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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List item
Mayzent : EPAR - Risk-management-plan summary (PDF/142.15 KB)
First published: 23/01/2020
Last updated: 18/02/2022
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 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
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
13/01/2020
|
Contact address |
Vista Building |
Product information
06/07/2023 Mayzent - EMEA/H/C/004712 - II/0020
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.