Hepsera

Withdrawn

This medicine's authorisation has been withdrawn

adefovir dipivoxil

Overview

The marketing authorisation for Hepsera has been withdrawn at the request of the marketing-authorisation holder.

Hepsera : EPAR - Summary for the public

Hepsera : EPAR - Risk-management-plan summary

Product information

Hepsera : EPAR - Product Information

Latest procedure affecting product information: IB/0086

20/04/2021

This medicine’s product information is available in all official EU languages.
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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).

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

• Marketing authorisation issued:
  06/03/2003
• 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

AdoptedReference Number: EMA/443748/2019

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

AdoptedReference Number: EMA/275269/2013

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

AdoptedReference 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