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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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