The Priority Review

Approvals Brief

CHMP adopts positive opinion on Fondaparinux sodium Evumed

On 12 November 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a marketing authorization for Fondaparinux sodium Evumed, a generic of Arixtra. The product is intended for prevention of venous thromboembolic events in adults undergoing major orthopaedic or abdominal surgery, immobilised patients, and for treatment of unstable angina, myocardial infarction, superficial-vein thrombosis, deep-vein thrombosis and pulmonary embolism.

Primary source

EMA medicine page (CHMP opinion), November 13, 2026

Fondaparinux sodium Evumed (fondaparinux sodium): EMA CHMP opinion

Read the source: Fondaparinux sodium Evumed (fondaparinux sodium): EMA CHMP opinion ema.europa.eu

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