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: Xeloda
Active Ingredient(s): Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Note: This consent is valid for 2 years from 5 August 2001.
Product: Xeloda
Active Ingredient(s): Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Note: This consent is valid for 2 years from 5 August 2001.
Dated this 20th day of June 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).