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: Extraneal
Active Ingredients: Calcium chloride dihydrate 257mg/L Icodextrin 75g/L Magnesium chloride hexahydrate 51mg/L Sodium chloride 5.4g/L Sodium lactate 4.5g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, New South Wales, Australia
Product: Fentanyl-Hameln
Active Ingredient: Fentanyl citrate 50Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Gadovist
Active Ingredient: Gadobutrol 302.36mg/mL equivalent to 0.5mmol/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering AG, Charlottenburg, Berlin, Germany
Product: Gadovist
Active Ingredient: Gadobutrol 604.72mg equivalent to 1mmol/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering AG, Charlottenburg, Berlin, Germany
Product: Kaletra
Active Ingredients: Lopinavir 133.3mgRitonavir 33.3mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Cardinal Health Oral Technologies, St Petersburg, Florida, United States of America
Product: Kaletra
Active Ingredients: Lopinavir 80mg/mL Ritonavir 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Product: Viracept
Active Ingredient: Nelfinavir mesilate 58.5mg/g equivalent 50mg/g nelfinavir free base
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Ltd, Basel, Switzerland
Product: Viracept
Active Ingredient: Nelfinavir mesilate 292.25mg equivalent 250mg nelfinavir free base
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Ltd, Basel, Switzerland Roche Farma S.A., Leganes (Madrid), Spain
Dated this 24th day of July 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).