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: Claratyne
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Schering-Plough Laboratories NV, Antwerp, Belgium
Product: Isabelle
Active Ingredients: Drospirenone 3mg
Ethinylestradiol 0.03mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Lupin Limited, Madhya Pradesh, India
Product: PhoxiliumT 1.2 mmol/L, phosphate
Small Compartment A
Active Ingredients: Calcium chloride dihydrate 3.68g/L
Magnesium chloride hexahydrate 2.44g/L
Large Compartment B
Active Ingredients: Dibasic sodium phosphate dihydrate 0.225g/L
Potassium chloride 0.314g/L
Sodium bicarbonate 2.92g/L
Sodium chloride 6.44g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Gambro Pty Limited (NZ)
Manufacturer: Gambro Dasco SpA, Sondalo, Italy
Product: Robitussin Chesty Cough Relief
Active Ingredient: Bromhexine hydrochloride 1.602mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Dated this 23rd 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).