

tartrate

Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07

November 2021POM

1622BRU16092074P Axcel Mometasone 0.1%

Ointment Mometasone Furoate

(micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd08 November 2016 till 07

November 2021

POM

1623BRU16092075P 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 2021POM

1624

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

1625BRU16102079P Baxter Chlorhexidine Acetate

0.1% w/v Antiseptic Solution

Chlorhexidine (as

Acetate)

Baxter Healthcare Pty Ltd, AustraliaZuellig Pharma (B) Sdn Bhd

08 November 2019 till 26

Jan 2024

GSL

1626BRU16102080P 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

1627BRU16102081P 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

1628

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., MalaysiaZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021

POM

1629BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic

and Services S.r.l., ItalyZuellig Pharma (B) Sdn Bhd

08 November 2016 till 07

November 2021

POM

1630BRU16102085P Loxin Injection (5ml amp)

(Dopamine HCl)

Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

08 November 2016 till 07

November 2021

POM

1631BRU16102086P 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

1632BRU16102087P 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

BDMCA/RMP/0719 Page 111 of 157

Page 112: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1633BRU16102088P 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

1634

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

1635BRU16102090NP 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

1636BRU16102091P 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

1637 BRU16112092PRisperidone Orally

Disintegrating Tablet 3mgRisperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1638 BRU16112093PRisperidone Orally

Disintegrating Tablet 2mgRisperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1639 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd.21 March 2017 till

20 March 2022POM

1640 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5mlY.S.P. Industries (M) Sdn. Bhd.,

MalaysiaAsterix United (B) Sdn Bhd.

21 March 2017 till

20 March 2022POM

1641 BRU16112096POspexin 1000mg Film-coated

TabletCephalexin 1000mg Sandoz GmBH, Austria

Zuellig Pharma (B) Sdn

Bhd.21 March 2017 till

20 March 2022POM

1642 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mgY.S.P Industries (M) Sdn Bhd,

MalaysiaAsterix United (B) Sdn Bhd.

21 March 2017 till

20 March 2022GSL

1643 BRU16112098NP Calamine Lotion with MentholCalamine 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

1644 BRU16112099PToujeo 300 units/ml Solution

For Injection In Pre-Filled Pen

Insulin glargine 300units/ml

(10.91mg/ml)

Sanofi-Aventis Deutschland GmbH,

GermanyMediPharm Sdn Bhd.

21 March 2017 till

20 March 2022 POM

1645 BRU16112100PApo-Levocarb Tablet

100mg/25mgLevodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd,

21 March 2017 till

20 March 2022POM

1646 BRU16112101PExviera 250mg Film Coated

Tablets

Dasabuvir (as sodium monohydrate)

250mgAbbVie Ireland NL B.V, Ireland Zuellig Pharma (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

BDMCA/RMP/0719 Page 112 of 157

Page 113: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1647 BRU16112102NPWhite Balsem, Three Legs

Brand

Methyl salicylate 18% w/w, Menthol

9% w/w and Camphor 5% w/w

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022 GSL

1648 BRU16112103NPTinea Skin Solution, Three

Legs Brand

Salicylic acid 5% w/v and Benzoic acid

2% w/v

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1649 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/vSyarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1650 BRU16112105PFurosemide-hameln 10mg/ml

InjectionFurosemide 10mg/ml

Hameln Pharmaceuticals

GmbH,Germany Medicorp Sdn Bhd

21 March 2017 till

20 March 2022POM

1651 BRU16112106NPTolnaftate Cream Three Legs

BrandTolnaftate 1% w/v

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1652 BRU16112107NPUbat Serbuk Cap Kaki Tiga

600mg/sac

Acetylsalicylic acid (Aspirin) 600mg /

sachet

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

21 March 2017 till

20 March 2022GSL

1653 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

1654 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

1655 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

1656 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75gYung Shin Pharmaceutical Ind. Co.

Ind., Republic of ChinaK-Seri Pharma Sdn. Bhd.

21 March 2017 till

20 March 2022POM

1657 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir sulphate)GlaxoSmithKline Pharmaceuticals

S.A., PolandZuellig Pharma (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1658 BRU16122113P Apo-Alendronate 70mg tabletAlendronate Sodium Trihydrate eq to

Alendronic acid 70mgApotex Inc. Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1659 BRU16122114PTensiber Film Coated Tablet

300mgIrbesartan 300mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1660 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5% w/vHOE Pharmaceuticals Sdn. Bhd.,

MalaysiaG & H Trading Company

21 March 2017 till

20 March 2022GSL

1661 BRU16122116P Apo-Quetiapine 25mg TabletQuetiapine Fumarate equivalent to

25mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1662 BRU16122117P Apo-Quetiapine 100mg TabletQuetiapine Fumarate equivalent to

100mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1663 BRU16122118P Apo-Quetiapine 200mg TabletQuetiapine Fumarate equivalent to

200mg QuetiapineApotex Inc, Canada MediPharm Sdn Bhd

21 March 2017 till

20 March 2022POM

1664 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company21 March 2017 till

20 March 2022GSL (10’s x 15,

10’s x 50 )

BDMCA/RMP/0719 Page 113 of 157

Page 114: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1665 BRU16122120NPBetadine® 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

1666 BRU16122121NP 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 2022 GSL

1667 BRU16122122NPBetadine® Antiseptic Skin

Cleanser 7.5% w/vPovidone-Iodine 7.5% w/v PT Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn.

Bhd.21 March 2017 till

20 March 2022GSL

1668 BRU16122123POxynorm Sterile Solution for

Injection or Infusion 10mg/mL

Oxycodone hydrochloride 10mg/ml

(equivalent to 9 mg/ml Oxycodone)

B.Braun Melsungen AG, Berlin,

Germany

Zuellig Pharma (B) Sdn.

Bhd.

21 March 2017 till

20 March 2022 POM

1669 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare21 March 2017 till

20 March 2022POM

1670 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

1671 BRU16122126POxynorm 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 2022 POM

1672 BRU16122127PShintamet Film Coated Tablet

200mgCimetidine 200mg

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

MalaysiaAsterix United (B) Sdn. Bhd.

21 March 2017 till

20 March 2022POM

1673

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

1674

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

1675BRU17012130PS2;

BRU17012130PS3

Tarceva Tablet 100mg Erlotinib 100mg Roche SpA, Italy (S2); F.Hoffman La

Roche AG, Switzerland (S3)

Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1676BRU17012131PS2;

BRU17012131PS3

Tarceva Tablet 150mg Erlotinib 150mg Roche SpA, Italy (S2); F.Hoffman La

Roche AG, Switzerland (S3)

Hongkiat Trading & Co 21 March 2017 till

20 March 2022

POM

1677BRU17012132P Apo-Gliclazide 30mr MR

tablet

Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1678BRU17012134NP 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

1679

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

1680BRU17012136NP 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

BDMCA/RMP/0719 Page 114 of 157

Page 115: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1681BRU17012137P 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

1682BRU17012138P 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

1683BRU17012139P Selegos 5mg Tablet Selegiline

Hydrochloride 5mg

Medochemie Ltd., Cyprus Hong Kiat Tradin

g Co

21 March 2017 till

20 March 2022

POM

1684BRU17012140P

Timolol-POS 0.5% Eye DropTimolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH,

Germany

Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1685BRU17012141P

Metformin Tablet 500mgMetformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd., Malaysia Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1686BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn. Bhd.,Malaysia Medicorp Sdn. Bhd 21 March 2017 till

20 March 2022

POM

1687BRU17012143NP

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

1688

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

1689BRU17012145P 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

1690 BRU17022146P Azarga Eye Drops SuspensionBrinzolamide 10mg/ml

Timolol maleate 5mg/mlS.A. Alcon, Couvreur N.V., Belgium Zuellig Pharma (B) Sdn Bhd

21 March 2017 till

20 March 2022POM

1691 BRU17022147PPharmaniaga Dermasole

Cream 0.1% w/wBetamethasone 17-valerate 0.1% w/w

Pharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022POM

1692 BRU17022148PJardiance 10mg Film-coated

TabletEmpagliflozin 10mg

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

1693 BRU17022149PJardiance 25mg Film-coated

TabletEmpagliflozin 25mg

Boehringer Ingelheim Pharma GmbH

& Co. KG, Germany

Hongkiat Trading &

Company21 March 2017 till

20 March 2022POM

1694 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mgPharmaniaga Manufacturing Berhad,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022POM

1695 BRU17022153PTargin 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

1696 BRU17022154PTargin 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

BDMCA/RMP/0719 Page 115 of 157

Page 116: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1697 BRU17022155PTargin 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

1698 BRU17022156PTargin 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 2022

POM

1699 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company21 March 2017 till

20 March 2022GSL

1700 BRU17022158NPEffervescent Mouthwash

Tablets

Thymol EP 0.77mg;

Menthol EP 1.87mg JL Bragg Ltd, UKHongkiat Trading &

Company

21 March 2017 till

20 March 2022 GSL

1701 BRU17022159P Salmol Expectorant

Each 5ml contains:

Salbutamol Sulfate equivalent to

Salbutamol 1.0 mg;

Guaiphenesin 50.0 mg

Biolab Co., Ltd, ThailandHongkiat Trading &

Company

21 March 2017 till

20 March 2022 POM

1702 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mgMega Lifesceinces Public Company

Limited, ThailandG&H Trading Co

21 March 2017 till

20 March 2022POM

1703 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mgMega Lifesceinces Public Company

Limited, ThailandG&H Trading Co

21 March 2017 till

20 March 2022POM

1704 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/vSM Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Co

21 March 2017 till

20 March 2022GSL

1705 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 2022 GSL

1706 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn Bhd21 March 2017 till

20 March 2022POM

1707 BRU17032165PAsthator 4mg Chewable

TabletMontelukast sodium 4.160mg eq. to

montelukast 4mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July

2022

POM

1708 BRU17032166PAsthator 5mg Chewable

TabletMontelukast sodium 5.20mg eq. to

montelukast 5mg

Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July

2022

POM

1709 BRU17032167P Asthator 10mgTabletMontelukast 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/0719 Page 116 of 157

Page 117: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1710 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

