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:

Apo-Entecavir
Entecavir monohydrate 0.53mg equivalent to entecavir 0.5mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Apo-Entecavir
Entecavir monohydrate 1.06mg equivalent to entecavir 1mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Apo-Moxifloxacin
Moxifloxacin hydrochloride 436.33mg equivalent to moxifloxacin 400mg
Tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Enstilar
Betamethasone dipropionate 643mcg/g equivalent to betamethasone 500mcg/g
Calcipotriol monohydrate 52.2mcg/g equivalent to calcipotriol 50mcg/g
Foam
LEO Pharma Limited
LEO Laboratories Limited, Dublin, Ireland
Colep Laupheim GmbH & Co KG, Laupheim, Germany

Dated this 7th day of May 2018.

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