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: Venclexta
Active Ingredient: Venetoclax 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AbbVie Limited
Manufacturers: AbbVie Ireland NL B.V., Sligo, Ireland
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland
   
Product: Venclexta
Active Ingredient: Venetoclax 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AbbVie Limited
Manufacturers: AbbVie Ireland NL B.V., Sligo, Ireland
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland
   
Product: Venclexta
Active Ingredient: Venetoclax 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AbbVie Limited
Manufacturers: AbbVie Ireland NL B.V., Sligo, Ireland
Fournier Laboratories Ireland Limited, Carrigtwohill, 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
Manufacturers: AbbVie Ireland NL B.V., Sligo, Ireland
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland


Dated this 14th day of August 2020.

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