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.
Hepsera : EPAR - Summary for the public (PDF/73.02 KB)
First published: 09/07/2009
Last updated: 27/05/2013
Hepsera : EPAR - Risk-management-plan summary (PDF/101.97 KB)
First published: 08/08/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis B, Chronic
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
20/04/2021 Hepsera - EMEA/H/C/000485 - IB/0086
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.