Kogenate FS Regulatory Post-Marketing Surveillance

KOGENATE® FS , Local Post Authorization Safety Study

To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.

Inclusion Criteria:

• Patients with diagnosis of hemophilia A
• Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
• Signed the informed consent form to participate in this study.
• For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available
• For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available
• For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
• Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

• Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.