Hepsera

Withdrawn

This medicine's authorisation has been withdrawn

adefovir dipivoxil

Overview

On 31 December 2022, the European Commission withdrew the marketing authorisation for Hepsera (adefovir dipivoxil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gilead Sciences Ireland UC, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Hepsera was granted marketing authorisation in the EU on 6 March 2003 for the treatment of adults with chronic hepatitis B. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2008. 

The European Public Assessment Report (EPAR) for Hepsera is updated to indicate that the marketing authorisation is no longer valid.

Hepsera : EPAR - Summary for the public

Hepsera : EPAR - Risk-management-plan summary

Product information

Hepsera : EPAR - Product Information

Hepsera : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Hepsera
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000485
• Marketing authorisation holder:
  Gilead Sciences Ireland UC

  IDA Business & Technology Park; Carrigtohill; County Cork; T45 DP77; Ireland

• Opinion adopted:
  21/11/2002
• Marketing authorisation issued:
  06/03/2003
• Withdrawal of marketing authorisation:
  31/12/2022
• Revision:
  27

Assessment history

Changes since initial authorisation of medicine

Hepsera : EPAR - Procedural steps taken and scientific information after authorisation

Hepsera-H-C-485-PSUSA-00000060-201809 : EPAR - Scientific Conclusion

Adopted Reference Number: EMA/443748/2019

Hepsera-H-C-485-FUM-0062 : EPAR - Assessment Report

Adopted Reference Number: EMA/275269/2013

Hepsera-H-C-485-P46-0066 : EPAR - Assessment Report

Adopted Reference Number: EMA/CHMP/52392/2013

Hepsera-H-C-485-II-0030 : EPAR - Assessment Report - Variation

Initial marketing authorisation documents

Hepsera : EPAR - Scientific Discussion

Hepsera : EPAR - Procedural steps taken before authorisation