Maviret

RSS

glecaprevir / pibrentasvir

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

Overview

Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older 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.

This EPAR was last updated on 24/04/2019

Authorisation details

Product details
Name
Maviret
Agency product number
EMEA/H/C/004430
Active substance
glecaprevir / pibrentasvir
International non-proprietary name (INN) or common name
glecaprevir / pibrentasvir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AP57
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
AbbVie Deutschland GmbH Co. KG
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
26/07/2017
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

11/03/2019 Maviret - EMEA/H/C/004430 - II/0012

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years.

Assessment history

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