sofosbuvir / velpatasvir / voxilaprevi
Table of contents
This is a summary of the European public assessment report (EPAR) for Vosevi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vosevi.
For practical information about using Vosevi, patients should read the package leaflet or contact their doctor or pharmacist.
Vosevi : EPAR - Summary for the public (PDF/132.71 KB)
First published: 22/09/2017
Last updated: 04/11/2021
Vosevi : EPAR - Risk-management-plan summary (PDF/87.1 KB)
First published: 26/02/2019
Last updated: 09/02/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis C, Chronic
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
12/01/2023 Vosevi - EMEA/H/C/004350 - WS/2356
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antivirals for systemic use
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).