Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Cetrotide
Active Ingredient(s): Cetrorelix acetate 0.26mg equivalent to 0.25 mg cetrorelix base
Dosage Form: Injection with diluent
New Zealand Sponsor: Asta Medica Australasia Pty Limited
Manufacturer(s): Asta Medica AG, Halle-Kunsebeck, Germany
Product: Cetrotide
Active Ingredient(s): Cetrorelix acetate 3.12mg equivalent to 3.00 mg cetrorelix base
Dosage Form: Injection with diluent
New Zealand Sponsor: Asta Medica Australasia Pty Limited
Manufacturer(s): Asta Medica AG, Halle-Kunsebeck, Germany
Product: Codral Cough, Cold & Flu Day & Night
Day capsule
Active Ingredient(s): Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
Dextromethorphan hydrobromide 10mg
Dosage Form: Capsule
Night capsule
Active Ingredient(s): Paracetamol 500mg
Chlorpheniramine maleate 2mg
Dextromethorphan hydrobromide 10mg
Dosage Form: Capsule
New Zealand Sponsor: Warner-Lambert Consumer Healthcare Pty Limited
Manufacturer(s): Parke Davis Pty Ltd, Caringbah, Sydney, New South Wales, Australia
Product: Pariet
Active Ingredient(s): Rabeprazole sodium 10mg equivalent to 9.42mg rabeprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Eisai Co Limited, Hiroki, Ohaza, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Pariet
Active Ingredient(s): Rabeprazole sodium 20mg equivalent to 18.85mg rabeprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Eisai Co Limited, Hiroki, Ohaza, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Pro-Epanutin
Active Ingredient(s): Fosphenytoin disodium 75mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Parke Davis (Division Warner Lambert NZ Limited)
Manufacturer(s): Warner-Lambert Export Limited, Dun Laoghaire, Co. Dublin, Eire
Product: Repril
Active Ingredient(s): Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Mollet del Valles, Barcelona, Spain
Product: Repril
Active Ingredient(s): Enalapril maleate 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Mollet del Valles, Barcelona, Spain
Product: Repril
Active Ingredient(s): Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Mollet del Valles, Barcelona, Spain
Product: Repril
Active Ingredient(s): Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck Farma y Quimica SA, Mollet del Valles, Barcelona, Spain
Product: Romicin
Active Ingredient(s): Roxithromycin 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Romicin
Active Ingredient(s): Roxithromycin 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
Product: Zyban
Active Ingredient(s): Bupropion hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Inc, Zebulon, North Carolina, United States of America
Dated this 11th day of May 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).