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: Coversyl
Active Ingredient: Perindopril erbumine 8mg
Dosage Form: Tablet
New Zealand Sponsor: Servier Laboratories Limited
Manufacturers: Les Laboratoires Servier Industrie, Gidy, France
Servier (Ireland) Industries Ltd, Moneylands, Arklow, County Wicklow, Ireland
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 100µg
Dosage Form: PEG-Intron Redipen
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Rebetol capsule
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 120µg
Dosage Form: PEG-Intron Redipen
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Rebetol capsule
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 150µg
Dosage Form: PEG-Intron Redipen
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Rebetol capsule
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 50µg
Dosage Form: PEG-Intron Redipen
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Rebetol capsule
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Active Ingredient: Peginterferon alfa-2b 80µg
Dosage Form: PEG-Intron Redipen
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Active Ingredient: Ribavirin 200mg
Dosage Form: Rebetol capsule
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Animal Health Limited
Product: PEG-Intron Redipen Injector
Active Ingredient: Peginterferon alfa-2b 100µg
Dosage Form: Dual cartridge Redipen
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: PEG-Intron Redipen Injector
Active Ingredient: Peginterferon alfa-2b 120µg
Dosage Form: Dual cartridge Redipen
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: PEG-Intron Redipen Injector
Active Ingredient: Peginterferon alfa-2b 150µg
Dosage Form: Dual cartridge Redipen
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: PEG-Intron Redipen Injector
Active Ingredient: Peginterferon alfa-2b 50µg
Dosage Form: Dual cartridge Redipen
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: PEG-Intron Redipen Injector
Active Ingredient: Peginterferon alfa-2b 80µg
Dosage Form: Dual cartridge Redipen
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Limited, (Biotechnology Plant), Singapore, Singapore
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: Vinorelbine Injection Concentrate
Active Ingredient: Vinorelbine tartrate 13.85mg equivalent to 10mg vinorelbine
Dosage Form: Concentrate for injection
New Zealand Sponsor: Mayne Pharma Pty Limited
Manufacturer: Mayne Pharma Pty Limited, Mulgrave North, Victoria, Australia
Dated this 1st day of July 2005.
MARK JACOBS, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on
6 July 2001).