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-Cal
Active Ingredient(s): Calcium carbonate 625mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Apo-Cal
Active Ingredient(s): Calcium carbonate 1,250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Estelle-35 ED
Active Ingredient(s): Cyproterone acetate 2mg
Ethinyloestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing, div. Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: Estelle-35
Active Ingredient(s): Cyproterone acetate 2mg
Ethinyloestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing, div. Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: Focus Lens Fresh
Active Ingredient(s): Povidone 50mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Ciba Vision New Zealand
Manufacturer(s): Laboratoires Ciba Vision Faure, La Lombardiere Industrial Zone, Annonay Cedex, France
Product: Zodac
Active Ingredient(s): Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Leciva as, Praha, Czech Republic
Dated this 3rd day of July 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).