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: Adacel Polio
Active Ingredients: Diphtheria toxoid, adsorbed 2IU/dose
Pertactin 3µg/dose
Pertussis filamentous haemagglutinin 5µg/dose
Pertussis fimbriae 2+3 5µg/dose
Pertussis toxoid, adsorbed 2.5µg/dose
Polio virus type 1 40DAgU/dose
Polio virus type 2 8DAgU/dose
Polio virus type 3 32DAgU/dose
Tetanus toxoid 20IU/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Pasteur Limited, Toronto, Ontario, Canada
Sanofi Pasteur SA, Marcy L’Etoile, France
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: 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
Dated this 21st day of February 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).