Sebivo

Withdrawn

This medicine's authorisation has been withdrawn

telbivudine

Overview

The marketing authorisation for Sebivo has been withdrawn at the request of the marketing-authorisation holder.

Sebivo : EPAR - Summary for the public

Product information

Sebivo : EPAR - Product Information

Latest procedure affecting product information: T/0050

12/04/2018

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).

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; 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

AdoptedReference Number: EMA/760212/2014

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

Adopted

CHMP post-authorisation summary of positive opinion for Sebivo

AdoptedReference Number: EMA/CHMP/123824/2012

Initial marketing authorisation documents

Sebivo : EPAR - Scientific Discussion

Sebivo : EPAR - Procedural steps taken before authorisation