1711 BRU17032169PPHARMANIAGA 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

GSL

1712 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

1713 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

1714BRU17032172P 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

1715BRU17032173P 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

1716BRU17032174P 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

1717BRU17032175NP 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

1718

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

BDMCA/RMP/0719 Page 117 of 157

Page 118: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1719BRU17042177NP 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

1720BRU17042178P Anexate Injection 0.5mg/5ml Flumazenil 0.5mg Cenexi SAS, France Medicare 11 July 2017 till 10 July

2022

POM

1721BRU17042179P 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

1722

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

1723BRU17042181P Zimmex 20 Tablet Simvastatin 20mg Silom Medical Co Ltd, Thailand Medicorp Sdn Bhd 11 July 2017 till 10 July

2022

POM

1724BRU17042182P 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

1725

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

1726

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

1727

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

1728

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

BDMCA/RMP/0719 Page 118 of 157

Page 119: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1729

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

1730

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

1731BRU17042189P Cotren Vaginal Tablet 500mg Clotrimazole 500mg Biolab Company Ltd., Thailand Hongkiat Trading &

Company

11 July 2017 till 10 July

2022

P

1732BRU17042190P Axcel Bromhexine Tablet Bromhexine Hydrochloride 8mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 11 July 2017 till 10 July

2022

POM

1733BRU17042191P 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

1734BRU17042192P Zocol 150mg Capsule Fluconazole 150mg SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Co 11 July 2017 till 10 July

2022

POM

1735

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

1736BRU17052194P 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

1737BRU17052195P

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

1738BRU17052196P

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

1739

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

1740BRU17052198NP

Weng Heng Tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company 11 July 2017 till 10 July

2022

GSL

BDMCA/RMP/0719 Page 119 of 157

Page 120: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1741BRU17052199P

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

1742BRU17052200P

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

1743

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

1744BRU17052203P 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

1745BRU17052204P 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

1746BRU17052205P Anacaine Injection 1% Lidocaine

Hydrochloride 1%

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July

2022

POM

1747BRU17052206P Anacaine Injection 2% Lidocaine

Hydrochloride 2

%

SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July

2022

POM

1748BRU17052207NP Ferromed Tablet 200mg Ferrous Fumarate BP 200mg SM Pharmaceuticals Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July

2022

GSL

1749BRU17052208NP 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

1750BRU17052209P 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

1751

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

1752BRU17062211P HYOSCINE BUTYLBROMIDE

TABLET

Hyoscine N-butylbromide 10mg Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company 11 July 2017 till 10 July

2022

POM

BDMCA/RMP/0719 Page 120 of 157

Page 121: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1753

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

1754BRU17062213P 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

1755BRU17062214P 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

1756BRU17062215P Cosentyx 150mg Solution for

Injection in Pre-filled Pen

Secukinumab 150mg Novartis Pharma Stein AG,

Switzerland; Sandoz GmbH –

Schaftenau, Austria

Zuellig Pharma (B) Sdn Bhd

Sdn Bhd

11 July 2017 till 10 July

2022

POM

1757BRU17062216P 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

1758BRU17062217P XTANDI SOFT CAPSULES

40MG

Enzalutamide 40mg Catalent Pharma Solutions LLC, USA MediPharm Sdn Bhd 11 July 2017 till 10 July

2022

POM

1759BRU17062218P 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

1760BRU17062219NP 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

1761BRU17062220P 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

1762BRU17062221NP 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

1763BRU17062222NP 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

1764 BRU17072223P

Monoclox 500mg Powder for

Solution for Injection or

Infusion

Cloxacillin sodium equivalent to

cloxacillin 500mgMedochemie Ltd., Cyprus Medicorp Sdn Bhd 03 October 2017 till 02

October 2022POM

1765 BRU17072224P Simvor Tablets 10mg Simvastatin 10mgRanbaxy (Malaysia) Sdn Bhd.,

MalaysiaMedipharm Sdn Bhd

03 October 2017 till 02

October 2022POM

1766 BRU17072225P Gluvecron MR 30mg Tablet Gliclazide 30mgChina Chemical & Pharmaceutical Co.

Ltd., TaiwanMedicorp Sdn Bhd

03 October 2017 till 02

October 2022POM

BDMCA/RMP/0719 Page 121 of 157

Page 122: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1767 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

1768 BRU17072227PFlumazenil-Hameln 0.1mg/ml

injectionFlumazenil 0.1mg/ml

Hameln Pharmaceuticals GmbH,

GermanyMedicorp Sdn Bhd

03 October 2017 till 02

October 2022POM

1769 BRU17072228POxycontin® Controlled-

Release Tablets 10mg Oxycodone hydrochloride 10mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1770 BRU17072229POxycontin® Controlled-

Release Tablets 20mg Oxycodone hydrochloride 20mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1771 BRU17072230POxycontin® Controlled-

Release Tablets 40mg Oxycodone hydrochloride 40mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1772 BRU17072231POxycontin® Controlled-

Release Tablets 80mg Oxycodone hydrochloride 80mg Purdue Pharmaceuticals L.P., USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1773 BRU17082232PXeljanz Film-Coated Tablet

5mgTofacitinib (as citrate) 5mg

Pfizer Maufacturing Deutschland

GmbH, Germany Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1774BRU17082233P Amoxicap 250 capsule

Amoxicillin (as trihydrate 287mg)

250mg Hovid Bhd., Malaysia G&H Trading Company

03 October 2017 till 02

October 2022 POM

1775 BRU17082234PForxiga 5mg Film-Coated

TabletDapagliflozin 5mg AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1776 BRU17082235PForxiga 10mg Film-Coated

TabletDapagliflozin 10mg AstraZeneca Pharmaceuticals LP, USA Zuellig Pharma (B) Sdn Bhd

03 October 2017 till 02

October 2022POM

1777 BRU17082236P Motigut Suspension 1ml/1ml Domperidone 1mg/mlSquare Pharmaceuticals Ltd,

BangladeshHongkiat Trading Co

03 October 2017 till 02

October 2022POM

1778 BRU17082237P Tanzaril Tablet 50mg Losartan Potassium 50mg Silom Medical Co. Ltd, Thailand Medicorp Sdn Bhd03 October 2017 till 02

October 2022POM

1779BRU17082238P Maxiclear Sinus Relief Tablet

10mg

Phenylephrine hydrochloride 10mg Sigma Laboratories Ltd, India Medipharm Sdn Bhd 03 October 2017 till 02

October 2022P

1780BRU17082239P Shrizine Injection 25mg/ml Fluphenazine Decanoate BP 25mg/ml SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 03 October 2017 till 02

October 2022POM

1781BRU17082240P 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 2022POM

1782BRU17082241P 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

1783BRU17082242P 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 2022POM

1784BRU17082243P 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 2022POM

BDMCA/RMP/0719 Page 122 of 157

Page 123: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1785

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

1786

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

1787BRU17092246P HIPROGIN INJECTION

250MG/ML (1 ML AMPOULE)

Hydroxyprogesterone caproate

250mg/ml

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading Co03 October 2017 till 02

October 2022

POM

1788BRU17092247P Phebra Magnesium Sulfate

Heptahydrate 50% 2.5g/5mL

Magnesium Sulfate Heptahydrate

500mg/Ml

Phebra Pty Ltd, Australia G&H trading Co03 October 2017 till 02

October 2022

POM

1789BRU17092248P Phebra Magnesium Sulfate

Heptahydrate 50% 5g/10mL

Magnesium Sulfate Heptahydrate

500mg/Ml

Phebra Pty Ltd, Australia G&H Trading Co03 October 2017 till 02

October 2022

POM

1790

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

1791

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

BDMCA/RMP/0719 Page 123 of 157

Page 124: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1792

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

1793

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

1794BRU17092254P Ravimed Tablet 5mg Medroxyprogesterone acetate USP

5mg

Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

03 October 2017 till 02

October 2022POM

1795BRU17092255P 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 2022POM

1796BRU17092256P 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 2022POM

1797 BRU17112257P Azithromycin Tablets 250mg Azithromycin Dihydrate equivalent to

Azithromycin 250mgJubilant Generics Limited, India Asterix United (B) Sdn Bhd

27 February 2018 till 26

February 2023POM

1798 BRU17112258P Fybogel Orange Sachet Ispaghula Husk BP 3.5gReckitt Benckiser Healthcare (UK)

Ltd., UKZuellig Pharma (B) Sdn Bhd

27 February 2018 till 26

February 2023GSL

1799 BRU17112259NPParacetamol Osteo-Tab

Modified Release TabletsParacetamol 665mg Macleods Pharmaceuticals Ltd, India Medipharm Sdn Bhd

27 February 2018 till 26

February 2023P

1800 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.,

MalaysiaAsterix United (B) Sdn Bhd

27 February 2018 till 26

February 2023

POM

1801 BRU17112261P Dermosone Cream 0.1% Betamethasone (as Valerate) 0.1% w/w Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd27 February 2018 till 26

February 2023POM

1802 BRU17112262P Regpara® TABLETS 25MGCinacalcet hydrochloride 27.55mg eqv

to Cinacalcet 25mgOhara Pharmaceutical Co., Japan K-Seri Pharma Sdn Bhd

27 February 2018 till 26

February 2023POM

BDMCA/RMP/0719 Page 124 of 157

Page 125: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1803

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

1804BRU17122264P 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

1805BRU17122265P

Probitor capsule 20mgOmeprazole 20mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma Sdn Bhd 27 February 2018 till 26

February 2023 POM

1806BRU17122266P

Solbid tablet 10mgIsosorbide Dinitrate 10mg SM Pharmaceuticals Sdn Bhd, MalaysiaG & H Trading Company

27 February 2018 till 26

February 2023 POM

1807BRU17122267NP

Adelim Ringworm SolutionTolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd, MalaysiaSyarikat Rajamas Bersama

27 February 2018 till 26

February 2023 GSL

1808BRU17122268P Converium 300mg Tablet Irbesartan 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Company

27 February 2018 till 26

February 2023 POM

1809BRU17122269P Salazine Enteric Coated Tablet 500mgSulfasalazine 500mg Sriprasit Pharma Co. Ltd., Thailand Medicorp Sdn Bhd

27 February 2018 till 26

February 2023 POM

1810BRU17122270P Axcel Metronidazole-200 TabletMetronidazole 200mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

