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: Anastrozole
Active Ingredient: Anastrozole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Vishakapatnam, India
Product: Epiduo
Active Ingredients: Adapalene 0.1%w/w
Benzoyl peroxide 2.5%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Galderma Production Canada Inc., Quebec, Canada
Laboratories Galderma, Alby sur Cheran, France
Product: Litorstat
Active Ingredient: Atorvastatin calcium 10.359mg equivalent to atorvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Litorstat
Active Ingredient: Atorvastatin calcium 20.719mg equivalent to atorvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Litorstat
Active Ingredient: Atorvastatin calcium 41.439mg equivalent to atorvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Litorstat
Active Ingredient: Atorvastatin calcium 82.879mg equivalent to atorvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Losartan Potassium
Active Ingredient: Losartan potassium 100mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Losartan Potassium
Active Ingredient: Losartan potassium 25mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Losartan Potassium
Active Ingredient: Losartan potassium 50mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Luveris
Active Ingredient: Lutropin alfa, rch 75IU
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SA, Aubonne, Switzerland
Product: Parafast EXTRA (General Sale)
Active Ingredients: Caffeine 65mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Parafast EXTRA (Pharmacy Only)
Active Ingredients: Caffeine 65mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Yaz Plus
Active tablet:
Active Ingredients: Drospirenone 3mg
Ethinylestradiol betadex clathrate 0.02mg
Levomefolate calcium 0.451mg
Dosage Form: Tablet
Placebo tablet:
Active Ingredient: Levomefolate calcium 0.451mg
Dosage Form: Tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Schering GmbH und Co Produktions KG, Weimar, Germany
Dated this 30th day of March 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).