Harvoni

RSS

ledispavir 90 mg / sofosbuvir 400 mg

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

Overview

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 16/07/2018

Authorisation details

Product details
Name
Harvoni
Agency product number
EMEA/H/C/003850
Active substance
  • ledispavir 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
J05AX65
Additional 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
15
Date of issue of marketing authorisation valid throughout the European Union
17/11/2014
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

07/06/2018 Harvoni - EMEA/H/C/003850 - T/0067

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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