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: Beta
Active Ingredient(s): Betamethasone valerate 0.1215%w/w equivalent to betamethasone 0.1%
Dosage Form: Topical cream
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mount Wellington, Auckland
PSM Healthcare Limited, Wiri, Auckland
Product: Beta
Active Ingredient(s): Betamethasone valerate 0.1215%w/w equivalent to betamethasone 0.1%
Dosage Form: Topical ointment
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Pacific Pharmaceuticals Limited, Mount Wellington, Auckland
PSM Healthcare Limited, Wiri, Auckland
Product: Bisolvon Dry Junior
Active Ingredient(s): Dextromethorphan hydrobromide 0.1%w/v
Dosage Form: Oral solution
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim France, Zone Industrielle Colbert, Reims Cedex, France
Boehringer Ingelheim France, Zone Industrielle Lieu-dit "Le Fosse de l'Etang", Estrees Saint Denis, France
Product: Bisolvon Dry
Active Ingredient(s): Dextromethorphan hydrobromide 0.2%w/v
Dosage Form: Oral solution
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer(s): Boehringer Ingelheim France, Zone Industrielle Colbert, Reims Cedex, France
Boehringer Ingelheim France, Zone Industrielle Lieu-dit "Le Fosse de l'Etang", Estrees Saint Denis, France
Product: Didrocal
Active Ingredient(s): Disodium etidronate 200mg
Dosage Form: Didronel Tablet
Active Ingredient(s): Calcium carbonate 1.25g
Dosage Form: Filonel Tablet
New Zealand Sponsor: Pharmacia & Upjohn Limited Company
Manufacturer(s): Procter & Gamble France, Longjumeau, France
Procter & Gamble Pharmaceuticals, Norwich, New York, United States of America
Product: Zithromax
Active Ingredient(s): Azithromycin dihydrate 628.93mg equivalent to 600mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Pfizer Italiana S.p.A., Borgo San Michele, Latina, Italy
Pfizer Pty Limited Consumer Health Care Division, West Ryde, New South Wales, Australia
Dated this 10th day of July 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).