Harvoni

RSS

ledispavir / sofosbuvir

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

Overview

Harvoni is an antiviral medicine used to treat adults and children from 3 years of age with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.

Harvoni contains the active substances ledipasvir and sofosbuvir.

This EPAR was last updated on 25/01/2022

Authorisation details

Product details
Name
Harvoni
Agency product number
EMEA/H/C/003850
Active substance
  • ledipasvir
  • Sofosbuvir
International non-proprietary name (INN) or common name
  • ledispavir
  • sofosbuvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AX65
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
24
Date of issue of marketing authorisation valid throughout the European Union
17/11/2014
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

30/09/2021 Harvoni - EMEA/H/C/003850 - WS2157

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

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
4 ratings