Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new 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: Biostate
Active Ingredients: Dried factor VIII fraction 250IU
von Willebrand’s factor : Ristocetin cofactor 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Biostate
Active Ingredients: Dried factor VIII fraction 500IU
von Willebrand’s factor : Ristocetin cofactor 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: Clexane Forte
Active Ingredient: Enoxaparin sodium 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Maisons-Alfort Cedex, France
Product: Clexane Syringe
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Aventis Intercontinental, Maisons-Alfort Cedex, France
Aventis Pharma Le Trait, Le Trait, France
Product: Clexane Ampoule
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Maisons-Alfort Cedex, France
Product: Risperdal Consta
Active Ingredient: Risperidone 25mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 37.5mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 50mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Dated this 21st day of July 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).