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: Arcoxia
Active Ingredient: Etoricoxib 30mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme Corp, Elkton, United States of America
Product: Docetaxel
Active Ingredient: Docetaxel trihydrate 25.177mg equivalent to anhydrous docetaxel 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Docetaxel
Active Ingredient: Docetaxel trihydrate 100.71mg equivalent to anhydrous docetaxel 80mg
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Docetaxel
Active Ingredient: Docetaxel trihydrate 135.7mg equivalent to anhydrous docetaxel 120mg
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Granisetron
Active Ingredient: Granisetron hydrochloride 1.12mg equivalent to 1.0mg granisetron base
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Lanzol Relief
Active Ingredient: Lansoprazole 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Lanzol Relief
Active Ingredient: Lansoprazole 15mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Pantoprazole Sandoz
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to 20mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Gebze, Turkey
Product: Pantoprazole Sandoz
Active Ingredient: Pantoprazole sodium sesquihydrate 45.1mg equivalent to 40mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Gebze, Turkey
Product: Tasigna
Active Ingredient: Nilotinib hydrochloride monohydrate 220.6mg equivalent to 200mg nilotinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: UREX FORTE
Active Ingredient: Furosemide 500mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Baulkham Hills, Australia
Dated this 10th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).