#SFHS2611893AFrance Adds Apixaban Zydus Tablets to Approved Medicines List for Public Healthcare Use
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This order adds four Apixaban Zydus tablet presentations to the list of medicines approved for use by public healthcare institutions and public services in France. It covers 2.5 mg and 5 mg film-coated tablets supplied by Zydus France. Health insurance coverage applies only for listed therapeutic uses, including prevention of venous thromboembolism after planned hip or knee replacement surgery, prevention of stroke and systemic embolism in certain adults with non-valvular atrial fibrillation, and treatment or prevention of recurrent deep vein thrombosis and pulmonary embolism in adults. Hospitals, public healthcare purchasers, prescribers, and pharmacies should apply the coverage limits tied to these indications.
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Key Changes
- Adds four Apixaban Zydus tablet presentations to the approved medicines list for public healthcare use
- Sets health insurance coverage only for specified anticoagulant treatment and prevention indications
- Identifies the covered product codes, strengths, pack sizes, and supplier
Obligations
What this law requires
Hospitals, public healthcare institutions, and public services may use and procure the listed APIXABAN ZYDUS presentations only as specialties registered on the approved list for collective and public-service use: CIP 34009 302 556 9 8, 34009 302 557 0 4, 34009 302 557 1 1, and 34009 302 557 6 6.
Health insurance coverage for APIXABAN ZYDUS 2.5 mg must be limited to primary prevention of venous thromboembolic events in adult patients who have undergone planned total hip or knee replacement surgery.
Health insurance coverage for the listed APIXABAN ZYDUS specialties must be limited to prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation who have at least one specified risk factor, including prior stroke or transient ischemic attack, age 75 or over, hypertension, diabetes, or symptomatic heart failure NYHA class II or above.
Health insurance coverage for the listed APIXABAN ZYDUS specialties must be limited to treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism, in adults.