Dupixent

RSS

dupilumab

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

Overview

Dupixent is a medicine used to treat:

  • moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) in patients aged 12 years and over when treatments applied to the skin are not sufficient or appropriate. Patients from 6 months up to 12 years of age can also be given the medicine if their condition is severe.
  • severe asthma in patients aged 6 years and over, whose asthma is not properly controlled by appropriate combination therapy (corticosteroids taken by inhalation plus another medicine used for the prevention of asthma). Dupixent is added to maintenance treatment and is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’.
  • inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used in adults added to local treatment with corticosteroids when other treatments have not worked well enough.
  • moderate-to-severe prurigo nodularis (a long-term skin disease with a rash causing lumps with intense itching) in adults. It is used with or without topical (applied to the skin) corticosteroids.
  • eosinophilic oesophagitis (an allergic condition of the food pipe) in adults and children above 12 years of age who cannot take conventional treatment or for whom it is not working.

Dupixent contains the active substance dupilumab.

This EPAR was last updated on 17/08/2023

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
  • Prurigo
  • Esophageal Diseases
  • Asthma
  • Sinusitis
Anatomical therapeutic chemical (ATC) code
D11AH05
Publication details
Marketing-authorisation holder
Sanofi Winthrop Industrie
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
26/09/2017
Contact address

82 Avenue Raspail
94250 Gentilly
FRANCE

Product information

20/07/2023 Dupixent - EMEA/H/C/004390 - P46 012

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Agents for dermatitis, excluding corticosteroids

Therapeutic indication

Atopic dermatitis

Adults and adolescents
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Children 6 months to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.

Asthma

Adults and adolescents
Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Children 6 to 11 years of age
Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Chronic rhinosinusitis with nasal polyposis (CRSwNP)

Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

Prurigo Nodularis (PN)

Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

Eosinophilic esophagitis (EoE)

Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Assessment history

Changes since initial authorisation of medicine

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