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:

Bemfola
Follitropin alfa 75IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

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

Bemfola
Follitropin alfa 150IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

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

Bemfola
Follitropin alfa 225IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

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

Bemfola
Follitropin alfa 300IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

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

Bemfola
Follitropin alfa 450IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

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

Toujeo
Insulin glargine 300IU/mL equivalent to 10.91mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

Dated this 2nd day of October 2016.

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