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: Arrow - Metformin 1000
Active Ingredient: Metformin 1,000mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Limited, Baulkham Hills, New South Wales, Australia
Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Arrow - Metformin 250
Active Ingredient: Metformin 250mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Limited, Baulkham Hills, New South Wales, Australia
Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Arrow - Metformin 500
Active Ingredient: Metformin 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Limited, Baulkham Hills, New South Wales, Australia
Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Arrow - Metformin 850
Active Ingredient: Metformin 850mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Sigma Pharmaceuticals Pty Limited, Baulkham Hills, New South Wales, Australia
Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Arrow - Quinapril 10
Active Ingredient: Quinapril hydrochloride 10.85mg equivalent to 10mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratorios Norman SA, Tres Cantos, Madrid, Spain
Product: Arrow - Quinapril 20
Active Ingredient: Quinapril hydrochloride 21.7mg equivalent to 20mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratorios Norman SA, Tres Cantos, Madrid, Spain
Product: Arrow - Quinapril 5
Active Ingredient: Quinapril hydrochloride 5.425mg equivalent to 5mg quinapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Laboratorios Norman SA, Tres Cantos, Madrid, Spain
Product: Arrow - Simvastatin 10
Active Ingredient: Simvastatin 10mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Arrow - Simvastatin 20
Active Ingredient: Simvastatin 20mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Arrow - Simvastatin 40
Active Ingredient: Simvastatin 40mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Arrow - Simvastatin 5
Active Ingredient: Simvastatin 5mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Arrow - Simvastatin 80
Active Ingredient: Simvastatin 80mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Pharmaceuticals Inc, Mississauga, Ontario, Canada
Product: Cefuroxime
Active Ingredient: Cefuroxime sodium 1.6g equivalent to cefuroxime 1.5g
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Laboratorio Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Product: Cefuroxime
Active Ingredient: Cefuroxime sodium 802mg equivalent to cefuroxime 750mg
Dosage Forms: Powder for injection
Diluent
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Laboratorio Reig Jofre SA, Sant Adria de Besos, Barcelona, Spain
Product: DBL® Acetylcysteine
Active Ingredient: Acetylcysteine 200mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Erbitux
Active Ingredient: Cetuximab 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Ferro-F-Tab
Active Ingredients: Ferrous fumarate 310mg
Folic acid 0.35mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Product: Karvea
Active Ingredient: Irbesartan 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Karvea
Active Ingredient: Irbesartan 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Karvea
Active Ingredient: Irbesartan 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Karvezide
Active Ingredients: Hydrochlorothiazide 12.5mg
Irbesartan 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Karvezide
Active Ingredients: Hydrochlorothiazide 12.5mg
Irbesartan 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Bristol-Myers Squibb Company, Evansville, Indiana, United States of America
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Neo-B12
Active Ingredient: Hydroxocobalamin chloride 1.027mg equivalent to Hydroxocobalamin 1mg
Dosage Form: Solution for injection
New Zealand Sponsor: Mayne Pharma (NZ) Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Stocrin
Active Ingredient: Efavirenz 100mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Stocrin
Active Ingredient: Efavirenz 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Stocrin
Active Ingredient: Efavirenz 50mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Stocrin
Active Ingredient: Efavirenz 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Stocrin
Active Ingredient: Efavirenz 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Strepfen Intensive
Active Ingredient: Flurbiprofen 8.75mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Sutent
Active Ingredient: Sunitinib malate 16.7mg equivalent to 12.5mg Sunitinib
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia Srl, Marino del Tronto, Ascoli Piceno, Italy
Product: Sutent
Active Ingredient: Sunitinib malate 33.4mg equivalent to 25mg sunitinib
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia Srl, Marino del Tronto, Ascoli Piceno, Italy
Product: Sutent
Active Ingredient: Sunitinib malate 66.8mg equivalent to 50mg Sunitinib
Dosage Form: Capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia Srl, Marino del Tronto, Ascoli Piceno, Italy
Product: Systane Lubricating Eye Drops
Active Ingredients: Macrogol 400 0.4%w/v
Propylene glycol 0.3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alcon Laboratories Inc, Fort Worth, Texas, United States of America
Dated this 20th day of October 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).