Sebivo
Withdrawn
This medicine's authorisation has been withdrawn
telbivudine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Sebivo has been withdrawn at the request of the marketing-authorisation holder.
Sebivo : EPAR - Summary for the public
English (EN) (630.47 KB - PDF)
First published: Last updated:
български (BG) (804.14 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
español (ES) (691.41 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
čeština (CS) (771.3 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
dansk (DA) (631.84 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
Deutsch (DE) (693.47 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
eesti keel (ET) (630.76 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
ελληνικά (EL) (1.37 MB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
français (FR) (695.6 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
italiano (IT) (694.74 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
latviešu valoda (LV) (716.83 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
lietuvių kalba (LT) (720.61 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
magyar (HU) (703.31 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
Malti (MT) (709.35 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
Nederlands (NL) (632.51 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
polski (PL) (770.06 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
português (PT) (631.13 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
română (RO) (661.02 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
slovenčina (SK) (707.64 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
slovenščina (SL) (702.81 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
Suomi (FI) (692.42 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
svenska (SV) (690.77 KB - PDF)
First published: 27/02/2009Last updated: 14/01/2021
Product information
Sebivo : EPAR - Product Information
English (EN) (1.4 MB - PDF)
First published: Last updated:
български (BG) (1.66 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
español (ES) (1.34 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
čeština (CS) (1.56 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
dansk (DA) (1.41 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
Deutsch (DE) (1.41 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
eesti keel (ET) (1.35 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
ελληνικά (EL) (1.67 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
français (FR) (1.46 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
hrvatski (HR) (1.46 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
íslenska (IS) (1.36 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
italiano (IT) (1.37 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
latviešu valoda (LV) (1.52 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
lietuvių kalba (LT) (1.44 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
magyar (HU) (1.56 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
Malti (MT) (1.67 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
Nederlands (NL) (1.37 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
norsk (NO) (1.38 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
polski (PL) (1.59 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
português (PT) (1.34 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
română (RO) (1.48 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
slovenčina (SK) (1.88 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
slovenščina (SL) (1.51 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
Suomi (FI) (1.4 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
svenska (SV) (1.39 MB - PDF)
First published: 12/10/2009Last updated: 14/01/2021
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
English (EN) (581.67 KB - PDF)
First published: Last updated:
български (BG) (673.47 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
español (ES) (582.72 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
čeština (CS) (664.31 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
dansk (DA) (582.18 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
Deutsch (DE) (582.64 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
eesti keel (ET) (582.61 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
ελληνικά (EL) (669.46 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
français (FR) (582.58 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
hrvatski (HR) (610.09 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
íslenska (IS) (1.13 MB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
italiano (IT) (581.87 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
latviešu valoda (LV) (668.65 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
lietuvių kalba (LT) (649.69 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
magyar (HU) (665.68 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
Malti (MT) (668.55 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
Nederlands (NL) (581.77 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
norsk (NO) (1.13 MB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
polski (PL) (629.39 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
português (PT) (582.37 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
română (RO) (647.75 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
slovenčina (SK) (665.81 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
slovenščina (SL) (597.48 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
Suomi (FI) (582.04 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
svenska (SV) (582.46 KB - PDF)
First published: 21/10/2009Last updated: 14/01/2021
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 inhibitorsTherapeutic 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
Sebivo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (597.43 KB - PDF)
First published: Last updated:
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
English (EN) (647.25 KB - PDF)
First published: Last updated:
Sebivo-H-C-00713-P46-0057 : EPAR - Assessment Report
AdoptedReference Number: EMA/760212/2014
English (EN) (1.18 MB - PDF)
First published: Last updated:
Sebivo-H-C-713-R-0023 : EPAR - Assessment Report - Renewal
Adopted
English (EN) (1.22 MB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Sebivo
AdoptedReference Number: EMA/CHMP/123824/2012
English (EN) (680.52 KB - PDF)
First published: Last updated:
More information on Sebivo
Public statement on Sebivo: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/594353/2020
English (EN) (152.83 KB - PDF)
First published:
More information on Sebivo
Topics
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