Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Diovan
Active Ingredient: Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Diovan
Active Ingredient: Valsartan 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Diovan
Active Ingredient: Valsartan 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Mabthera
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Product: Rebif
Active Ingredient: Interferon beta-1a (rch) 22Ág equivalent to 6 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Rebif
Active Ingredient: Interferon beta-1a (rch) 44Ág equivalent to 12 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 16th day of January 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).