Overview
Recombinant human thrombopoietin is a full-length glycosylated cytokine produced by Chinese hamster ovary cells and is used to promote the generation of megakaryocytes and platelets. This drug is used in the treatment of thrombocytopenia.
Background
Recombinant human thrombopoietin is a full-length glycosylated cytokine produced by Chinese hamster ovary cells and is used to promote the generation of megakaryocytes and platelets. This drug is used in the treatment of thrombocytopenia.
Indication
用于治疗实体肿瘤化疗后所致的血小板减少症，使用对象为血小板低于50×109/L且医生认为有必要升高血小板数目。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/29 | Phase 4 | Not yet recruiting | |||
2024/06/04 | Phase 3 | Not yet recruiting | Shandong University | ||
2023/08/22 | Phase 4 | Not yet recruiting | |||
2023/07/13 | Phase 2 | Completed | JIANYANG WANG | ||
2022/10/18 | Phase 4 | Completed | |||
2022/06/09 | Phase 4 | Recruiting | The First Affiliated Hospital of Dalian Medical University | ||
2022/05/19 | Phase 3 | Recruiting | |||
2022/04/14 | Phase 3 | UNKNOWN | Yin Jie | ||
2022/02/28 | Not Applicable | Recruiting | |||
2022/02/01 | Phase 4 | UNKNOWN |
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 |
|---|---|---|---|---|---|
| Recombinant Human Thrombopoietin Injection | 国药准字S20050048 | 生物制品 | 注射剂 | 7/13/2020 | |
| Recombinant Human Thrombopoietin Injection | 国药准字S20050049 | 生物制品 | 注射剂 | 7/13/2020 |
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. | |||||