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: Aldara
Active Ingredient: Imiquimod 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: 3M Health Care (UK) Limited, Loughborough, Leicestershire, England
Product: Avandia
Active Ingredient: Rosiglitazone maleate 5.3mg equivalent to 4mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Avandia
Active Ingredient: Rosiglitazone maleate 10.6mg equivalent to 8mg rosiglitazone
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Cancidas
Active Ingredient: Caspofungin acetate 57.8mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Sumneytown Pike, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 60.6mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Sumneytown Pike, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 83.9mg equivalent to 70mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Sumneytown Pike, West Point, Pennsylvania, United States of America
Product: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Ispen Limited, Wrexham Industrial Estate, Clwyd, United Kingdom
Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Lipitor
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to 10mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Angers Cedex, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 21.69mg equivalent to 20mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Angers Cedex, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 43.38mg equivalent to 40mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Angers Cedex, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 86.76mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 100Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited, Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 250Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited, Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 500Ág
Salmeterol xinafoate 72.5Ág equivalent to 50Ág of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited, Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 20mg equivalent to 125Ág/dose
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 40mg equivalent to 250Ág/dose
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 8mg equivalent to 50Ág/dose
Salmeterol xinafoate 5.8mg equivalent to 25Ág/dose salmeterol
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Glaxo Wellcome Production, Evreux, France
Dated this 29th day of March 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).