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: Advate
Active Ingredient: Octocog alfa 2,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 3,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG,Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Myozyme
Active Ingredient: Alglucosidase alfa 52.5mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Dated this 9th day of April 2009.
KAREN ORSBORN, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).