Aduhelm: Withdrawal of the marketing authorisation application
aducanumab
Table of contents
Overview
Biogen Netherlands B.V. withdrew its application for a marketing authorisation of Aduhelm for the treatment of Alzheimer’s disease.
The company withdrew the application on 20 April 2022.
Key facts
Name |
Aduhelm |
Product number |
EMEA/H/C/005558 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/04/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Aduhelm (PDF/4.65 MB)
Adopted
First published: 01/08/2022
EMA/CHMP/557556/2022 -
List item
Withdrawal letter: Aduhelm (PDF/173.92 KB)
First published: 22/04/2022 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Aduhelm (aducanumab) (PDF/122.95 KB)
First published: 22/04/2022
EMA/225498/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').