This brand name is authorized in Canada, United States
The drug BEQVEZ contains one active pharmaceutical ingredient (API):
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Fidanacogene elaparvovec
UNII 413EU9081Y - FIDANACOGENE ELAPARVOVEC
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Fidanacogene elaparvovec is a gene therapy designed to introduce in the transduced cells a functional copy of the factor IX gene encoding a high-activity FIX variant (FIX-R338L, hFIX Padua). The AAVRh74var capsid is able to transduce hepatocytes, the natural site of factor IX synthesis. Single intravenous infusion of fidanacogene elaparvovec results in cell transduction and increase in circulating factor IX activity in patients with hemophilia B. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| BEQVEZ Solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02544156 |
| Country: US | FDA, National Drug Code | Identifier(s): 0069-0422, 0069-2005, 0069-2006, 0069-2007 |
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