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: Apo-Mometasone (Prescription)
Active Ingredient: Mometasone furoate 0.5mg/g equivalent to 50mcg per spray
Dosage Form: Nasal spray suspension
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Mometasone (Pharmacy only)
Active Ingredient: Mometasone furoate 0.5mg/g equivalent to 50mcg per spray
Dosage Form: Nasal spray suspension
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Riodine Povidone-Iodine Antiseptic Ointment
Active Ingredient: Povidone-iodine 10%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited, Perth, Australia
Product: Tecfidera
Active Ingredient: Dimethyl fumarate 120mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturer: Vifor Pharma, Villars-sur-Glane, Switzerland
Product: Tecfidera
Active Ingredient: Dimethyl fumarate 240mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturer: Vifor Pharma, Villars-sur-Glane, Switzerland
Dated this 17th day of July 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).