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 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: Pegasys
Active Ingredient: Peginterferon alfa-2a 270µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys
Active Ingredient: Peginterferon alfa-2a 360µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys RBV (Combination Product)
Active Ingredient: Peginterferon alfa-2a 270µg/mL
Dosage Form: Solution for injection
Active Ingredient: Ribavirin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Hoffmann-La Roche Inc, Nutley, United States of America
Patheon Inc, Mississauga, Canada
Product: Pegasys RBV (Combination Product)
Active Ingredient: Peginterferon alfa-2a 360µg/mL
Dosage Form: Solution for injection
Active Ingredient: Ribavirin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Hoffmann-La Roche Inc, Nutley, United States of America
Patheon Inc, Mississauga, Canada
Dated this 26th day of May 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).