BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Traditional...BRUNEI DARUSSALAM...
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020) No Product Registration Number Product Name 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 2020 till 05 October 2025 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 2020 till 05 October 2025 POM 3 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 4 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 5 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2015 till 05 October 2020 POM 6 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 7 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 8 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 9 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 10 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 11 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 12 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 2020 till 05 October 2025 POM 13 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 2020 till 05 October 2025 POM 14 BRU08030024P Augmentin Suspension 228mg/5ml Amoxycillin 200mg/5ml (as trihydrate); Clavulanic acid 28.5mg/5ml (as Potassium Clavulanate) Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM BDMCA/RMP/0820 Page 1 of 171
Transcript of BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY … Documents/Traditional...BRUNEI DARUSSALAM...
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name 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 2020 till 05
October 2025
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 2020 till 05
October 2025
POM
3 BRU08010003P Pharmaniaga Clarithromycin
Tablet 250mg
Clarithromycin 250mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
4 BRU08010004P Pharmaniaga Fluconazole
150mg Capsules
Fluconazole 150mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
5 BRU08010005P Pharmaniaga Ciprofloxacin
Tablet 500mg
Ciprofloxacin 500mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
6 BRU08020012P Pharmaniaga Cephalexin
Capsule 500mg
Cephalexin 500mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
7 BRU08020013P Pharmaniaga Metronidazole
Tablet 200mg
Metronidazole 200mg Pharmaniaga Manufacturing
Berhad Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
8 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
9 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
10 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
11 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
12 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 2020 till 05
October 2025
POM
13 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 2020 till 05
October 2025
POM
14 BRU08030024P Augmentin Suspension
228mg/5ml
Amoxycillin 200mg/5ml (as trihydrate);
Clavulanic acid 28.5mg/5ml (as Potassium
Clavulanate)
Glaxo Wellcome Production ZI de
la Peyenniere 53100 Mayenne
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 1 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
15 BRU08030025P Augmentin Suspension
457mg/5ml
Amoxycillin 400mg/5ml (as trihydrate);
Clavulanic acid 57mg/5ml (as Potassium
Clavulanate)
Glaxo Wellcome Production ZI de
la Peyenniere 53100 Mayenne
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
16 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
17 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 2 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
18 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
19 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) GlaxoSmithKline Manufacturing
SPA, Italy.
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
20 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
21 BRU08040040P Retrovir Oral Solution Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
22 BRU08040041P Zeffix Tablet Lamivudine 100mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
23 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
24 BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
25 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
26 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
27 BRU08040049P Diflucan IV Infusion 2mg/ml
(50ml)
Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
28 BRU08040050P Sulperazone IM/IV 1g Sulbactam (as Sodium) 500mg;
Cefoperazone (as Sodium) 500mg
Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
29 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
GSL
30 BRU08050053P Pharmaniaga Aciclovir Tablet
400mg
Aciclovir 400mg Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
31 BRU08050054P Pharmaniaga Cephalexin
Capsule 250mg
Cephalexin (as Anhydrous) Cephalexin
250mg
Pharmaniaga Manufacturing
Berhad, Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
32 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
33 BRU08050061P Unocef Injection 1000mg
(Vial)
Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
34 BRU08050062P Garasent 280mg Injection
(2ml Ampoule)
Gentamicin (as Sulphate BP) 280mg Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
35 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
36 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to
Gentamicin 0.3%w/w
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
37 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised) Duopharma Manufacturing (Bangi)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 3 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
38 BRU08050070P Betacin Eye Ear Drop Neomycin Sulphate 0.5% w/v;
Betamethasone Sodium Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 06 October 2020 till 05
October 2025
POM
39 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
40 BRU08050072P Fobancort Cream Fusidic acid 2%w/w; Betamethasone
Dipropionate 0.064%w/w equivalent to
Betamethasone 0.05%w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
41 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
42 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
43 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v; Dexamethsone
Phosphate 0.1%w/v
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
44 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg; Triamcinolone
Acetonide 1mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
45 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
46 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
47 BRU08060081P Betagen Eye/ Ear Drops Gentamicin Sulphate equivalent to
Gentamicin 0.3%; Betamethasone Sodium
Phosphate 0.1%
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
48 BRU08060082P Muprin Ointment Mupirocin 2.0%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2015 till 05
October 2020
POM
49 BRU08060083P Eryson Granules 200 Erythromycin ethylsuccinate equiv. to
eryhtromycin 200mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
50 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv. to
eryhtromycin 400mg/5ml
Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
51 BRU08060085P Neo Cream 0.5% (w/w) Neomycin sulphate 0.5%w/w Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
52 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
53 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
54 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
55 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
56 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to Cefuroxime
125mg/5mL
Glaxo Wellcome Operations,
Bernard Castle, United Kingdom.
