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: Janumet
Active Ingredients: Metformin hydrochloride 500mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base, as the monohydrate
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 64.25mg equivalent to 50mg base, as monohydrate phosphate
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 64.25mg equivalent to 50mg base, as monohydrate phosphate
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 32.13mg equivalent to 25mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy
Product: Januvia
Active Ingredient: Sitagliptin phosphate 64.25mg equivalent to 50mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy
Product: Januvia
Active Ingredient: Sitagliptin phosphate 128.5mg equivalent to 100mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy
Product: Modavigil
Active Ingredient: Modafinil 100mg
Dosage Form: Tablet
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: Laboratoires Macors, Auxerre, France
Laboratoires Opodex Industrie, Villeneuve la Garenne, France
Dated this 3rd day of December 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).