Epclusa

RSS

sofosbuvir / velpatasvir

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

Overview

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.

This EPAR was last updated on 06/07/2022

Authorisation details

Product details
Name
Epclusa
Agency product number
EMEA/H/C/004210
Active substance
  • Sofosbuvir
  • velpatasvir
International non-proprietary name (INN) or common name
  • sofosbuvir
  • velpatasvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05A
Accelerated assessmentAccelerated assessment

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.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
06/07/2016
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

19/05/2022 Epclusa - EMEA/H/C/004210 - SW/0065

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

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).

Assessment history

Changes since initial authorisation of medicine

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