Sebivo

RSS

telbivudine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Sebivo. 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 Sebivo.

This EPAR was last updated on 29/05/2018

Authorisation details

Product details
Name
Sebivo
Agency product number
EMEA/H/C/000713
Active substance
telbivudine
International non-proprietary name (INN) or common name
telbivudine
Therapeutic area (MeSH)
Hepatitis B, Chronic
Anatomical therapeutic chemical (ATC) code
J05AF11
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
24/04/2007
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

12/04/2018 Sebivo - EMEA/H/C/000713 - T/0050

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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