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 10/10/2017

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
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address

117 Allee des Parcs
69800
Saint-Priest
France

Product information

18/09/2017 Entecavir Mylan - EMEA/H/C/004377 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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