Zeposia

ozanimod

Table of contents

Opinion

On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zeposia. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted an extension to the existing indication as follows:1

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 colitisZeposia 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Key facts

Name
Zeposia
Agency product number
EMEA/H/C/004835
International non-proprietary name (INN) or common name
  • ozanimod
Active substance
  • ozanimod hydrochloride
Therapeutic area
Multiple Sclerosis, Relapsing-Remitting
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.

Date opinion adopted
14/10/2021
Company name
Bristol-Myers Squibb Pharma EEIG
Status
Positive
Application type
Post-authorisation

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