Fingolimod Accord

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fingolimod

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

Overview

Fingolimod Accord 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 (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord 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.

Fingolimod Accord is a ‘generic medicine’. This means that Fingolimod Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Gilenya. For more information on generic medicines, see the question-and-answer document here.

Fingolimod Accord contains the active substance fingolimod.

This EPAR was last updated on 03/07/2020

Authorisation details

Product details
Name
Fingolimod Accord
Agency product number
EMEA/H/C/005191
Active substance
fingolimod hydrochloride 
International non-proprietary name (INN) or common name
fingolimod
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AA27
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
25/06/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

Fingolimod Accord - EMEA/H/C/005191 -

Contents

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Pharmacotherapeutic group

  • Immunosuppressants

  • Selective immunosuppressants

Therapeutic indication

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

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

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