FABHALTA 5426117 Guía do usuario da estratexia de avaliación e mitigación de riscos
FABHALTA 5426117 Risk Evaluation and Mitigation Strategy Specifications Product Name: FABHALTA (iptacopan) Intended Use: Treatment of paroxysmal nocturnal hemoglobinuria (PNH) and proteinuria in primary immunoglobulin A nephropathy (IgAN) Risk: Lowered immune system function leading to increased risk of serious infections…