Kevzara

RSS

sarilumab

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

Overview

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.

This EPAR was last updated on 26/09/2017

Authorisation details

Product details
Name
Kevzara
Agency product number
EMEA/H/C/004254
Active substance
sarilumab
International non-proprietary name (INN) or common name
sarilumab
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AC14
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.

Publication details
Marketing-authorisation holder
sanofi-aventis groupe
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/06/2017
Contact address
54 Rue La Boetie
75008 Paris
France

Product information

24/08/2017 Kevzara - EMEA/H/C/004254 - IB/0002/G

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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.

Assessment history

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