Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: 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 (formerly Adria SP Inc), Alburquerque, New Mexico, United States of America
Product: Camptosar
Active Ingredient(s): Irinotecan hydrochloride 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia & Upjohn Company, Kalamazoo, Michigan, United States of America
Product: Diprivan
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca SpA, Caponago, Milan, Italy
Fresenius Kabi AB, Uppsala, Sweden
Product: Diprivan
Active Ingredient(s): Propofol 20mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca SpA, Caponago, Milan, Italy
Product: Infanrix-IPV
Active Ingredient(s): Adsorbed tetanus vaccine 80IU/mL
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Pertussis 69kDa outer membrane protein 16µg/mL
Pertussis filamentous haemagglutinin 50µg/mL
Polio virus type 1 80DAgU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Dated this 4th day of July 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).