Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new 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: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 18mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 27mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 36mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 54mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Dated this 12th day of February 2009.
STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).