Tecfidera

RSS

dimethyl fumarate

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

Overview

Tecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).

Tecfidera contains the active substance dimethyl fumarate.

This EPAR was last updated on 11/12/2020

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
20
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

24/11/2020 Tecfidera - EMEA/H/C/002601 - II/0063

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

How useful was this page?

Add your rating
Average
3 ratings