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Enoxapo
Published
Product name
Enoxapo
Active ingredient
Enoxaparin sodium
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Enoxapo (enoxaparin sodium) was approved for the following therapeutic use:
- Prevention of thromboembolic disorders of venous origin in patients undergoing orthopaedic and general surgery.
- Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.
- Prevention of thrombosis in extra-corporeal circulation during haemodialysis.
- Treatment of established deep vein thrombosis.
- Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
- Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).
How this medicine works
Enoxapo is a biosimilar medicine to Clexane. Enoxaparin sodium is a low molecular weight heparin (molecular weight approx. 4,500 Da, ranging between 4,100 Da to 4,600 Da). The drug substance is the sodium salt. In comparison with natural heparin, enoxaparin is characterised by a clear increase in the ratio between anti-Xa and anti-Ila activities which is always greater than 4. It has several actions on the coagulation pathway through binding to anti-thrombin III. The antithrombotic activity is related to inhibition of thrombin generation and inhibition of two main coagulation factors: Factor Xa and Thrombin. Enoxaparin also induces a sustained release of the Tissue Factor Pathway Inhibitor in vivo. In the experimental animal, enoxaparin was found to have potent anti-thrombotic properties with a minimum effect on bleeding.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Enoxapo was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- ENOXAPO enoxaparin sodium 20 mg/0.2 mL solution for injection syringe (210318)
- ENOXAPO enoxaparin sodium 40 mg/0.4 mL solution for injection syringe (210320)
- ENOXAPO enoxaparin sodium 60 mg/0.6 mL solution for injection syringe (210337)
- ENOXAPO enoxaparin sodium 80 mg/0.8 mL solution for injection syringe (210333)
- ENOXAPO enoxaparin sodium 100 mg/1.0 mL solution for injection syringe (210340)
- ENOXAPO enoxaparin sodium 120 mg/0.8 mL solution for injection syringe (210312)
- ENOXAPO enoxaparin sodium 150 mg/1.0 mL solution for injection syringe (210324)