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: Arrow – Ipratropium 250
Active Ingredient: Ipratropium bromide monohydrate 0.0261%w/v equivalent to ipratropium 0.025%w/v
Dosage Form: Solution for inhalation
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratoire Unither, Amiens Cedex 2, France
Product: Arrow – Ipratropium 500
Active Ingredient: Ipratropium bromide monohydrate 0.0261%w/v equivalent to ipratropium 0.025%w/v
Dosage Form: Solution for inhalation
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratoire Unither, Amiens Cedex 2, France
Product: Boston Simplus Multi-Action Solution
Active Ingredients: Baquacil 0.03mg/mL
Chlorhexidine gluconate 0.177mg/mL
Dosage Form: Contact lens solution
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturers: Bausch & Lomb Inc., Greenville, United States of America
Bausch & Lomb IOM SpA, Milan, Italy
Product: Clopidogrel Winthrop
Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to clopidogrel base 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Sanofi-Synthelabo Limited, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, United Kingdom
Product: Lemsip Max Cold & Flu Hot Drink Blackcurrant
Active Ingredient: Paracetamol 1,000mg
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Synermox
Active Ingredients: Amoxicillin sodium 1,060.2mg equivalent to 1000mg amoxicillin
Potassium clavulanate 238.25mg equivalent to 200mg clavulanic acid
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Istituto Biochimico Italiano Giovanni Lorenzini SpA, Aprilia, Italy
Product: Synermox
Active Ingredients: Amoxicillin sodium 530.1mg equivalent to 500mg amoxicillin
Potassium clavulanate 119.13mg equivalent to 100mg clavulanic acid
Dosage Form: Powder for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Istituto Biochimico Italiano Giovanni Lorenzini SpA, Aprilia, Italy
Dated this 3rd day of June 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).