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: Gonal-f Multidose for injection
Active Ingredient: Follitropin alpha 1,050IU equiv to 76.44Ág retrievable dose
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Industria Farmaceutica Serono SpA, Via de Blasio, Zone Industriale di Modugno, Bari, Italy
Product: Gonal-f Multidose for Injection
Active Ingredient: Follitropin alpha 450IU equiv to 32.76Ág retrievable dose
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limted
Manufacturer: Industria Farmaceutica Serono SpA, Zone Industriale di Modugno, Bari, Italy
Product: Sonata
Active Ingredient: Zaleplon 10mg
Dosage Form: Capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Sonata
Active Ingredient: Zaleplon 5mg
Dosage Form: Capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Xolair
Active Ingredient: Omalizumab 150mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Genentech Inc, South San Francisco, California, United States of America
Dated this 17th day of September 2004.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).