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: 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).