Dupixent

RSS

dupilumab

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

Overview

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.

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Dupixent
Agency product number
EMEA/H/C/004390
Active substance
dupilumab
International non-proprietary name (INN) or common name
dupilumab
Therapeutic area (MeSH)
Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code
D11AH05
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
2
Date of issue of marketing authorisation valid throughout the European Union
27/09/2017
Contact address
54 rue La Boetie
75008 Paris
France

Product information

07/09/2018 Dupixent - EMEA/H/C/004390 - IB/0010

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

Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

Assessment history

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