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 medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Aclasta
Active Ingredient: Zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to 50mg imatinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 478mg equivalent to 400mg imatinib
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche Diagnostics GmbH, Germany
Product: Herceptin
Active Ingredients: Trastuzumab 440mg
Dosage Form: Powder for infusion
Diluent
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Dated this 23rd day of April 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).