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: ReFacto
Active Ingredients: Moroctocog alfa 1,000IU equivalent to 90µg
Sodium chloride 0.9%w/v
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: ReFacto
Active Ingredients: Moroctocog alfa 2,000IU equivalent to 180µg
Sodium chloride 0.9%w/v
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: ReFacto
Active Ingredients: Moroctocog alfa 250IU equivalent to 23µg
Sodium chloride 0.9%w/v
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: ReFacto
Active Ingredient: Moroctocog alfa 500IU equivalent to 45µg
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 17th day of March 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).