EMA
approval
· 2025-07-11
EMA Authorised: Filsuvez (dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w)) — Chiesi Farmaceutici S.p.A
Summary
EMA authorised Filsuvez for epidermolysis bullosa dystrophica and junctional forms; the marketing authorization holder is Chiesi Farmaceutici S.p.A.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Epidermolysis Bullosa Dystrophica;Epidermolysis Bullosa, Junctional. MAH: Chiesi Farmaceutici S.p.A. Decision date: 15/05/2025. Orphan medicine