Is Telbivudine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Telbivudine.

Is Telbivudine approved by the US FDA?

Drugs@FDA lists 2 application product lines for Telbivudine, including TYZEKA (Discontinued); TYZEKA (Discontinued).

Is Telbivudine authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Telbivudine.

Are there safety signals or safety updates for Telbivudine?

US FDA: 2 entries (latest 2018-12-27).

Active substance

Telbivudine

SFDA 1
US FDA 2
EMA 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SEBIVO 600 MG F-C TABLETS	600 mg	Film-coated tablet · Oral use	1 Blister	SAR 1482.85	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TYZEKA	600MG	tablet · oral	NOVARTIS	Discontinued	25 Oct 2006
TYZEKA	100MG/5ML	solution · oral	NOVARTIS	Discontinued	28 Apr 2009

EMA European Union — centrally authorised medicines

Sebivo Novartis Europharm Limited · Withdrawn · authorised 24 Apr 2007 · ATC J05AF11

Therapeutic indication (EMA)

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.

Safety signals and safety-related labeling changes

US FDA 27 Dec 2018 TYZEKA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Dec 2018 TYZEKA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for telbivudine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.