Sovaldi
sofosbuvir
Table of contents
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.
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List item
Sovaldi : EPAR - Medicine overview (PDF/151.26 KB)
First published: 05/02/2014
Last updated: 14/08/2020
EMA/290219/2020 -
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List item
Sovaldi : EPAR - Risk-management-plan summary (PDF/94.17 KB)
First published: 18/02/2019
Last updated: 09/02/2023
Authorisation details
Product details | |
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Name |
Sovaldi
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Agency product number |
EMEA/H/C/002798
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Active substance |
Sofosbuvir
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International non-proprietary name (INN) or common name |
sofosbuvir
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Therapeutic area (MeSH) |
Hepatitis C, Chronic
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Anatomical therapeutic chemical (ATC) code |
J05AX15
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Accelerated 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 | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
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Revision |
28
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2014
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Contact address |
IDA Business & Technology Park |
Product information
12/01/2023 Sovaldi - EMEA/H/C/002798 - WS/2356
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
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30/04/2020
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21/07/2017
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16/12/2016
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02/12/2016
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24/04/2015
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24/04/2015
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25/07/2014
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27/06/2014
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21/02/2014
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22/11/2013
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European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C22/11/2013