Notice Type
Notice Title

Consent to the Distribution of New Medicines

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:
Product: Aristocal
Active Ingredient: Calcium carbonate 1250mg equivalent to elemental calcium 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Beximco Pharmaceuticals New Zealand Limited
Manufacturer: Beximco Pharmaceuticals Limited, Gazipur, Bangladesh
Product: Artelac Rebalance
Active Ingredient: Sodium hyaluronate 1.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturer: Tubilux Pharma SpA, Rome, Italy
Product: Parafast
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: Zoledronic Alphapharm
Active Ingredient: Zoledronic acid monohydrate 0.8528mg/mL equivalent to zoledronic acid 0.8mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Hikma Farmaceutica (Portugal) Lda, Sintra, Portugal
Dated this 24th day of January 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).