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FABHALTA Manuals & User Guides

User manuals, setup guides, troubleshooting help, and repair information for FABHALTA products.

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FABHALTA manuals

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FABHALTA Risikovurderings- og risikoreduktionsstrategi brugermanual

23. august 2025

FABHALTA Risk Evaluation and Mitigation Strategy Product Specifications Risk: serious infections caused by encapsulated bacteria Application Number: NDA 218276 Application Holder: Novartis Pharmaceuticals Corporation Initial REMS Approval: 12/2023 Most Recent…

FABHALTA 5426117 Brugervejledning til risikovurdering og afbødningsstrategi

10. oktober 2024

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…

FABHALTA® (iptacopan) REMS: Risikovurdering og -reduktionsstrategi

REMS dokument

This document outlines the Risk Evaluation and Mitigation Strategy (REMS) for FABHALTA® (iptacopan), detailing requirements for healthcare providers, patients, and pharmacies to mitigate the risk of serious infections caused by…