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:
Manufacturer:

Afluria Quad
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15mcg
Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15mcg
Influenza virus B/Brisbane/60/2008 - like strain 15mcg
Influenza virus B/Phuket/3073/2013 - like strain 15mcg
Suspension for injection
Seqirus (NZ) Limited
Seqirus Pty Limited, Melbourne, Australia

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

Noxafil
Posaconazole 40mg/mL
Oral suspension
Merck Sharp & Dohme (New Zealand) Limited
Patheon Inc, Whitby, Canada

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

Noxafil
Posaconazole 100mg
Modified release tablet
Merck Sharp & Dohme (New Zealand) Limited
NV Organon, Oss, Netherlands

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

Noxafil
Posaconazole 18mg/mL
Concentrate for injection
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH, Innishannon, Ireland

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

Sporanox
Itraconazole 100mg
Capsule
Janssen-Cilag (New Zealand) Limited
Janssen-Cilag SpA, Latina, Italy


Dated this 7th day of September 2018.

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