Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
BEQVEZ 0.79 – 1.21 × 1013 vector genomes/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless to slightly brown solution with a pH of 6.8 – 7.8 and an osmolarity of approximately 348 mOsm/L. |
Fidanacogene elaparvovec is a gene therapy medicinal product that consists of a recombinant viral capsid derived from a naturally occurring adeno-associated viral serotype Rh74 (AAVRh74var) packaging genome containing the human coagulation factor IX (FIX) transgene modified to be a high factor IX activity (Padua) variant known as FIX-R338L.
Fidanacogene elaparvovec is produced in human embryonic kidney cells by recombinant DNA technology.
Each mL of fidanacogene elaparvovec contains 0.79 – 1.21 × 1013 vector genomes (vg).
Each vial contains an extractable volume of 1 mL.
The quantitative information regarding actual concentration, and patient dose calculation is provided in the Lot Information Sheet (LIS) accompanying the medicinal product for treatment.
The total number of vials in each pack corresponds to the dosing requirement for the individual patient, depending on the patient’s body weight and actual concentration (see sections 4.2 and 6.5).
Excipient with known effect:
This medicinal product contains 4.55 mg sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fidanacogene elaparvovec |
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. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate monohydrate (E339) |
BEQVEZ is supplied in a 2 mL cyclic olefin copolymer vial with an elastomeric stopper and plastic snapfit cap. Each vial contains sufficient volume to ensure 1 mL of extractable volume.
The total number of vials in each finished pack corresponds to the dosing requirement of the individual patient, depending on the body weight and actual concentration, and is provided on the package and LIS. The finished pack will consist of vials, which are included in the inner carton, and placed in the outer carton (patient-specific pack).
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/24/1838/001
Date of first authorisation: 24 July 2024
| Drug | Countries | |
|---|---|---|
| BEQVEZ | Canada, United States |
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