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.
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.
Therapeutic Area (MeSH)
ATC Code
L04AA27
ATC Item
xl 04 aa 27
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| fingolimod hydrochloride | N/A | 芬戈莫德 |
EMA Name
Fingolimod Accord
Medicine Name
Fingolimod Accord
Aliases
N/ANo risk management plan link.