Zeposia

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ozanimod

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

Overview

Zeposia is a medicine used to treat adults with the following diseases:

  • relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a disease in which the immune system (the body’s defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord. In RRMS, the patient has flare-ups (relapses) followed by periods with milder or no symptoms (remission). Zeposia is used in patients with active disease, which means that patients have relapses or signs of active inflammation on scans;
  • ulcerative colitis, a disease causing inflammation and ulcers in the lining of the gut, when the disease is moderately to severely active. Zeposia is used when standard treatment or biological agents (medicines made by cells grown in a laboratory) have not worked well enough or cannot be used by the patient.

Zeposia contains the active substance ozanimod.

This EPAR was last updated on 21/12/2021

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
  • Colitis, Ulcerative
Anatomical therapeutic chemical (ATC) code
L04AA38
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
Bristol-Myers Squibb Pharma EEIG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
20/05/2020
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

18/11/2021 Zeposia - EMEA/H/C/004835 - II/0002/G

Product information documents contain:

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

Immunosuppressants

Therapeutic indication

Multiple sclerosis

  • 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.


Ulcerative colitis

  • Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Assessment history

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