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: Ataris
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan LLC, Caguas, Puerto Rico
Product: Ataris
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan LLC, Caguas, Puerto Rico
Product: Luveris
Active Ingredient: Lutropin alfa, rch 22.5µg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Merck Serono SA, Aubonne, Switzerland
Product: Prolia
Active Ingredient: Denosumab 60mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
Product: Voltaren Osteo
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to 1% diclofenac
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Xanopt
Active Ingredient: Latanoprost 0.0525mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Wintac Limited, Karnataka, India
Dated this 4th day of August 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).