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-Doxazosin
Active Ingredient: Doxazosin mesilate 1.22mg equivalent to 1mg doxazosin
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Doxazosin
Active Ingredient: Doxazosin mesilate 2.44mg equivalent to 2mg doxazosin
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Doxazosin
Active Ingredient: Doxazosin mesilate 4.87mg equivalent to 4mg doxazosin
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Apo-Terbinafine
Active Ingredient: Terbinafine hydrochloride 281.3mg equivalent to terbinafine 250mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Calcitriol-DP
Active Ingredient: Calcitriol 0.25µg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Mega Lifesciences Limited, Bangpoo Industrial Estate, Samutprakarn, Thailand
Product: Duac Once Daily Gel
Active Ingredients: Benzoyl peroxide 66.7mg/g
Clindamycin phosphate 12.8mg/g
Dosage Form: Topical gel
New Zealand Sponsor: David Sparks Limited
Manufacturer: Stiefel Laboratories (Ireland) Limited, Sligo, Ireland
Product: LuxClean
Active Ingredients: Carmellose sodium 0.5g
Poloxamer 0.5g
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Tubilux Pharma SpA, Pomezia, Rome, Italy
Product: Otrinase Hayfever Relief
Active Ingredient: Beclomethasone dipropionate 50µg/dose
Dosage Form: Nasal spray suspension
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited
Manufacturer: Douglas Pharmaceuticals Limited, Lincoln, Auckland
Product: ProActiv Solution Renewing Cleanser
Active Ingredient: Benzoyl peroxide 2.5%w/w
Dosage Form: Lotion
New Zealand Sponsor: Guthy-Renker New Zealand
Manufacturer: Teradoran Pty Limited, trading as Kenkay Pharmaceuticals, Narellan, New South Wales, Australia
Product: ProActiv Solution Repairing Lotion
Active Ingredient: Benzoyl peroxide 2.5%w/w
Dosage Form: Lotion
New Zealand Sponsor: Guthy-Renker New Zealand
Manufacturer: Teradoran Pty Limited, trading as Kenkay Pharmaceuticals, Narellan, New South Wales, Australia
Dated this 23rd day of February 2006.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).