Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Arrow - Losartan potassium & Hydrochlorothiazide
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Candestar
Active Ingredient: Candesartan cilexetil 4mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Candestar
Active Ingredient: Candesartan cilexetil 8mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Candestar
Active Ingredient: Candesartan cilexetil 16mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Candestar
Active Ingredient: Candesartan cilexetil 32mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Ezemibe
Active Ingredient: Ezetimibe 10mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: FEIBA NF
Active Ingredient: Factor VIII inhibitor bypassing fraction 2500U
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Industriestrasse 72, Vienna, Austria
Baxter AG, Lange Allee 24-B, Vienna, Austria
Product: I-Losartan potassium & Hydrochlorothiazide
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Losartan Potassium & Hydrochlorothiazide
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Vimovo
Active Ingredients: Esomeprazole magnesium trihydrate 22.3mg equivalent to esomeprazole 20mg
Naproxen 500mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Patheon Pharmaceuticals Inc, Ohio, United States of America
Product: Your Pharmacy Cold & Flu Relief PE
Active Ingredients: Codeine phosphate hemihydrate 6mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Your Pharmacy Pain Relief Plus
Active Ingredients: Codeine phosphate hemihydrate 9.75mg
Doxylamine succinate 5mg
Paracetamol 450mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 19th day of May 2011.
PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).