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: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Ipsen Biopharm Limited, Wrexham Industrial Estate, Clwyd, United Kingdom
Product: Invega
Active Ingredient: Paliperidone 3mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Alza Corporation, Vacaville, California, United States of America
Janssen-Cilag Manufacturing LLC, Gurabo, Puerto Rico
Product: Invega
Active Ingredient: Paliperidone 6mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Alza Corporation, Vacaville, California, United States of America
Janssen-Cilag Manufacturing LLC, Gurabo, Puerto Rico
Product: Invega
Active Ingredient: Paliperidone 9mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Alza Corporation, Vacaville, California, United States of America
Janssen-Cilag Manufacturing LLC, Gurabo, Puerto Rico
Product: Invega
Active Ingredient: Paliperidone 12mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Zevalin
Active Ingredient: Ibritumomab tiuxetan 1.6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Dated this 19th day of October 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).