Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine 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
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany
Note: This consent is valid for two years from 10 January 2008.
Product: Herceptin
Active Ingredients: Trastuzumab 440mg
Water for injection 20mL
Dosage Form: Powder for infusion
Diluent
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Note: This consent is valid for two years from 8 November 2007.
Dated this 12th day of October 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).