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EMA Product

Epclusa

Product approved by European Medicines Agency (EU)

Basic Information

Epclusa

Regulatory Information

EMEA/H/C/004210

Authorised

July 6, 2016

May 26, 2016

22

September 26, 2023

Company Information

Ireland

IDA Business & Technology Park Carrigtohill County Cork T45 DP77

GILEAD SCIENCES IRELAND UC

Drug Classification

Accelerated Assessment

Active Ingredients

Active Substances Detail

Sofosbuvirvelpatasvir

Detailed Information

Therapeutic Indication

### 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).

Overview Summary

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.

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