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: Coldrex PE Phenylephrine Congestion Clear
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to Phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Sydney, Australia
Product: Gaviscon Pregnancy
Active Ingredients: Potassium bicarbonate 20mg/mL
Sodium alginate 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Hydralyte (Orange Flavoured)
Active Ingredients: Citric acid 178.11mg/g
Glucose 590.36mg/g
Potassium citrate monohydrate 89.81mg/g
Sodium chloride 106.65mg/g
Dosage Form: Powder
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: Mega Lifesciences (Australia) Pty Limited, Melbourne, Australia
Product: Hydralyte (Apple Blackcurrant Flavoured)
Active Ingredients: Citric acid 179.64mg/g
Glucose 595.47mg/g
Potassium citrate monohydrate 90.59mg/g
Sodium chloride 107.57mg/g
Dosage Form: Powder
New Zealand Sponsor: Hydration Pharmaceuticals Pty Limited
Manufacturer: Mega Lifesciences (Australia) Pty Limited, Melbourne, Australia
Product: Ropaccord
Active Ingredient: Ropinirole hydrochloride 5.7mg equivalent to Ropinirole 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Dated this 10th day of January 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).