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

See also