Reason for request

Reassessment

-


Clinical Benefit

Substantial

the Committee deems that the clinical benefit of DIFICLIR (fidaxomicin) 200 mg film-coated tablets remains substantial in the MA indication.


Clinical Added Value

moderate

The introduction of an alternative dosing regimen (extended-pulsed dosing) does not modify the previous conclusions of the Transparency Committee (CT). The Committee considers that DIFICLIR (fidaxomicin) 200 mg film-coated tablets maintains a moderate clinical added value (CAV III) in the treatment of C. difficile infections.


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