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: Adacel
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 2.5mcg
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Pasteur Limited, Toronto, Canada
Sanofi Pasteur Inc, Pennsylvania, United States of America
   
Product: Eylea
Active Ingredient: Aflibercept 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Regeneron Pharmaceuticals Inc, New York, United States of America
   
Product: Stelara
Active Ingredient: Ustekinumab 45mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
   
Product: Stelara
Active Ingredient: Ustekinumab 90mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America


Dated this 9th day of July 2019.

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