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: ADT Booster
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Statens Serum Institut, Copenhagen, Denmark
Product: Rasilez
Active Ingredient: Aliskiren hemifumarate 165.75mg equivalent to 150mg aliskiren
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Rasilez
Active Ingredient: Aliskiren hemifumarate 331.5mg equivalent to 300mg aliskiren
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Wilate
Active Ingredients: Factor VIII, human 450IU
von Willebrand’s factor: Ristocetin cofactor 400IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Octapharma Pharmazeutika Productionsges, Vienna, Austria
Product: Wilate
Active Ingredients: Factor VIII, human 900IU
von Willebrand’s factor: Ristocetin cofactor 800IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Octapharma Pharmazeutika Productionsges, Vienna, Austria
Dated this 7th day of January 2008.
LES STEPHENS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).