🇪🇺 Dupilumab (SAR231893) in European Union

EMA authorised Dupilumab (SAR231893) on 26 September 2017

Marketing authorisation

EMA — authorised 26 September 2017

  • Application: EMEA/H/C/004390
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Dupixent
  • 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 eos
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is Dupilumab (SAR231893) approved in European Union?

Yes. EMA authorised it on 26 September 2017.

Who is the marketing authorisation holder for Dupilumab (SAR231893) in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.