Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

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: Humira Pen
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany
Product: Pegatron Combination Therapy (Combination Product)
Component: PEG-Intron Redipen
Active Ingredient: Peginterferon alfa-2b 100µg
Dosage Form: Powder for injection
Diluent
Manufacturer: Schering-Plough Limited (Biotechnology Plant), Singapore
Component: Rebetol Capsule
Active Ingredient: Ribavirin 200mg
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough, a division of Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Component: PEG-Intron Redipen
Active Ingredient: Peginterferon alfa-2b 120µg
Dosage Form: Powder for injection
Diluent
Manufacturer: Schering-Plough Limited (Biotechnology Plant), Singapore
Component: Rebetol Capsule
Active Ingredient: Ribavirin 200mg
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough, a division of Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Component: PEG-Intron Redipen
Active Ingredient: Peginterferon alfa-2b 150µg
Dosage Form: Powder for injection
Diluent
Manufacturer: Schering-Plough Limited (Biotechnology Plant), Singapore
Component: Rebetol Capsule
Active Ingredient: Ribavirin 200mg
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough, a division of Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Component: PEG-Intron Redipen
Active Ingredient: Peginterferon alfa-2b 50µg
Dosage Form: Powder for injection
Diluent
Manufacturer: Schering-Plough Limited (Biotechnology Plant), Singapore
Component: Rebetol Capsule
Active Ingredient: Ribavirin 200mg
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough, a division of Schering-Plough Animal Health Limited
Product: Pegatron Combination Therapy (Combination Product)
Component: PEG-Intron Redipen
Active Ingredient: Peginterferon alfa-2b 80µg
Dosage Form: Powder for injection
Diluent
Manufacturer: Schering-Plough Limited (Biotechnology Plant), Singapore
Component: Rebetol Capsule
Active Ingredient: Ribavirin 200mg
Manufacturer: Schering-Plough Products Inc, Pridco Industrial Park, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough, a division of Schering-Plough Animal Health Limited
Dated this 26th day of October 2007.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).