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 Pharmaceutical Sector
Manufacturer: Watson Laboratories Inc, Carmel NY, United States of America
Note: This consent is valid for two years from 29 September 2007.
Product: Apo-Primidone
Active Ingredient: Primidone 250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Note: This consent is valid for two years from 1 November 2007.
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid for two years from 18 October 2007.
Product: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to 50mg imatinib base
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid for two years from 18 October 2007.
Dated this 4th day of October 2007.
LES STEPHENS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).