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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 (PDF/1.34 MB) (new)
First published: 01/06/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
09/05/2023 Gilenya - EMEA/H/C/002202 - IB/0081/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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
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) 14-17 December 201518/12/2015
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