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:

Esbriet
Pirfenidone 267mg
Capsule
Roche Products (NZ) Limited
Catalent Pharma Solutions LLC, Kentucky, United States of America

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

Misodel
Misoprostol 200mcg
Pessary
Pharmaco (NZ) Limited
Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom

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

Misopess
Misoprostol 200mcg
Pessary
Pharmaco (NZ) Limited
Ferring Controlled Therapeutics Limited, East Kilbride, United Kingdom

Dated this 16th day of June 2016.

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