Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 13 February 2018


Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:
- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy
- 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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Category Value
Agency product number EMEA/H/C/002202
Orphan designation No
Date First Approved 17-03-2011
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Novartis Europharm Limited

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti