Hepsera
adefovir dipivoxil
Table of contents
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.
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List item
Hepsera : EPAR - Summary for the public (PDF/73.02 KB)
First published: 09/07/2009
Last updated: 27/05/2013 -
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List item
Hepsera : EPAR - Risk-management-plan summary (PDF/101.97 KB)
First published: 08/08/2019
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
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Anatomical therapeutic chemical (ATC) code |
J05AF08
|
Publication details | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
26
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Date of issue of marketing authorisation valid throughout the European Union |
06/03/2003
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Contact address |
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
Pharmacotherapeutic group
Nucleoside and nucleotide reverse transcriptase inhibitors
Therapeutic indication
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.