Dupixent
dupilumab
Table of contents
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.
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List item
Dupixent : EPAR - Summary for the public (PDF/158.77 KB)
First published: 11/10/2017
Last updated: 23/03/2023
EMA/86864/2023 -
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List item
Dupixent : EPAR - Risk-management-plan summary (PDF/262.53 KB)
First published: 28/06/2019
Last updated: 23/03/2023
Authorisation details
Product details | |
---|---|
Name |
Dupixent
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Agency product number |
EMEA/H/C/004390
|
Active substance |
dupilumab
|
International non-proprietary name (INN) or common name |
dupilumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
D11AH05
|
Publication details | |
---|---|
Marketing-authorisation holder |
Sanofi Winthrop Industrie
|
Revision |
29
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Date of issue of marketing authorisation valid throughout the European Union |
26/09/2017
|
Contact address |
82 Avenue Raspail |
Product information
20/07/2023 Dupixent - EMEA/H/C/004390 - P46 012
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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16/12/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 202228/01/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 202016/10/2020
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20/09/2019
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28/06/2019
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01/03/2019
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01/03/2019
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21/07/2017