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: Kwells
Active Ingredient: Hyoscine hydrobromide trihydrate 0.3mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Sigma Pharmaceuticals Pty Limited, Norwest Business Park, Baulkham Hills, New South Wales, Australia
Product: Rhesonativ
Active Ingredients: Anti-D [Rho] immunoglobulin 1250IU/2mL
Plasma protein fraction 165mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturer: Octapharma AB, Stockholm, Sweden
Product: Rhesonativ
Active Ingredients: Anti-D [Rho] immunoglobulin 625IU/mL
Plasma protein fraction 165mg
Dosage Form: Solution for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturer: Octapharma AB, Stockholm, Sweden
Product: Sensodyne Total Care Gel
Active Ingredients: Potassium nitrate 50mg/g
Sodium fluoride 2.21mg/g
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
Product: Sensodyne Total Care
Active Ingredients: Potassium nitrate 50mg/g
Sodium fluoride 2.21mg/g
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
Product: Tysabri
Active Ingredient: Natalizumab 20mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturers: Hospira, Inc., McPherson, Kansas, United States of America
Teva Parenteral Medicines, Inc., Irvine, California, United States of America
Dated this 21st day of September 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).