27 February 2018 till 26

February 2023 POM

1811BRU17122271NP Dermorub Liniment Muscle & JointMethyl salicylate 25% v/v Winwa Medical Sdn. Bhd., Malaysia

Medicorp Sdn Bhd27 February 2018 till 26

February 2023 GSL

1812BRU17122272P 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

1813BRU17122273NP Bisacodyl Tablets 5mg Bisacodyl 5mg Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

27 February 2018 till 26

February 2023

P

1814BRU17122274P Alfutor ER Tablets 10mg Alfuzosin Hydrochloride 10mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26

February 2023

POM

1815BRU17122275P 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

BDMCA/RMP/0719 Page 125 of 157

Page 126: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1816BRU17122276P 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

1817BRU17122277P 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

1818BRU17122278NP 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

1819BRU17122279P 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

1820BRU17122281NP 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

1821BRU17122282P 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

1822BRU17122283P Ibuspan Tablet 200mg Ibuprofen 200mg SM Pharmacetuicals Sdn Bhd,

Malaysia

G & H Trading Company 27 February 2018 till 26

February 2023

P

1823BRU17122284NP 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

1824BRU17122285P 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

1825BRU17122286NP 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

1826BRU17122287P 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

1827BRU18012288P Irbesartan Tablets 150mg Irbesartan 150mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1828BRU18012289P Irbesartan Tablets 300mg Irbesartan 300mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1829BRU18012290P 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

1830

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

1831BRU18012292P Zykadia™ 150mg Hard

Capsule

Ceritinib 150mg Novartis Pharma AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26

February 2023

POM

1832BRU18012293P 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/0719 Page 126 of 157

Page 127: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1833

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

1834BRU18012295PS1;

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

1835BRU18012296PS1;

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

1836BRU18012297NP 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

1837BRU18012298NP 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

1838BRU18012299P 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

1839BRU18012300P 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

1840BRU18012301NP 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/0719 Page 127 of 157

Page 128: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1841

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;

Selenium (as Sodium Selenate

Brunel Healthcare Manufacturing

Limited, UK

Rico Agencies 27 February 2018 till 26

February 2023

GSL

1842 BRU18022303NPGlycophos 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 Bhd06 June 2018 till 05 June

2023P

BDMCA/RMP/0719 Page 128 of 157

Page 129: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1843 BRU18022304NPNutrilite 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 Bhd06 June 2018 till 05 June

2023GSL

1844 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 Bhd06 June 2018 till 05 June

2023POM

BDMCA/RMP/0719 Page 129 of 157

Page 130: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1845 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 Bhd06 June 2018 till 05 June

2023POM

1846 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 Bhd06 June 2018 till 05 June

2023POM

1847 BRU18022308P Jakavi 10mg tabletRuxolitinib phosphate 13.2mg eq. to

10mg Ruxolitinib

Novartis Pharma Stein, AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1848 BRU18022309PHYDROCORTISONE INJECTION

100MG

Each vial contains Hydrocortisone

Sodium Succinate BP equivalent to

Hydrocortisone 100mg

SM Pharmaceuticals Sdn Bhd.,

MalaysiaG&H Trading Company

06 June 2018 till 05 June

2023POM

1849BRU18022310P;

BRU18022310PS2

Opsumit 10mg Film-coated

TabletMacitentan 10mg

Patheon Italia S.p.A., Italy; Excella

GmbH & Co. KG., Germany (S2)Medipharm Sdn Bhd

06 June 2018 till 05 June

2023POM

1850 BRU18022311P URACTONUM 25MG TABLET Spironolactone 25mg Medochemie Ltd., CyprusHongkiat Trading &

Company

06 June 2018 till 05 June

2023POM

1851 BRU18022312P

Perjeta Concentrate for

Solution for Infusion

420mg/14ml

Pertuzumab 420mg Roche Diagnostics GmbH, Germany Medipharm Sdn Bhd06 June 2018 till 05 June

2023POM

1852 BRU18022313PCefepime-AFT Powder for

Injection 1G

Cefepime Hydrochloride equivalent to

Cefepime 1G

Qilu Pharmaceutical Co. Ltd., P.R.

ChinaMedipharm Sdn Bhd

06 June 2018 till 05 June

2023POM

BDMCA/RMP/0719 Page 130 of 157

Page 131: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1853 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 Bhd06 June 2018 till 05 June

2023GSL

1854 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 Bhd06 June 2018 till 05 June

2023GSL

1855 BRU18022316PCelecoxib Sandoz Capsule

200mgCelecoxib 200mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1856 BRU18022317NPMicroshield® 2 Chlorhexidine

Skin CleanserChlorhexidine Gluconate 2% w/v Ensign Laboratories Pty Ltd., Australia Medicorp Sdn Bhd

06 June 2018 till 05 June

2023GSL

1857 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 Bhd06 June 2018 till 05 June

2023GSL

1858 BRU18022319PTalgesil 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

2023POM

1859 BRU18032320P Norfox tablet Norfloxacin 400mgThe United Drug (1996) Co. Ltd.,

Thailand Medicorp Sdn Bhd

06 June 2018 till 05 June

2023POM

1860 BRU18032321P Domil Suspension 5mg/5ml Domperidone 5mg/5ml Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd06 June 2018 till 05 June

2023POM

1861 BRU18032322PLatanostill 50mcg/ml Eye

Drops SolutionLatanoprost 50 mcg/ml Bruschettini s.r.I., Italy Medicorp Sdn Bhd

06 June 2018 till 05 June

2023POM

BDMCA/RMP/0719 Page 131 of 157

Page 132: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1862 BRU18032323PGardasil 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 Bhd06 June 2018 till 05 June

2023POM

1863 BRU18032324PEntresto 50mg Film-coated

TabletsSacubitril 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

2023POM

1864 BRU18032325PEntresto 100mg Film-coated

TabletsSacubitril 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

2023POM

1865 BRU18032326PEntresto 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

2023POM

1866 BRU18032327P Dyna Amoxycillin 125mg/5ml Amoxycillin (as trihydrate) 125mg/5ml Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 June 2018 till 05 June

2023POM

1867 BRU18032328P Winofen suspension 2% w/v Ibuprofen 100mg/5ml Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd06 June 2018 till 05 June

2023P

1868 BRU18032329P Wincort 1% cream Hydrocortisone acetate 1% w/w Winwa Medical Sdn Bhd, Malaysia Medicorp Sdn Bhd06 June 2018 till 05 June

2023POM

1869 BRU18032330P Acugesic Tablet 50mg Tramadol HCl 50mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd06 June 2018 till 05 June

2023POM

1870 BRU18032331NPMicroshield® Handrub

Solution

Chlorhexidine Gluconate 0.5% w/v in

Ethanol 70% v/vEnsign Laboratories Pty Ltd., Australia Medicorp Sdn Bhd

06 June 2018 till 05 June

2023GSL

1871 BRU18032332P Defuzin Cream 2% w/w Fusidic acid 2% w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 June 2018 till 05 June

2023POM

1872 BRU18032333P Hydrochlorzide-50 Tablet Hydrochlorothiazide 50mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

06 June 2018 till 05 June

2023POM

1873 BRU18032334PSIMBRINZA* 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

2023POM

1874 BRU18032335NP Hexidin Cream 1% Chlorhexidine Gluconate 1% w/w Noripharma Sdn Bhd, Malaysia G&H Trading Company06 June 2018 till 05 June

2023GSL

BDMCA/RMP/0719 Page 132 of 157

Page 133: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1875 BRU18032336NPGreen Balsem, Three Legs

Brand

Menthol........... 10% w/w

Camphor......... 4% w/wSyarikat Wen Ken Drug Sdn Bhd.,

MalaysiaSyarikat Rajamas Bersama

06 June 2018 till 05 June

2023GSL

1876

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

1877BRU18042338P Novatretin™ 25mg Capsules Acitretin 25mg

Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd06 June 2018 till 05 June

2023POM

1878BRU18042339P Novatretin™ 10mg Capsules Acitretin 10mg

Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd06 June 2018 till 05 June

2023POM

1879

BRU18042340P

Axcel Metoclopramide Tablet

Metoclopramide Hydrochloride

equivalent to Anhydrous

Metoclopramide Hydrochloride 10mgKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

06 June 2018 till 05 June

2023

POM

1880

BRU18042341P TADIM Colistimethate Sodium

1 Million IU Powder for

Nebuliser Solution Vial

Colistimethate Sodium 1 Million IU

Xellia Pharmaceuticals ApS, Denmark G&H Trading Company06 June 2018 till 05 June

2023

POM

1881BRU18042342P

Clovix 75mg tabletClopidogrel 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

1882BRU18042343P

AXCEL CETIRIZINE TABLETCetirizine dihydrochloride 10mg

Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd06 June 2018 till 05 June

2023P

1883

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

1884BRU18042345P

Ibrance Capsules 75mg Palbociclib 75mg Pfizer Manufacturing Deutschland

GmbH, Germany Zuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1885BRU18042346P

Ibrance Capsules 100mg Palbociclib 100mg Pfizer Manufacturing Deutschland

GmbH, Germany Zuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1886BRU18042347P

Ibrance Capsules 125mg Palbociclib 125mg Pfizer Manufacturing Deutschland

GmbH, Germany Zuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1887BRU18042348P TULIP® 40MG FILM-COATED

TABLETAtorvastatin (as Atorvastatin calcium)

40mgLek Pharmaceuticals d.d , Solvenia Zuellig Pharma (B) Sdn Bhd

06 June 2018 till 05 June

2023POM

1888

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

BDMCA/RMP/0719 Page 133 of 157

Page 134: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1889BRU18062350P 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

1890BRU18062351P 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

1891BRU18062352P ANALPAN INJECTION

75MG/3ML

Diclofenac Sodium 75mg/3ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

06 June 2018 till 05 June

2023

POM

1892

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

1893

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

1894

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

1895BRU18062356P 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

1896BRU18062357NP Potrelease TR Tablet 600mg Potassium Chloride 600mg SM Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

P

BDMCA/RMP/0719 Page 134 of 157

Page 135: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1897

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

1898BRU18062359P Encardil Tablet 10mg Enalapril Maleate 10mg SM Pharmaceuticals Sdn Bhd.,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

