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: Nevanac
Active Ingredient: Nepafenac 1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon Laboratories (Australia) Pty Limited
Manufacturer: Alcon Laboratories Inc, Texas, United States of America
Dated this 13th day of June 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).