Regulatory PathRegulatory requirements compared

Active substance

Velpatasvir

Safety signals and safety-related labeling changes

  • US FDA 27 Apr 2022 EPCLUSA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 27 Apr 2022 EPCLUSA — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations
  • US FDA 15 Nov 2019 VOSEVI — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for velpatasvir →

Combinations containing Velpatasvir

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.