sofosbuvir / velpatasvir
Table of contents
Epclusa is an antiviral medicine used to treat patients from 3 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus. Hepatitis C virus occurs in several varieties (genotypes), and Epclusa can be used to treat hepatitis C caused by all genotypes of the virus.
Epclusa contains the active substances sofosbuvir and velpatasvir.
Epclusa : EPAR - Medicine overview (PDF/132.7 KB)
First published: 28/07/2016
Last updated: 18/01/2022
Epclusa : EPAR - Risk-management-plan summary (PDF/85.32 KB)
First published: 21/02/2019
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||
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
12/01/2023 Epclusa - EMEA/H/C/004210 - 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
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 202112/11/2021