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: Avastin
Active Ingredient: Bevacizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Genentech Inc, California, United States of America
Product: Nupentin
Active Ingredient: Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Nupentin
Active Ingredient: Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Nupentin
Active Ingredient: Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia
Product: Simponi
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Simponi SmartJect Injector
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Dated this 28th day of March 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).