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-Mycophenolate
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Mycophenolate
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Biotrue Multi-Purpose Solution
Active Ingredients: Polidronium chloride 0.001mg/g
Polihexanide 0.0013mg/g
Dosage Form: Contact lens solution
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturer: Bausch & Lomb Inc, South Carolina, United States of America
Product: Lemsip flexi Nasal Decongestant Cold & Flu
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to Phenylephrine 5mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Magnesium Sulphate Injection
Active Ingredient: Magnesium sulfate heptahydrate 50%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Martindale Pharmaceuticals, Essex, United Kingdom
Product: Moist-i
Active Ingredient: Hypromellose 3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: FDC Limited, B-8, District Aurangabad, India
Product: Potassium 10mmol
Active Ingredient: Potassium chloride 7.385g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, New South Wales, Australia
Product: Potassium 40mmol
Active Ingredient: Potassium chloride 2.95g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, New South Wales, Australia
Product: Trajenta
Active Ingredient: Linagliptin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Ohio, United States of America
Product: Your Pharmacy Day + Night Sinus Pain Relief PE
Day Tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 31st day of May 2012.
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).