Prognia
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🇪🇺EU · EMAAuthorisedATC: L04AJ03Orphan Medicine

Aspaveli(pegcetacoplan)

Hemoglobinuria, Paroxysmal

Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ)

EMA Authorisation: 13/12/2021

INN: pegcetacoplan

Indication

Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

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.