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: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Recombinate
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter Healthcare Corporation, Thousand Oaks, California, United States of America
Baxter Healthcare Corporation, Los Angeles, United States of America
Product: Recombinate
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter Healthcare Corporation, Thousand Oaks, California, United States of America
Baxter Healthcare Corporation, Los Angeles, United States of America
Product: Recombinate
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter Healthcare Corporation, Thousand Oaks, California, United States of America
Baxter Healthcare Corporation, Los Angeles, United States of America
Dated this 23rd day of December 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).