ledispavir 90 mg / sofosbuvir 400 mg

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Harvoni. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Harvoni.

For practical information about using Harvoni, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/08/2019

Authorisation details

Product details
Agency product number
Active substance
  • ledipasvir 90 mg
  • sofosbuvir 400 mg
International non-proprietary name (INN) or common name
ledispavir 90 mg / sofosbuvir 400 mg
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
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
Date of issue of marketing authorisation valid throughout the European Union
Contact address

IDA Business & Technology Park
County Cork
T45 DP77

Product information

01/08/2019 Harvoni - EMEA/H/C/003850 - R/0080


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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years (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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