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Opinions on drugs - Posted on Oct 13 2014

Reason for request



Actual benefit


the actual benefit of DEFITELIO is moderate in the Marketing Authorisation indication.

Improvement in actual benefit

IV (mineur)

In light of the available data which have a low level of evidence even though there are study designs only requiring a few patients, and due to the severity of the disease and the absence of an alternative, the Committee considers that DEFITELIO provides a minor improvement in actual benefit (IAB IV) in the therapeutic strategy for treatment of severe hepatic VOD post-HCST.

Ce produit fait l'objet d'un avis d'efficience rendu par la Commission évaluation économique et santé publique le 18 février 2014

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