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: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Enbrel
Active Ingredient: Etanercept 50mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Enbrel
Active Ingredient: Etanercept 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Dated this 7th day of March 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).