Sebivo

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Withdrawn

This medicine's authorisation has been withdrawn

telbivudine
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 5 November 2020, the marketing authorisation of Sebivo (telbivudine) ceased to be valid in the European Union (EU). Novartis Europharm Limited confirmed that it discontinued the marketing of the product due to commercial reasons. 

The European Public Assessment Report (EPAR) for Sebivo is updated to indicate that the marketing authorisation is no longer valid.

Sebivo : EPAR - Summary for the public

English (EN) (630.47 KB - PDF)

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български (BG) (804.14 KB - PDF)

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español (ES) (691.41 KB - PDF)

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čeština (CS) (771.3 KB - PDF)

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dansk (DA) (631.84 KB - PDF)

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Deutsch (DE) (693.47 KB - PDF)

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eesti (ET) (630.76 KB - PDF)

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ελληνικά (EL) (1.37 MB - PDF)

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français (FR) (695.6 KB - PDF)

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italiano (IT) (694.74 KB - PDF)

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latviešu (LV) (716.83 KB - PDF)

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lietuvių (LT) (720.61 KB - PDF)

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magyar (HU) (703.31 KB - PDF)

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Malti (MT) (709.35 KB - PDF)

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Nederlands (NL) (632.51 KB - PDF)

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polski (PL) (770.06 KB - PDF)

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português (PT) (631.13 KB - PDF)

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română (RO) (661.02 KB - PDF)

Prima publicare: 27/02/2009 Cea mai recent: 14/01/2021
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slovenčina (SK) (707.64 KB - PDF)

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slovenščina (SL) (702.81 KB - PDF)

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suomi (FI) (692.42 KB - PDF)

Prima publicare: 27/02/2009 Cea mai recent: 14/01/2021
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svenska (SV) (690.77 KB - PDF)

Prima publicare: 27/02/2009 Cea mai recent: 14/01/2021
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Product information

Sebivo : EPAR - Product Information

English (EN) (1.4 MB - PDF)

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български (BG) (1.66 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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español (ES) (1.34 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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čeština (CS) (1.56 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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dansk (DA) (1.41 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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Deutsch (DE) (1.41 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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eesti (ET) (1.35 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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ελληνικά (EL) (1.67 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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français (FR) (1.46 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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hrvatski (HR) (1.46 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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italiano (IT) (1.37 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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latviešu (LV) (1.52 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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lietuvių (LT) (1.44 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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magyar (HU) (1.56 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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Malti (MT) (1.67 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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Nederlands (NL) (1.37 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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polski (PL) (1.59 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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português (PT) (1.34 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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română (RO) (1.48 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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slovenčina (SK) (1.88 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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slovenščina (SL) (1.51 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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suomi (FI) (1.4 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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svenska (SV) (1.39 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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Íslenska (IS) (1.36 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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norsk (NO) (1.38 MB - PDF)

Prima publicare: 12/10/2009 Cea mai recent: 14/01/2021
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Latest procedure affecting product information:T/0050
12/04/2018
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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)

Prima publicare: Cea mai recent:
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български (BG) (673.47 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

español (ES) (582.72 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

čeština (CS) (664.31 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

dansk (DA) (582.18 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

Deutsch (DE) (582.64 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

eesti (ET) (582.61 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

ελληνικά (EL) (669.46 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

français (FR) (582.58 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

hrvatski (HR) (610.09 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

italiano (IT) (581.87 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
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latviešu (LV) (668.65 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
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lietuvių (LT) (649.69 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

magyar (HU) (665.68 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

Malti (MT) (668.55 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

Nederlands (NL) (581.77 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

polski (PL) (629.39 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

português (PT) (582.37 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

română (RO) (647.75 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

slovenčina (SK) (665.81 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

slovenščina (SL) (597.48 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

suomi (FI) (582.04 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
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svenska (SV) (582.46 KB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

Íslenska (IS) (1.13 MB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

norsk (NO) (1.13 MB - PDF)

Prima publicare: 21/10/2009 Cea mai recent: 14/01/2021
Vizualizare

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 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.

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)

Prima publicare: Cea mai recent:
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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)

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Sebivo-H-C-00713-P46-0057 : EPAR - Assessment Report

Adopted Reference Number: EMA/760212/2014

English (EN) (1.18 MB - PDF)

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Sebivo-H-C-713-R-0023 : EPAR - Assessment Report - Renewal

Adopted

English (EN) (1.22 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Sebivo

Adopted Reference Number: EMA/CHMP/123824/2012

English (EN) (680.52 KB - PDF)

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Sebivo : EPAR - Scientific Discussion

English (EN) (885.34 KB - PDF)

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Sebivo : EPAR - Procedural steps taken before authorisation

English (EN) (597.43 KB - PDF)

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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)

Prima publicare:
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