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: Onicit
Active Ingredient: Palonosetron 50µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Cardinal Health 410 Inc., Albuqueque, United States of America
Product: Solox
Active Ingredient: Lansoprazole 15mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Liconsa SA, Poligono Industrial Miralcampo, Azuqueca de Henares, Guadalajara, Spain
Product: Sumagran
Active Ingredient: Sumatriptan succinate 140mg equivalent to sumatriptan 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Sumagran
Active Ingredient: Sumatriptan succinate 70mg equivalent to sumatriptan 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: TheraTears Liquid Gel
Active Ingredient: Carmellose sodium 9.243g/kg equivalent to 10mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Vital Pharma Inc, Riviera Beach, Florida, United States of America
Product: Tramedo
Active Ingredient: Tramadol hydrochloride 50mg
Dosage Form: Capsule
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturers: Alphapharm Pty Limited, Antimony Street, Carole Park, Brisbane, Queensland, Australia
Alphapharm Pty Limited, Garnet Street, Carole Park, Brisbane, Queensland, Australia
Product: Trometamol 0.3 Molar
Active Ingredient: Trometamol 36.33g/L equivalent to 0.3mol/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Pt Chevalier, Auckland
Product: Vinorelbine Ebewe
Active Ingredient: Vinorelbine tartrate 13.85mg/mL equivalent to 10mg/mL of vinorelbine
Dosage Form: Concentrate for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Zimstat
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Zimstat
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Zimstat
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Product: Zimstat
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Genpharm Inc., Etobicoke, Ontario, Canada
Dated this 27th day of July 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).