Mayzent

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siponimod

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

Overview

Mayzent is a medicine used to treat adults with an advanced form of multiple sclerosis (MS) known as secondary progressive MS.

It is used in patients with active disease, which means that patients still have relapses or signs of inflammation can be seen in scans.

Mayzent contains the active substance siponimod.

This EPAR was last updated on 04/05/2020

Authorisation details

Product details
Name
Mayzent
Agency product number
EMEA/H/C/004712
Active substance
Siponimod fumaric acid
International non-proprietary name (INN) or common name
siponimod
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04
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
2
Date of issue of marketing authorisation valid throughout the European Union
13/01/2020
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

02/04/2020 Mayzent - EMEA/H/C/004712 - IB/0002/G

Contents

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Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

Assessment history

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