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).