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: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland
Product: Herceptin
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Basel, Switzerland
Genentech Inc., South San Francisco, California, United States of America
Dated this 19th day of September 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).