EMA Authorised: Fabhalta (iptacopan hydrochloride monohydrate) — Novartis Europharm Limited

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Summary

The European Medicines Agency authorized Fabhalta (iptacopan hydrochloride monohydrate) from Novartis Europharm Limited for paroxysmal nocturnal hemoglobinuria,…

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Diseases / indications

• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• FABHALTA (IPTACOPAN)

Snippet

Status: Authorised. Therapeutic area: Hemoglobinuria, Paroxysmal. MAH: Novartis Europharm Limited. Decision date: 19/12/2025. Orphan medicine