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
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: DSM Pharmaceuticals Inc, North Carolina, United States of America
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Enbrel
Active Ingredient: Etanercept 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: DSM Pharmaceuticals Inc, North Carolina, United States of America
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, Ravensburg, 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, Ravensburg, Germany
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Gardasil
Active Ingredients: Human Papillomavirus (HPV) 11 L1 Protein 80µg/mL
Human Papillomavirus (HPV) 16 L1 Protein 80µg/mL
Human Papillomavirus (HPV) 18 L1 Protein 40µg/mL
Human Papillomavirus (HPV) 6 L1 Protein 40µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp and Dohme (NZ) Limited
Manufacturers: Merck Sharp & Dohme Corp, Pennsylvania, United States of America
Merck Sharp & Dohme BV, Haarlem, The Netherlands
Dated this 13th day of July 2011.
MARK JACOBS, Acting 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).