This is a summary of the European public assessment report (EPAR) for Gilenya. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. it is not intended to provide practical advice on how to use Gilenya.
For practical information about using Gilenya, patients should read the package leaflet or contact their doctor or pharmacist.
Gilenya : EPAR - Summary for the public (PDF/81.35 KB)
First published: 30/03/2011
Last updated: 12/02/2018
Gilenya : EPAR - Risk-management-plan summary (PDF/221.18 KB)
First published: 11/07/2018
Last updated: 11/07/2018
|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||
02/07/2018 Gilenya - EMEA/H/C/002202 - IA/0051
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Gilenya is indicated as single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following adult patient groups:
- patients 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 two or more disabling relapses in one year, and with one 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