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: Coco-Scalp
Active Ingredients: Coal tar solution 12%w/w
Salicylic acid 2%w/w
Sulphur 4%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Bioglan AB, Malmo, Sweden
Product: Sequence Fluoride Rinse System - Fresh Mint Flavor
Satchet 1
Active Ingredient: Sodium fluoride 430mg/g
Satchet 2
Active Ingredient: Stannous fluoride 30mg/g
Dosage Form: Powder for mouthwash
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: Sequence Fluoride Rinse System - Tangy Tangerine Flavour
Satchet 1
Active Ingredient: Sodium fluoride 440mg/g
Satchet 2
Active Ingredient: Stannous fluoride 85mg/g
Dosage Form: Powder for mouthwash
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: Sequence Fluoride Rinse System
Fresh Mint component:
Satchet 1
Active Ingredient: Sodium fluoride 430mg/g
Satchet 2
Active Ingredient: Stannous fluoride 30mg/g
Tangy Tangerine Component:
Satchet 1
Active Ingredient: Sodium fluoride 440mg/g
Satchet 2
Active Ingredient: Stannous fluoride 85mg/g
Dosage Form: Powder for mouthwash
New Zealand Sponsor: Ivoclar Vivadent Limited
Manufacturer: Pascal Company Inc, Bellevue, Washington, United States of America
Product: Strepsils Easy Breathing Vapour Ampoules
Active Ingredients: Menthol 35.55mg
Pine needle oil 9mg
Pumilio pine oil 103.05mg
Terpineol 66.6mg
Dosage Form: Liquid filled inhalation capsule
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, United Kingdom
Product: Zeffix
Active Ingredient: Lamivudine 5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
GlaxoSmithKline Inc, Mississauga, Ontario, Canada
Product: Zeffix
Active Ingredient: Lamivudine 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Dated this 3rd day of April 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).