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Opinions on drugs - Posted on Jun 22 2011

Reason for request

Reassessment of the actual benefit and the improvement in actual benefit, in pursuance of Article R-163-21 of the Social Security Code.


Clinical Benefit


Given the reduced efficacy of dronedarone by comparison with amiodarone in terms of the recurrence of AF, the worrisome serious adverse effects reported since dronedarone went on the market (in particular hepatic impairment, interstitial lung disease and cardiac decompensation) and the drug interactions with other medicines used in the prevention of CV (in particular AVK), the Transparency Committee considers that the actual benefit provided by MULTAQ is insufficient to justify the continued reimbursement of its cost by National Insurance.

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