VONCENTO (human coagulation factor VIII + von Willebrand factor)
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Oct 12 2016
Reason for request
Extension of Inclusion
No clinical benefit demonstrated in prophylaxis of bleeding episodes of von Willebrand disease.
- VONCENTO has Marketing Authorisation in prophylaxis of bleeding episodes regardless of the patient's age, in the treatment of bleeding episodes or in prophylaxis and treatment of surgical bleeding in patients aged < 12 years with von Willebrand disease.
- Clinical data on its efficacy and safety represent a low level of evidence.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
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