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: AmBisome
Active Ingredient: Amphotericin B 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturers: Gilead Sciences Inc, Covina Boulevard, San Dimas, California, United States of America
Gilead Sciences Inc, Cliffside Drive, San Dimas, California, United States of America
Product: ReFacto
Active Ingredient: Moroctocog alfa 1,000IU equivalent to 90 Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Ltd
Manufacturers: Octapharma AB, Stockholm, Sweden
Wyeth Farma S.A., San Sebastian de los Reyes, Madrid, Spain
Product: ReFacto
Active Ingredient: Moroctocog alfa 250IU equivalent to 23Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Ltd
Manufacturers: Octapharma AB, Stockholm, Sweden
Wyeth Farma S.A., San Sebastian de los Reyes, Madrid, Spain
Product: ReFacto
Active Ingredient: Moroctocog alfa 500IU equivalent to 45Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Ltd
Manufacturers: Octapharma AB, Stockholm, Sweden
Wyeth Farma S.A., San Sebastian de los Reyes, Madrid, Spain
Dated this 20th day of January 2005.
BARRY BORMAN, acting as Deputy Director-General, Public Health, for the period 5 January 2005 to 24 January 2005 (pursuant to delegation given by the Minister of Health on 6 July 2001).