Eftrenonacog alfa is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology. Haemophilia B is an X-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma level of factor IX is increased thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| B02BD04 | Coagulation factor IX | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| ALPROLIX Powder and solvent for solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
Eftrenonacog alfa is an active ingredient of these brands:
Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Cyprus (CY)Estonia (EE)Finland (FI)France (FR)Hong Kong (HK)Ireland (IE)Israel (IL)Japan (JP)Lithuania (LT)Netherlands (NL)New Zealand (NZ)Poland (PL)Romania (RO)Spain (ES)Turkey (TR)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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