Notice Type
Departmental
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:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Ciprofloxacin Actavis
Ciprofloxacin hydrochloride 3.5mg/mL equivalent to Ciprofloxacin 3mg/mL
Eye drops, solution
Actavis New Zealand Limited
FDC Limited, Waluj, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Imatinib - Dr Reddy’s
Imatinib mesilate 119.47mg equivalent to Imatinib 100mg
Capsule
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Vishakapatnam, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Imatinib - Dr Reddy’s
Imatinib mesilate 477.88mg equivalent to Imatinib 400mg
Capsule
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Vishakapatnam, India

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturer:

Ionolyte
Magnesium chloride hexahydrate 0.3g/L
Potassium chloride 0.3g/L
Sodium acetate trihydrate 4.63g/L
Sodium chloride 6.02g/L
Solution for infusion
Fresenius Kabi New Zealand Limited
Fresenius Kabi France, Louviers, France

Dated this 16th day of September 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).