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: Helixate SF
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturer: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Product: Helixate SF
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturer: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Product: Helixate SF
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturer: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturers: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Kogenate FS
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturers: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Kogenate FS
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Bayer New Zealand Limited Pharmaceutical Division
Manufacturers: Bayer Corporation, Biological Products, Berkeley, California, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 14th day of June 2007.
BARRY BORMAN, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).