Dimherity: Withdrawal of the marketing authorisation application

dimethyl fumarate

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
  • dimethyl fumarate
Active substance
  • dimethyl fumarate
Date of withdrawal
24/03/2022
Company making the application
Sandoz GmbH
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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