A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)

The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.

Inclusion Criteria

• Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
• Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
• Negative factor VIII (FVIII) inhibitor test at study entry.
• Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.

Exclusion Criteria

• Previous participation in this study. Participation is defined as signed informed consent.
• Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
• Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.