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🇪🇺EU · EMAAuthorisedATC: L04AOrphan Medicine

Fabhalta(iptacopan hydrochloride monohydrate)

Hemoglobinuria, Paroxysmal

Marketing Authorisation Holder: Novartis Europharm Limited

EMA Authorisation: 17/05/2024

INN: iptacopan

Indication

Paroxysmal nocturnal haemoglobinuria Fabhalta is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated (see section 5.1).

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.