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: Actilyse
Active Ingredient: Alteplase 10mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 20mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 50mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Epilim 100 Crushable
Active Ingredient: Sodium valproate 100mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Synthelabo Limited, Fawdon, Tyne & Wear, United Kingdom
Product: Epilim CR
Active Ingredients: Sodium valproate 199.8mg
Valproic acid 87mg
Dosage Form: Modified release tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Synthelabo Limited, Fawdon, Tyne & Wear, United Kingdom
Product: Epilim EC
Active Ingredient: Sodium valproate 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Synthelabo Limited, Fawdon, Tyne & Wear, United Kingdom
Product: Epilim EC
Active Ingredient: Sodium valproate 500mg
Dosage Form: Modified release tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Synthelabo Limited, Fawdon, Tyne & Wear, United Kingdom
Product: Epilim Intravenous
Active Ingredient: Sodium valproate 400mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Rorer Pharmaceuticals Limited, Hampden Park, Eastbourne, East Sussex, United Kingdom
Product: Epilim Liquid
Active Ingredient: Sodium valproate 40mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Winthrop Industrie, Colomiers, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Universal Products (Lytham) Manufacturing Limited, Fairfield, Greenhalgh, Kirkham, Preston, Lancashire, United Kingdom
Product: Epilim
Active Ingredient: Sodium valproate 40mg/mL
Dosage Form: Syrup
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Winthrop Industrie, Colomiers, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Universal Products (Lytham) Manufacturing Limited, Fairfield, Greenhalgh, Kirkham, Preston, Lancashire, United Kingdom
Product: Fluvax vaccine
Active Ingredients: Influenza virus A/Wisconsin/67/2005 (H3N2) like strain 15µg/dose
Influenza virus B/Malaysia/2506/2004 - like strain 15µg/dose
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1-like strain 15µg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Parkville, Victoria, Australia
Product: Infanrix-penta
Active Ingredients: Diphtheria toxoid, adsorbed 30IU/dose
Hepatitis B surface antigen, recombinant 10µg/dose
Pertactin 8µg/dose
Pertussis filamentous haemagglutinin 25µg/dose
Pertussis toxoid, adsorbed 25µg/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 40IU/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Product: Rotarix
Active Ingredient: Rotavirus vaccine 1,000,000CCID50
Dosage Form: Powder for oral suspension
Diluent
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Dated this 16th day of July 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).