EMA indication:
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.3
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▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via their national pharmacovigilance reporting system. Suspected adverse reactions should also be reported to Sobi via email at [email protected].
Abbreviations
C3, complement 3; C3G, C3 glomerulopathy; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; RAS, renin-angiotensin system.
Footnotes
* p<0.001 based on logistic regression or hypothesis testing for the odds ratio.1
References
Fakhouri F, et al. N Engl J Med 2025;393:2210–20.
Fakhouri F, et al. N Engl J Med 2025;393:2210–20 (Supplementary appendix).
Aspaveli EMA Summary of product characteristics. Swedish Orphan Biovitrum AB (publ) January 2026