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: BCG vaccine (freeze dried)
Active Ingredient: BCG vaccine 8MCFU/mL
Dosage Form: Powder for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Pasteur Limited, Toronto, Ontario, Canada
Product: Fragmin
Active Ingredient: Dalteparin sodium 10,000IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Recip AB, Lindhagensgatan 133, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Fragmin
Active Ingredient: Dalteparin sodium 12,500IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Recip AB, Lindhagensgatan 133, Stockholm, SwedenVetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Fragmin
Active Ingredient: Dalteparin sodium 25,000IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Recip AB, Lindhagensgatan 133, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Viale G.B., Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Dated this 22nd day of August 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).