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: Amlodipine Pfizer
Active Ingredient: Amlodipine besilate 6.9348mg equivalent to amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Amlodipine Pfizer
Active Ingredient: Amlodipine besilate 13.8696mg equivalent to amlodipine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Amlodipine 10
Active Ingredient: Amlodipine besilate 13.8696mg equivalent to amlodipine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Auro-Amlodipine 5
Active Ingredient: Amlodipine besilate 6.9348mg equivalent to amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Hyderabad, India
Product: Benadryl Dry, Tickly Cough
Active Ingredient: Pholcodine 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Australia
Product: Dexmethsone
Active Ingredient: Dexamethasone 4mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited
Manufacturer: Strides Arcolab Limited, Bangalore, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 25.55mg equivalent to 20mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 12.775mg equivalent to 10mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Escitalopram
Active Ingredient: Escitalopram oxalate 6.388mg equivalent to 5mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Fasturtec
Active Ingredient: Rasburicase 7.5mg
Dosage Form: Powder for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Gruppo Lepetit Srl, Anagni, Italy
Product: Flebogamma 5% DIF
Active Ingredient: Normal immunoglobulin 0.5g
Dosage Form: Solution for infusion
New Zealand Sponsor: Lateral Grifols Pty Limited
Manufacturer: Instituto Grifols S.A, Barcelona, Spain
Product: Kogenate FS
Active Ingredient: Octocog alfa 3000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare LLC, Berkeley, United States of America
Product: Men’s Regaine Extra Strength Foam
Active Ingredient: Minoxidil 5%w/w
Dosage Form: Foam
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: DPT Laboratories Limited, San Antonio, United States of America
Product: Posurdex
Active Ingredient: Dexamethasone 700µg
Dosage Form: Intraocular implant
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, Westport, Ireland
Product: Prepkit-C
Active Ingredients: Aspartame 2.36mg/g
Citric acid, anhydrous 771.868mg/g
Heavy magnesium oxide 225.128mg/g
Macrogol 3350 755.68mg/g
Potassium chloride 10.55mg/g
Sodium chloride 37.33mg/g
Sodium picosulfate 0.64mg/g
Sodium sulfate 80.62mg/g
Dosage Form: Powder for oral solution
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: DFC Pharmamed, Thornleigh, Australia
Dated this 14th day of December 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).