Tibsovo: Withdrawal of the marketing authorisation application
Agios Netherlands B.V. withdrew its application for a marketing authorisation of Tibsovo for the treatment of acute myeloid leukaemia (AML), a cancer of white blood cells.
The company withdrew the application on 13 October 2020.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').