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EMA approval · 2025-07-04

EMA Authorised: Orfadin (nitisinone) — Swedish Orphan Biovitrum International AB

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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

  • Orfadin (nitisinone)

Snippet

Status: Authorised. Therapeutic area: Tyrosinemias. MAH: Swedish Orphan Biovitrum International AB. Decision date: 03/07/2025