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: Avamys
Active Ingredient: Fluticasone furoate 27.5µg
Dosage Form: Nasal spray suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Barnard Castle, Co. Durham, United Kingdom
Product: Hysite
Active Ingredient: Latanoprost 50µg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium, Puurs, Belgium
Product: Janumet
Active Ingredients: Metformin hydrochloride 1,000mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Product: Janumet
Active Ingredients: Metformin hydrochloride 500mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Product: Janumet
Active Ingredients: Metformin hydrochloride 850mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Product: Maxigesic
Active Ingredients: Ibuprofen 150mg
Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Matrix Laboratories Limited, Sinnar, Nashik, Maharashta, India
Product: Xalaplus
Active Ingredients: Latanoprost 50µg/mL
Timolol maleate 6.83mg/mL equivalent to 5mg/mL timolol
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium, Puurs, Belgium
Dated this 27th day of February 2009.
STUART POWELL, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).