Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Pacific Buspirone
Active Ingredient: Buspirone hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Pacific Buspirone
Active Ingredient: Buspirone hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 100Ág
Dosage Form: Powder for injection
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
Manufacturer: Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 120Ág
Dosage Form: Powder for injection
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
Manufacturer: Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limted
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 150Ág
Dosage Form: Powder for injection
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
Manufacturer: Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 50Ág
Dosage Form: Powder for injection
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
Manufacturer: Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 80Ág
Dosage Form: Powder for injection
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
Manufacturer: Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: PEG-Intron
Active Ingredient: Peginterferon alfa-2b 100Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: PEG-Intron
Active Ingredient: Peginterferon alfa-2b 120Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: PEG-Intron
Active Ingredient: Peginterferon alfa-2b 150Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: PEG-Intron
Active Ingredient: Peginterferon alfa-2b 50Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: PEG-Intron
Active Ingredient: Peginterferon alfa-2b 80Ág
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty imited
Manufacturer: Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Tractocile
Active Ingredient: Atosiban acetate 7.95mg/mL equivalent to Atosiban 7.5 mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Ferring AB, Limhamn, Sweden
Dated this 1st day of July 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).