MedPath

Bemiparin

Generic Name
Bemiparin
Drug Type
Small Molecule
CAS Number
91449-79-5
Unique Ingredient Identifier
PUE0TO3XDR

Overview

Bemiparin is an antithrombotic and belongs to the group of drugs known as the low molecular weight heparins (LMWH). Like semuloparin, bemiparin is classified as an ultra-LMH because of its low mean molecular mass of 3600 daltons, which is a unique property of this class . These heparins have lower anti-thrombin activity than the traditional low molecular weight heparins and act mainly on factor-Xa, reducing the risk of bleeding due to selectivity for this specific clotting factor. Interestingly, current research is underway for the potential benefit of bemiparin in the treatment of tumors and diabetic foot ulcers .

Indication

Bemiparin is indicated in the following cases: To prevent blood clots in the veins after general abdominal surgery in patients with a moderate risk of venous thromboembolism; in the prevention of the thromboembolic disease in non-surgical patients; prevention of clotting in the extracorporeal circuit during hemodialysis; to prevent blood clots in the veins after a major orthopedic surgery in patients with high risk of venous thromboembolism; secondary prevention of venous thromboembolism; recurrence in patients with deep vein thrombosis; transient prevention and treatment of deep vein thrombosis (DVT) .

Associated Conditions

  • Extracorporeal Clotting During Hemodialysis
  • Thromboembolism

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/10/06
Not Applicable
Recruiting
2020/10/27
Phase 3
UNKNOWN
Clinica Universidad de Navarra, Universidad de Navarra
2020/06/09
Phase 2
Terminated
Fundación de investigación HM
2018/07/26
Early Phase 1
Completed
2016/06/16
Phase 3
UNKNOWN
Instituto de Investigación Marqués de Valdecilla
2016/06/09
Not Applicable
Completed
Mohamed Sayed Mohamed Abbas
2015/11/18
Phase 4
Completed
2013/06/18
Phase 3
Completed
Berlin-Chemie AG Menarini Group
2012/06/28
Not Applicable
Completed
2012/04/30
Not Applicable
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
HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 2,500 IU ANTI-XA/0.2 ML
SIN16463P
INJECTION, SOLUTION
2,500 IU Anti-Xa/0.2 ml
4/1/2022
HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 3,500 IU ANTI-XA/0.2 ML
SIN16462P
INJECTION, SOLUTION
3,500 IU Anti-Xa/0.2 ml
4/1/2022

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Bemiparin Sodium Injection
国药准字HJ20140019
化学药品
注射剂
11/26/2024
Bemiparin Sodium Injection
国药准字HJ20140018
化学药品
注射剂
11/26/2024
Bemiparin Sodium Injection
H20140019
化学药品
注射剂
3/5/2020
Bemiparin Sodium Injection
H20140018
化学药品
注射剂
3/5/2020

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.

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