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: Intron A Redipen
Active Ingredient(s): Interferon alfa-2b 15MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron A Redipen
Active Ingredient(s): Interferon alfa-2b 25MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron A Redipen
Active Ingredient(s): Interferon alfa-2b 50MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron-A
Active Ingredient(s): Interferon alfa-2b 10MIU
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron-A
Active Ingredient(s): Interferon alfa-2b 30MIU
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron-A
Active Ingredient(s): Interferon alfa-2b 10MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Intron-A
Active Ingredient(s): Interferon alfa-2b 6MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Rebetron (Combination Product)
Active Ingredient(s): Interferon alfa-2b 6MIU/mL
Dosage Form: Solution for injection
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Active Ingredient(s): Ribavirin 200mg
Dosage Form: Capsule
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Rebetron (Combination Product)
Active Ingredient(s): Interferon alfa-2b 15MIU/mL
Dosage Form: Solution for injection
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Active Ingredient(s): Ribavirin 200mg
Dosage Form: Capsule
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
New Zealand Sponsor: Schering-Plough Pty Limited
Dated this 6th day of September 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).