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 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.

This EPAR was last updated on 23/08/2022

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
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
AbbVie Deutschland GmbH Co. KG
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
26/07/2017
Contact address

Knollstrasse
67061 Ludwigshafen
Germany

Product information

19/05/2022 Maviret - EMEA/H/C/004430 - SW/0050

Other EU languages available icon 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:

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

Changes since initial authorisation of medicine

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