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, which were referred to the Minister of Health under the provisions of section 24(5) of the Act, and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Apo-Bromocriptine
Bromocriptine mesilate 2.9mg
equivalent to bromocriptine 2.5mg

Tablet
Apotex NZ Limited
Apotex Inc, Weston, Canada

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

Colofac
Mebeverine hydrochloride 135mg
Tablet
BGP Products
Mylan Laboratories SAS, Chatillon sur Charlaronne, France

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

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH, Innishannon, Ireland

Dated this 3rd day of July 2017.

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