POM

1899BRU18062360NP 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

1900BRU18062361P Pharmaniaga Ranitidine Tablet

150mg

Ranitidine (as hydrochloride) 150mg Pharmaniaga Manufacturing Berhad,

Malaysia

G&H Trading Company 06 June 2018 till 05 June

2023

POM

1901BRU18062362P Apo-Carvedilol 6.25mg Tablet Carvedilol 6.25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1902BRU18062363P Apo-Carvedilol 25mg Tablet Carvedilol 25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June

2023

POM

1903

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

1904BRU18062365P 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

1905BRU18062366P 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

1906BRU18062367P 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

1907BRU18062368NP 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

BDMCA/RMP/0719 Page 135 of 157

Page 136: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1908

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

1909BRU18062370NP 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

1910

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

1911

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

1912BRU18072373P Apo-Ranitidine 150mg Tablet Ranitidine 150mg Apotex Inc, Canada MediPharm Sdn Bhd 05 September 2018 till 04

September 2023

POM

1913BRU18072374P Axcel Iridin Linctus Pholcodine 10mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd 05 September 2018 till 04

September 2023

POM

1914BRU18072375P 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

1915BRU18072376P 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

1916BRU18072377P Terbin Cream 1% Terbinafine Hydrochloride 10mg/g SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 05 September 2018 till 04

September 2023

GSL

1917

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

BDMCA/RMP/0719 Page 136 of 157

Page 137: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

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

1919BRU18072380NP 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

1920BRU18072381P 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

1921BRU18082382P Tolanz ODT Tablets 5mg Olanzapine 5mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

1922BRU18082383P Tolanz ODT Tablets 10mg Olanzapine 10mg Torrent Pharmaceuticals Limited,

India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04

September 2023

POM

1923BRU18082384NP 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

1924BRU18082385P 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

1925BRU18082386P 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

1926BRU18082387P 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

1927BRU18082388P 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

1928BRU18082389P 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

1929BRU18082390P TAGRISSO 40MG FILM-

COATED TABLETS

Osimertinib 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

1930BRU18082391P TAGRISSO 80MG FILM-

COATED TABLETS

Osimertinib 80mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

1931BRU18082392P Adezio Tablet 10mg Cetirizine Hydrohloride 10mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company

05 September 2018 till 04

September 2023

P

1932BRU18082393P 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

1933BRU18082394P XALKORI 200MG HARD

CAPSULES

Crizotinib 200mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

1934BRU18082395P XALKORI 250MG HARD

CAPSULES

Crizotinib 250mg Pfizer Manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

1935BRU18082396P Normaten Tablet 100mg Atenolol 100mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company

05 September 2018 till 04

September 2023

POM

BDMCA/RMP/0719 Page 137 of 157

Page 138: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1936BRU18082397P Brilinta 60mg Film-coated

Tablet

Ticagrelor 60mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04

September 2023

POM

1937BRU18082398P 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

1938BRU18082399P 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

1939BRU18082400P Normaten Tablet 50mg Atenolol 50mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company

05 September 2018 till 04

September 2023

POM

1940BRU18082401P Adroten Tablet 5mg Bisoprolol Fumarate 5mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company

05 September 2018 till 04

September 2023

POM

1941BRU18092402P Mapenem (1G Injection) Meropenem trihydrate and sodium

carbonate 1.28g (equivalent to

Meropenem 1g)

Siam Bheasach Co., Ltd., Thailand K-Seri Pharma Sdn. Bhd11 December 2018 till 10

December 2023

POM

1942

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

1943BRU18092404P Apo-Fluvoxamine 50mg tablet Fluvoxamine maleate 50mg Apotex Inc. Canada, Canada Medicorp Sdn. Bhd 11 December 2018 till 10

December 2023POM

1944BRU18092405P Ultiva Injection 5mg Each single use vial contains 5mg

remifentanil (as hydrochloride).

GlaxoSmithKline Manufacturing,

S.P.A., Italy.

Zuellig Pharma Sdn Bhd11 December 2018 till 10

December 2023

POM

1945BRU18092406P 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 2023POM

1946BRU18092407P 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 2023POM

1947BRU18092408P Halaven 0.5mg/ml Solution

for Injection

Eribulin mesilate Biogen U.S. Corporation, USA. Medipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

1948BRU18092409P 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 2023POM

1949

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

BDMCA/RMP/0719 Page 138 of 157

Page 139: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1950

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

1951BRU18092412P 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 2023POM

1952BRU18092413NP 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 2023GSL

1953BRU18092414NP SW Aqueous Cream Cetomacrogol 1000 2.75%w/w

White Soft Paraffin 17.85%w/w

Sunward Pharmaceutical Sdn Bhd,

Malaysia

G & H Trading Company11 December 2018 till 10

December 2023

GSL

1954

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

1955

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

1956

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

1957BRU18092418P Prolia Solution for Injection

60mg/mL (Prefilled Syringe)

Denosumab 60mg/mL Amgen Manufacturing Limited,

United States

MediPharm Sdn Bhd11 December 2018 till 10

December 2023

POM

1958BRU18102419PS1 &

BRU18102419PS2Zient® 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 Bhd11 December 2018 till 10

December 2023

POM

1959 BRU18102420PSimulect Lyophilisate for

Injection 20mg per vialBasiliximab 20mg

Novartis Pharma Stein AG,

SwitzerlandZuellig Pharma (B) Sdn Bhd

11 December 2018 till 10

December 2023POM

1960 BRU18102421NP Calcium Lactate Tablet 300mg Calcium Lactate 300mgSunward Pharmaceutical Sdn Bhd,

MalaysiaG&H Trading Company

11 December 2018 till 10

December 2023GSL

1961 BRU18102422P Sulpin F.C. Tablets 200mg Sulpiride 200mgTaiwan Biotech Co. Ltd., Taiwan,

Republic of ChinaK-Seri Pharma Sdn Bhd

11 December 2018 till 10

December 2023POM

BDMCA/RMP/0719 Page 139 of 157

Page 140: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1962 BRU18102423PQuetiapine 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 2023POM

1963 BRU18102424PQuetiapine 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 2023POM

1964 BRU18102425PQuetiapine 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 2023POM

1965 BRU18102426NPVolulyte 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,

GermanyZuellig Pharma (B) Sdn Bhd

11 December 2018 till 10

December 2023

POM

1966 BRU18102427PHydrogen 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 2023GSL

1967 BRU18102428PAxcel Prednisolone-5mg EC

TabletsPrednisolone 5mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

11 December 2018 till 10

December 2023POM

1968 BRU18102429PPraluent 75mg Solution for

Injection in Pre-filled Pen Alirocumab 75mg/ml

Sanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd

11 December 2018 till 10

December 2023POM

1969 BRU18102430PPraluent 150mg Solution for

Injection in Pre-filled Pen Alirocumab 150mg/ml

Sanofi-Aventis Deutschland GmbH,

GermanyMedipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

1970 BRU18102431PPraluent 75mg Solution for

Injection in Pre-filled SyringeAlirocumab 75mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

1971 BRU18102432PPraluent 150mg Solution for

Injection in Pre-filled SyringeAlirocumab 150mg/ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

1972 BRU18102433PUdoxan 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 2023POM

1973 BRU18102434PLignopad®medicated plaster

5%w/wLidocaine 5% w/w Teikoku Seiyaku Co Ltd, Japan Zuellig Pharma (B) Sdn Bhd

11 December 2018 till 10

December 2023POM

1974 BRU18102435PCEFTREX INJECTION 1G IV

CEFTRIAXONE

Ceftriaxone sodium equivalent to

Ceftriaxone 1GBiolab Co Ltd, Thailand

Hongkiat Trading &

Company

11 December 2018 till 10

December 2023POM

1975 BRU18102436P Doxymycin-100 CapsulesDoxycycline Hyclate BP equivalent to

Doxycycline 100mg

Beacons Pharmaceuticals Pte Ltd,

Singapore

Hongkiat Trading &

Company

11 December 2018 till 10

December 2023POM

1976 BRU18102437NP Optrex Multi Action Eye WashHamamelis Water (Witch Hazel) 13.0%

v/v

Reckitt Beckinser Healthcare

International Ltd, UKSyarikat Aliaa Sdn Bhd

11 December 2018 till 10

December 2023GSL

1977 BRU18102438NP Optrex Rehydrating Eye Drops Sodium Hyaluronate 0.165%w/wReckitt Beckinser Healthcare

International Ltd, UKSyarikat Aliaa Sdn Bhd

11 December 2018 till 10

December 2023GSL

BDMCA/RMP/0719 Page 140 of 157

Page 141: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1978 BRU18102439PCandesartan Sandoz tablet

8mgCandesartan cilexetil 8mg Lek Pharmaceuticals d.d., Slovenia Zuellig Pharma (B) Sdn Bhd

11 December 2018 till 10

December 2023POM

1979 BRU18102440P Keytruda 25mg/mL Pembrolizumab 25mg/mL MSD Ireland (Carlow), Ireland Zuellig Pharma (B) Sdn Bhd11 December 2018 till 10

December 2023POM

1980

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

1981BRU18112442P FRESOFOL 2% MCT/LCT

EMULSION FOR INJECTION OR

INFUSION

Propofol 20mg/ml Fresenius Kabi Austria GMBH (Plant

Graz), Austria

Zuellig Pharma (B) Sdn Bhd11 December 2018 till 10

December 2023

POM

1982BRU18112443P FRESOFOL 1% MCT/LCT

EMULSION FOR INJECTION OR

INFUSION

Propofol 10mg/ml Fresenius Kabi Austria GMBH (Plant

Graz), Austria

Zuellig Pharma (B) Sdn Bhd11 December 2018 till 10

December 2023

POM

1983BRU18112444NP SURGICAL SPIRIT Methylated spirit 98.8% v/v Sanchuan Medical Sdn BHd, Malaysia SWL Biomed Sales &

Services

11 December 2018 till 10

December 2023GSL

1984BRU18112445P 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 2023POM

1985BRU18112446P 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 2023POM

1986BRU18112447P VERAPIME POWDER FOR

SOLUTION FOR INJECTION

1G/VIAL

Cefepime Hydrochloride Monohydrate

equivalent to Cefepime 1g

DEMO S.A. Pharmaceutical Industry,

Greece

Medicorp Sdn Bhd11 December 2018 till 10

December 2023

POM

1987

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

BDMCA/RMP/0719 Page 141 of 157

Page 142: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1988

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

1989

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

BDMCA/RMP/0719 Page 142 of 157

Page 143: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

1990

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

1991BRU18112452P 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 2023POM

1992BRU18112453P Midazolam-Hameln 5mg/ml

Injection, 3ml

Midazolam (as hydrochloride)

