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: Act-3
Active Ingredient(s): Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): R P Scherer Holdings Pty Limited, Braeside, Victoria, Australia
Product: Colgate FluoroCare 200 Daily Flouride Mouth Rinse - Cool Mint
Active Ingredient(s): Sodium fluoride 0.044%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate FluoroCare 200 Daily Fluoride Mouth Rinse - Cherry
Active Ingredient(s): Sodium fluoride 0.04422%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate FluoroCare 200 Daily Fluoride Mouth Rinse - Grape
Active Ingredient(s): Sodium fluoride 0.04421%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate Gel-Kam Fluoride Treatment Gel - Fruit & Berry
Active Ingredient(s): Stannous fluoride 0.44%w/w
Dosage Form: Oral topical gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate NeutraFluor 9000 Fluoride Topical Gel - Mint
Active Ingredient(s): Sodium fluoride 1.9999%w/v
Dosage Form: Oral topical gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Colgate NeutraFluor 9000 Fluoride Topical Gel - Very Berry
Active Ingredient(s): Sodium fluoride 1.9999%w/v
Dosage Form: Oral topical gel
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Factive
Active Ingredient(s): Gemifloxacin mesylate sesquihydrate 426.39mg equivalent to 320mg gemifloxacin pure free base
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SB Pharmaco PR Inc, Barrio Certenejas, Cidra, Puerto Rico
Product: Oraflam
Active Ingredient(s): Diclofenac potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Dagra Pharma BV, Diemen, The Netherlands
Dated this 5th day of December 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).