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.

  • List item

    Questions and answers on the withdrawal for the marketing authorisation of Dimherity (dimethyl fumarate) (PDF/122.82 KB) (updated)


    First published: 25/03/2022
    Last updated: 03/11/2022
    EMA/173087/2022

  • 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
    22/02/2022
    Company making the application
    Sandoz GmbH
    Withdrawal type
    Initial authorisation

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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