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 set out in the Schedule hereto:
Schedule
Product: Enbrel
Active Ingredient: Etanercept 50mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: MonoFIX-VF
Active Ingredient: Factor IX 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Product: MonoFIX-VF
Active Ingredient: Factor IX 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia
Dated this 8th day of December 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).