Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan ... - BPFK

No.ActiveIngredientTrade Mark/ Registration No.(MAL07050912A)Comparator ProductsAustraliaManufactureriii) Stocrin Tablets 600mg(MAL20032164A)Merck Sharp & Dohme (Australia) Pty Ltd,Australiaiv) Stocrin Capsule 200mg(MAL19992039AR)Bristol-Myers Squibb Holding Pharma Ltd,United StatesV) Stocrin Capsule 100mg(MAL19992038AR)Bristol-Myers Squibb Holding Pharma Ltd,United Statesvi) Stocrin Capsule 50mg(MAL19992037AR)Bristol-Myers Squibb Holding Pharma Ltd,United States5. Indinavir i) Crixivan Capsule 400mg(MAL19970276AR)Merck & Co Inc, United States6. Nelfinavir i) Viracept Film-CoatedTablet 250mg(MAL05032533A)ii) Viracept Tablets 250mg(MAL20020815AS)7. Saquinavir i) Invirase Hard-GelatinCapsule 200mg(MAL19970498A)ii) Invirase Film-CoatedTablet 500mg(MAL07081488A)Roche Farma S.A, SpainF.Hoffmann-LA Roche Ltd, SwitzerlandF.Hoffmann-LA Roche Ltd, SwitzerlandRoche Farma S.A, Spain8. Atazanavir i) Reyataz Capsule 200mg(MAL20061580AR)ii) Reyataz Capsule 100mg(MAL20061578AR)iii) Reyataz Capsule 150mg(MAL20061579AR)Bristol-Myers Squibb Company, UnitedStatesBristol-Myers Squibb Company, UnitedStatesBristol-Myers Squibb Company, UnitedStates9. Darunavir i) Prezista 300 mg Film-Coated Tablets(MAL20081771A)Janssen Cilag SPA, Italy

No.ActiveIngredientTrade Mark/ Registration No.Comparator ProductsManufacturer10. Raltegravir i) Isentress 400mg Tablet(MAL20081777AR)Merck & Co Inc., United States11. Maraviroc i) Celsentri Film-CoatedTablets 150mg(MAL20081833A)ii) Celsentri Film-CoatedTablets 300mg(MAL20081834A)Godecke GmBH, GermanyGodecke GmBH, Germany12 Etravirine i) Intelence 100mg Tablets(MAL20091947A)Janssen-Cilag S.P.A, Italy13 Darunavir i) Prezista 300mg Film-Coated Tablets(MAL20081771A)14. Tenofovir Tenvir Film-Coated TabletMAL20091933AJanssen Cilag S.P.A, ItalyCipla Ltd, India* This list is not meant to be exhaustive and will be updated from time to time according to theregistration of new antiretroviral drugs in Malaysia.