Dupixent

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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) when treatments applied to the skin are not sufficient or appropriate. Patients from 6 up to 12 years of age can also be given the medicine if their condition is severe.

Dupixent may be added to maintenance treatment for severe asthma in patients aged 6 years or more, whose asthma is not properly controlled by appropriate combination therapy (high-dose corticosteroids over 12 years of age, medium-to-high dose in those younger, 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 can also be added to local treatment with corticosteroids for adults who have inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used when other treatments have not worked well enough.

Dupixent contains the active substance dupilumab.

This EPAR was last updated on 17/01/2023

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
Anatomical therapeutic chemical (ATC) code
D11AH05
Publication details
Marketing-authorisation holder
Sanofi Winthrop Industrie
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
26/09/2017
Contact address

82 Avenue Raspail
94250 Gentilly
France

Product information

16/12/2022 Dupixent - EMEA/H/C/004390 - T/0067

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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

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.

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 to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 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), 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.

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

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.

Assessment history

Changes since initial authorisation of medicine

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