Zeposia

RSS

ozanimod

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

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.

This EPAR was last updated on 27/05/2020

Authorisation details

Product details
Name
Zeposia
Agency product number
EMEA/H/C/004835
Active substance
ozanimod hydrochloride
International non-proprietary name (INN) or common name
ozanimod
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AA
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
Celgene Europe BV 
Date of issue of marketing authorisation valid throughout the European Union
20/05/2020
Contact address

Winthontlaan 6 N
3526 KV Utrecht
Netherlands

Product information

20/05/2020 Zeposia - EMEA/H/C/004835 -

Contents

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Pharmacotherapeutic group

  • Immunosuppressants

  • Selective 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.

Assessment history

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