Pursuant to section 20 of the Medicines Act 1981 (the “Act”), 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: Caelyx
Active Ingredient: Doxorubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Ben Venue Laboratories Inc, Ohio, United States of America
Product: Levemir Flexpen
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: Use in children 6–17 years
Product: Levemir Innolet
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: Use in children 6–17 years
Product: Levemir Penfill
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: Use in children 6–17 years
Product: Levemir Flexpen
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: To include combination use with oral anti-diabetic agents
Product: Levemir Innolet
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: To include combination use with oral anti-diabetic agents
Product: Levemir Penfill
Active Ingredient: Insulin detemir 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Brennum Park, Hillerod, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Indication change: To include combination use with oral anti-diabetic agents
Product: Rapamune
Active Ingredient: Sirolimus 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Coated Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: Rapamune
Active Ingredient: Sirolimus 2mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: Rapamune
Active Ingredient: Sirolimus 5mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 100µg
Salmeterol xinafoate 72.5µg equivalent to 50µg of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 250µg
Salmeterol xinafoate 72.5µg equivalent to 50µg of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide Accuhaler
Active Ingredients: Fluticasone propionate 500µg
Salmeterol xinafoate 72.5µg equivalent to 50µg of salmeterol base
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
Glaxo Wellcome Production, Evreux, France
Product: Seretide
Active Ingredients: Fluticasone propionate 20mg equivalent to 125µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/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 250µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/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 50µg/dose
Salmeterol xinafoate 5.8mg equivalent to 25µg/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 12th day of October 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).