Sovaldi

RSS

sofosbuvir

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

Overview

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.

This EPAR was last updated on 18/02/2019

Authorisation details

Product details
Name
Sovaldi
Agency product number
EMEA/H/C/002798
Active substance
Sofosbuvir
International non-proprietary name (INN) or common name
sofosbuvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AX15
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
16
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

17/09/2018 Sovaldi - EMEA/H/C/002798 - R/0050

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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