Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany
Product: Rebif
Active Ingredient: Interferon beta-1a, rch 22µg equivalent to 6 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Industria Farmaceutica Serono SpA, Bari, Italy
Laboratoires Serono SA, Aubonne, Switzerland
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Rebif
Active Ingredient: Interferon beta-1a, rch 44µg equivalent to 12 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Industria Farmaceutica Serono SpA, Bari, Italy
Laboratoires Serono SA, Aubonne, Switzerland
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 19th day of April 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).