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: Apo-Cetirizine
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Dimetapp Headcold and Flu
Active Ingredients: Ibuprofen 200mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer: Wyeth SpA, Aprilia (Lt), Italy
Product: Levonelle
Active Ingredient: Levonorgestrel 750Ág
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Gedeon Richter Limited, Budapest, Hungary
Product: Rectogesic
Active Ingredient: Glyceryl trinitrate 0.2%w/w
Dosage Form: Rectal oinment
New Zealand Sponsor: ESR Limited
Manufacturer: Mayne Pharma Pty Limited, Salisbury South, South Australia, Australia
Product: Refresh Contacts
Active Ingredient: Carmellose sodium 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Ireland
Product: Sensodyne Dual Protection - (Fresh Mint Gel with Fluoride)
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 0.221%w/w
Triclosan 0.3%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Stafford-Miller (NZ) Limited
Manufacturer: Stafford-Miller (Ireland) Limited, Dungarvan, Co. Waterford, Eire
Dated this 17th day of April 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).