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: Anesia
Active Ingredient: Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Chacharwadi-Vasana, Ahmedabad, Gujarat, India
Product: Cefotaxime
Active Ingredient: Cefotaxime sodium 524mg equivalent to Cefotaxime 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Reig Jofre SA, Calle Jarama s/n, Poligono Industrial, Toledo, Spain
Product: Cefotaxime
Active Ingredient: Cefotaxime sodium 1048mg equivalent to Cefotaxime 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Reig Jofre SA, Calle Jarama s/n, Poligono Industrial, Toledo, Spain
Product: Cefotaxime
Active Ingredient: Cefotaxime sodium 2097mg equivalent to Cefotaxime 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Reig Jofre SA, Calle Jarama s/n, Poligono Industrial, Toledo, Spain
Product: DP-Quetiapine
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to Quetiapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Martintar, Nadi, Fiji
Product: DP-Quetiapine
Active Ingredient: Quetiapine fumarate 115.13mg equivalent to Quetiapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Martintar, Nadi, Fiji
Product: DP-Quetiapine
Active Ingredient: Quetiapine fumarate 230.31mg equivalent to Quetiapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Martintar, Nadi, Fiji
Product: DP-Quetiapine
Active Ingredient: Quetiapine fumarate 345.46mg equivalent to Quetiapine 300mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Martintar, Nadi, Fiji
Product: Juvederm Forma
Active Ingredient: Hyaluronic acid 24mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Zone Artisanale de pre-Mairy, Pringy, France
Product: Juvederm Refine
Active Ingredient: Hyaluronic acid 18mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Zone Artisanale de pre-Mairy, Pringy, France
Product: Juvederm Ultra
Active Ingredient: Hyaluronic acid 24mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Zone Artisanale de pre-Mairy, Pringy, France
Product: Juvederm Ultra Plus
Active Ingredient: Hyaluronic acid 24mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Zone Artisanale de pre-Mairy, Pringy, France
Product: Juvederm Voluma
Active Ingredient: Hyaluronic acid 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan France, Zone Artisanale de pre-Mairy, Pringy, France
Product: Letara
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals (Fiji) Limited, Martintar, Nadi, Fiji
Product: Minirin Melt
Active Ingredient: Desmopressin 60µg
Dosage Form: Wafer
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Blagrove, Swindon, Wiltshire, United Kingdom
Product: Minirin Melt
Active Ingredient: Desmopressin 120µg
Dosage Form: Wafer
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Blagrove, Swindon, Wiltshire, United Kingdom
Product: Minirin Melt
Active Ingredient: Desmopressin 240µg
Dosage Form: Wafer
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Blagrove, Swindon, Wiltshire, United Kingdom
Product: Oxaliplatin Actavis
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Oxaliplatin Actavis 50
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for infusion
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Ranifast 150
Active Ingredient: Ranitidine hydrochloride 168mg equivalent to Ranitidine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Canada
Product: Ranifast 300
Active Ingredient: Ranitidine hydrochloride 336mg equivalent to Ranitidine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Dated this 14th day of September 2009.
MARK RICHARDS, 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).