This is a summary of the European public assessment report (EPAR) for Dupixent. 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 Dupixent.
For practical information about using Dupixent, patients should read the package leaflet or contact their doctor or pharmacist.
Dupixent : EPAR - Summary for the public (PDF/95.15 KB)
First published: 11/10/2017
Last updated: 11/10/2017
Dupixent : EPAR - Risk-management-plan summary (PDF/82.28 KB)
First published: 28/06/2019
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06/05/2019 Dupixent - EMEA/H/C/004390 - X/0004/G
- 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.
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 201901/03/2019