With this NIS long-term data for the effectiveness in bleeding
prevention and on QoL will be generated.
Primary objectives:
· Annual bleeding rate defined as episodes per year in patients with Vihuma treatment, differentiated by prophylaxis and on demand treatment
· Dose and frequency of Vihuma applications in comparision to previously used factor VIII products
Secondary objectives:
· AE and subsequent suspected ADR (AE assessed as causally related with Vihuma treatment)
· AE with bleeding = AE of special interest (AESI) with extended bleeding documentation, for e.g. if the duration and severity of the bleeding is within the situation as expected or unexpected
· Occurrence and characterization of FVIII inhibitors to Vihuma
· QoL determined with the Euroqol EQ-5D in adults and the EQ-5D-Y in adolescents.