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: Cozaar
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Cozaar
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Fluarix
Active Ingredients: Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1 - like strain 30Ág/mL
Influenza virus haemagglutin B/Sichuan/379/99 - like strain 30Ág/mL
Influenza virus haemagglutin type A/Moscow/10/99 H3N2 - like strain 30Ág/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturers: GlaxoSmithKline Biologicals, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany
Product: Lipostat (original formulation)
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia
Product: Lipostat (original formulation)
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia
Product: Lipostat (original formulation)
Active Ingredient: Pravastatin sodium 5mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia
Product: Lipostat
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia
Product: Plavix
Active Ingredient: Clopidogrel hydrogen sulfate 97.875mg equivalent to 75 mg free base
Dosage Form: Film coated tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturers: Sanofi Winthrop Industrie, Ambares, France
Sanofi Winthrop Limited, Fawdon, Newcastle-upon-Tyne, United Kingdom
Product: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Zenapax
Active Ingredient: Daclizumab 5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Product: Zenapax
Active Ingredient: Daclizumab 5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Dated this 19th day of June 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).