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LIST OF COMPARATOR PRODUCTS FOR FIXED DOSE COMBINATIONBil.1.TEST PRODUCTS(Pharmaceuticalname)Pseudoephedrinehydrochloride 60mg+ triprolidinehydrochloride<strong>2.</strong>5mgTrade Mark/Registration No./Reference No.1. <strong>Actifed</strong> <strong>Tablet</strong>(MAL19860267A)<strong>2.</strong> <strong>Actifed</strong> <strong>Tablet</strong>(MAL19989031AC)Comparator ProductsManufacturerThe Wellcome Foundation Ltd, UKParke Davis Pty Ltd, Australia3. <strong>Actifed</strong> <strong>Tablet</strong>(MAL19940560A)Wellcome Ltd, AutraliaThis product can be obtained from Korea, Singapore, Vietnam, Cambodia,Indonesia, Sri Lanka, India and Thailand(Information obtained via an email from GSK dated 26 th Sept 2012 )<strong>2.</strong>Chlordiazepoxide5mg + clidiniumbromide <strong>2.</strong>5mgLibrax Roche Dragee(MAL19880019A)F. Hoffman La Roche Switzerland3 Losartan 100mg +Hydrochlorothiazide 25mg4 Amoxycillin +Clavulanic Acid5 Atropine Sulphate25mcg +Diphenoxylate HCl<strong>2.</strong>5mg6 Triamterene +hydrochlorothiazide7 Levonorgestrel0.15mg +Ethinylestradiol0.03mgFortzaar <strong>Tablet</strong>(MAL20013017AR)1. Augmentin <strong>Tablet</strong> 375mg(MAL19871292A)<strong>2.</strong> Augmentin <strong>Tablet</strong> 625mg(MAL19986474A)3. Augmentin <strong>Tablet</strong> 1g(MAL19972945A)Lomotil <strong>Tablet</strong> (PBKD871651A)1. Dyazide <strong>Tablet</strong>MAL19950581A<strong>2.</strong> Dyazide <strong>Tablet</strong>MAL19871039AMicrogynon 30 <strong>Tablet</strong>(MAL19900570A)Merck Sharp & Dohme Ltd, UKSmithkline Beecham PharmaceuticalsUnited KingdomSmithkline Beecham PharmaceuticalsUnited KingdomSmithkline Beecham PharmaceuticalsUnited KingdomSearle Labs, AustraliaSmithKline Beecham Pharm, UKSmithKline & French (Aust),AustraliaSchering AG Berlin, Germany
LIST OF COMPARATOR PRODUCTS FOR FIXED DOSE COMBINATIONBil.TEST PRODUCTS(Pharmaceuticalname)8 Levonorgestrel0.15mg + Ethinylestradiol 0.03mg +Ferrous Fumarate75mg9 CyproteroneAcetate <strong>2.</strong>0mg +Ethinyl Estradiol0.035mgTrade Mark/Registration No./Reference No.Microgynon 30 ED FE <strong>Tablet</strong>(MAL19900571A)1. Diane 35 <strong>Tablet</strong>(MAL19900568A)<strong>2.</strong> Diane-35 <strong>Tablet</strong>(MAL20001806ASC)Comparator ProductsManufacturerSchering AG Berlin, GermanySchering GHBH & Co ProductionsKG, GermanyPT Schering Indonesia10 AmilorideHydrochloride 5mg+Hydrochlorothiazide 50mg11 Chlordiazepoxide5mg + ClidiniumBromide <strong>2.</strong>5mgModuretic 50/5 <strong>Tablet</strong>MAL19920200ARLibrax Roche DrageeMAL19880019AFrosst Iberica S.A, SpainF. Hoffman La-Roche, Switzerland12 Sulphamethoxazole400mg +Trimethorprim80mg.13 Trimethoprim 90mg+ Sulphadiazine410mg <strong>Tablet</strong>Bactrim Roche <strong>Tablet</strong>MAL19870887AF. Hoffman La Roche Ltd, SwitzerlandProduct is available from Albania, Angola, Argentina, Armenia, Aruba,Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium,Benin, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada,Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Estonia,Ethiopia, Georgia, Germany, Greece, Guatemala, Hong Kong, Iceland,Indonesia, Iraq, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libya,Luxembourg, Netherlands, New Zealand, Nigeria, Norway, Oman,Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar,Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, SriLanka, Sudan, Sweden, Switzerland, Thailand, Turkey, Ukraine, UnitedArab Emirates, Vietnam, Yemen, Zimbabwe (Information obtained via aletter from Roche dated 24 th July 2012 )Triglobe <strong>Tablet</strong> 500mg,Astrazeneca SwedenMAL19870919AR,
LIST OF COMPARATOR PRODUCTS FOR FIXED DOSE COMBINATIONBil.TEST PRODUCTS(Pharmaceuticalname)14 Paracetamol 500mg+ Dihydrocodeine10mg15 ChlorpheniramineMaleate 2 mg,Paracetamol 500mg, PhenylephrineHydrochloride 10mg16 Phenylephrine HCL10mg+Triprolidine HCL<strong>2.</strong>5mg.17 Atropine Sulphate0.025mg +DiphenoxylateHydrochloride25mgTrade Mark/Registration No./Reference No.Codopar 118 <strong>Tablet</strong>,MAL1986042938A+DF 118 <strong>Tablet</strong> 30mg.MAL19962828ASPiriton <strong>Tablet</strong> 4mg,MAL07082871AC+Codral Relief DecongestantActidil <strong>Tablet</strong> <strong>2.</strong>5mgMAL19890070A+Codral Relief DecongestantLomotil <strong>Tablet</strong> <strong>2.</strong>5mgMAL20000044ARComparator ProductsManufacturerGlaxosmithkline PharmaceuticalSdn Bhd, MalaysiaGlaxoSmithKline South AfricaHaupt Pharma Wulfing Gmbh,GermanyJohnson & Johnson AustraliaThe Wellcome Foundation LTD,London, UnitedKingdomJohnson & Johnson AustraliaPharmacia Ltd, United KingdomThis product can be obtained from Botwana and South Africa.(Information obtained via a letter from Johnson & Johnson dated 9 th August2012)18 Atenolol 100mg +Chlorthalidone25mg19 Irbesartan +HydrochlorothiazideTenoretic <strong>Tablet</strong>MAL19871032ACoaprovel 150mg/1<strong>2.</strong>5mg <strong>Tablet</strong>MAL20014479ACoaprovel 300mg <strong>Tablet</strong>MAL20014478AAstrazeneca UK Ltd, United KingdomSanofi Winthrop Industrie, FranceNote:If you need further clarification, kindly email to mazuwin@bpfk.gov.my andadilah@bpfk.gov.myUpdated on 5/10/2012
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