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: Curam
Active Ingredients: Amoxicillin sodium 1.06g equivalent to amoxicillin 1g
Potassium clavulanate 238.3mg equivalent to clavulanic acid 200mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Reig Jofre SA, Toledo, Spain
Product: Curam
Active Ingredients: Amoxicillin sodium 530mg equivalent to amoxicillin 500mg
Potassium clavulanate 119.15mg equivalent to clavulanic acid 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Reig Jofre SA, Toledo, Spain
Product: Eltroxin
Active Ingredient: Levothyroxine sodium 111.26µg equivalent to thyroxine sodium 100µg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome GmbH & Co, Bad Oldesloe, Germany
Product: Eltroxin
Active Ingredient: Levothyroxine sodium 55.63µg equivalent to thyroxine sodium 50µg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome GmbH & Co, Bad Oldesloe, Germany
Product: Fosamax Plus
Active Ingredients: Alendronate sodium 91.37mg equivalent to 70mg anhydrous free acid
Colecalciferol 70µg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD Frosst Iberica SA, Alcala de Henares, Madrid, Spain
Product: Hydrogen Peroxide Neutralising Tablets
Active Ingredient: Catalase 0.1mg
Dosage Form: Tablet for contact lens solution
New Zealand Sponsor: Advanced Medical Optics Australia Pty Limited
Manufacturer: Nicholas Piramal India Limited, Parel, Mumbai, India
Product: Norspan
Active Ingredient: Buprenorphine 10mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Norspan
Active Ingredient: Buprenorphine 20mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Norspan
Active Ingredient: Buprenorphine 5mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mundipharma New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Octanate
Active Ingredient: Factor VIII, human 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma Pharmazeutika Productionsges, Vienna, Austria
Octapharma, Lingolsheim, France
Product: Octanate
Active Ingredient: Factor VIII, human 250IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma Pharmazeutika Productionsges, Vienna, Austria
Octapharma, Lingolsheim, France
Product: Octanate
Active Ingredient: Factor VIII, human 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: Octapharma Pharmazeutika Productionsges, Vienna, Austria
Octapharma, Lingolsheim, France
Dated this 10th day of November 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).