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 medicines set out in the Schedule hereto:
Schedule
Product: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals Corporation, Suffern, New York, United States of America
Note: This consent is valid for two years from 7 September 2003.
Product: Glivec
Active Ingredient: Imatinib mesilate 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 consent is valid for two years from 18 October 2003.
Product: Glivec
Active Ingredient: Imatinib mesilate 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 consent is valid for two years from 18 October 2003.
Dated this 17th day of September 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).