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 29/07/2020

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.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
21
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

03/07/2020 Harvoni - EMEA/H/C/003850 - X/0081/G

Contents

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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

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