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 3 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 06/07/2022

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
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.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

30/05/2022 Sovaldi - EMEA/H/C/002798 - SW/0079

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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 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.

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults 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

Related content

How useful was this page?

Add your rating
Average
1 rating
2 ratings