✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 150

14 NOVEMBER 2013

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).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 150





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
7 November 2013
Medicines, Consent, Distribution, Galvus Met, Janumet, Januvia
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health