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 4 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
57 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2015 till 05
October 2020
POM
58 BRU08070092P Eryson Tablet 250 Erythromycin Stearate BP equivalent to
Eryhthromycin 250mg
Duopharma Manufacturing (Bangi)
Sdn. Bhd.
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
59 BRU08070094P Ecocort Cream Econazole Nitrate 1% w/w; Triamcinolone
Acetonide 0.1% w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
60 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
61 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent to
Amoxicillin 250mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
62 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
63 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
64 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
65 BRU08070103P Fortum® Injection 1g Ceftazidime (as Pentahydrate) 1g GlaxoSmithKline Manufacturing
SPA, Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
66 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
67 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
68 BRU08080107P HOE Gentamicin Cream 0.1%
w/w
Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
69 BRU08080108P Beprogent Cream Betamethasone (as dipropionate) 0.05%,
Gentamicin (as sulphate 0.1%)
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
70 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg (Ampicillin
250mg & Sulbactam 125mg)
Pfizer Global Supply Japan Inc,
Japan
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
71 BRU08080115P Vaxcel Cefuroxime 750mg
Injection
Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
72 BRU08080116P Vaxcel Ceftriaxone 1g
Injection
Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
73 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as 17-
valerate) 0.1%
Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
74 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar strain RABIES
PM/WI 38-1503-3M) produced on VERO cell
line, inactivated and purifed
06 October 2020 till 05 October
2025
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
75 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w; Hydrocortisone
1% w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P
BDMCA/RMP/0820 Page 5 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
76 BRU08090120P Fobancort Ointment Sodium Fusidate 2%w/w; Betamethasone
0.05%w/w (as Dipropionate 0.064%)
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
77 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w; Hydrocortisone
1.0%w/w
Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P;POM
78 BRU08090124P Ciprobay® 200 Infusion
Solution
Ciprofloxacin (as lactate) 200mg Bayer AG, Leverkeusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
79 BRU08090125P Vaxcel Ceftazidime 2g Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
80 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
81 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
82 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
83 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
GSL
84 BRU08090131P Beamoxy Capsule 500 Amoxicillin (as Trihydrate) 500mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
85 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
86 BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent to
Amoxicillin 500mg
Duopharma (M) Sdn Bhd Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
87 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 2020 till 05
October 2025
POM
88 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl monohydrate) 500mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
89 BRU08100140P Avelox Infusion Solution
0.4g/250ml
Moxifloxacin (as Hydrochloride) 400mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
90 BRU08100141P Avelox 400mg Tablet Moxifloxacin (as Hydrochloride) 400mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
91 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
92 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P
93 BRU08110150P Avaxim 160U Suspension for
Injection in a prefilled Syringe
Inactivated Hepatitis A Virus (GBM strain)
160u/0.5ml
Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
94 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 6 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
95 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing
SPA Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
96 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
P
97 BRU08110154P Axcel Eryhthromycin ES Tablet
400mg
Erythromycin (as ethyl succinate) 400mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
98 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
99 BRU08110156P Axcel Eryhthromycin ES-200
Suspension
Erythromycin (as Ethylsuccinate) 200mg/5ml Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
100 BRU08110159P SW Miconazole Cream 2%
w/w
Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
101 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
102 BRU08110163P CoAprovel 150/12.5mg Film-
coated Tablet
Irbesartan 150mg, Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
103 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate) 250mg Bayer Pharma AG, Leverkusen,
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
104 BRU08120167P Axcel Cephalexin 250mg
Caspule
Cephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
105 BRU08120168P Axcel Cephalexin 125mg
Suspension
Cephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
106 BRU08120169P Cloxacillin Capsule 250 Cloxacillin (as Sodium) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
107 BRU08120170P Hydrocrotisone Cream 1%
w/w
Hydrocortisone acetate BP 1%w/w Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
P ; POM
108 BRU08120171P Beamoxy Tablet 250 Amoxicillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
109 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
110 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate) 0.05%,
Salicylic acid 2.0%
Hoe Pharmaceuticals Sdn Bhd
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
111 BRU08120180P Zithromax Film-coated Tablet
250mg
Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 7 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
112 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg; Sulbactam (as
sodium) 250mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
113 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg; Sulbactam
(as sodium) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
114 BRU09010183P Vaxcel Ceftriaxone-500mg
Injection
Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
115 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate) 75mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
116 BRU09010187P Symbicort Turbuhaler
160/4.5mcg dose
Budenoside 160mcg; Formoterol fumarate
dihydrate 4.5mcg
AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
117 BRU09010188P CoAprovel 300/12.5mg film-
coated tablet
Irbesartan 300mg; Hydrochlorothiazide
12.5mg
Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
118 BRU09010191PS1 &
BRU09010191PS2
Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
119 BRU09010194P Pulmicort turbuhaler
100mcg/dose
Budenoside 100mcg AstraZeneca AB, Sodertalje,
Sweden
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
