Regulatory Decision Summary for Fraxiparine / Fraxiparine Forte
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 this SNDS is to seek approval to expand the indication of Fraxiparine (nadroparin) to prevent venous thromboembolism (VTE) in nonsurgical patients such as: "those in high risk medical patients (respiratory failure and/or respiratory infection and/or cardiac failure), immobilised due to acute illness or hospitalised in an intensive care unit".
Why was the decision issued?
Ageno et al. (2016) conducted a meta-analysis of high standard meeting the standards required by Health Canada. In this meta-analysis including more than 7,500 patients, nadroparin appeared to be similar in efficacy with respect to the prevention of clinically meaningful venous thromboembolic events and tolerability (major bleeding) in comparison with other active treatments. Nadroparin was associated with a trend toward reduced symptomatic VTE and a significant reduction in major VTE in comparison with placebo. These results support the favourable benefit-risk profile associated with nadroparin for the prophylaxis of VTE in medical patients.
Decision issued
Approved; issued a Notice of Compliance