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 that 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: Emla
Active Ingredient(s): Lignocaine 2.5%w/w
Prilocaine 2.5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Eprex
Active Ingredient(s): Epoetin alfa 84Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen Pharmaceutica NV, Beerse, Belgium
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Rapamune
Active Ingredient(s): Sirolimus 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This product has provisional consent that expires on 11 January 2003.
Dated this 15th day of November 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).