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: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Ispen Limited, Clwyd, United Kingdom
Product: Lescol XL
Active Ingredient: Fluvastatin sodium 84.24mg equivalent to 80mg fluvastatin
Dosage Form: Modified release tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Lescol
Active Ingredient: Fluvastatin sodium 21.06mg equivalent to fluvastatin 20mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Product: Lescol
Active Ingredient: Fluvastatin sodium 42.12mg equivalent to fluvastatin 40mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Dated this 31st August day of August 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).