DIFICLIR (fidaxomicin) - Clostridium difficile infection
Opinions on drugs -
Posted on
Mar 04 2024
Reason for request
Reassessment
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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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