Gilenya

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fingolimod

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 13/08/2018

Authorisation details

Product details
Name
Gilenya
Agency product number
EMEA/H/C/002202
Active substance
fingolimod hydrochloride 
International non-proprietary name (INN) or common name
fingolimod
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AA27
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
17/03/2011
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

02/07/2018 Gilenya - EMEA/H/C/002202 - IA/0051

Contents

  • 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.

Pharmacotherapeutic group

IMMUNOSUPPRESSANTS

Therapeutic indication

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).

or:
 

  • 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.

Assessment history

Changes since initial authorisation of medicine

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