Gilenya

RSS

fingolimod

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

Overview

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.

This EPAR was last updated on 11/09/2019

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 monitoringAdditional 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
23
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

03/09/2019 Gilenya - EMEA/H/C/002202 - II/0053

Contents

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 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).

or

  • 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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
2 ratings
1 rating