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: Accarb
Active Ingredient: Acarbose 50mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Product: Accarb
Active Ingredient: Acarbose 100mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Product: Actemra
Active Ingredient: Tocilizumab 20mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Chugai Pharmaceutical Co Limited, Utsunomiya, Tochigi, Japan
Product: Arrow - Amlodipine 10
Active Ingredient: Amlodipine besilate 13.88mg equivalent to amlodipine 10.0mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Limited, Croydon South, Victoria, Australia
Product: Arrow - Amlodipine 5
Active Ingredient: Amlodipine besilate 6.94mg equivalent to amlodipine 5.0mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Limited, Croydon South, Victoria 3136, Australia
Product: Arrow - Etidronate
Active Ingredient: Disodium etidronate 200mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Arrow Pharmaceuticals Limited, Croydon South, Victoria, Australia
Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: Arrow - Gliclazide
Active Ingredient: Gliclazide 80mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Edmond Pharma Srl, Paderno Dugnano, Milano, Italy
Product: Arrow - Topiramate 25
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Topirimate
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Topirimate
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Topirimate
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: A-Scabies
Active Ingredient: Permethrin 5%w/w
Dosage Form: Lotion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Hoe Pharmaceuticals Sdn. Bhd., Jalan Sultan Mohamed, Bandar Sultan Suleiman, Pelabuhan Klang, Selangor, Malaysia
Product: Atripla
Active Ingredients: Efavirenz 600mg
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Toronto Region Operations, Mississauga, Ontario, Canada
Product: Cilodex
Active Ingredients: Ciprofloxacin hydrochloride 0.33%w/v equivalent to 0.3% ciprofloxacin
Dexamethasone 1%w/v
Dosage Form: Ear drops
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: SA Alcon Couvreur NV, Puurs, Belgium
Product: DBL® Oxaliplatin for injection
Active Ingredient: Oxaliplatin 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Australia Pty Limited, Mulgrave, Victoria, Australia
Product: DBL® Oxaliplatin for injection
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Australia Pty Limited, Mulgrave, Victoria, Australia
Product: DBL® Oxaliplatin for injection
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Australia Pty Limited, Mulgrave, Victoria, Australia
Product: Dimetapp Daytime/Nightime Liquid Caps
Daytime
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Paracetamol 300mg
Dosage Form: Capsule
Nightime
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Doxylamine succinate 6.25mg
Paracetamol 300mg
Dosage Form: Capsule
New Zealand Sponsor: Wyeth Consumer Healthcare a Division of Wyeth (NZ) Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Victoria, Australia
Product: Dimetapp Nightime Cold & Flu Liquid Caps
Active Ingredients: Dextromethorphan hydrobromide monohydrate 10mg
Doxylamine succinate 6.25mg
Paracetamol 300mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Wyeth Consumer Healthcare a Division of Wyeth (NZ) Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Victoria, Australia
Product: Irinotecan
Active Ingredient: Irinotecan hydrochloride trihydrate 20mg/mL equivalent to irinotecan 17.33mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: GP-Pharm, S.A., Poligono Industrial Els Vinyets-Els Fogars, Barcelona, Spain
Product: Lopresor
Active Ingredient: Metoprolol tartrate 5mg
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Stein AG, Stein, Switzerland
Product: Vigamox
Active Ingredient: Moxifloxacin hydrochloride 0.545%w/v equivalent to moxifloxacin 0.5%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Laboratories Inc, Fort Worth, Texas, United States of America
Dated this 20th day of July 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).