Overview
No overview information available.
Background
No background information available.
Indication
用于血浆凝血因子Ⅷ（FⅧ）缺乏的甲型血友病（罕见病）治疗。在纠正或预防出血、急诊或择期手术中，本品起到暂时代替缺失的凝血因子的作用。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/07 | Phase 4 | Recruiting | Runhui WU | ||
2022/10/17 | Phase 3 | Recruiting | |||
2022/02/22 | Phase 1 | Completed | Jiangsu Gensciences lnc. | ||
2021/04/29 | Phase 1 | Completed | Jiangsu Gensciences lnc. | ||
2018/11/20 | N/A | UNKNOWN | Kaifeng Pharmaceutical (Group) Co., Ltd. | ||
2016/10/21 | N/A | Active, not recruiting | |||
2015/06/26 | Phase 1 | Completed | |||
2014/12/11 | Phase 4 | UNKNOWN | St. James's Hospital, Ireland | ||
2014/12/03 | Phase 3 | Completed | |||
2014/11/04 | Not Applicable | UNKNOWN | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
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. | |||||