Tecfidera

RSS

dimethyl fumarate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Tecfidera. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tecfidera.

For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/07/2019

Authorisation details

Product details
Name
Tecfidera
Agency product number
EMEA/H/C/002601
Active substance
dimethyl fumarate
International non-proprietary name (INN) or common name
dimethyl fumarate
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AX
Publication details
Marketing-authorisation holder
Biogen Netherlands B.V.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
30/01/2014
Contact address

Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

29/03/2019 Tecfidera - EMEA/H/C/002601 - IA/0057

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Therapeutic indication

Treatment of adult patients with relapsing remitting multiple sclerosis.

Assessment history

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