120 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
121 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services
Madrid S.A.U., Madrid, Spain
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
122 BRU09020204P Beamoxy Tablet 500 Amoxicillin (as trihydrate 575mg) 500mg Upha Pharmaceutical Mfg (M) Sdn
Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
POM
123 BRU09020206P Bricanyl Turbuhaler
0.5mg/dose
Terbutaline Sulphate 0.5mg/dose AstraZeneca Dunkerque
Production, Dunkerque Cedex 2,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
124 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate 0.064%)
0.05% & Salicylic acid 3% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 8 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
125 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
126 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/v HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
127 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
P
128 BRU09020211P Lantus 100units/ml for
Optiset
Insulin Glargine (HOE 901) 100units/ml Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
129 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
130 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg GlaxoSmithKline Pharmaceuticals
S.A., Poland
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
131 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
132 BRU09030216P Cordarone Injection
150mg/3ml
Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
133 BRU09030217PS1 &
BRU09030217PS2
Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie,
France (S1); Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
134 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 2020 till 05
October 2025
POM
135 BRU09030219P Cataflam 1.5% Oral Drops
Suspension
Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
136 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 Bhd 06 October 2015 till 05
October 2020
POM
137 BRU09030221P Lignocaine HCl BP Injection
1% (5ml)
Lidocaine HCl (Lignocaine HCl) 1%
(50mg/5ml)
Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 9 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
138 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
139 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto
Rico
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
140 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
141 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate 0.064%)
0.05% w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
142 BRU09030226P Benosone-N Cream Betamethasone (as Valerate 0.12%) 0.1%
w/w; Neomycin Sulphate 0.5%w/w
HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2015 till 05
October 2020
POM
143 BRU09030227P Pocin H Ear Drop Neomycin Sulphate B.P. 3,400 i.u.;
Polymyxin B Sulphate B.P.10,000 i.u;
Hydrocortisone B.P.10mg
Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
144 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
145 BRU09040229P Unasyn Powder for Oral
Suspension 250mg/5ml
Sultamicillin (as tosilate) 250mg Pfizer Italia S.R.L., Latina, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
146 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
147 BRU09040231P Knowful Capsule 400mg Piracetam 400mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2015 till 05
October 2020
POM
148 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 Bhd 06 October 2020 till 05
October 2025
POM
149 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
150 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
151 BRU09040235P Voltaren 75mg/3ml solution
for injection
Diclofenac Sodium 75mg/3ml Lek Pharmaceuticals d.d, Slovenia Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
152 BRU09040237P Depo-Medrol Sterile Aqueous
Suspension 40mg/ml (5ml)
Methylprednisolone Acetate 200mg/5ml Pfizer Manufacturing Belgium NV,
Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
153 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega
Baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
154 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SpA, Italy Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 10 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
155 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
156 BRU09040244P Cloderm Cream Clobetasone (as butyrate) 0.05%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading & Co 06 October 2020 till 05
October 2025
POM
157 BRU09040245NP Bisacodyl Suppositories Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2020 till 05
October 2025
P
158 BRU09040246P U-Closone Ointment Clobetasol butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
159 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
160 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
161 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg,
Indapamide 1.25mg
Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
162 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
163 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12% w/w)
0.1% w/w, Neomycin Sulphate 0.50%w/w
HOE Pharmaceuticals Sdn Bhd,
Malaysia
06 October 2020 till 05 October
2025
06 October 2020 till 05
October 2025
POM
164 BRU09050254P Benosone Ointment Betamethasone 0.1% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
165 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P
166 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/v HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
167 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
168 BRU09060259P Vaxcel Cefuroxime 1.5g
Injection
Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd,
Malaysia
Medicorp Sdn Bhd 06 October 2020 till 05
October 2025
POM
169 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 2020 till 05
October 2025
POM
170 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn
Bhd
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
171 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Saglik, Gida ve Tarim
Urunleri San. Ve Tic. A.S. Yenisehir
Mahallesi, Turkey
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
172 BRU09060264P Voltaren 12.5mg
Suppositories
Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
173 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 11 of 171
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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
174 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
175 BRU09060268P SW Betamethasone Cream Betamethasone (as valerate) 0.1%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
176 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
P
177 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium trihydrate)
20mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
178 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
179 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega
Baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
180 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
181 BRU09070275P Unasyn IM/IV 1.5g Sulbactam (as sodium 546.4mg) 500mg &
Ampicillin (as sodium 1084.6mg) 1000mg
Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
182 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain)
80u per 0.5ml
Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
183 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Recipharm Uppsala AB, Bjorkgatan
30, SE-751 82 Uppsala, Sweden.
