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: NeutraGard Plus (Tropical Blast flavour)
Active Ingredient: Sodium fluoride 0.2%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: NeutraGard Plus (Mint flavour)
Active Ingredient: Sodium fluoride 0.2%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: NeutraGard (Mint flavour)
Active Ingredient: Sodium fluoride 1.155%w/w
Dosage Form: Oral topical gel
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: NeutraGard (Tropical Blast flavour)
Active Ingredient: Sodium fluoride 1.155%w/w
Dosage Form: Oral topical gel
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: Nicabate CQ Clear
Active Ingredient: Nicotine 14mg/24h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: Alza Corporation, Palo Alto, California, United States of America
Product: Nicabate CQ Clear
Active Ingredient: Nicotine 21mg/24h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: Alza Corporation, Palo Alto, California, United States of America
Product: Nicabate CQ Clear
Active Ingredient: Nicotine 7mg/24h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: Alza Corporation, Palo Alto, California, United States of America
Dated this 22nd day of March 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).