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INDUSTRY:

Pharma

TOPIC:

Regulatory & Legal

TITLE:

EMA: On the 27 September 2017, the European Commission granted a Marketing Authorisation for Dupixent (dupilumab), indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The Marketing Authorization Holder for this medicinal product is sanofi-aventis groupe.

BRIEF:

EMA: EC granted the Marketing Authorisation for Dupixent (dupilumab) 300 mg solution for injection from sanofi-aventis groupe. Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. (ATC code: L04AC).

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