15mg/3ml

Hameln Pharmaceuticals GmbH,

Germany

Medicorp Sdn Bhd 11 December 2018 till 10

December 2023POM

1993BRU18112454P APO-ATENIDONE TABLETS

100/25MG

Atenolol 100mg and Chlorthalidone

25mg

Apotex Inc, Canada Medicorp Sdn Bhd 11 December 2018 till 10

December 2023POM

1994BRU18112455P Torio Tablet Simvastatin 10mg Unison Laboratories Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 11 December 2018 till 10

December 2023POM

1995BRU18112456P Arvastatil 10mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq. to

Atorvastatin 10mg

One-Pharma Industrial

Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd11 December 2018 till 10

December 2023

POM

1996BRU18112457P Arvastatil 20mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq. to

Atorvastatin 20mg

One-Pharma Industrial

Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd11 December 2018 till 10

December 2023

POM

1997BRU18112458P Arvastatil 40mg Film Coated

Tablets

Atorvastatin calcium Trihydrate eq. to

Atorvastatin 40mg

One-Pharma Industrial

Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd11 December 2018 till 10

December 2023

POM

1998

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

1999BRU18112460P 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 2023POM

2000BRU18112461P IMACH INJECTION 1ML Chlorpheniramine maleate 10mg/1ml SM Pharmaceuticals Sdn Bhd,

Malaysia

G&H Trading Company 11 December 2018 till 10

December 2023POM

BDMCA/RMP/0719 Page 143 of 157

Page 144: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2001BRU18112462NP Silverderm cream Silver Sulfadiazine 1% w/w T.O. Chemicals (1979) Ltd, Thailand Medicorp Sdn Bhd 11 December 2018 till 10

December 2023P

2002BRU18112463P 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 2023POM

2003BRU18112464P Lenvima 4mg Hard Capsule Lenvatinib 4mg (equivalent to 4.90mg

levatinib mesilate)

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

2004BRU18112465P Lenvima 10mg Hard Capsule Lenvatinib 10mg (equivalent to

12.25mg levatinib mesilate

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10

December 2023POM

2005BRU18112466P KISQALI 200MG FILM-COATED

TABLET

Ribociclib succinate equivalent to

200mg ribociclib

Novartis Singapore Pharmaceutical

Manufacturing Pte Ltd., Singapore

Zuellig Pharma (B) Sdn Bhd11 December 2018 till 10

December 2023

POM

2006BRU18112467P Zylovaa Tablet 50mg Losartan Potassium 50mg Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company

11 December 2018 till 10

December 2023POM

2007BRU18122468P CLOXABIOTIC INJECTION

500MG

Cloxacillin sodium BP equivalent to

cloxacillin 500mg

Karnataka Antibiotics &

Pharmaceuticals Limited (A. Govt of

India Enterprise), India

K-Seri Pharma Sdn. Bhd04 March 2019 till 03

March 2024POM

2008BRU18122469P Losartan Potassium Tablet

50mg

Losartan Potassium 50mg Jubilant Generics Limited, INDIA.Asterix United (B) Sdn Bhd.

04 March 2019 till 03

March 2024POM

2009BRU18122470P Losartan Potassium Tablet

100mg

Losartan Potassium 100mg Jubilant Generics Limited, INDIA.Asterix United (B) Sdn Bhd.

04 March 2019 till 03

March 2024POM

2010BRU18122471P 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 2024POM

2011BRU18122472NP 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 2024POM

2012BRU18122473P Dyna Ferrous Fumarate Tablet Ferrous Fumarate 200mg Dynapharm (M) Sdn Bhd (65683-V),

Pulau Pinang, MalaysiaMedicorp Sdn Bhd

04 March 2019 till 03

March 2024GSL

2013

BRU18122474P OXYNORM 5MG CAPSULES Each capsule contains:

4.5mg oxycodone as 5mg oxycodone

hydrochloride.

Bard Pharmaceuticals Limited, United

Kingdom. Zuellig Pharma (B) Sdn Bhd04 March 2019 till 03

March 2024POM

2014

BRU18122475P OXYNORM 10MG CAPSULES Each capsule contains:

9mg oxycodone as 10mg oxycodone

hydrochloride.

Bard Pharmaceuticals Limited, United

Kingdom. Zuellig Pharma (B) Sdn Bhd04 March 2019 till 03

March 2024POM

2015

BRU18122476P OXYNORM 20MG CAPSULES Each capsule contains:

18mg oxycodone as 20mg oxycodone

hydrochloride.

Bard Pharmaceuticals Limited, United

Kingdom. Zuellig Pharma (B) Sdn Bhd04 March 2019 till 03

March 2024POM

BDMCA/RMP/0719 Page 144 of 157

Page 145: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2016

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 Bhd04 March 2019 till 03

March 2024POM

2017

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 Bhd04 March 2019 till 03

March 2024POM

2018

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 Bhd04 March 2019 till 03

March 2024POM

2019

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 Company04 March 2019 till 03

March 2024P

2020BRU18122481P Kary Uni® Ophthalmic

Suspension (Pirenoxine

0.005%)

Pirenoxine 0.05mg/ mL Santen Pharmaceutical Co., JapanMediPharm Sdn Bhd

04 March 2019 till 03

March 2024POM

BDMCA/RMP/0719 Page 145 of 157

Page 146: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2021

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 2024GSL

2022BRU18122483NP 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 2024GSL

2023BRU18122484NP Mifulin lotion Salicylic acid 12% Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company04 March 2019 till 03

March 2024GSL

2024BRU18122485P Ketazon shampoo Ketoconazole 2g/100ml Siam Bheasach Co Ltd, Thailand

K-Seri Pharma Sdn. Bhd.04 March 2019 till 03

March 2024 GSL

2025

BRU18122486P DURATOCIN® 100mcg/ml

Injection

Carbetocin 100mcg/ml Ferring GmbH, Germany

Repacker: Zuellig Pharma Specialty

Solutions Group Pte. Ltd., Singapore

Zuellig Pharma (B) Sdn Bhd04 March 2019 till 03

March 2024POM

2026

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 2024GSL

2027 BRU19012488P BENZAPEN 2.4MIU INJECTIONSterile Penicillin G Benzathine 1.8G (2.4

MU)

Karnataka Antibiotics &

Pharmaceuticals Ltd., IndiaK-Seri Pharma Sdn Bhd

04 March 2019 till 03

March 2024POM

2028 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

2029 BRU19012490NPMENTHOLATUM DEEP

HEATING PLASTERL-Menthol 4.26%

Teh Seng Pharmaceutical Mfg. Co.,

Ltd., Taiwan, R.O.CHamitan Marketing

04 March 2019 till 03

March 2024GSL

2030 BRU19012491PFENTANYL-HAMELN 50

MCG/ML INJECTION

Fentanyl citrate (0.157mg) eq. to

fentanyl 0.1mg/2ml

Hameln Pharmaceuticals GmbH,

GermanyMedicorp Sdn Bhd

04 March 2019 till 03

March 2024POM

2031 BRU19012492P AXINOL TABLET 20MG Trimetazidine dihydrochloride 20mgT.O Chemicals (1970) Co. Ltd.,

Thailand.Medicorp Sdn Bhd

04 March 2019 till 03

March 2024POM

2032 BRU19012493P

HCQS

(HYDROXYCHLOROQUINE

TABLETS BP 200MG)

Hydroxychloroquine Sulfate BP 200mg Ipca Laboratories Limited, India. K-Seri Pharma Sdn Bhd04 March 2019 till 03

March 2024POM

BDMCA/RMP/0719 Page 146 of 157

Page 147: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2033 BRU19012494PVAXCEL 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 2024POM

2034 BRU19012495NPPOVIDONE IODINE, THREE

LEGS BRAND

Povidone Iodine 10% w/v Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

04 March 2019 till 03

March 2024GSL

2035 BRU19012496P ALTRATM TABLET 10MG

Montelukast 10mg (as montelukast

sodium 10.66mg)Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaHongkiat Trading & Co.

04 March 2019 till 03

March 2024POM

2036 BRU19012497PAXCEL DIPHENHYDRAMINE

PAEDIATRIC SYRUP

Diphenhydramine hydrochloride 7mg /

5ml

Ammonium chloride 67.5mg / 5mlKotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd

04 March 2019 till 03

March 2024POM

2037 BRU19012498NPVISIPAQUE 320 MG I/ML,

SOLUTION FOR INJECTIONIodixanol 652 mg/ml eq to 320 mg I/ml

GE Healthcare (Shanghai) Co., Ltd,

ChinaMedipharm Sdn Bhd

04 March 2019 till 03

March 2024POM

2038BRU19012499PS1 &

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 Company04 March 2019 till 03

March 2024POM

2039BRU19012500PS1 &

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 Company04 March 2019 till 03

March 2024POM

2040BRU19012501PS1 &

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 2024POM

BDMCA/RMP/0719 Page 147 of 157

Page 148: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2041 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 2024POM

2042 BRU19012503NPREGIOCIT SOLUTION FOR

HAEMOFILTRATION

Sodium chloride 5.03 g/L

Sodium citrate 5.29 g/L Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd04 March 2019 till 03

March 2024POM

2043 BRU19012504PPYRONIUM INJECTION

200MCG/MLGlycopyrrolate 200mcg/ml

SM Pharmaceuticals Sdn Bhd,

MalaysiaMedicorp Sdn Bhd

04 March 2019 till 03

March 2024POM

2044 BRU19012505PHERCEPTIN SOLUTION FOR

INJECTION 600MG/5MLTrastuzumab 600mg/5ml

F.Hoffmann-La Roche Ltd.,

Kaiseraugst, SwitzerlandMedipharm Sdn Bhd

04 March 2019 till 03

March 2024POM

2045 BRU19012506PEZETIMIBE SANDOZ TABLET

10MGEzetimibe 10mg

Lek Pharmaceuticals, Ljubljana,

Slovenia Zuellig Pharma (B) Sdn.

