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 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: Glivec
Active Ingredient: Imatinib mesylate 119.5mg equivalent to 100mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This product has consent that expires on 18 October 2003.
Product: Glivec
Active Ingredient: Imatinib mesylate 59.75mg equivalent to 50mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This product has consent that expires on 18 October 2003.
Dated this 10th day of July 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).