Reason for request

Change in the conditions of inclusion. Inclusion on the list of medicines approved for use by hospitals in the extension of indication “Restoration of patency of intravascular catheters (central venous catheters and dialysis catheters), blocked by a forming or recently formed thrombus”.

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Clinical Benefit

Substantial

The actual benefit of ACTOSOLV UROKINASE is substantial.


Clinical Added Value

moderate

In the indication “restoration of patency of intravascular catheters (central venous catheters and dialysis catheters), blocked by forming or recently formed fibrin clots” the proprietary products ACTOSOLV UROKINASE 100,000 and 600,000 IU provides a moderate improvement in actual benefit (IAB III) during their therapeutic use.


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Évaluation des médicaments