EMA Authorised: Orladeyo (berotralstat dihydrochloride) — BioCryst Ireland Limited

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Summary

The EMA authorised Orladeyo (berotralstat dihydrochloride) for hereditary angioedema, with BioCryst Ireland Limited as the marketing authorization holder.

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Diseases / indications

• Hereditary Angioedema

Drugs mentioned

• ORLADEYO (berotralstat hydrochloride)

Snippet

Status: Authorised. Therapeutic area: Angioedemas, Hereditary. MAH: BioCryst Ireland Limited. Decision date: 12/02/2026