Basic Information
Dimethyl fumarate Accord
Regulatory Information
EMEA/H/C/006471
April 22, 2024
March 21, 2024
2
July 11, 2024
Company Information
unite kingdom
Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF
Accord Healthcare Ltd.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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).
Overview Summary
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 contains the active substance dimethyl fumarate and 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](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).