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:

Amiodarone Infusion
Amiodarone hydrochloride 50mg/mL
Solution for infusion
REX Medical Limited
Bioindustria Laboratorio Medicinali SpA, Alessandria, Italy

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

BeneFIX
Nonacog alfa 3000IU
Injection with diluent
Pfizer New Zealand Limited
Wyeth Farma SA, Madrid, Spain

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

Neutroval
Filgrastim 600mcg/mL
Solution for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

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

Xergic
Fexofenadine hydrochloride 120mg
Film coated tablet
Mylan New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

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

Xergic
Fexofenadine hydrochloride 180mg
Film coated tablet
Mylan New Zealand Limited
Dr Reddy’s Laboratories Limited, Andhra Pradesh, India

Dated this 31st day of July 2015.

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