Dimethyl fumarate Accord
dimethyl fumarate
Table of contents
Overview
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.
-
List item
Dimethyl fumarate Accord : EPAR - Medicine overview (PDF/143.37 KB)
First published: 22/02/2023
EMEA/H/C/005950 -
-
List item
Dimethyl fumarate Accord : EPAR - Risk-management-plan summary (PDF/102.52 KB)
First published: 22/02/2023
Authorisation details
Product details | |
---|---|
Name |
Dimethyl fumarate Accord
|
Agency product number |
EMEA/H/C/005950
|
Active substance |
dimethyl fumarate
|
International non-proprietary name (INN) or common name |
dimethyl fumarate
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AX07
|
Generic |
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 |
15/02/2023
|
Contact address |
Accord Healthcare S.L.U. |
Product information
15/02/2023 Dimethyl fumarate Accord - EMEA/H/C/005950 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Immunosuppressants
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).