Maviret
glecaprevir / pibrentasvir
Table of contents
Overview
Maviret is an antiviral medicine used to treat adults and children from 3 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus.
Maviret contains the active substances glecaprevir and pibrentasvir.
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List item
Maviret : EPAR - Medicine overview (PDF/117.41 KB)
First published: 17/08/2017
Last updated: 28/07/2021
EMA/409726/2017 -
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List item
Maviret : EPAR - Risk-management-plan summary (PDF/39.96 KB)
First published: 24/04/2019
Last updated: 16/02/2023
Authorisation details
Product details | |
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Name |
Maviret
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Agency product number |
EMEA/H/C/004430
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Hepatitis C, Chronic
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Anatomical therapeutic chemical (ATC) code |
J05AP57
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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 |
AbbVie Deutschland GmbH Co. KG
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Revision |
22
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Date of issue of marketing authorisation valid throughout the European Union |
26/07/2017
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Contact address |
Knollstrasse |
Product information
02/03/2023 Maviret - EMEA/H/C/004430 - IB/0055
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
Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.
Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.
Assessment history
News
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23/04/2021
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
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23/06/2017
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23/06/2017