Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Viale G.B. Monza, Milan, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: BeneFIX
Active Ingredient: Nonacog alfa 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Farma S.A., Ctra de Madrid-Burgos, San Sebastian de los Reyes, Madrid, Spain
Product: BeneFIX
Active Ingredient: Nonacog alfa 250IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Farma S.A., Ctra de Madrid-Burgos, San Sebastian de los Reyes, Madrid, Spain
Product: BeneFIX
Active Ingredient: Nonacog alfa 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Farma S.A., Ctra de Madrid-Burgos, San Sebastian de los Reyes, Madrid, Spain
Dated this 27th day of September 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).