TABLE 2.
Licensed products for the treatment of haemophilia A and B
| Product type | Licensed products a | MA holder/company name | Indication (abbreviated) |
|---|---|---|---|
|
Recombinant FVIII concentrate (rFVIII) |
Advate | Takeda Manufacturing Austria AG | Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) |
| Adynovi | Baxalta Innovations GmbH | ||
| Afstyla | CSL Behring GmbH | ||
| Elocta | Swedish Orphan Biovitrum AB (publ) | ||
| Esperoct | Novo Nordisk A/S | ||
| Jivi | Bayer AG | ||
| Kogenate Bayer | Bayer AG | ||
| Kovaltry | Bayer Pharma AG | ||
| Helixate NexGen | Bayer AG | ||
| NovoEight | Novo Nordisk A/S | ||
| Nuwiq | Octapharma AB | ||
| Obizur | Baxalta Innovations GmbH | ||
| Recombinate | Baxter Healthcare | ||
| ReFacto AF | Pfizer Europe MA EEIG | ||
| Vihuma | Octapharma AB | ||
|
Plasma‐derived FVIII concentrate (pdFVIII) |
Beriate | CSL Behring GmbH | |
| Haemoctin | Biotest (UK) Ltd | ||
| Hemofil | Baxter U.S. | ||
| Immunate | Baxter | ||
| Monoclate | CSL Behring GmbH | ||
| Octanate | Octapharma AB | ||
| Wilate | Octapharma AB | ||
|
Recombinant FIX concentrate (rFIX) |
Alprolix | Swedish Orphan Biovitrum AB (publ) | Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) |
| BeneFIX | Pfizer Europe MA EEIG | ||
| Idelvion | CSL Behring GmbH | ||
| Reflixia | Novo Nordisk A/S | ||
| Rixubis | Baxalta Innovations GmbH | ||
|
Plasma‐derived FIX concentrate (pdFIX) |
AlphaNine SD | Grifols | |
| Mononine | CSL Behring GmbH |
a
For plasma‐derived products, the list is only partial, especially regarding nationally licensed products in the EU. Adapted from “Jivi Report on the Maintenance of the Orphan Designation”. Available at: https://www.ema.europa.eu/en/documents/orphan-maintenance-report/jivi-orphan-designation-withdrawal-assessment-report-initial-authorisation_en.pdf.