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
184 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg Aspen Port Elizabeth (Pty) Ltd,
Republic of South Africa
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
185 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2020 till 05
October 2025
P
186 BRU09070282P SW Hydrocortisone Cream 1%
w/w
Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
187 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
188 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium trihydrate)
40mg
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
189 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
190 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
191 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
192 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
P
BDMCA/RMP/0820 Page 12 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name 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 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
GSL
194 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim
Indonesia, Bogor, Indonesia
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
195 BRU09080295P Pulmicort® Turbuhaler®
200mcg/dose
Budesonide (micronised) Ph Eur
200mcg/dose
AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
196 BRU09080296P Epilim Intravenous 400mg/
vial
Sodium Valproate 400mg Sanofi S.p.A, Via Valcanello, 4
03012 Anagni, Italy
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
197 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
198 BRU09080299P Beafemic Suspension
50mg/5ml
Mefenamic acid 50mg/5mL Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
199 BRU09080300PS1 &
BRU09080300PS2
Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn. Bhd, Malaysia (S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
200 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
201 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
202 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
203 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd,
Malaysia
Asterix United Sdn Bhd 06 October 2020 till 05
October 2025
GSL & P
204 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France MediPharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
205 BRU09080308P Atrovent N 20µg/ puff
Metered Dose Inhaler
Ipratropium bromide anyhdrous 20mcg (as
monohydrate 21mcg)
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
206 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
207 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg;
Loratadine 5mg
Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
208 BRU09090313P Typhim Vi Single Dose Purified Vi Capsular polysaccharides of
Salmonella typhi (Ty2 strain) 25µg/0.5ml
Sanofi Pasteur, Campus Merieux,
France & Sanofi Pasteur, Parc
industrial d'Incarville, France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
209 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
210 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 13 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
211 BRU09090318P Cataflam® 50 Tablet Diclofenac Potassium 50mg Novartis Saglik, Gida ve Tarim
Urunleri San. Ve Tic. A.S. Yenisehir
Mahalledi, Turkey
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
212 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type
Plasminogen Activator (alteplase) 50mg
Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
213 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
214 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
P
215 BRU09090327P Metalyse Injection
10,000units
Tenecteplase 10,000units (50mg) Boehringer Ingelheim Pharma
GmbH & Co. KG, Germany
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
216 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg; Micronised
Hesperidine 50mg
Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
GSL
217 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate 6.94mg);
Valsartan 80mg
Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
218 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 2020 till 05
October 2025
POM
219 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
220 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P
221 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2020 till 05
October 2025
POM
222 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
223 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd,
Malaysia.
