Sebivo

Withdrawn

This medicine's authorisation has been withdrawn

telbivudine

Overview

On 5 November 2020, the marketing authorisation of Sebivo (telbivudine) ceased to be valid in the European Union (EU). Novartis Europharm Limited confirmed that it discontinued the marketing of the product due to commercial reasons. 

The European Public Assessment Report (EPAR) for Sebivo is updated to indicate that the marketing authorisation is no longer valid.

Sebivo : EPAR - Summary for the public

Product information

Sebivo : EPAR - Product Information

Sebivo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Sebivo
• Active substance:
  telbivudine
• International non-proprietary name (INN) or common name:
  telbivudine
• Therapeutic area (MeSH):
  Hepatitis B, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AF11

Pharmacotherapeutic group

Nucleoside and nucleotide reverse transcriptase inhibitors

Therapeutic indication

Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

Initiation of Sebivo 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000713
• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park; Merrion Road; Dublin 4; D04 A9N6; Ireland

• Opinion adopted:
  22/02/2007
• Marketing authorisation issued:
  24/04/2007
• Revision:
  20

Assessment history

Changes since initial authorisation of medicine

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

Sebivo-H-C-PSUSA-2880-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/413022/2017

Sebivo-H-C-00713-P46-0057 : EPAR - Assessment Report

Adopted Reference Number: EMA/760212/2014

Sebivo-H-C-713-R-0023 : EPAR - Assessment Report - Renewal

Adopted

CHMP post-authorisation summary of positive opinion for Sebivo

Adopted Reference Number: EMA/CHMP/123824/2012

Initial marketing authorisation documents

Sebivo : EPAR - Scientific Discussion

Sebivo : EPAR - Procedural steps taken before authorisation