β¨ Medicine Approvals
12 JUNE 2008
NEW ZEALAND GAZETTE, No. 98
2597
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 Produktionsges, 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).
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2008, No 98
Gazette.govt.nz —
NZ Gazette 2008, No 98
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare3 June 2008
Medicines Act, New Medicine, Alendrate, Pacific Pharmaceuticals, Concentrated Bicarbonate Haemodialysis Solution, Fresenius Medical Care, Doloproct, CSL Biotherapies, Erbitux, Pharmacy Retailing, ProActiv Solution, Guthy-Renker, Pronativ, Octapharma
- John Hazeldine, Acting Deputy Director-General, Sector Accountability and Funding Directorate