Sebivo

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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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Sebivo has been withdrawn at the request of the marketing-authorisation holder.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

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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