Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Copegus
Ribavirin 200mg
Film coated tablet
Roche Products (NZ) Limited
Patheon Inc, Ontario, Canada

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Metvix
Methyl aminolevulinate hydrochloride 200mg/g
equivalent to Methyl aminolevulinate 160mg/g
Topical cream
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Penn Pharmaceutical Services Limited, Gwent, United Kingdom

Product:

Active Ingredient:

Dosage Form:
Manufacturers:



Active Ingredient:
Dosage Form:
Manufacturers:

New Zealand Sponsor:

Pegasys RBV (Combination Product)
Component 1

Peginterferon alfa-2a 270mcg/mL
Solution for injection
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany
Component 2
Ribavirin 200mg
Film coated tablet
Hoffmann-La Roche Inc, New Jersey, United States of America
Patheon Inc, Ontario, Canada
Roche Products (NZ) Limited

Product:

Active Ingredient:

Dosage Form:
Manufacturers:



Active Ingredient:
Dosage Form:
Manufacturers:

New Zealand Sponsor:

Pegasys RBV (Combination Product)
Component 1

Peginterferon alfa-2a 360mcg/mL
Solution for injection
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany
Component 2
Ribavirin 200mg
Film coated tablet
Hoffmann-La Roche Inc, New Jersey, United States of America
Patheon Inc, Ontario, Canada
Roche Products (NZ) Limited

Dated this 8th day of May 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).