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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:

Humira
Adalimumab 10mg/0.2mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Humira
Adalimumab 20mg/0.4mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Humira
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Humira Pen
Adalimumab 50mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Aesica Queenborough Limited, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Tamiflu
Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL
when reconstituted with 55mL of water
Powder for oral suspension
Roche Products (NZ) Limited
Rottendorf Pharma GmbH, Ennigerloh, Germany

Dated this 6th day of April 2018.

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