✨ 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 PDF NZ Gazette 2008, No 98


Gazette.govt.nz PDF NZ Gazette 2008, No 98





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
3 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