Bhd

04 March 2019 till 03

March 2024POM

2046 BRU19022507PAPO-FLUCONAZOLE 100MG

TABLETSFLUCONAZOLE 100MG Apotex Inc., Canada Medipharm Sdn Bhd

04 March 2019 till 03

March 2024POM

2047BRU19022508NP NUTRILITE IRON FOLIC TABLET IRON 10MG

FOLATE (FOLIC ACID) 0.133MG

Access Business Group LLC, USAAmway (B) Sdn Bhd

04 March 2019 till 03

March 2024GSL

2048BRU19022509P CEFATUM INJECTION 1G CEFTAZIDIME 1GM Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading &

Company

04 March 2019 till 03

March 2024POM

BDMCA/RMP/0719 Page 148 of 157

Page 149: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2049BRU19022510NP Folic Acid Tablets 5mg FOLIC ACID 5MG HOVID Bhd., Malaysia

G&H Trading Company 04 March 2019 till 03

March 2024GSL

2050BRU19022511P Clopine 100MG Tablet Clozapine 100mg Douglas Manufacturing Ltd., New

ZealandK-Seri Pharma Sdn Bhd

04 March 2019 till 03

March 2024POM

2051BRU19022512P Vaxcel Omeprazole 40mg

Injection

Omeprazole Sodium equivalent to

Omeprazole 40mgKotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03

March 2024POM

2052BRU19022513NP Medon 500 capsule Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company04 March 2019 till 03

March 2024GSL

2053BRU19022514P Bufencon Injection Betamethasone (as dipropionate) 5mg &

Betamethasone (as phosphate disodium)

2mg

Yung Shin Pharmaceutical Ind. Co.

Ltd., Taiwan, Republic of China Asterix (B) Sdn Bhd04 March 2019 till 03

March 2024POM

2054BRU19022515NP PARACETAMOL-AFT

SOLUTION FOR INFUSION

10MG/ML

Paracetamol 10mg/ml S.M. Farmaceutici SRL, Italy MediPharm Sdn Bhd

04 March 2019 till 03

March 2024POM

2055BRU19022516P Domi Injection 15mg (3ml

Amp)

Midazolam HCl equivalent to Midazolam

15mg/3mlDuopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd04 March 2019 till 03

March 2024POM

2056BRU19022517P Baraclude® 0.5mg Tablets Entecavir 0.5mg Bristol-Myers Squibb Company, USA

Medipharm Sdn Bhd04 March 2019 till 03

March 2024POM

2057BRU19022518NP Tricera Cleanser 1.6% w/w Pine Tar 1.6% HOE Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

04 March 2019 till 03

March 2024GSL

2058BRU19022519P 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 2024POM

2059BRU19022520P KENO ORAL PASTE Triamcinolone acetonide 1 mg/g T.O. CHEMICALS (1979) LTD., Thailand

Medicorp Sdn Bhd04 March 2019 till 03

March 2024POM

2060BRU19022521P ATRACURIUM-HAMELN

10MG/ML INJECTION, 2.5ML

Atracurium besilate 25mg in 2.5ml

(10mg/ml)

Hameln Pharmaceuticals GmbH,

Germany Medicorp Sdn Bhd04 March 2019 till 03

March 2024POM

2061BRU19022522NP Kidz PCM 250 Suspension

(Strawberry)

Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau

Pinang, MalaysiaYuh Hua Trading Company

04 March 2019 till 03

March 2024GSL

2062BRU19022523NP Povil Antacid Tablet Dried Aluminium Hydroxide 250 mg,

Magnesium Hydroxide 250 mg,

Simethicone 50 mg

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia Medicorp Sdn Bhd04 March 2019 till 03

March 2024GSL

2063BRU19022524P Inlyta® 1mg Film-Coated

Tablet

Axitinib 1mg Pfizer manufacturing Deutschland

GmbH, Germany

Zuellig Pharma (B) Sdn.

Bhd

04 March 2019 till 03

March 2024POM

2064BRU19022525P Inlyta® 5mg Film-Coated

Tablet

Axitinib 5mg Pfizer manufacturing Deutschland

GmbH, GermanyZuellig Pharma (B) Sdn Bhd

04 March 2019 till 03

March 2024POM

2065BRU19022526P Taflotan Ophthalmic Solution

0.0015%

Tafluprost 0.00015% Santen Pharmaceutical Co., Ltd.,

Shiga Plant, JapanMediPharm Sdn Bhd

04 March 2019 till 03

March 2024POM

2066BRU19022527NP Paracil suspension 250mg/5ml Paracetamol 250mg/5ml SM Pharmaceuticals Sdn Bhd,

MalaysiaG& H Trading Company

04 March 2019 till 03

March 2024GSL

BDMCA/RMP/0719 Page 149 of 157

Page 150: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2067BRU19022528P DTI for Injection 200mg Dacarbazine 200mg Korea United Pharm, Inc., Republic of

Korea

Kingsley Medical Supplies

Sdn Bhd

04 March 2019 till 03

March 2024POM

2068BRU19022529P Sildegra 100mgTablets Sildenafil Citrate 140.4mg equivalent to

Sildenafil 100mg

Sandoz Private Limited, IndiaZuellig Pharma (B) Sdn Bhd

04 March 2019 till 03

March 2024POM

2069 BRU19032530PImexa powder for oral

suspension 200mg/5mlAzithromycin 200mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd

Hongkiat Trading &

Company 16 July 2019 till 15 July

2024POM

2070 BRU19032531P Dysolvon Syrup (Raspberry) Bromhexine hydrochloride 4mg/5ml Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd16 July 2019 till 15 July

2024P

2071 BRU19032532NP Paracil Tablet 500mg Paracetamol 500mgSM Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

16 July 2019 till 15 July

2024GSL

2072 BRU19032533NPCap Kaki Tiga Ai Kan Shan

Fever PowderParacetamol 500mg / sachet

Syarikat Wen Ken Drug Sdn Bhd,

MalaysiaSyarikat Rajamas Bersama

16 July 2019 till 15 July

2024GSL

2073 BRU19032534NP Dyna Calamine Lotion Calamine Powder 150mg/ml (15% w/v) Dynapharm (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd16 July 2019 till 15 July

2024GSL

2074 BRU19032535PGazyva Concentrate for

Solution for InfusionObinutuzumab 1000mg/40mL Roche Diagnostics GmbH, Germany MediPharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2075 BRU19032536P Pyrimine Tablet 60mg Pyridostigmine Bromide 60mg Sriprasit Pharma Co., Ltd., Thailand Medicorp Sdn Bhd16 July 2019 till 15 July

2024POM

2076 BRU19032537PCeftriaxone-AFT Powder for

Injection 1g

Ceftriaxone sodium 1.079g (equivalent

to ceftriaxone 1g)Qilu Pharmaceutical Co., Ltd., China MediPharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2077 BRU19032538NP U-Lite Effervescent Granules

Each 4.1gm contains:

Sodium Bicarbonate 1.76g

Citric Acid 0.72g

Sodium Citrate 0.63g

Tartaric Acid 0.89g

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia Medicorp Sdn Bhd

16 July 2019 till 15 July

2024

GSL

2078 BRU19032539P Coldmax Suspension

Each 5ml contains:

Paracetamol 250mg

Pseudoephedrine HCl 15mg

Chlorpheniramine Maleate 1mg

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia Medicorp Sdn Bhd

16 July 2019 till 15 July

2024P

2079 BRU19032540NPKidz PCM 250 Suspension

(Orange)Paracetamol 250mg/5ml

Winwa Medical Sdn Bhd, Pulau

Pinang, Malaysia Medicorp Sdn Bhd

16 July 2019 till 15 July

2024GSL

2080 BRU19032541NP UNI-MA ENEMA SOLUTION

Each 118ml (delivered dose) contains::

Sodium bisphosphonate 19g; Sodium

phosphate 7g

Unison Laboratories Co., Ltd.,

ThailandK-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024 P

2081 BRU19032542P Ciprocep Tablet 250mgCiprofloxacin Hydrochloride 291.5mg

equivalent to Ciprofloxacin 250mgT.O. Pharma Co. Ltd., Thailand Medicorp Sdn Bhd

16 July 2019 till 15 July

2024 POM

2082 BRU19032543PFerriprox 1000mg Film Coated

Tablet Deferiprone 1000mgApotex Inc., Canada Medicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

BDMCA/RMP/0719 Page 150 of 157

Page 151: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2083 BRU19032544P Octocaine 100

Each ml contains:

i) Lidocaine Hydrochloride 20mg

ii) Epinephrine bitartrate 0.018mg

Novocol Pharmaceutical of Canada

Inc., CanadaMedicorp Sdn Bhd

16 July 2019 till 15 July

2024 POM

2084 BRU19032545NP ANIOSGEL 85 NPC

Ethanol 70%

(700mg/g i.e 755ml/L Laboratoires Anios, France K-Seri Pharma Sdn Bhd16 July 2019 till 15 July

2024 GSL

2085BRU19032546NP ANTHPHLAMINE S LOTION Methylsalicylate 20% w/w

L-Menthol 6% w/w

Yuhan Corporation, South Korea Kingsley Medical Supplies

Sdn Bhd

16 July 2019 till 15 July

2024

GSL

2086BRU19032547NP Woods Peppermint Cough

Syrup for Children

Guaiphenesin 50mg/5ml IDS Manufacturing Sdn Bhd, Malaysia M.S. Makmur Trading

Company

16 July 2019 till 15 July

2024

GSL

2087

BRU19032548NP Xubil Oral Solution Each 5ml contains:

Monobasic sodium phosphate 2.4 g;

Dibasic sodium phosphate 0.9 g

Unison Laboratories Co., Ltd.,

Thailand

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July

2024

POM

2088 BRU19042549POxytocin-Richter Solution for

Injection 10 IU/1mlOxytocin 10 I.U./1ml Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024POM

2089 BRU19042550P Vivic Tablet 100mg Sildenafil 100mgXepa-Soul Pattinson (Malaysia) Sdn

Bhd, Malaysia

Hongkiat Trading &

Company16 July 2019 till 15 July

2024POM

2090 BRU19042551PRequip PD 24 hour Prolonged

Release Tablet 4mg

Ropinirole hydrochloride (eq to 4mg

ropinirole free base)Glaxo Wellcome S.A, Spain Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024 POM

2091 BRU19042552NP Axcel Folic Acid 5mg Folic Acid 5mg Kotra Pharma (M) Sdn Bhd, Malaysia Medicorp Sdn Bhd16 July 2019 till 15 July

2024GSL

2092 BRU19042553PMaxigesic Tablet

500mg/150mg

Paracetamol 500mg

Ibuprofen 150mg Sigma Laboratories Ltd, India Medipharm Sdn Bhd16 July 2019 till 15 July

2024 P

2093 BRU19042554PArnetin 50mg/2ml Solution

for Injection/Infusion

Ranitidine (as ranitidine hydrochloride)

50mg/2ml Medochemie Ltd., Cyprus Medicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2094 BRU19042555P Clavomax 625mg Tablet

Each tablet contains:

573.96mg Amoxicillin Trihydrate (eq. to

Amoxicillin 500mg) and 148.91mg

Potassium Clavulanate (eq. to

Clavulanic acid 125mg)

China Chemical & Pharmaceutical Co.

