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 - Brimonidine
Active Ingredient: Brimonidine tartrate 0.2%v/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: FDC Limited, District Aurangabad, India
Product: Fampyra
Active Ingredient: Fampridine 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Biogen Idec NZ Limited
Manufacturers: Alkermes Pharma Ireland Limited, Co. Westmeath, Ireland
Patheon Inc, Ontario, Canada
Product: Imodium Zapid
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Wiltshire, United Kingdom
Product: Macleans - Sensitive Fresh Mint
Active Ingredients: Potassium nitrate 5%w/w
Sodium fluoride 0.3094%w/w equivalent to 1400ppm fluoride
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Medco Low Dose Aspirin
Active Ingredient: Aspirin 75mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Pedialyte Glucose and Electrolyte oral powder (Orange Flavour)
Active Ingredients: Citric acid 20.13mg/g
Glucose 753.18mg/g
Potassium citrate 71.52mg/g
Sodium chloride 67.75mg/g
Sodium citrate 32.45mg/g
Dosage Form: Powder
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Aspen Pharma Pty Limited, Baulkham Hills, Australia
Product: Pedialyte Glucose and Electrolyte oral powder (Raspberry Flavour)
Active Ingredients: Citric acid 19.29mg/g
Glucose 731.28mg/g
Potassium citrate 69.11mg/g
Sodium chloride 65.9mg/g
Sodium citrate 32.14mg/g
Dosage Form: Powder
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Aspen Pharma Pty Limited, Baulkham Hills, Australia
Dated this 27th day of October 2011.
DR MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation (pursuant to delegation given by the Minister of Health on 6 July 2001).