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Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod, Multiple Sclerosis, Relapsing-Remitting, Date of authorisation: 25/06/2020, Revision: 3, Status: Authorised

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.

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