Vanflyta

RSS

quizartinib

Refused
This medicine was refused authorisation for use in the European Union.

Overview

The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).

The Agency issued its opinion on 17 October 2019. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
 

This EPAR was last updated on 06/01/2020

Application details

Product details
Name
Vanflyta
Active substance
quizartinib dihydrochloride
International non-proprietary name (INN) or common name
quizartinib
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
L01XE
Application details
Marketing-authorisation applicant
Daiichi Sankyo Europe GmbH
Date of opinion
17/10/2019
Date of refusal of marketing authorisation
19/12/2019

Assessment history

How useful was this page?

Add your rating