Regulatory Decision Summary for Lovenox and Lovenox HP
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of the submission is to seek the marketing authorization of Lovenox (enoxaparin sodium) for the following indication for the prevention of thrombus formation in the extracorporeal circulation during hemodialysis.
Why was the decision issued?
Results reported from three published studies that assessed the safety and efficacy of enoxaparin sodium in hemodialysis patients support the proposed use of Lovenox (enoxaparin sodium) for the prevention of thrombus formation in the extracorporeal circulation during hemodialysis, in patients not at risk of hemorrhage.
In addition, the product has a long history of use during hemodialysis sessions in many countries worldwide including Europe. No new safety concerns were identified with the product and the known risks are well addressed in the product monograph.
Given the above, it has been determined that, despite the limitations of the data from published studies, the benefit risk profile of Lovenox , at a dose ranging from 0.5-1.0 mg/kg, is considered favourable in patients who are not at high risk of hemorrhage for the prevention of thrombus formation in the extracorporeal circulation during hemodialysis .
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.