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: Humira Pen
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Ltd
Manufacturers: Aesica Pharmaceuticals Limited, Queenborough, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Ltd
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany
Product: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Manufacturer: Patheon Inc, Toronto Region Operations (TRO), Mississauga, Ontario, Canada
Product: Tracleer
Active Ingredient: Bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Manufacturer: Patheon Inc, Toronto Region Operations (TRO), Mississauga, Ontario, Canada
Dated this 6th day of April 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).