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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

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Clinical Added Value

no clinical added value

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