Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Biostate
Active Ingredients: Dried factor VIII fraction 500IU
von Willebrand’s factor : Ristocetin cofactor 1000IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: CSL Limited, Broadmeadows, Australia
Product: Biostate
Active Ingredients: Dried factor VIII fraction 1000IU
von Willebrand’s factor : Ristocetin cofactor 2000IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Broadmeadows, Australia
Product: Fentanyl Citrate
Active Ingredient: Fentanyl citrate 78.5µg/mL equivalent to fentanyl 50µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Essex, United Kingdom
Product: Victoza
Active Ingredient: Liraglutide 6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Copenhagen, Denmark
Dated this 17th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).