GlaxoSmithKline (GSK) confirmed that the European Commission (EC) has granted an amendment of their marketing authorisation for their anti-clotting agent (antithrombotic) Arixtra® (fondaparinux) in the European Union for a new therapeutic indication. Fondaparinux 1.5 and 2.5 mg is now indicated for thetreatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. It is the only anti-clotting agent to have this indication.
Fondaparinux 1.5 and 2.5 mg is currently approved for use in the EU for the prevention of venous thromboembolic events (VTE), 2.5 mg is additionally approved for the treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and for the treatment of ST segment elevation myocardial infarction (STEMI) and 5mg, 7.5mg and 10mg are approved for initial treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE).
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