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: Colpocin-T
Active Ingredient: Metronidazole 5mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Kryoneri, Athens, Greece
Product: Luxotine
Active Ingredient: Paroxetine hydrochloride 22.21mg equivalent to paroxetine 20mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Sandoz Pharmaceuticals GmbH, Gerlingen, Germany
Product: m-Doxazosin
Active Ingredient: Doxazosin mesilate 1.213mg equivalent to doxazosin 1mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Dexcel Limited, Or Akiva, Israel
Product: m-Doxazosin
Active Ingredient: Doxazosin mesilate 2.426mg equivalent to doxazosin 2mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Dexcel Limited, Or Akiva, Israel
Product: m-Doxazosin
Active Ingredient: Doxazosin mesilate 4.852mg equivalent to doxazosin 4mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Dexcel Limited, Or Akiva, Israel
Product: m-Mometasone
Active Ingredient: Mometasone furoate 1mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India
Product: Opti-Free Replenish
Active Ingredients: Myristamidopropyl dimethylamine 0.005%
Polyquaternium-1 0.001%
Dosage Form: Contact lens solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alcon Laboratories Inc, Fort Worth, Texas, United States of America
Product: Zilisten
Active Ingredient: Cefuroxime sodium 1754mg equivalent to 1500mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Kryoneri, Athens, Greece
Product: Zilisten
Active Ingredient: Cefuroxime sodium 877mg equivalent to 750mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Kryoneri, Athens, Greece
Dated this 28th day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).