Sovaldi is an antiviral medicine used in combination with other medicines to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver.
Sovaldi contains the active substance sofosbuvir.
Sovaldi : EPAR - Medicine overview (PDF/86.98 KB)
First published: 05/02/2014
Last updated: 18/02/2019
Sovaldi : EPAR - Risk-management-plan summary (PDF/368.94 KB)
First published: 18/02/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis C, Chronic
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
23/08/2019 Sovaldi - EMEA/H/C/002798 - PSUSA/00010134/201812
- 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
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Antivirals for systemic use
Sovaldi is indicated in combination with other medicinal products 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.
World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines25/07/2014
European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C21/02/2014
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013
European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C22/11/2013