Exviera
dasabuvir
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Exviera. 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 Exviera.
For practical information about using Exviera, patients should read the package leaflet or contact their doctor or pharmacist.
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Exviera : EPAR - Summary for the public (PDF/77.26 KB)
First published: 12/02/2015
Last updated: 08/02/2018 -
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Exviera : EPAR - Risk-management-plan summary (PDF/89.17 KB)
First published: 12/02/2015
Last updated: 12/04/2023
Authorisation details
Product details | |
---|---|
Name |
Exviera
|
Agency product number |
EMEA/H/C/003837
|
Active substance |
dasabuvir sodium
|
International non-proprietary name (INN) or common name |
dasabuvir
|
Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
Anatomical therapeutic chemical (ATC) code |
J05AP09
|
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 | |
---|---|
Marketing-authorisation holder |
AbbVie Ltd
|
Revision |
26
|
Date of issue of marketing authorisation valid throughout the European Union |
14/01/2015
|
Contact address |
Vanwall Business Park
Vanwall Road Maidenhead Berkshire SL6 4UB United Kingdom |
Product information
12/08/2022 Exviera - EMEA/H/C/003837 - WS2430
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
Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
For hepatitis C virus (HCV) genotype specific activity.