G & H Trading Company 06 October 2020 till 05
October 2025
GSL
224 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Manufacturing Deutschland
GmbH, Germany
(Manufacturing, packaging, testing
and release)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
225 BRU09100338NP Uphamol 250 Suspension
(Fruity)
Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Bintang Ria Sdn Bhd 06 October 2015 till 05
October 2020
GSL
226 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
227 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 14 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
228 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 Bhd 06 October 2020 till 05
October 2025
GSL
229 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mg Pfizer Pharmaceutical LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
230 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg-
crystalline) 40mg
Pfizer pharmaceuticals LLC, vega
baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
231 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine Citrate
35mg
Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
P
232 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine 250mg/5mL
(Carbocisteine)
Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn Bhd 06 October 2020 till 05
October 2025
P
233 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
234 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901) Sanofi-Aventis Deutschland GmbH,
Germany
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
235 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg -
crystalline) 10mg
Pfizer pharmaceutical LLC, vega
baja Puerto Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
236 BRU09110357PS2 Atrovent Unit Dose Vial (UDV)
250mcg/2ml
Ipratropium bromide anhydrous 250mcg (as
monohydrate 261mcg)
Laboratoire Unither, France (S2) Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
237 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml;
Ammonium Chloride 135mg/5ml
Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
238 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Duopharma Manufacturing (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
P
239 BRU09110362P Carin Tablet 10mg Loratadine 10mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
P
240 BRU09110363P Rhinathiol 2% for Children
Syrup
Carbocisteine 100mg/5ml Unither Liquid Manufacturing,
France
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
P
241 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate) 500mg &
Cilastatin Sodium 500mg
Merck Sharp & Dohme Corp, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
242 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Pharmaceuticals LLC, Vega
Baja, USA (Pfizer Vega Baja)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
243 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 2020 till 05
October 2025
POM
244 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie,
France
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
245 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd.,
Malaysia
Asterix United (B) Sdn Bhd 06 October 2020 till 05
October 2025
GSL & P
246 BRU09120377P Vascor 40mg Film-coated
Tablet
Simvastatin 40mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 15 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name 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 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
P
248 BRU09120379P Covastin Film-coated Tablet
10mg
Simvastatin 10mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
249 BRU09120380P CCM Metformin
Hydrochloride Tablet 500mg
Metformin HCl 500mg DUOPHARMA (M) SDN. BHD.,
Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
POM
250 BRU09120381PS2 Co-Diovan 80/12.5 Film-
coated Tablets
Valsartan 80mg; Hydrochlorothiazide
12.5mg
Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
251 BRU09120382P Rhinathiol® Promethazine
syrup
Carbocisteine 100mg/5ml; Promethazine HCl
2.5mg/5ml
Unither Liquid Manufacturing,
France
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
252 BRU09120383P Methotrexate CS injection
1000mg in 10ml
Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
253 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg Aspen Port Elizabeth (Pty) Ltd,
Republic of South Africa
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
254 BRU10010385PS1 &
BRU10010385PS2
Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie,
France (S1) & Kotra Pharma (M)
Sdn Bhd., Malaysia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
255 BRU10010386PS1 &
BRU10010386PS2
Atrovent Unit Dose Vial
0.5mg/2ml
Ipratropium bromide (as monohydrate)
500mcg/2ml
Laboratoires Unither, Amiens
cedex, France (S2)
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
256 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd,
Singapore
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
257 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate 6.94mg);
Valsartan 160mg
Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
258 BRU10010390NPS1,
BRU10010390NPS2 &
BRU10010390NPS3
Dulcolax 5mg Tablet Bisacodyl 5mg Delpharm Reims S.A.S., France (S3) MediPharm Sdn Bhd 06 October 2020 till 05
October 2025
P
259 BRU10010391PS1 &
BRU10010391PS2
Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
260 BRU10010392PS1 &
BRU10010392PS2
Co-Diovan 160/25 Film-coated
Tablets
Valsartan 160mg; Hydrochlorothiazide 25mg Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
261 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP 4mg/5ml Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn BHd 06 October 2015 till 05
October 2020
P
262 BRU10010396P Beafemic Capsule 250mg Mefenamic acid 250mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
263 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 16 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
264 BRU10010399P Seretide Accuhaler 50/500 Salmeterol 50mcg (as Xinafoate), Fluticasone
propionate 500mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
265 BRU10020402P Solu-Medrol Sterile Powder
500mg
Methyprednisolone (as Sodium succinate)
500mg
Pfizer Manufacturing Belgium
N.V., Belgium
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
266 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2015 till 05
October 2020
POM
267 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
268 BRU10020406P Combivent Unit Dose Vials
Nebuliser Solution
Per 2.5ml - Ipratropium bromide (as
monohydrate 522mcg) 500mcg; Salbutamol
2.5mg (as sulphate 3.013mg)
Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
269 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mg Duopharma Manufacturing (Bangi)
Sdn. Bhd.
