Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: BioMarin International Ltd., Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
ROCTAVIAN 2 × 1013 vector genomes/mL solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. A clear, colourless to pale yellow solution with a pH of 6.9-7.8 and an osmolarity of 364-445 mOsm/L. |
Valoctocogene roxaparvovec is a gene therapy medicinal product that expresses the B-domain deleted SQ form of human coagulation factor VIII (hFVIII-SQ). It is a non-replicating recombinant adeno-associated virus serotype AAV5 based vector containing the cDNA of the B-domain deleted SQ form of human coagulation factor VIII gene under the control of a liver-specific promoter.
Valoctocogene roxaparvovec is produced in a baculovirus expression system that derived from cells of Spodoptera frugiperda (Sf9 cell line) by recombinant DNA technology.
Each mL of valoctocogene roxaparvovec solution for infusion contains 2 × 1013 vector genomes.
Each vial contains 16 × 1013 vector genomes of valoctocogene roxaparvovec in 8 mL solution.
Excipient with known effect: This medicinal product contains 29 mg sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Valoctocogene roxaparvovec |
Valoctocogene roxaparvovec is an adeno-associated virus serotype 5 (AAV5) based gene therapy vector causing the expression of the B-domain deleted SQ form of a recombinant human factor VIII (hFVIII-SQ) under the control of a liver-specific promoter. The expressed hFVIII-SQ replaces the missing coagulation factor VIII needed for effective haemostasis. |
| List of Excipients |
|---|
|
Disodium phosphate dodecahydrate (E339) |
10 mL vial (cyclic olefin polymer plastic resin) with a stopper (chlorobutyl rubber with fluoropolymer coating), crimp seal (aluminium) and flip-off cap (polypropylene) containing 8 mL of solution for infusion.
Each carton contains 1 vial.
BioMarin International Ltd., Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
Date of first authorisation: 24 August 2022
Date of latest renewal: 24 July 2023
| Drug | Countries | |
|---|---|---|
| ROCTAVIAN | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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