Hepsera

RSS

adefovir dipivoxil

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

Overview

This is a summary of the European public assessment report (EPAR) for Hepsera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Hepsera.

This EPAR was last updated on 08/08/2019

Authorisation details

Product details
Name
Hepsera
Agency product number
EMEA/H/C/000485
Active substance
adefovir dipivoxil
International non-proprietary name (INN) or common name
adefovir dipivoxil
Therapeutic area (MeSH)
Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
J05AF08
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
06/03/2003
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

25/07/2019 Hepsera - EMEA/H/C/000485 - PSUSA/00000060/201809

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

  • Hepatitis B
  • chronic

Therapeutic indication

Hepsera is indicated for the treatment of chronic hepatitis B in adults with:

  • compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);
  • decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

Assessment history

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