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: Copegus
Active Ingredient: Ribavirin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Patheon Inc, Mississauga, Ontario, Canada
Product: Paroxetine 20 mg
Active Ingredient: Paroxetine mesilate 25.83mg equivalent to 20mg paroxetine base
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Heumann PCS GmbH, Feucht, Germany
Synthon Hispania SL, Sant Boi de Llobregat, Barcelona, Spain
Product: Pegasys (notification received 28 July 2004)
Active Ingredient: Peginterferon alfa-2a 270Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys (notification received 28 July 2004)
Active Ingredient: Peginterferon alfa-2a 360Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys (notification received 29 July 2004)
Active Ingredient: Peginterferon alfa-2a 270Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys (notification received 29 July 2004)
Active Ingredient: Peginterferon alfa-2a 360Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Dated this 29th day of January 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).