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 06/05/2021

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
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

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.

Pharmacotherapeutic group

Nucleoside and nucleotide reverse transcriptase inhibitors

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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