On 27 June 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Dupixent. The marketing authorisation holder for this medicinal product is sanofi-aventis groupe.
“Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults
patients and adolescents 12 years and older who are candidates for systemic therapy.”
For information, the full indications for Dupixent will be as follows:
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.
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 FeNO (see section 5.1), who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
*New text in bold, removed text as strikethrough
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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.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 201901/03/2019