Basic Information
Fingolimod Accord
Regulatory Information
EMEA/H/C/005191
June 25, 2020
April 30, 2020
9
May 16, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Overview Summary
Fingolimod Accord is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly. Fingolimod Accord is a ‘generic medicine’. This means that Fingolimod Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Gilenya. Fingolimod Accord contains the active substance fingolimod.