Reason for request
Inclusion on the list of medicines approved for hospital use.
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Clinical Benefit
Insufficient |
For infections where C. difficile has not been identified, the actual benefit is insufficient. |
Substantial |
The actual benefit of DIFICLIR is substantial in the context of documented C. difficile infections (presence of the toxin being demonstrated in stools) |
Clinical Added Value
moderate |
In view of the data available, the Committee considers that DIFICLIR enables a moderate improvement in actual benefit (ASMR III) in the management of documented C. difficile infections. |
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Évaluation des médicaments