K-Seri Pharma Sdn Bhd 06 October 2020 till 05
October 2025
POM
270 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
271 BRU10020410P Etoposide CS 100mg/5ml
Injection
Etoposide 100mg/5ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
272 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg;
Pseudoephedrine HCl 30mg
Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
273 BRU10020412P Seretide Accuhaler 50/100 Salmeterol 50mcg (as Xinafoate), Fluticasone
propionate 100mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
274 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
275 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
P
276 BRU10020415P Adalat LA 30 Tablet Nifedipine 30mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
277 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto
Rico, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
278 BRU10020418P;
BRU10020418PS2
Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mg Novartis Pharma Stein AG,
Switzerland; LTS Lohmann
Therapie-Systeme AG, Germany
(S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
279 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
280 BRU10030423P Rhinathiol 5% Adult
Expectorant Syrup
Carbocisteine 5g/100ml Unither Liquid Manufacturing,
France
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
P
281 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
282 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
K-Seri Pharma Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 17 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
283 BRU10030428P Adalat LA 60 Tablet Nifedipine 60mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
284 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
285 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
286 BRU10030432P Cisplatin CS Injection
50mg/50ml
Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
287 BRU10030433P Terramycin Ophthalmic
Ointment
Per g - Oxytetracycline 5mg; Polymyxin B
10,000units
PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
288 BRU10030435P Adriamycin CS Injection
50mg/25ml
Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited,
Australia
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
289 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide 225mg;
Magnesium hydroxide 200mg; Simethicone
USP 25mg
Sanofi‐aventis S.p.A., Origgio, Italy Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
GSL
290 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd,
Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
291 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 Bhd 06 October 2020 till 05
October 2025
POM
292 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
293 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
294 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
295 BRU10040444NP Cartril-S 500mg Capsule Glucosamine HCl 472.5mg equivalent to
Glucosamine content in Glucosamine
Sulphate 500mg
Duopharma Manufacturing (Bangi)
Sdn. Bhd., Malaysia
K-Seri Pharma Sdn BHd 06 October 2020 till 05
October 2025
GSL
296 BRU10040445P Seretide Accuhaler 50/250 Salmeterol (as Xinafoate) 50mcg; Fluticasone
Propionate 250mcg
GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
297 BRU10040452P;
BRU10040452PS2
Nitroderm TTS® 10 Glyceral trinitrate/ nitroglycerin 50mg
(10mg/24hr)
Novartis Pharma Stein AG,
Switzerland; LTS Lohmann
Therapie-Systeme AG, Germany
(S2)
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
298 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
299 BRU10040454NP ColimixTM Syrup Per 5ml - Simethicone (activated
dimethicone) 50mg; dicylcomine HCl 5mg
Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
GSL
BDMCA/RMP/0820 Page 18 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
300 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5% Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
301 BRU10040457PS2 Co-Diovan 160/12.5mg
Tablets
Valsartan HCl 160mg; Hydrochlorothiazide
12.5mg
Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
302 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
303 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM P
304 BRU10040461P Cytarabine CS injection
1000mg /10ml
Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
305 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen tartrate) Delpharm Huningue S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
306 BRU10050463P Nebido 1000mg/4ml, Solution
for Injection
Testosterone undecanoate 250mg(equiv. to
testosterone 157.9mg)
Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
307 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Delpharm Reims S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
P
308 BRU10050466NP Uphamol Suspension 250
(Orange)
Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M)
Sdn Bhd, Malaysia
Bintang Ria Sdn Bhd 06 October 2015 till 05
October 2020
GSL & P
309 BRU10050468P Remicade Powder for
Concentrate for Solution for
Infusion 100mg/vial
Infliximab (cA2 IgG) 100mg/vial Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
310 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
GSL
311 BRU10050471P Zyvox Infusion Bag
600mg/300ml
Linezolid 600mg/300ml Fresenius Kabi Norge As, Halden,
Norway
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
312 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
313 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia)
Sdn Bhd, Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
POM
314 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
315 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim
Urunleri San. Ve Tic.A.S., Istanbul,
Turkey
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
316 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
317 BRU10050479P Cozaar 100mg film-coated
tablet
Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
318 BRU10050480P Dalacin T Topical Solution 1% Clindamycin (as phosphate) 10mg/Ml Zoetis LLC, Kalamazoo, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
319 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
P
BDMCA/RMP/0820 Page 19 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
320 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg) Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
321 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn.
