Sebivo
telbivudine
Table of contents
Overview
The marketing authorisation for Sebivo has been withdrawn at the request of the marketing-authorisation holder.
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 |
Product information
12/04/2018 Sebivo - EMEA/H/C/000713 - T/0050
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).
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
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.