Product type Licensed products1 Indication (abbreviated)
Recombinant FVIII concentrate (rFVIII) Advate Adynovi Afstyla Elocta Esperoct Jivi Kogenate Bayer Kovaltry Helixate NexGen NovoEight Nuwiq Recombinate ReFacto AF Vihuma Voncento
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
Plasma-derived FVIII concentrate (pdFVIII) Beriate Haemoctin Hemofil Immunate Monoclate Octanate Wilate
Recombinant FIX concentrate (rFIX) Alprolix BeneFIX Idelvion NovoSeven Reflixia Rixubis
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency)
Plasma-derived FIX concentrate (pdFIX) AlphaNine SD Mononine
1 For plasma-derived products the list is a partial list only, especially regarding nationally licensed products in EU. From Jivi Report on the Maintenance of the Orphan Designation (https://www.ema.europa.eu/en/documents/orphan-maintenance-report/jivi-orphan-designation-withdrawal-assessment-report-initial-authorisation_en.pdf). 1 For plasma-derived products the list is a partial list only, especially regarding nationally licensed products in EU. From Jivi Report on the Maintenance of the Orphan Designation (https://www.ema.europa.eu/en/documents/orphan-maintenance-report/jivi-orphan-designation-withdrawal-assessment-report-initial-authorisation_en.pdf). 1 For plasma-derived products the list is a partial list only, especially regarding nationally licensed products in EU. From Jivi Report on the Maintenance of the Orphan Designation (https://www.ema.europa.eu/en/documents/orphan-maintenance-report/jivi-orphan-designation-withdrawal-assessment-report-initial-authorisation_en.pdf).