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 - Mometasone
Active Ingredient: Mometasone furoate 1mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Glenmark Pharmaceuticals Limited, Himachal Pradesh, India
Product: Gaviscon Strawberry
Active Ingredients: Calcium carbonate 80mg
Sodium alginate 250mg
Sodium bicarbonate 133.5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Hydralyte Apple Blackcurrant Flavoured Electrolyte Ice Blocks
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.2mg/mL
Sodium chloride 2.5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: The Hydration Pharmaceutical Trust, Epping, Australia
Product: Hydralyte Orange Flavoured Electrolyte Ice Blocks
Active Ingredients: Citric acid monohydrate 4.8mg/mL
Glucose monohydrate 16mg/mL
Potassium citrate monohydrate 2.2mg/mL
Sodium chloride 2.5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: The Hydration Pharmaceutical Trust, Epping, Australia
Product: Nortriptyline NRIM
Active Ingredient: Nortriptyline hydrochloride 11.4mg equivalent to nortriptyline base 10mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: Centaur Pharmaceuticals Private Limited, Maharashtra, India
Intas Pharmaceuticals Limited, Gujarat, India
Glochem Industries Limited, Andhra Pradesh, India
Product: Nortriptyline NRIM
Active Ingredient: Nortriptyline hydrochloride 28.5mg equivalent to nortriptyline base 25mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: Centaur Pharmaceuticals Private Limited, Maharashtra, India
Intas Pharmaceuticals Limited, Gujarat, India
Glochem Industries Limited, Andhra Pradesh, India
Product: Risedronate Sandoz
Active Ingredient: Risedronate sodium hemipentahydrate 40.2mg equivalent to risedronate sodium 35mg and risedronic acid 32.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Kocaeli, Turkey
Dated this 2nd day of May 2013.
DR DON MACKIE, 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).