Overview
Nadroparin is a low molecular weight heparin (LMWH) which, when bound to antithrombin III (ATIII), accelerates the inactivation of factor II and factor Xa. Nadroparin halts the coagulation pathway by inhibiting the activation of thrombin (factor IIa) by factor Xa. The amplification of the fibrin clotting cascade is stopped once factors Xa and IIa are inactivated. It is derived from porcine sources and has a mean molecular size of 5000 daltons. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.
Background
Nadroparin is a low molecular weight heparin (LMWH) which, when bound to antithrombin III (ATIII), accelerates the inactivation of factor II and factor Xa. Nadroparin halts the coagulation pathway by inhibiting the activation of thrombin (factor IIa) by factor Xa. The amplification of the fibrin clotting cascade is stopped once factors Xa and IIa are inactivated. It is derived from porcine sources and has a mean molecular size of 5000 daltons. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.
Indication
Nadroparin is used for prophylaxis of thromboembolic disorders and general surgery in orthopedic surgery, treatment of deep vein thrombosis, prevention of clotting during hemodialysis and treatment of unstable angina and non-Q wave myocardial infarction.
Associated Conditions
- Clotting
- Deep Vein Thrombosis
- Pulmonary Embolism
- Unstable Angina Pectoris
- Venous Thromboembolism
- Non-q wave myocardial infarction
- Thromboembolic phenomena
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/19 | Not Applicable | Not yet recruiting | Shanghai Zhongshan Hospital | ||
2022/11/18 | N/A | Completed | |||
2021/07/29 | Phase 4 | Completed | Clinique Saint Pierre Ottignies | ||
2021/07/26 | Phase 4 | Completed | |||
2020/08/11 | Phase 2 | Recruiting | |||
2019/11/22 | Phase 4 | Completed | |||
2019/08/26 | Phase 3 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2019/08/26 | Phase 3 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2016/12/09 | Not Applicable | Completed | Leiden University Medical Center | ||
2016/11/08 | 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 |
|---|---|---|---|---|---|
| FRAXIPARINE INJECTION 7600 IU AXA/0.8 mL | SIN15473P | INJECTION | 7600 IU AXA/0.8 mL | 4/27/2018 | |
| FRAXIPARINE INJECTION 9500 IU AXA/1.0 mL | SIN15474P | INJECTION | 9500 IU AXA/1.0 mL | 4/27/2018 | |
| FRAXIPARINE MULTIDOSE INJECTION 9500 iu AXA/ml | SIN11872P | INJECTION | 9500 iu AXA/ml | 4/5/2002 | |
| FRAXIPARINE FORTE INJECTION 19,000 iu Axa/ml | SIN11292P | INJECTION | 19000 iu Axa/ml | 3/21/2000 | |
| FRAXIPARINE INJECTION 2850 IU AXA/0.3 mL | SIN02147P | INJECTION | 2850 IU AXA/0.3 mL | 6/25/1988 | |
| FRAXIPARINE INJECTION 3800 IU AXA/0.4 mL | SIN14223P | INJECTION | 3800 IU AXA/0.4 mL | 9/12/2012 | |
| FRAXIPARINE INJECTION 5700 IU AXA/0.6 mL | SIN14222P | INJECTION | 5700 IU AXA/0.6 mL | 9/12/2012 | |
| FRAXIPARINE INJECTION 1900 IU AXA/0.2 mL | SIN15472P | INJECTION | 1900 IU AXA/0.2 mL | 4/27/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20163060 | 化学药品 | 注射剂 | 12/25/2020 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20020469 | 化学药品 | 注射剂 | 3/30/2021 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20030925 | 化学药品 | 注射剂 | 11/6/2019 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20030926 | 化学药品 | 注射剂 | 11/6/2019 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20063909 | 化学药品 | 注射剂 | 7/7/2020 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H19990078 | 化学药品 | 注射剂 | 11/6/2019 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H19990079 | 化学药品 | 注射剂 | 11/6/2019 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20000706 | 化学药品 | 注射剂 | 3/30/2021 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20060190 | 化学药品 | 注射剂 | 1/8/2020 | |
| Low Molecular Weight Heparin Calcium Injection | 国药准字H20060191 | 化学药品 | 注射剂 | 1/8/2020 |
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 |
|---|---|---|---|---|---|
| FRAXIPARINE FORTE Nadroparin calcium 11,400 Anti- Xa IU/0.6mL injection syringe | 67149 | Medicine | A | 12/14/1998 | |
| FRAXIPARINE nadroparin calcium 9500IU anti-Xa/1.0mL | 51313 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE FORTE Nadroparin calcium 15,200 Anti- Xa IU/0.8mL injection syringe | 67148 | Medicine | A | 12/14/1998 | |
| FRAXIPARINE nadroparin calcium 5700IU anti-Xa/0.6mL | 51311 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE nadroparin calcium 1900IU anti-Xa/0.2mL | 51308 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE nadroparin calcium 7600IU anti-Xa/0.8mL | 51312 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE nadroparin calcium 3800IU anti-Xa/0.4mL | 51310 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE nadroparin calcium 2850IU anti-Xa/0.3mL | 51309 | Medicine | A | 9/11/1995 | |
| FRAXIPARINE FORTE Nadroparin calcium 19,000 Anti- Xa IU/1.0mL injection syringe | 67145 | Medicine | A | 12/14/1998 |