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Exarane/Exarane Forte
Published
Product name
Exarane/Exarane Forte
Active ingredient
Enoxaparin sodium
Submission type
New Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Exarane/Exarane Forte (enoxaparin sodium) was approved for the following therapeutic use:
- Prevention of thrombo-embolic 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
Exarane/Exarane Forte is a biosimilar of Clexane. In comparison with natural heparin enoxaparin sodium is characterised by a clear increase in the ratio between anti-factor Xa and anti-factor IIa activities which is always greater than 4.
It has several actions on the coagulation pathway through binding to anti-thrombin III. The anti-thrombotic activity is related to inhibition of thrombin generation and inhibition of two main coagulation factors: factor Xa and thrombin. Enoxaparin sodium also induces a sustained release of the tissue factor pathway inhibitor in vivo.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Exarane/Exarane Forte was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- EXARANE enoxaparin sodium 40mg/0.4mL solution for injection prefilled syringe (375490)
- EXARANE enoxaparin sodium 100mg/1mL solution for injection prefilled syringe (375491)
- EXARANE FORTE enoxaparin sodium 120mg/0.8mL solution for injection prefilled syringe (375492)
- EXARANE enoxaparin sodium 80mg/0.8mL solution for injection prefilled syringe (375493)
- EXARANE enoxaparin sodium 20mg/0.2mL solution for injection prefilled syringe (375494)
- EXARANE enoxaparin sodium 60mg/0.6mL solution for injection prefilled syringe (375495)
- EXARANE FORTE enoxaparin sodium 150mg/1mL solution for injection prefilled syringe (375496)