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 - Carvedilol
Active Ingredient: Carvedilol 3.125mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Elpen SA, Pikermi Attica, Greece
Product: Arrow - Carvedilol
Active Ingredient: Carvedilol 6.25mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Elpen SA, Pikermi Attica, Greece
Product: Arrow - Carvedilol
Active Ingredient: Carvedilol 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Elpen SA, Pikermi Attica, Greece
Product: Arrow - Carvedilol
Active Ingredient: Carvedilol 25mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Elpen SA, Pikermi Attica, Greece
Product: Arrow - Topiramate 15
Active Ingredient: Topiramate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Topiramate 25
Active Ingredient: Topiramate 25mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Topiramate 50
Active Ingredient: Topiramate 50mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow - Tramadol SR 100
Active Ingredient: Tramadol hydrochloride 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Arrow - Tramadol SR 150
Active Ingredient: Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Arrow - Tramadol SR 200
Active Ingredient: Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Hosur, Tamil Nadur, India
Product: Avastin
Active Ingredient: Bevacizumab 100mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Product: Benadryl PE for the Family Chesty Cough & Nasal Congestion
Active Ingredients: Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL equivalent to 0.82mg/mL phenylephrine
Dosage Form: Syrup
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Victoria, Australia
Product: Benadryl PE for the Family Dry Cough & Nasal Congestion
Active Ingredients: Dextromethorphan hydrobromide monohydrate 0.2%w/v
Phenylephrine hydrochloride 0.1%w/v
Dosage Form: Syrup
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Victoria, Australia
Product: Hydrocortisone Butyrate Cream
Active Ingredient: Hydrocortisone butyrate 0.1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceutical Industries Limited, Haifa Bay, Israel
Product: Hydrocortisone Butyrate Ointment
Active Ingredient: Hydrocortisone butyrate 0.1%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceutical Industries Limited, Haifa Bay, Israel
Product: Ipramol Steri-Neb
Active Ingredients: Ipratropium bromide monohydrate 0.5mg
Salbutamol sulfate 3mg
Dosage Form: Solution for inhalation
New Zealand Sponsor: Norton Healthcare Limited (NZ Branch Office)
Manufacturer: Norton Healthcare Limited, Preston Brook, Runcorn, Cheshire, United Kingdom
Product: Lemsip Ibuprofen All Night Cold & Flu
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Lemsip Ibuprofen All Night Cold & Flu
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Lignocaine 2% Gel
Active Ingredient: Lidocaine 20mg
Dosage Form: Topical gel
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer (Perth) Pty Limited, Bentley, Western Australia, Australia
Product: Lipazil
Active Ingredient: Gemfibrozil 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland, New Zealand
Product: Maxigesic (Pharmacy Only)
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: Methylthioninium Chloride Injection
Active Ingredient: Methylthioninium chloride 1%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Harold Hill, Romford, Essex, United Kingdom
Product: Nicorette Icy Mint Gum
Active Ingredient: Nicotine 2.2mg equivalent to 11mg nicotine resinate
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Nicorette Icy Mint Gum
Active Ingredient: Nicotine 4.4mg equivalent to 22mg nicotine resinate
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Nicotrol Icy Mint Gum
Active Ingredient: Nicotine 2.2mg equivalent to 11mg nicotine resinate
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Nicotrol Icy Mint Gum
Active Ingredient: Nicotine 4.4mg equivalent to 22mg nicotine resinate
Dosage Form: Chewing gum
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Replagal
Active Ingredient: Agalsidase alfa 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Chesapeake Biological Laboratories Inc (CBL), Baltimore, Maryland, United States of America
Product: Ritalin LA
Active Ingredient: Methylphenidate hydrochloride 10mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Elan Holdings, Gainesville, Georgia, United States of America
Product: Setrona
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to sertraline 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Setrona
Active Ingredient: Sertraline hydrochloride 55.96mg equivalent to sertraline 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Simponi
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Product: Simponi SmartJect Injector
Active Ingredient: Golimumab 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Product: Sprycel
Active Ingredient: Dasatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Tamsulosin Hydrochloride
Active Ingredient: Tamsulosin hydrochloride 0.4mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Transipeg
Active Ingredient: Macrogol 3350 5.9g
Dosage Form: Powder for oral solution
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Laboratoires M. Richard, ZI des Reys de Saulce, Saulce sur Rhone, France
Product: Zidoval
Active Ingredient: Metronidazole 7.5mg/g
Dosage Form: Vaginal gel
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: DPT Laboratories Limited, San Antonio, Texas, United States of America
Product: Codral Day and Night Cold and Flu
Active Ingredients: Chlorphenamine maleate 2mg
(Night Dose) Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Active Ingredients: Codeine phosphate hemihydrate 9.5mg
(Day Dose) Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Probiotec Pharma Pty Limited, Laverton North, Victoria, Australia
Johnson & Johnson Pty Limited, Cape Town, South Africa
Dated this 11th day of December 2009.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).