1. Male subjects with severe hemophilia A (FVIII:C
2. Age from 1 to 18 years
3. Previously untreated patients (PUPs) or previously treated patients (PTPs) with factor
VIII
4. No previous history of FVIII inhibitors
5. Legally authorized representatives of pediatric patients agree to provide written
informed consent form
6. Patients who are scheduled by their hematologist to initiate prophylaxis with ReFacto
AF or to continue previously initiated prophylaxis with ReFacto AF, including patients
who are switching from prophylaxis with another FVIII product to ReFacto AF.
1. Subject has known hypersensitivity to the active substance or any of the excipients.
2. Subject has known allergic reaction to hamster proteins
3. Presence of any bleeding disorder in addition to hemophilia A.
4. Treatment with any investigational agent or device within the past 30 days.
5. Any other contraindications according to Summary of Product Characteristics
6. Unsuitable to participate in study for any other reason as assessed by investigator