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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Galvus
Active Ingredient: Vildagliptin 50mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farmaceutica SA, Barcelona, Spain
Novartis Pharma Stein AG, Stein, Switzerland
Product: Galvus Met
Active Ingredients: Metformin hydrochloride 850mg
Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Galvus Met
Active Ingredients: Metformin hydrochloride 1000mg
Vildagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Janumet
Active Ingredients: Metformin hydrochloride 500mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico
Product: Janumet
Active Ingredients: Metformin hydrochloride 850mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico
Product: Janumet
Active Ingredients: Metformin hydrochloride 1000mg
Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico
Product: Januvia
Active Ingredient: Sitagliptin phosphate monohydrate 32.13mg equivalent to Sitagliptin 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Merck Sharp & Dohme SpA, Pavia, Italy
Product: Januvia
Active Ingredient: Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Merck Sharp & Dohme SpA, Pavia, Italy
Product: Januvia
Active Ingredient: Sitagliptin phosphate monohydrate 128.5mg equivalent to Sitagliptin 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Limited, Northumberland, United Kingdom
Merck Sharp & Dohme SpA, Pavia, Italy
Dated this 7th day of November 2013.
DR DON MACKIE, 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).