Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Botox
Active Ingredient(s): Botulinum A toxin 100U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer(s): Allergan Berkeley, Berkeley, California, United States of America
Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Eire
Biological Laboratories Europe, Carrentrila, Ballina, County Mayo, Eire
Northview Pacific Labs, Berkeley, California, United States of America
Pharmacia, Alburquerque, New Mexico, United States of America
Dated this 21st day of November 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).