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 Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Galvumet
Metformin hydrochloride 850mg
Vildagliptin 50mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Tuas, Singapore

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Galvumet
Metformin hydrochloride 1000mg
Vildagliptin 50mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Tuas, Singapore

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Maviret
Glecaprevir 100mg
Pibrentasvir 40mg
Film coated tablet
AbbVie Limited
AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland

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

Nifuran
Nitrofurantoin 50mg
Tablet
W M Bamford & Co Limited
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

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

Nifuran
Nitrofurantoin 100mg
Tablet
W M Bamford & Co Limited
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

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

Riodine Antiseptic Ointment
Povidone-iodine 10%w/w
Topical ointment
Orion Laboratories (NZ) Limited
Orion Laboratories Pty Limited, Perth, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Scandonest 2% Special
Adrenaline 1:100,000
Mepivacaine hydrochloride 2%
Solution for injection
Ivoclar Vivadent Limited
Specialities Septodont, Paris, France


Dated this 24th day of September 2018.

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