Entecavir Mylan

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entecavir

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

Overview

This is a summary of the European public assessment report (EPAR) for Entecavir Mylan. 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 Entecavir Mylan.

For practical information about using Entecavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/07/2022

Authorisation details

Product details
Name
Entecavir Mylan
Agency product number
EMEA/H/C/004377
Active substance
entecavir monohydrate
International non-proprietary name (INN) or common name
entecavir
Therapeutic area (MeSH)
Hepatitis B
Anatomical therapeutic chemical (ATC) code
J05AF10
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

21/06/2022 Entecavir Mylan - EMEA/H/C/004377 - R/0008

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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

Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

  • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
  • decompensated liver disease.


For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.

Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.

Assessment history

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