Sebivo

RSS

telbivudine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Sebivo has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 14/01/2021

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

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

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

Contents

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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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