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-Donepezil
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Donepezil
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Letrozole
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Arrow - Doxorubicin
Active Ingredient: Doxorubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Hydralyte Ready to use Apple/Blackcurrant Flavoured Electrolyte Solution
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.213mg/mL
Sodium chloride 2.528mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: The Hydration Pharmaceutical Trust, Victoria, Australia
Product: Hydralyte Ready to use Orange Flavoured Electrolyte Solution
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.213mg/mL
Sodium chloride 2.528mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: The Hydration Pharmaceutical Trust, Victoria, Australia
Product: Hydroxo-B12
Active Ingredient: Hydroxocobalamin chloride 1.027mg/mL equivalent to Hydroxocobalamin 1mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Biologici Italia Laboratoires Srl, Milan, Italy
Dated this 1st day of August 2012.
DR PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).