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: Dilatrend
Active Ingredient: Carvedilol 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche SpA, Via Morelli, Segrate, Italy
Product: Dilatrend
Active Ingredient: Carvedilol 25mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche SpA, Via Morelli, Segrate, Italy
Product: Dilatrend
Active Ingredient: Carvedilol 3.125mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche SpA, Via Morelli, Segrate, Italy
Product: Dilatrend
Active Ingredient: Carvedilol 6.25mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche SpA, Via Morelli, Segrate, Italy
Product: Invanz
Active Ingredient: Ertapenem sodium 209.2mg/mL equivalent to 200mg/mL ertapenem free acid
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Laboratoires Merck Sharp & Dohme - Chibret, Clermont-Ferrand, France
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 98.5mg equivalent to 75mg oseltamivir
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland
Product: Tamiflu
Active Ingredient: Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 12mg/mL when reconstituted with 52mL of water
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche AG, Basel, Switzerland
Dated this 5th day of April 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).