Gilenya 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 (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya 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.
Gilenya contains the active substance fingolimod.
Gilenya : EPAR - Medicine overview (PDF/81.82 KB)
First published: 30/03/2011
Last updated: 18/12/2018
Gilenya : EPAR - Risk-management-plan summary (PDF/198.65 KB)
First published: 11/07/2018
Last updated: 18/12/2018
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|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
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Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
17/12/2018 Gilenya - EMEA/H/C/002202 - IB/0052
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Gilenya is 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 (for exceptions and information about washout periods see sections 4.4 and 5.1).
- 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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 201518/12/2015
New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya18/12/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 201525/09/2015
European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya20/04/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 201220/01/2012