Overview
Concizumab has been used in trials studying the treatment of Haemophilia A and Congenital Bleeding Disorder.
Background
Concizumab has been used in trials studying the treatment of Haemophilia A and Congenital Bleeding Disorder.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/18 | N/A | Not yet recruiting | |||
2024/02/29 | N/A | ENROLLING_BY_INVITATION | |||
2021/11/26 | Phase 3 | Recruiting | |||
2021/06/10 | N/A | AVAILABLE | |||
2019/09/10 | Phase 3 | Active, not recruiting | |||
2019/09/09 | Phase 3 | Active, not recruiting | |||
2017/06/22 | Phase 2 | Completed | |||
2017/06/22 | Phase 2 | Completed | |||
2015/07/07 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novo Nordisk | 0169-2081 | SUBCUTANEOUS | 100 mg in 1 mL | 12/10/2024 | |
| Novo Nordisk | 0169-2080 | SUBCUTANEOUS | 100 mg in 1 mL | 12/10/2024 | |
| Novo Nordisk | 0169-2084 | SUBCUTANEOUS | 40 mg in 1 mL | 12/10/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/13/2024 | ||
Authorised | 12/13/2024 |
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 |
|---|---|---|---|---|---|
| ALHEMO concizumab 150mg / 1.5 mL solution for injection prefilled pen | 394067 | Medicine | A | 7/5/2023 | |
| ALHEMO concizumab 300 mg / 3 mL solution for injection prefilled pen | 394066 | Medicine | A | 7/5/2023 | |
| ALHEMO concizumab 15 mg / 1.5 mL solution for injection prefilled pen | 394068 | Medicine | A | 7/5/2023 | |
| ALHEMO concizumab 60 mg / 1.5 mL solution for injection prefilled pen | 394065 | Medicine | A | 7/5/2023 |