Mayzent
siponimod
Table of contents
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.
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List item
Mayzent : EPAR - Medicine overview (PDF/120.12 KB)
First published: 23/01/2020
EMA/629863/2019 -
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Mayzent : EPAR - Risk-management-plan summary (PDF/263.66 KB)
First published: 23/01/2020
Authorisation details
Product details | |
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Name |
Mayzent
|
Agency product number |
EMEA/H/C/004712
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Active substance |
Siponimod fumaric acid
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International non-proprietary name (INN) or common name |
siponimod
|
Therapeutic area (MeSH) |
Multiple Sclerosis, Relapsing-Remitting
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Anatomical therapeutic chemical (ATC) code |
L04
|
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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
13/01/2020
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Contact address |
Product information
07/01/2021 Mayzent - EMEA/H/C/004712 - PSUSA/00010818/202003
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
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.