Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine 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 Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
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 Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
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 Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
Alza Corporation, Vacaville, California, United States of America
Dated this 6th day of August 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).