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 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: Advate
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 1000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 1500IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Hameln Pharmaceuticals GmbH, Hameln, Germany
Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: DBLT Docetaxel, Concentrated Injection
Active Ingredient: Docetaxel 10mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturers: Hospira Australia Pty Limited, Melbourne, Australia
Zydus Hospira Oncology Limited (ZHOPL), Gujarat, India
Dated this 20th day of June 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).