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: Leucomax
Active Ingredient: Molgramostim 150Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 150Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 300Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 300Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Novartis Pharma AG, Basel, Switzerland
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 400Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 400Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 50Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Leucomax
Active Ingredient: Molgramostim 700Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Dated this 31st day of January 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).