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:

Diclofenac Anti-Inflammatory Pain Relief Gel
Diclofenac sodium 10mg/g
Topical gel
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Odefsey
Emtricitabine 200mg
Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25mg
Tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Rottendorf Pharma GmbH, Ennigerloh, Germany

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

Stelara
Ustekinumab 130mg
Concentrate for infusion
Janssen-Cilag (New Zealand) Limited
Cilag AG, Schaffhausen, Switzerland

Dated this 26th day of January 2018.

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