Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: CSL Behring GmbH, D-35041 Marburg, Germany
Hemgenix 1 × 1013 genome copies/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Clear, colourless solution. |
Etranacogene dezaparvovec is a gene therapy medicinal product that expresses the human coagulation Factor IX. It is a non-replicating, recombinant adeno-associated virus serotype 5 (AAV5) based vector containing a codon-optimised cDNA of the human coagulation Factor IX variant R338L (FIX-Padua) gene under the control of a liver-specific promoter (LP1). Etranacogene dezaparvovec is produced in insect cells by recombinant DNA technology.
Each mL of etranacogene dezaparvovec contains 1 × 1013 genome copies (gc).
Each vial contains an extractable volume of 10 mL of concentrate for solution for infusion, containing a total of 1 × 1014 genome copies.
The total number of vials in each pack corresponds to the dosing requirement for the individual patient, depending on the patient’s body weight (see sections 4.2 and 6.5).
Excipient with known effect: This medicinal product contains 35.2 mg sodium per vial (3.52 mg/mL).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etranacogene dezaparvovec |
Etranacogene dezaparvovec is a gene therapy product designed to introduce a copy of the human Factor IX coding DNA sequence into hepatocytes to address the root cause of the Haemophilia B disease. Etranacogene dezaparvovec partially or completely ameliorates the deficiency of circulating Factor IX procoagulant activity in patients with Haemophilia B. |
| List of Excipients |
|---|
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Sucrose |
10 mL solution in a Type I glass vial with stopper (chlorobutyl rubber), aluminium seal with a flip-off cap.
Hemgenix is supplied in a vial containing 10 mL.
The total number of vials in each finished pack corresponds to the dosing requirement of the individual patient, depending on the body weight, and is provided on the package.
CSL Behring GmbH, D-35041 Marburg, Germany
EU/1/22/1715/001
| Drug | Countries | |
|---|---|---|
| HEMGENIX | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States |
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