This is a summary of the European public assessment report (EPAR) for Kevzara. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kevzara.
For practical information about using Kevzara, patients should read the package leaflet or contact their doctor or pharmacist.
Kevzara : EPAR - Summary for the public (PDF/82.76 KB)
First published: 29/06/2017
Last updated: 29/06/2017
Kevzara : EPAR - Risk management plan summary (PDF/110.18 KB)
First published: 11/05/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Sanofi Winthrop Industrie
|Date of issue of marketing authorisation valid throughout the European Union||
82 Avenue Raspail
18/11/2022 Kevzara - EMEA/H/C/004254 - T/0034
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.
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.