Zeposia
ozanimod
Table of contents
Overview
Zeposia is a medicine used to treat adults with relapsing-remitting multiple sclerosis (RRMS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms (remission). It is used in patients with active disease, which means that patients have relapses or signs of active inflammation on scans.
Zeposia contains the active substance ozanimod.
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List item
Zeposia: EPAR - Medicine overview (PDF/117.61 KB)
First published: 27/05/2020
EMA/171870/2020 -
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List item
Zeposia: EPAR - Risk-management-plan summary (PDF/156.03 KB)
First published: 27/05/2020
Authorisation details
Product details | |
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Name |
Zeposia
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Agency product number |
EMEA/H/C/004835
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Active substance |
ozanimod hydrochloride
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International non-proprietary name (INN) or common name |
ozanimod
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Therapeutic area (MeSH) |
Multiple Sclerosis, Relapsing-Remitting
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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 |
Bristol-Myers Squibb Pharma EEIG
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Date of issue of marketing authorisation valid throughout the European Union |
20/05/2020
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Contact address |
Product information
09/10/2020 Zeposia - EMEA/H/C/004835 - T/0001
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
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Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.