Fidanacogene elaparvovec is a gene therapy designed to introduce a functional copy of the high activity Padua variant of the factor IX gene (FIX-R338L) in the transduced cells to address the monogenic root cause of haemophilia B.
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 |
|---|---|---|
| B02BD17 | 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 | |
|---|---|---|---|
| BEQVEZ Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC | |
| BEQVEZ Solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
Fidanacogene elaparvovec is an active ingredient of these brands:
United States (US)Austria (AT)Canada (CA)Lithuania (LT)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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