Sebivo
Withdrawn
This medicine's authorisation has been withdrawn
telbivudine
MedicineHumanWithdrawn
- 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The European Public Assessment Report (EPAR) for Sebivo is updated to indicate that the marketing authorisation is no longer valid.
Product information
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).
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.
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