Overview
Telbivudine is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Telbivudine is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.
Indication
For the treatment of chronic hepatitis B in adult and adolescent patients ≥16 years of age with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Associated Conditions
- Chronic Hepatitis B Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/12/19 | Phase 4 | Completed | |||
2018/03/19 | Phase 4 | Completed | Third Affiliated Hospital, Sun Yat-Sen University | ||
2016/09/09 | Phase 4 | Terminated | |||
2016/07/07 | Phase 4 | UNKNOWN | |||
2016/05/17 | Phase 4 | UNKNOWN | Seng Gee Lim | ||
2015/11/26 | Phase 1 | UNKNOWN | Third Affiliated Hospital, Sun Yat-Sen University | ||
2015/05/19 | Phase 2 | Completed | Chang Gung Memorial Hospital | ||
2014/11/26 | N/A | UNKNOWN | Beijing Ditan Hospital | ||
2014/10/01 | N/A | UNKNOWN | Beijing Ditan Hospital | ||
2014/02/07 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SEBIVO | novartis pharmaceuticals canada inc | 02288389 | Tablet - Oral | 600 MG | 12/14/2006 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SEBIVO 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 07388001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized | |
| SEBIVO 20 mg/ml SOLUCION ORAL | 07388003 | SOLUCIÓN ORAL | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.