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: NovoRapid FlexPen
Active Ingredient: Insulin aspart 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
Product: NovoRapid Penfill
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Novo Nordisk Pharmaceutique S.A., Chartres Cedex, France
Product: NovoRapid
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Tritace
Active Ingredient: Ramipril 1.25mg
Dosage Form: Tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pharma Deutschland GmbH, Frankfurt am Main, Germany
Aventis Pharma SpA, Scoppito, L’Aquila, Italy
Product: Tritace
Active Ingredient: Ramipril 10mg
Dosage Form: Tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Pharma Deutschland GmbH, Frankfurt am Main, Germany
Product: Tritace
Active Ingredient: Ramipril 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pharma Deutschland GmbH, Frankfurt am Main, Germany
Aventis Pharma SpA, Scoppito, L’Aquila, Italy
Product: Tritace
Active Ingredient: Ramipril 5mg
Dosage Form: Tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturers: Aventis Pharma Deutschland GmbH, Frankfurt am Main, Germany
Aventis Pharma SpA, Scoppito, L’Aquila, Italy
Dated this 10th day of March 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).