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: Creon 10000
Active Ingredient: Pancreatin 150mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Solvay Pharmaceuticals GmbH, Neustadt, Germany
Product: Creon Forte
Active Ingredient: Pancreatin 300mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Solvay Pharmaceuticals GmbH, Neustadt, Germany
Product: Octanate
Active Ingredient: Factor VIII, human 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma AB, Stockholm, Sweden
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Product: Octanate
Active Ingredient: Factor VIII, human 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma AB, Stockholm, Sweden
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Product: Octanate
Active Ingredient: Factor VIII, human 1000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma AB, Stockholm, Sweden
Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
Octapharma, Lingolsheim, France
Dated this 3rd 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).