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: Bronconex Acticap
Active Ingredient(s): Mometasone furoate 200µg/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Limited, Singapore, Singapore
Product: Bronconex Acticap
Active Ingredient(s): Mometasone furoate 400µg/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Limited, Singapore, Singapore
Product: Cefuroxime Sodium
Active Ingredient(s): Cefuroxime sodium 1,578mg equivalent to 1500mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Biopharma SrL, Santa Palomba, Rome, Italy
Product: Cefuroxime Sodium
Active Ingredient(s): Cefuroxime sodium 263mg equivalent to 250mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Biopharma SrL, Santa Palomba, Rome, Italy
Product: Cefuroxime Sodium
Active Ingredient(s): Cefuroxime sodium 789mg equivalent to 750mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Biopharma SrL, Santa Palomba, Rome, Italy
Product: Duro-Tuss Decongestant
Active Ingredient(s): Pholcodine 1mg/mL
Pseudoephedrine hydrochloride 4mg/mL
Dosage Form: Linctus
New Zealand Sponsor: 3M Pharmaceuticals - a division of 3M New Zealand Limited
Manufacturer(s): 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia
Product: Lamictal
Active Ingredient(s): Lamotrigine 2mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Inc, Zebulon, North Carolina, United States of America
Product: Lipitor
Active Ingredient(s): Atorvastatin calcium 86.76mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Product: Methylphenidate
Active Ingredient(s): Methylphenidate hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing, a division Douglas Pharmaceuticals Limited, Lincoln, Auckland
Dated this 25th day of May 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).