Dimethyl fumarate Accord


dimethyl fumarate

This medicine is authorised for use in the European Union.


Dimethyl fumarate Accord 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 adolescents 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).

Dimethyl fumarate Accord is a ‘generic medicine’. This means that Dimethyl fumarate Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Dimethyl fumarate Accord is Tecfidera. For more information on generic medicines, see the question-and-answer document here.

Dimethyl fumarate Accord contains the active substance dimethyl fumarate.

This EPAR was last updated on 22/02/2023

Authorisation details

Product details
Dimethyl fumarate Accord
Agency product number
Active substance
dimethyl fumarate
International non-proprietary name (INN) or common name
dimethyl fumarate
Therapeutic area (MeSH)
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

15/02/2023 Dimethyl fumarate Accord - EMEA/H/C/005950 -

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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

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

Assessment history

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