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: Alendrate
Active Ingredient: Alendronate sodium trihydrate 13.05mg equivalent to 10mg alendronic acid
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Alendrate
Active Ingredient: Alendronate sodium trihydrate 91.37mg equivalent to 70mg alendronic acid
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland
Product: Concentrated Bicarbonate Haemodialysis Solution
Active Ingredients: Calcium chloride dihydrate 8.2g/L
Glacial acetic acid 6.3g/L
Glucose monohydrate 69.4g/L
Magnesium chloride hexahydrate 5.7g/L
Potassium chloride 5.2g/L
Sodium chloride 214.8g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Doloproct (new source)
Active Ingredients: Fluocortolone pivalate 1mg
Lidocaine hydrochloride, anhydrous 40mg
Dosage Form: Suppository
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Istituto de Angeli SrL, Regello, Florence, Italy
Product: Doloproct Cream (new formulation)
Active Ingredients: Fluocortolone pivalate 0.1%w/w
Lidocaine hydrochloride, anhydrous 2%w/w
Dosage Form: Rectal cream
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Intendis Manufacturing SpA, Segrate, Milano, Italy
Product: Erbitux
Active Ingredient: Cetuximab 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited, t/a Healthcare Logistics
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Merck KGaA, Darmstadt, Germany
Product: ProActiv Solution 3-Step system
Active Ingredient: Benzoyl peroxide 2.5%w/w
Dosage Form: Lotion (Renewing)
Active Ingredient: Benzoyl peroxide 2.5%w/w
Dosage Form: Lotion (Repairing)
New Zealand Sponsor: Guthy-Renker New Zealand
Manufacturer: Teradoran Pty Limited, t/a Kenkay Pharmaceuticals, Narellan, Sydney, Australia
Product: Pronativ
Active Ingredients: Factor II 220IU
Factor IX 500IU
Factor VII 180IU
Factor X 360IU
Plasma protein fraction 260mg
Protein C (human) 140IU
Protein S precursor 140IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma Pharmazeutika Productionsges, Vienna, Austria
Octapharma, Lingolsheim, France
Dated this 3rd day of June 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).