Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new 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: Advate
Active Ingredient: Octocog alfa 1,000IU
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 1,500IU
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 250IU
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 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Lithicarb FC
Active Ingredient: Lithium carbonate 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: Lithicarb FC
Active Ingredient: Lithium carbonate 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Dated this 4th day of July 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).