Dupixent

RSS

dupilumab

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

Overview

Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry).

Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma. Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’. 

Dupixent contains the active substance dupilumab.

This EPAR was last updated on 03/10/2019

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 monitoringAdditional 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
5
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

01/08/2019 Dupixent - EMEA/H/C/004390 - II/0012

Contents

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

How useful was this page?

Add your rating
Average
3 ratings
2 ratings
1 rating