Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new 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: Xeloda
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, T/A Roche Consumer Health, Hertfordshire, United Kingdom
Product: Xeloda
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, T/A Roche Consumer Health, Hertfordshire, United Kingdom
Dated this 8th day of May 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).