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: Apo-Amlodipine
Active Ingredient: Amlodipine besilate 3.5mg equivalent to 2.5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Canada
Product: Codral Relief Head Cold
Active Ingredient: Phenylephrine hydrochloride 10mg/mL
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Duro-Tuss Chesty Cough Lozenges Sugar Free Lime
Active Ingredients: Bromhexine hydrochloride 8mg
Cetylpyridinium chloride monohydrate 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturers: Nestle Australia Limited, Blacktown, Australia
iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia
Product: Duro-Tuss Chesty Cough Sugar Free Eucalyptus & Menthol
Active Ingredients: Bromhexine hydrochloride 8mg
Cetylpyridinium chloride monohydrate 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturers: Nestle Australia Limited, Blacktown, Australia
iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia
Product: Mucinex (General Sale)
Active Ingredient: Guaifenesin 600mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Catalent Pharma Solutions LLC, Winchester, United States of America
Reckitt Benckiser Inc, Fort Worth, United States of America
Product: Mucinex (Restricted)
Active Ingredient: Guaifenesin 600mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Catalent Pharma Solutions LLC, Winchester, United States of America
Reckitt Benckiser Inc, Fort Worth, United States of America
Product: NeutraFluor 5000 Sensitive
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 1.105%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate Oral Pharmaceuticals, Dallas, United States of America
Product: Protecta Derm
Active Ingredients: Dimeticone copolyol 1.04%w/w
Zinc oxide 12.5%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmasol Limited, Hampshire, United Kingdom
Product: Rivamil
Active Ingredient: Rivastigmine tartrate 2.4mg equivalent to 1.5mg rivastgamine
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Merck SL, Barcelona, Spain
Product: Rivamil
Active Ingredient: Rivastigmine tartrate 4.8mg equivalent to 3mg rivastgamine
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Merck SL, Barcelona, Spain
Product: Rivamil
Active Ingredient: Rivastigmine tartrate 7.2mg equivalent to 4.5mg rivastgamine
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Merck SL, Barcelona, Spain
Product: Rivamil
Active Ingredient: Rivastigmine tartrate 9.6mg equivalent to 6mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Merck SL, Barcelona, Spain
Dated this 21st day of May 2010.
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).