Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Risperdal Consta
Active Ingredient: Risperidone 25mg
Dosage Form: Vial Powder for injection
Prefilled Syringe Diluent
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 37.5mg
Dosage Form: Vial Powder for injection
Prefilled syringe Diluent
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 50mg
Dosage Form: Vial Powder for injection
Prefilled syringe Diluent
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Dated this 2nd day of June 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).