EMA
approval
· 2025-07-04
EMA Authorised: Orfadin (nitisinone) — Swedish Orphan Biovitrum International AB
Summary
The European Medicines Agency authorised Orfadin (nitisinone) by Swedish Orphan Biovitrum International AB for hereditary tyrosinemia type I, with decision date…
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Tyrosinemias. MAH: Swedish Orphan Biovitrum International AB. Decision date: 03/07/2025