Vosevi

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sofosbuvir / velpatasvir / voxilaprevi

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Vosevi
Agency product number
EMEA/H/C/004350
Active substance
  • Sofosbuvir
  • velpatasvir
  • voxilaprevi
International non-proprietary name (INN) or common name
  • sofosbuvir
  • velpatasvir
  • voxilaprevi
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05A
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
26/07/2017
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

30/05/2022 Vosevi - EMEA/H/C/004350 - SW/0055

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:

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.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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).

Assessment history

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