EMA Authorised: Roctavian (valoctocogene roxaparvovec) — BioMarin International Limited

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Summary

The European Medicines Agency authorised Roctavian (valoctocogene roxaparvovec) from BioMarin International Limited as a conditional, orphan-designated therapy.…

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Diseases / indications

• Hemophilia

Drugs mentioned

• Roctavian (valoctocogene roxaparvovec)

Snippet

Status: Authorised. MAH: BioMarin International Limited. Decision date: 11/11/2025. Conditional approval. Orphan medicine