Aliqopa: Withdrawal of the marketing authorisation application
copanlisib
Table of contents
Overview
Bayer AG withdrew its application for a marketing authorisation of Aliqopa for the treatment of adult patients with previously treated marginal zone lymphoma (MZL), a cancer of a type of white blood cells called B lymphocytes or B cells.
The company withdrew the application on 20 December 2021.
Key facts
Name |
Aliqopa |
Product number |
EMEA/H/C/004334 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/12/2021 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Aliqopa (PDF/5.34 MB)
Adopted
First published: 10/02/2023
EMA/948113/2022 -
List item
Withdrawal letter: Aliqopa (PDF/101.98 KB)
First published: 28/01/2022 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Aliqopa (copanlisib) (PDF/114.84 KB)
First published: 28/01/2022
EMA/38839/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').