Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Favint
Active Ingredient: Tiotropium bromide monohydrate 22.5Ág equivalent to tiotropium 18Ág
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Product: Somatuline Autogel
Active Ingredient: Lanreotide 24.6%w/w
Dosage Form: Solution for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer: Beaufour Ipsen Industrie, Dreux, France
Product: Zometa
Active Ingredient: Zoledronic acid monohydrate 0.8528mg/mL equivalent to zoledronoc acid anhydrous 0.8mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma AG, Stein, Switzerland
Dated this 23rd day of April 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).