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: | Eylea |
Active Ingredient: | Aflibercept 40mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturers: | Regeneron Pharmaceuticals Inc, New York, United States of America Bayer AG, Berlin, Germany |
Product: | Imbruvica |
Active Ingredient: | Ibrutinib 140mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Catalent CTS Inc, Missouri, United States of America Cilag AG, Schaffhausen, Switzerland |
Product: | Venclexta |
Active Ingredient: | Venetoclax 10mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
Product: | Venclexta |
Active Ingredient: | Venetoclax 50mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
Product: | Venclexta |
Active Ingredient: | Venetoclax 100mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
Product: | Venclexta (Combination pack) |
Component 1: | |
Active Ingredient: | Venetoclax 10mg |
Dosage Form: | Film coated tablet |
Component 2: | |
Active Ingredient: | Venetoclax 50mg |
Dosage Form: | Film coated tablet |
Component 3: | |
Active Ingredient: | Venetoclax 100mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
Dated this 31st day of October 2019.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).