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: Act-HIB vaccine (notification received 17 May 2004)
Active Ingredient: Haemophilus influenzae type b vaccine 10µg
Dosage Form: Powder for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pasteur SA, Marcy L’Etoile, France Gruppo Lepetit SpA., Localita Vacanello, Anagni (Frosinone), Italy
Product: Act-HIB vaccine (notification received 28 July 2004)
Active Ingredient: Haemophilus influenzae type b vaccine 10µg
Dosage Form: Powder for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pasteur SA, Marcy L’Etoile, France Gruppo Lepetit SpA., Localita Vacanello, Anagni (Frosinone), Italy
Product: Helixate SF
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Helixate SF
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Helixate SF
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, California, United States of America
Product: Pneumovax 23 vaccine
Active Ingredient: Pneumococcal polysaccharide vaccine 50µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Dated this 24th day of March 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).