Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: L04AA27

Fingolimod Accord(fingolimod hydrochloride)

Multiple Sclerosis, Relapsing-Remitting

Marketing Authorisation Holder: Accord Healthcare S.L.U.

EMA Authorisation: 25/06/2020

INN: fingolimod

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.