Bhd., Malaysia
G & H Trading Company 06 October 2020 till 05
October 2025
POM
322 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim
Urunleri San. Ve Tic.A.S., Istanbul,
Turkey
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
323 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 Bhd 06 October 2020 till 05
October 2025
POM
324 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Pharmaceuticals LLC, Vega
Baja, P.R. 00693, United States
[primary packaging site: Pfizer
Manufacturing Deutschland
GmbH, Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
325 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing,
France.
Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
326 BRU10060496P Stilnox 10mg film-coated
tablet
Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
327 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide (Scopolamine
Butylbromide) 5mg/5ml
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
328 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
329 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen tartrate
2.4mg)
Novartis Farmaceutica S.A., Spain Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
330 BRU10060500P Syntocinon 10IU solution for
injection
Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG,
Switzerland
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
331 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen tartrate
9.6mg)
Novartis Farmaceutica S.A., Spain Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
332 BRU10060502P Zyvox film-coated tablet
600mg
Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto
Rico, United States
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
333 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 2020 till 05
October 2025
POM
334 BRU10060505P Myfortic Gastro-Resistant
tablet 180mg
Mycophenolic Acid 180mg (as Sodium Salt
192.4mg)
Novartis Pharma Produktions
GmbH, Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
335 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg;
Pholcodine 4mg; Ephedrine HCl 7.2mg
Sanofi-Aventis Pakistan Limited,
Pakistan
Medipharm Sdn Bhd 06 October 2015 till 05
October 2020
POM
BDMCA/RMP/0820 Page 20 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
336 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Pharmaceuticals LLC, Vega
Baja, P.R. 00693, United States
[primary packaging site: Pfizer
Manufacturing Deutschland
GmbH, Freiburg, Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
337 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
338 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
GSL & P
339 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg; Pseudoephedrine HCl
60mg
Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
340 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd.,
Singapore
G & H Trading Company 06 October 2020 till 05
October 2025
POM
341 BRU10070513PS2 Desferal 500mg Desferrioxamine Methane Sulphonate Wasserburger Arzneimittelwerk
GmbH, Wasserburg
Germany
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
342 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
343 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w; Hydrocortisone
1%w/w
Xepa-Soul Pattinson (M) Sdn Bhd,
Malaysia
Hongkiat Trading & Company 06 October 2020 till 05
October 2025
P
344 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mg Merck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
345 BRU10070517P Singulair® Chewable Tablet
5mg
Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd.,
United Kingdom
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
346 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing
SpA., Italy
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
347 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mg Pharmacia & Upjohn Company
LLC, Kalamazoo, USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
348 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as Rivastigmine
hydrogen tartrate 7.2mg)
Novartis Farmaceutica S.A., Spain Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
349 BRU10070521P Epilim Chrono 500mg Scored
Film-coated Tablet
Sodium valproate 500mg (Sodium valproate
333mg & Valproic acid 145mg)
Sanofi Winthrop Industries, France Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
350 BRU10070522P Ritalin® Modified Release
Capsule 30mg
Methylphenidate HCl 30mg Recro Gainsville LLC, USA Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
351 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate); Valsartan
160mg
Novartis Farmaceutica SA, Barbera
del Valles
(Barcelona) Spain
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
BDMCA/RMP/0820 Page 21 of 171
-
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
MINISTRY OF HEALTH, BRUNEI DARUSSALAM
LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED AUGUST 2020)
No Product Registration
Number
Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of
current and until the end of
the validity period as
stated)
Product
Classification
352 BRU10080529P Nasacort Aqueous Nasal Spray Triamcinolone Acetonide 55mcg/actuation Aventis Pharma UK Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
353 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
354 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin sulphate
10mg; Hydrocortisone 5mg; Aesculin 10mg
PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2020 till 05
October 2025
POM
355 BRU10080532P Prostin VR Paediatric® Sterile
Solution 500mcg
Alprostadil 500mcg/ml Pharmacia & Upjohn Company,
USA
Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
356 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05
October 2025
POM
357 BRU10080534PS2 Fosamax 70mg Tablet Alendronate sodium 91.37 (as trihydrate)
equivalent to alendronic acid 70mg
Aesica Pharmaceuticals GmbH,
