Hepsera
adefovir dipivoxil
Table of contents
Overview
The marketing authorisation for Hepsera has been withdrawn at the request of the marketing-authorisation holder.
-
List item
Hepsera : EPAR - Summary for the public (PDF/1.22 MB)
First published: 09/07/2009
Last updated: 01/03/2023 -
-
List item
Hepsera : EPAR - Risk-management-plan summary (PDF/683.38 KB)
First published: 08/08/2019
Last updated: 01/03/2023
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 |
27
|
| Date of issue of marketing authorisation valid throughout the European Union |
06/03/2003
|
| Contact address |
IDA Business & Technology Park |
Product information
20/04/2021 Hepsera - EMEA/H/C/000485 - IB/0086
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
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.