Dimherity: Withdrawal of the marketing authorisation application
dimethyl fumarate
Table of contents
Overview
Sandoz GmbH withdrew its application for a marketing authorisation of Dimherity for the treatment of adults with relapsing remitting multiple sclerosis (MS).
The company withdrew the application on 22 February 2022.
Key facts
Name |
Dimherity |
Product number |
EMEA/H/C/006042 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
22/02/2022 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Dimherity (PDF/670.98 KB)
Adopted
First published: 03/11/2022
EMEA/H/C/5955/0000 -
List item
Withdrawal letter: Dimherity (PDF/61.08 KB)
First published: 29/03/2022 -
List item
Questions and answers on the withdrawal for the marketing authorisation of Dimherity (dimethyl fumarate) (PDF/122.82 KB)
First published: 25/03/2022
Last updated: 03/11/2022
EMA/173087/2022 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').