Overview
No overview information available.
Indication
Beroctocog alfa is indicated for the prevention and control of bleeding in patients with hemophilia A or acquired Factor VIII (FVIII) deficiency. It is also indicated for surgical/invasive procedures in adult and pediatric patients with von Willebrand Disease in who desmopression is either ineffective or contraindicated. It is not indicated for patients with severe (i.e. type 3) von Willebrand Disease whom are undergoing major surgery.
Associated Conditions
- Bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/11/29 | N/A | Completed | |||
2012/03/23 | Phase 4 | Completed | |||
2006/05/10 | Phase 4 | Completed |
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 |
|---|---|---|---|---|---|
| ALPHANATE FOR INJECTION 500 iu/vial | SIN09032P | INJECTION, POWDER, FOR SOLUTION | 500 iu/vial | 11/28/1996 | |
| ALPHANATE FOR INJECTION 1000 iu/vial | SIN09030P | INJECTION, POWDER, FOR SOLUTION | 1000 iu/vial | 11/28/1996 | |
| Optivate | SIN13191P | INJECTION, POWDER, FOR SOLUTION | 100 iu/ml | 3/16/2006 | |
| ALPHANATE FOR INJECTION 250 iu/vial | SIN09031P | INJECTION, POWDER, FOR SOLUTION | 250 iu/vial | 11/28/1996 |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BERIATE 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PERFUSION | 63023 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| FANHDI 100 UI FVIII/120 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60602 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| HAEMATE P 2400/1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION. | Csl Behring S.A. | 56868 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| BERIATE 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE Y PARA PERFUSION | 63009 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| FANHDI 25 UI FVIII/30 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60601 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| FANHDI 50 UI FVIII/60 UI FVW POR ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 60600 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| HAEMATE P 1200 UI/500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE O PERFUSION. | Csl Behring S.A. | 56867 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | 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. | |||||
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