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: Cisatracurium-AFT
Active Ingredient: Cisatracurium besilate 0.268%w/v equivalent to Cisatracurium 0.2%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmathen SA, Attiki, Greece
Product: Cisatracurium-AFT
Active Ingredient: Cisatracurium besilate 0.669%w/v equivalent to Cisatracurium 0.5%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmathen SA, Attiki, Greece
Product: Neutrogena T/Sal Therapeutic Shampoo
Active Ingredient: Salicylic acid 3%
Dosage Form: Shampoo
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Neutrogena Corporation, California, United States of America
Product: Relvar© Ellipta©
Active Ingredients: Fluticasone furoate 100mcg
Vilanterol trifenatate 40mcg equivalent to Vilanterol 25mcg
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Relvar© Ellipta©
Active Ingredients: Fluticasone furoate 200mcg
Vilanterol trifenatate 40mcg equivalent to Vilanterol 25mcg
Dosage Form: Powder for inhalation
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Dated this 5th day of December 2013.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).