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: Aerius
Active Ingredient: Desloratadine 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Laboratories NV, B-2220 Heist-op-den-Berg, Belgium
Schering-Plough Pty Limited, Baulkham Hills, New South Wales, Australia
Product: Claramax
Active Ingredient: Desloratadine 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Schering-Plough Laboratories NV, B-2220 Heist-op-den-Berg, Belgium
Schering-Plough Pty Limited, Baulkham Hills, New South Wales, Australia
Product: Prevenar
Active Ingredients: Diphtheria CRM 197 protein conjugate 20µg
Pneumococcal Polysaccharide type 14 2µg/dose
Pneumococcal Polysaccharide type 18C 2µg/dose
Pneumococcal Polysaccharide type 19F 2µg/dose
Pneumococcal Polysaccharide type 23F 2µg/dose
Pneumococcal Polysaccharide type 4 2µg/dose
Pneumococcal Polysaccharide type 6B 4µg/dose
Pneumococcal Polysaccharide type 9V 2µg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Lederle Vaccines, Pearl River, New York, United States of America
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Viale G.B., Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Sifrol
Active Ingredient: Pramipexole hydrochloride 1mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Product: Sifrol
Active Ingredient: Pramipexole hydrochloride 1.5mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Product: Sifrol
Active Ingredient: Pramipexole hydrochloride 125µg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Product: Sifrol
Active Ingredient: Pramipexole hydrochloride 250µg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Pfizer Pharmaceuticals LLC, Arecibo, Puerto Rico
Dated this 23rd day of February 2006.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).