Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/08/13 | Phase 1 | Completed | |||
2011/11/04 | N/A | APPROVED_FOR_MARKETING | Janssen Infectious Diseases BVBA | ||
2011/04/25 | Phase 1 | Completed | |||
2011/02/08 | Phase 1 | Completed | Tibotec BVBA | ||
2010/10/07 | Phase 2 | Completed | |||
2010/10/06 | Phase 2 | Completed | |||
2009/11/13 | Phase 1 | Completed | Tibotec BVBA | ||
2009/10/08 | Phase 1 | Completed | |||
2009/06/01 | Phase 2 | Completed | Janssen Infectious Diseases BVBA | ||
2009/01/26 | Phase 1 | Completed | Tibotec BVBA |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Products, LP | 59676-701 | ORAL | 100 mg in 1 1 | 10/17/2023 | |
| Janssen Products, LP | 59676-702 | ORAL | 20 mg in 1 1 | 10/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/5/2014 |
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. | |||||
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