Nadroparin

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.

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
Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT	2024/03/19	NCT06319131	Not Applicable	Not yet recruiting	Shanghai Zhongshan Hospital
Nadroparin Pharmacokinetics in Different Stages of COVID-19	2022/11/18	NCT05621915	N/A	Completed	Medical University of Lublin
Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients	2021/07/29	NCT04982055	Phase 4	Completed	Clinique Saint Pierre Ottignies
Safety of Anticoagulant Therapy After Endoscopic Treatment	2021/07/26	NCT04976543	Phase 4	Completed	Qilu Hospital of Shandong University
Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine	2020/08/11	NCT04507178	Phase 2	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis	2019/11/22	NCT04173429	Phase 4	Completed	Qilu Hospital of Shandong University
Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study	2019/08/26	NCT04067505	Phase 3	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters	2019/08/26	NCT04066764	Phase 3	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Leiden Trial in Prevention of Post-Operative ThromboEmbolic Events	2016/12/09	NCT02987946	Not Applicable	Completed	Leiden University Medical Center
LMWH Infusion as Anticoagulation for Home HD	2016/11/08	NCT02957877	Phase 4	UNKNOWN	Alice Ho Miu Ling Nethersole Hospital

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	ASPEN NOTRE DAME DE BONDEVILLE	SIN15473P	INJECTION	7600 IU AXA/0.8 mL	4/27/2018
FRAXIPARINE INJECTION 9500 IU AXA/1.0 mL	ASPEN NOTRE DAME DE BONDEVILLE	SIN15474P	INJECTION	9500 IU AXA/1.0 mL	4/27/2018
FRAXIPARINE MULTIDOSE INJECTION 9500 iu AXA/ml	ASPEN NOTRE DAME DE BONDEVILLE	SIN11872P	INJECTION	9500 iu AXA/ml	4/5/2002
FRAXIPARINE FORTE INJECTION 19,000 iu Axa/ml	ASPEN NOTRE DAME DE BONDEVILLE	SIN11292P	INJECTION	19000 iu Axa/ml	3/21/2000
FRAXIPARINE INJECTION 2850 IU AXA/0.3 mL	ASPEN NOTRE DAME DE BONDEVILLE	SIN02147P	INJECTION	2850 IU AXA/0.3 mL	6/25/1988
FRAXIPARINE INJECTION 3800 IU AXA/0.4 mL	ASPEN NOTRE DAME DE BONDEVILLE	SIN14223P	INJECTION	3800 IU AXA/0.4 mL	9/12/2012
FRAXIPARINE INJECTION 5700 IU AXA/0.6 mL	ASPEN NOTRE DAME DE BONDEVILLE	SIN14222P	INJECTION	5700 IU AXA/0.6 mL	9/12/2012
FRAXIPARINE INJECTION 1900 IU AXA/0.2 mL	ASPEN NOTRE DAME DE BONDEVILLE	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
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
FRAXIPARINE FORTE Nadroparin calcium 11,400 Anti- Xa IU/0.6mL injection syringe	67149	Aspen Pharmacare Australia Pty Ltd	Medicine	A	12/14/1998
FRAXIPARINE nadroparin calcium 9500IU anti-Xa/1.0mL	51313	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE FORTE Nadroparin calcium 15,200 Anti- Xa IU/0.8mL injection syringe	67148	Aspen Pharmacare Australia Pty Ltd	Medicine	A	12/14/1998
FRAXIPARINE nadroparin calcium 5700IU anti-Xa/0.6mL	51311	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE nadroparin calcium 1900IU anti-Xa/0.2mL	51308	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE nadroparin calcium 7600IU anti-Xa/0.8mL	51312	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE nadroparin calcium 3800IU anti-Xa/0.4mL	51310	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE nadroparin calcium 2850IU anti-Xa/0.3mL	51309	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/11/1995
FRAXIPARINE FORTE Nadroparin calcium 19,000 Anti- Xa IU/1.0mL injection syringe	67145	Aspen Pharmacare Australia Pty Ltd	Medicine	A	12/14/1998

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FRAXIPARINE	Aspen Pharmacare Canada Inc.	02450615	Solution - Subcutaneous , Intravenous	9500 UNIT / ML	2/5/1998
FRAXIPARINE FORTE	Aspen Pharmacare Canada Inc.	02450666	Solution - Intravenous , Subcutaneous	19000 UNIT / ML	6/22/1999
FRAXIPARINE FORTE	Aspen Pharmacare Canada Inc.	02240114	Solution - Subcutaneous , Intravenous	19000 UNIT / ML	6/22/1999
FRAXIPARINE	Aspen Pharmacare Canada Inc.	02450623	Solution - Subcutaneous , Intravenous	9500 UNIT / ML	2/5/1998
FRAXIPARINE	Aspen Pharmacare Canada Inc.	02236913	Solution - Intravenous , Subcutaneous	9500 UNIT / ML	2/5/1998
FRAXIPARINE	Aspen Pharmacare Canada Inc.	02450658	Solution - Intravenous , Subcutaneous	9500 UNIT / ML	2/5/1998
FRAXIPARINE	Aspen Pharmacare Canada Inc.	02450631	Solution - Intravenous , Subcutaneous	9500 UNIT / ML	2/5/1998
FRAXIPARINE FORTE	Aspen Pharmacare Canada Inc.	02450674	Solution - Subcutaneous , Intravenous	19000 UNIT / ML	6/22/1999

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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