Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of new medicines set out in the Schedule hereto:
Schedule
Product: Alendronate Pfizer
Active Ingredient: Alendronate sodium 91.363mg equivalent to alendronic acid 70mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Alendronate 70
Active Ingredient: Alendronate sodium 91.363mg equivalent to alendronic acid 70mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Ceftriaxone
Active Ingredient: Ceftriaxone sodium 596mg equivalent to ceftriaxone 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1193mg equivalent to ceftriaxone 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Auro-Ceftriaxone
Active Ingredient: Ceftriaxone sodium 2386mg equivalent to ceftriaxone 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Ceftriaxone Pfizer
Active Ingredient: Ceftriaxone sodium 596mg equivalent to ceftriaxone 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Ceftriaxone Pfizer
Active Ingredient: Ceftriaxone sodium 1193mg equivalent to ceftriaxone 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Ceftriaxone Pfizer
Active Ingredient: Ceftriaxone sodium 2386mg equivalent to ceftriaxone 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India
Product: Oralair
Active Ingredient: Grass pollen extract 100IR
Dosage Form: 100 IR Sublingual tablet
Active Ingredient: Allergen extracts 300IR/mL
Dosage Form: 300 IR Sublingual tablet
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Osny Pharma S.A.S, Osny, France
Product: Oralair
Active Ingredient: Grass pollen extract 300IR
Dosage Form: Sublingual tablet
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Osny Pharma S.A.S, Osny, France
Product: Sensodyne Multi Action Isoactive Foaming Gel
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 0.254%w/w equivalent to fluoride 1149ppm
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Ultradent Products Inc, Utah, United States of America
Product: Sensodyne Whitening Isoactive Foaming Gel
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 0.254%w/w equivalent to fluoride 1149ppm
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Ultradent Products Inc, Utah, United States of America
Product: Soliris
Active Ingredient: Eculizumab 300mg
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Dated this 25th day of August 2011.
DEBORAH KENT, Acting Deputy Director-General, Clinical Leadership, Protection and Regulation (pursuant to delegation given by the Minister of Health on 6 July 2001).