Ltd, TaiwanMedicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2095 BRU19042556P Chlorop Eye Ointment 1% Chloramphenicol 10mg/g (1%)SM Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

16 July 2019 till 15 July

2024POM

2096 BRU19042557P Akoset Injection 20mg/2ml Frusemide 20mg/2ml Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd16 July 2019 till 15 July

2024POM

BDMCA/RMP/0719 Page 151 of 157

Page 152: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2097 BRU19042558PLipiodol Ultra Fluid 480mg

l/ml, Solution for Injection

Ethyl esters of iodized fatty acids of

poppy seed oil corresponds to iodine

480mg/ml

Delpharm Tours, FranceManning Jaya Trading (B)

Sdn Bhd

16 July 2019 till 15 July

2024 POM

2098 BRU19042559NPPovil Antacid Mixture

(Peppermint)

Each 10ml contains:

Aluminium Hydroxide 400 mg

Magnesium Hydroxide 400 mg

Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company16 July 2019 till 15 July

2024 GSL

2099 BRU19042560P Betacort Cream 0.1% w/w

Each gram cream contains:

Betamethasone Valerate equivalent to

1mg Betamethasone (0.1%w/w).

SM Biomed Sdn Bhd, Malaysia G&H Trading Company16 July 2019 till 15 July

2024 POM

2100 BRU19042561PCravit Ophthalmic Solution

0.5%Levofloxacin hydrate 5mg/mL

Santen Pharmaceutical Asia Pte. Ltd.,

SingaporeMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2101 BRU19042562P Esmya Tablet 5mg Ulipristal Acetate 5mg Cenexi, France Zuellig Pharma (B) Sdn Bhd16 July 2019 till 15 July

2024POM

2102 BRU19042563P Apo-Amilzide Tablet

Each tablet contains:

Hydrochlorothiazide 50mg,

Amiloride Hydrochloride 5mg

Apotex Inc., Canada Medipharm Sdn Bhd16 July 2019 till 15 July

2024 POM

2103 BRU19042564P Tenof-EM TabletEmtricitabine 200mg, Tenofovir

Disproxil Fumarate 300mgHetero Labs Limited, India K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024POM

2104 BRU19042565P Freederm Lotion Terbinafine HCl 1% w/v Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company16 July 2019 till 15 July

2024GSL

2105 BRU19042566NP Yellow Lotion 0.4%Acriflavine Hydrochloride 0.4% w/v

Winwa Medical Sdn Bhd, Malaysia Yuh Hua Trading Company16 July 2019 till 15 July

2024GSL

2106 BRU19042567P

Kovaltry Powder and Solvent

for Solution for Injection

250IU/vial

Powder - Antihemophilic Factor

(Recombinant Factor VIII) 250IU

Diluent - Water for InjectionBayer Healthcare LLC, USA Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2107 BRU19042568P

Kovaltry Powder and Solvent

for Solution for Injection

500IU/vial

Powder - Antihemophilic Factor

(Recombinant Factor VIII) 500IU

Diluent - Water for Injection

Bayer Healthcare LLC, USA Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2108 BRU19042569P Lamitor 50mg Tablet Lamotrigine 50mgTorrent Pharmaceuticals Limited,

IndiaK-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024POM

2109 BRU19042570P Onsia Tablet 8mgOndansetron hydrochloride dihydrate

(9.977mg) eq to ondansetron 8mgSiam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024 POM

2110 BRU19042571PTivicay™ 50mg Film‐Coated

Tablets

Dolutegravir 50mg (as dolutegravir

sodium)

Glaxo Operations UK Ltd, United

KingdomZuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2111 BRU19042572PMinirin® Nasal Spray

0.1mg/ml

Desmopressin acetate 0.1mg/ml eq. to

89mcg desmopressin (10mcg/dose)Ferring GmBH, Germany Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024 POM

BDMCA/RMP/0719 Page 152 of 157

Page 153: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2112 BRU19042573P URSA 250MG CAPSULE Ursodeoxycholic acid 250mg Daewoong Pharmaceutical Co. Ltd.,

Republic of Korea

Kingsley Medical Supplies

Sdn Bhd16 July 2019 till 15 July

2024POM

2113 BRU19042574PSpiriva Respimat 2.5mcg

Solution for Inhalation

Per puff: 2.5mcg Tiotropium eq. to

3.124mcg tiotropium bromide

monohydrate

Boehringer Ingelheim Pharma GmBH

& Co. KG, Germany

Hongkiat Trading &

Company

16 July 2019 till 15 July

2024 POM

2114 BRU19042575PLavudin Standard F.C. Tablet

100mgLamivudine 100mg

Standard Chem. & Pharm. Co. Ltd,

Taiwan

Kingsley Medical Supplies

Sdn Bhd16 July 2019 till 15 July

2024POM

2115 BRU19042576PFaslodex Solution for Injection

250mg/5mlFulvestrant 250mg/5ml

Vetter Pharma-Fertigung GmbH & Co.

KG, GermanyZuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2116 BRU19042577NP

Multibic potassium-Free

Solution for Haemofiltration

(Solution, sterile)

1000 ml of the ready-to-use solution

contain:

Sodium chloride 6.136 g;

Sodium hydrogen carbonate 2.940 g

Calcium chloride dihydrate 0.2205 g

Magnesium chloride hexahydrate

0.1017 g

Glucose monohydrate 1.100 g

(anhydrous glucose 1.000 g)

Fresenius Medical Care Deutschland

GmbH, GermanyMedix Supplier

16 July 2019 till 15 July

2024

GSL

2117 BRU19052578P Pregeb Capsules 75mg Pregabalin 75mg Torrent Pharmaceuticals Ltd., India K-Seri Pharma (B) Sdn Bhd16 July 2019 till 15 July

2024POM

2118 BRU19052579NPOmnipaque 300mg l/mL,

Solution for Injection/Infusion

Iohexol (INN) 300 mg I/ml (647 mg

equivalent to 300mg I)GE Healthcare (Shanghai) Co., China Medipharm Sdn Bhd

16 July 2019 till 15 July

2024 POM

2119 BRU19052580NPOmnipaque 350mg l/mL,

Solution for Injection/InfusionIohexol (INN) 350 mg I/ml (755 mg

equivalent to 350mg I)

GE Healthcare (Shanghai) Co., China Medipharm Sdn Bhd16 July 2019 till 15 July

2024 POM

2120 BRU19052581P Streptin Injection 1g Streptomycin Sulphate equivalent to

Streptomycin 1g

SM Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

16 July 2019 till 15 July

2024POM

2121 BRU19052582PAricept Evess 5mg

Orodispersible Tablet Donepezil hydrochloride 5mg

Bushu Pharmaceuticals Ltd. 950,

JapanMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2122 BRU19052583PAricept Evess 10mg

Orodispersible TabletDonepezil hydrochloride 10mg

Bushu Pharmaceuticals Ltd. 950,

JapanMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2123 BRU19052584P Yucomy Shampoo 2% w/w Ketoconazole 20mg/g (2% w/w)Y.S.P Industries (M) Sdn Bhd.,

MalaysiaAsterix United (B) Sdn Bhd

16 July 2019 till 15 July

2024GSL

2124 BRU19052585P Mapin 0.4mg/ml Injection Naloxone Hydrochloride 0.4mg/ml Duopharma (M) Sdn Bhd., Malaysia K-Seri Pharma Sdn Bhd16 July 2019 till 15 July

2024POM

2125 BRU19052586P Apo-Warfarin 1mg Tablet Warfarin Sodium 1mg Apotex Inc., Canada Medipharm Sdn Bhd16 July 2019 till 15 July

2024POM

BDMCA/RMP/0719 Page 153 of 157

Page 154: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2126BRU19052587PS1 &

BRU19052587PS2Medovir 400mg Tablet Aciclovir 400mg

Medochemie Ltd- Central Factory,

Limassol, Cyprus (S1); Medochemie

(Far East) Ltd. – Oral Factory, Bing

Duong Province, Vietnam (S2)

Hongkiat Trading &

Company

16 July 2019 till 15 July

2024POM

2127 BRU19052588P Bisloc 2.5 Bisoprolol Fumarate 2.5mg Unison Laboratories Co., Thailand K-Seri Pharma Sdn Bhd16 July 2019 till 15 July

2024POM

2128 BRU19052589P Derzid CreamEach 100g contains betamethasone

valerate equivalent to

betamethasone 0.1g (0.1% w/w)

Unison Laboratories Co. Ltd., Thailand K-Seri Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024 POM

2129 BRU19052590PPentasa® Prolonged Release

Tablet 500mgMesalazine 500mg

Ferring International Center SA,

SwitzerlandZuellig Pharma Sdn Bhd

16 July 2019 till 15 July

2024POM

2130 BRU19052591PApo-montelukast Chewable

Tablets 4mg USPMontelukast (as sodium) 5mg Apotex Research Private Ltd, India Medicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2131 BRU19052592PApo-montelukast Chewable

Tablets 5mg USPMontelukast (as sodium) 5mg Apotex Research Private Ltd, India Medicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2132 BRU19052593PApo-montelukast Tablets

