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: Aporyl
Active Ingredient: Amorolfine hydrochloride 5.57%w/v equivalent to Amorolfine free base 5%w/v
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Farmaclair, Saint Clair, France
Product: Humira
Active Ingredient: Adalimumab 10mg/0.2mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Product: Reparo
Active Ingredient: Amorolfine hydrochloride 5.57%w/v equivalent to Amorolfine free base 5%w/v
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Farmaclair, Saint Clair, France
Product: Robitussin Cold & Chesty Cough
Active Ingredients: Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Olic (Thailand) Limited, Ayutthaya Province, Thailand
Fareva Richmond Inc, Virginia, United States of America
Product: Tivicay
Active Ingredient: Dolutegravir 50mg equivalent to Dolutegravir sodium 52.6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Tybost
Active Ingredient: Cobicistat 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada
Dated this 22nd day of August 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).