Overview
Certoparin is part of the heparins of low molecular weight that presents high activity against the coagulation factor Xa. It is normally used to prevent deep venous thrombosis.
Indication
Used in the prevention and treatment of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and in the treatment of myocardial infarction.
Associated Conditions
- Deep Vein Thrombosis
- Thrombotic events caused by General Surgery
- Thrombotic events caused by Mobility decreased
- Thrombotic events caused by Stroke, Ischemic
Research Report
Certoparin Sodium: A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile
1.0 Executive Summary
Certoparin sodium is a low-molecular-weight heparin (LMWH), a class of antithrombotic agents derived from unfractionated heparin (UFH). It functions as a potent, indirect inhibitor of coagulation Factor Xa. Produced via a specific chemical depolymerization process, Certoparin possesses a unique pharmacological profile that distinguishes it from UFH and other LMWHs, rendering these agents clinically non-interchangeable. Its primary mechanism of action involves binding to and potentiating the activity of antithrombin III, which leads to the selective neutralization of Factor Xa and a subsequent reduction in thrombin generation and fibrin clot formation.
Clinically, Certoparin has a well-established evidence base for the prophylaxis of venous thromboembolism (VTE) in a wide range of high-risk medical and surgical patients. It has demonstrated non-inferiority to UFH with a superior safety profile in acutely ill elderly patients. A peculiar and advantageous feature of Certoparin is its use at a fixed, weight-independent dose for the treatment of deep vein thrombosis (DVT), which simplifies clinical protocols and may reduce dosing errors. Emerging evidence also supports its safe and effective use for VTE prevention in high-risk pregnancies.
Clinical Trials
| Title | Posted | Study ID | Phase | Status | Sponsor | 
|---|---|---|---|---|---|
| 2012/08/08 | Phase 1 | Completed | |||
| 2010/08/11 | Phase 3 | Completed | |||
| 2007/03/23 | Phase 3 | Completed | |||
| 2006/04/06 | Phase 3 | Completed | |||
| 2005/09/20 | Phase 4 | UNKNOWN | University Medicine Greifswald | ||
| 2005/09/15 | Phase 3 | 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 | 
|---|---|---|---|---|---|
| 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. | |||||
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 | 
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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