dimethyl fumarate

This medicine is authorised for use in the European Union.


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 in adults and children from 13 years of age 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 20/09/2023

Authorisation details

Product details
Agency product number
Active substance
dimethyl fumarate
International non-proprietary name (INN) or common name
dimethyl fumarate
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Biogen Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

15/09/2023 Tecfidera - EMEA/H/C/002601 - R/0083

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Assessment history

Changes since initial authorisation of medicine

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