Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Mabthera
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
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
Dated this 11th day of February 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).