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:

Bortezomib Mylan
Bortezomib 3.5mg
Powder for injection
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

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

Nuwiq
Simoctocog alfa 250IU
Powder for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Nuwiq
Simoctocog alfa 500IU
Powder for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Nuwiq
Simoctocog alfa 1000IU
Powder for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Nuwiq
Simoctocog alfa 2000IU
Powder for injection
Octapharma New Zealand Limited
Octapharma AB, Stockholm, Sweden
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 5mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 10mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 15mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 20mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 30mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 40mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

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

Oxycodone Modified Release Tablets
Oxycodone hydrochloride 80mg
Modified release tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America

Dated this 25th day of August 2016.

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