Aspaveli

pegcetacoplan · Swedish Orphan Biovitrum AB (publ)
ORPHAN AUTHORISED IN THE EU

What Aspaveli is used for

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.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).

Key facts

Brand
Aspaveli
Active substance
pegcetacoplan
Disease area
Hemoglobinuria, Paroxysmal
Medicine group
Immunosuppressants
ATC code
L04AJ03
Marketing authorisation holder
Swedish Orphan Biovitrum AB (publ)
Authorised in the EU since
2021

Official information

In the USA

Same active substance: Syfovre, Empaveli

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Aspaveli used for?

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.

What is the active substance in Aspaveli?

Aspaveli contains pegcetacoplan.

Who makes Aspaveli?

The EU marketing authorisation holder is Swedish Orphan Biovitrum AB (publ).

Is Aspaveli an orphan medicine?

Yes. Aspaveli is designated an orphan medicine in the EU, for a rare disease (Hemoglobinuria, Paroxysmal).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.