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
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28/04/2020 Kevzara - EMEA/H/C/004254 - PSUSA/00010609/201907
- 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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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.