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: Nimenrix
Active Ingredients: Neisseria meningitidis Group A polysaccharide 5mcg
Neisseria meningitidis Group C polysaccharide 5mcg
Neisseria meningitidis Group W135 polysaccharide 5mcg
Neisseria meningitidis Group Y polysaccharide 5mcg
Tetanus toxoid 44mcg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
Product: Ultibro Breezhaler 110/50
Active Ingredients: Glycopyrronium bromide 63 mcg equivalent to Glycopyrronium 50mcg
Indacaterol maleate 143 mcg equivalent to Indacaterol 110mcg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Schweizerhalle AG, Schweizerhalle, Switzerland
Dated this 10th day of October 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).