10mgMontelukast (as sodium) 10mg Apotex Research Private Ltd, India Medicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2133 BRU19052594P SW Bromhexine Elixir Bromhexine Hydrochloride 4mg/5mlSunward Pharmaceutical Sdn Bhd,

MalaysiaG&H Trading Company

16 July 2019 till 15 July

2024POM

2134 BRU19052595P Allersin Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5mlSunward Pharmaceuticals Sdn Bhd,

MalaysiaG&H Trading Company

16 July 2019 till 15 July

2024P

2135 BRU19052596PQuetiapine Sandoz 100mg

TabletsQuetiapine (as fumarate) 100mg

Sandoz Ilac Sanayi ve Ticaret A.S,

TurkeyZuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2136 BRU19052597P Cifloxin Infusion (2mg/ml) Ciprofloxacin 2mg/ml Siam Bheasach Co. Ltd., Thailand K-Seri Pharma (B) Sdn Bhd16 July 2019 till 15 July

2024POM

2137 BRU19052598NP Tiger Balm Soft

) Cajuput Oil 13.0% w/w

ii) Menthol 12.0% w/w

iii) Camphor 10.0% w/w

iv) Clove Oil 1.5% w/w

Tiger Balm (M) Sdn Bhd., Malaysia Hamitan Marketing

16 July 2019 till 15 July

2024 GSL

2138 BRU19052599P Vizomet Cream 0.1% w/w Mometasone Furoate 0.1% w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaSyarikat Bumimedic

16 July 2019 till 15 July

2024POM

2139 BRU19052600P Vizomet Ointment 0.1% w/w Mometasone Furoate 0.1% w/wXepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaSyarikat Bumimedic

16 July 2019 till 15 July

2024POM

2140 BRU19052601PEperon Film Coated Tablets

2mgRisperidone 2mg

Medochemie Ltd (Central Factory),

Cyprus

Hongkiat Trading &

Company16 July 2019 till 15 July

2024POM

2141 BRU19052602PQuetiapine Sandoz 25mg

TabletsQuetiapine (as fumarate) 25mg

Sandoz Ilac Sanayi ve Ticaret A.S,

Turkey

Zuellig Pharma (B) Sdn Bhd

2602P16 July 2019 till 15 July

2024POM

2142 BRU19072603P

Vectibix Concentrate for

Solution for Infusion

100mg/vial

Each vial contains 100mg of

panitumumab in 5ml

Amgen Manufacturing Limited,

United StatesMedipharm Sdn Bhd

16 July 2019 till 15 July

2024 POM

BDMCA/RMP/0719 Page 154 of 157

Page 155: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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 BRU19072604P

Simponi I.V. Concentrate for

Solution for Infusion

12.5mg/1ml

Golimumab 12.5mg/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd16 July 2019 till 15 July

2024 POM

2144 BRU19072605PSovenor 10mcg/hr

Transdermal Patch

Buprenorphine 10mg/patch (10

mcg/hr)

LTS Lohmann Therapie-Systeme AG,

GermanyZuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2145 BRU19072606PSovenor 5mcg/hr Transdermal

PatchBuprenorphine 5mg/patch (5mcg/hr)

LTS Lohmann Therapie-Systeme AG,

GermanyZuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2146 BRU19072607NP Thelban Suspension Albendazole 100mg/5ml Biolab Company Ltd., ThailandHongkiat Trading &

Company16 July 2019 till 15 July

2024GSL

2147 BRU19072608NPXenetix 300 Solution for

Injection

Iobitridol 65.81g/100ml (corresponding

to 30g iodine/100mlGuerbet, France

Manning Jaya Trading (B)

Sdn Bhd

16 July 2019 till 15 July

2024 POM

2148 BRU19072609NPXenetix 350 Solution for

Injection

Iobitridol 76.78g/100ml (corresponding

to 35g iodine/100ml)Guerbet, France

Manning Jaya Trading (B)

Sdn Bhd

16 July 2019 till 15 July

2024 POM

2149 BRU19072610PFycompa 2mg Film-Coated

TabletsPerampanel 2mg

Eisai Manufacturing Limited. United

KingdomMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2150 BRU19072611PFycompa 4mg Film-Coated

TabletsPerampanel 4mg

Eisai Manufacturing Limited. United

KingdomMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2151 BRU19072612PFycompa 8mg Film-Coated

TabletsPerampanel 8mg

Eisai Manufacturing Limited. United

KingdomMedipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2152 BRU19072613NP Renal-Sol B1

Each litre of concentrate contains:

Sodium Chloride (BP) 30.58g;

Sodium Bicarbonate (BP) 66.00g;

Highly Purified Water (B) 1000.0ml

Renal Laboratories Sdn Bhd,

Malaysia K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024GSL

2153 BRU19072614P Tacarline Injection 1mg/ml

Each ampoule contains:

Adrenaline Acid Tartate 1.8mg/ml Duopharma (M) Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024POM

2154 BRU19072615PRanexa Prolonged-release

Tablet 375mgRanolazine 375mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2155 BRU19072616PRanexa Prolonged-release

Tablet 500mgRanolazine 500 mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2156 BRU19072617PRanexa Prolonged-release

Tablet 750mgRanolazine 750 mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd

16 July 2019 till 15 July

2024POM

2157 BRU19072618P SotaHexal 80mg Tablet Sotalol Hydrochloride 80mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd16 July 2019 till 15 July

2024POM

2158 BRU19072619PZafibral 200mg Tablets Film

CoatedBezafibrate 200mg Medochemie Ltd, Cyprus G & H Trading Company

16 July 2019 till 15 July

2024POM

BDMCA/RMP/0719 Page 155 of 157

Page 156: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2159 BRU19072620PApo-Azathioprine 50mg

tabletsAzathioprine 50mg RPG Lifesciences Limited, India Medicorp Sdn. Bhd

16 July 2019 till 15 July

2024POM

2160 BRU19072621P

Pergoveris Powder and

Solvent for Solution for

Injection

One vial contains 150IU (equivalent to

11 micrograms) of follitropin alfa (r-

hFSH) and 75IU (equivalent to 3

micrograms) of lutropin alfa (r-hLH).

Merck Serono S.A. (MS-Aubonne),

SwitzerlandG & H Trading Company

16 July 2019 till 15 July

2024POM

2161 BRU19072622P Trustiva Tablet

i) Efavirenz 600mg

ii) Emtricitabine 200mg

iii) Tenofovir Disoproxil Fumarate

300mg eq. to Tenofovir Disoproxil

245mg

Hetero Labs Limited, India K-Seri Pharma Sdn Bhd

16 July 2019 till 15 July

2024

POM

2162 BRU19072623P Miloz Injection 15mg/3ml Midazolam 5mg/mlPT Novell Pharmaceutical

Laboratories, IndonesiaG&H Trading Company

16 July 2019 till 15 July

2024POM

2163 BRU19072624P Pemirex Injection 100mg Pemetrexed 100mgKorea United Pharm Inc., Republic of

Korea

Kingsley Medical Supplies

Sdn Bhd

16 July 2019 till 15 July

2024POM

2164 BRU19072625P Pemirex Injection 500mg Pemetrexed 500mgKorea United Pharm Inc., Republic of

Korea

Kingsley Medical Supplies

Sdn Bhd

16 July 2019 till 15 July

2024POM

2165 BRU19072626PTapcom-S Ophthalmic

SolutionTafluprost 15μg/ml, Timolol 5mg/ml Laboratoire Unither, France Medipharm Sdn Bhd

16 July 2019 till 15 July

2024POM

2166 BRU19072627P

Cyramza 100mg/10ml

Concentrate For Solution For

Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA Zuellig Pharma Sdn Bhd

16 July 2019 till 15 July

2024 POM

2167 BRU19072628P

Cyramza 500mg/50ml

Concentrate For Solution For

Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA Zuellig Pharma Sdn Bhd

16 July 2019 till 15 July

2024 POM

2168 BRU19072629PHydrocortisone cream 1%

W/WHydrocortisone 1% w/w

Xepa-Soul Pattinson (Malaysia) Sdn

Bhd, MalaysiaSyarikat BumiMedic

16 July 2019 till 15 July

2024POM

2169 BRU19072630NPMicroshield 4 Chlorhexidine

Surgical HandwashChlorhexidine Gluconate 4% w/v Alliance Formulations, India Medicorp Sdn Bhd

16 July 2019 till 15 July

2024 GSL

2170 BRU19072631P Glumil 850mg Tablet Metformin Hydrochloride 850mgThe United Drug (1996) Co., Ltd.,

ThailandMedicorp Sdn Bhd

16 July 2019 till 15 July

2024POM

2171 BRU19072632NPBetadine Sore Throat Spray

0.45% w/vPovidone-Iodine 0.45% w/v

Mundipharma Pharmaceuticals Ltd.,

Cyprus

Zuellig Pharma (B) Sdn.

Bhd

16 July 2019 till 15 July

2024GSL

2172 BRU19072633P

Fludarabine Sandoz

50mg/2Ml concentrate FOR

Solution for Injection or

Infusion

Fludarabine phosphate 50mg/2ml Ebewe Pharma

Ges.m.b.H.Nfg.KG, AustriaZuellig Pharma Sdn Bhd

16 July 2019 till 15 July

2024 POM

BDMCA/RMP/0719 Page 156 of 157

Page 157: BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … › Shared Documents › Importation... · LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 2019) No Product Registration Number

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY

MINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED JULY 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

2173 BRU19072634P

Platol (Cisplatin Concentrate

for Solution for Infusion

50mg/50ml)

Cisplatin 50mg/50ml Venus Remedies Limited, IndiaKingsley Medical Supplies

Sdn Bhd

16 July 2019 till 15 July

2024 POM

2174 BRU19072635P

Doxorubicin 2mg/ml

concentrate for solution for

infusion

Doxorubicin hydrochloride 2mg/ml Sichuan Huiyu Pharmaceutical

Co., Ltd., China

Kingsley Medical Supplies

Sdn Bhd

16 July 2019 till 15 July

2024 POM

2175 BRU19072636PMontelukast Sandoz 10mg

Film-coated Tablet10mg montelukast

Sandoz Ilac Sanayi ve Ticaret A.S.,

Turkey

Zuellig Pharma (B) Sdn

Bhd

16 July 2019 till 15 July

2024POM

BDMCA/RMP/0719 Page 157 of 157