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: Synagis
Active Ingredient(s): Palivizumab 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories SpA, Campoverde di Aprilia, Latina, Italy
Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Product: Synagis
Active Ingredient(s): Palivizumab 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories SpA, Campoverde di Aprilia, Latina, Italy
Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
Dated this 9th day of August 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).