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:

Boostrix
Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Tetanus toxoid, adsorbed 20IU
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France

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

DBL™ Mitoxantrone Hydrochloride Injection Concentrate
Mitoxantrone hydrochloride 2.33mg/mL equivalent to Mitoxantrone 2mg/mL
Concentrate for infusion
Hospira NZ Limited
Hospira Australia Pty Limited, Melbourne, Australia
Zydus Hospira Oncology Limited (ZHOPL), Ahmedabad, India

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

Simponi
Golimumab 50mg
Solution for injection
Janssen-Cilag (New Zealand) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

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

Simponi SmartJect Injector
Golimumab 50mg
Solution for injection
Janssen-Cilag (New Zealand) Limited
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America

Dated this 20th day of November 2015.

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