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.
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 |
|---|---|---|
| B02BD15 | 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 | |
|---|---|---|---|
| ROCTAVIAN Solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
Valoctocogene roxaparvovec is an active ingredient of these brands:
United States (US)Austria (AT)Croatia (HR)Estonia (EE)France (FR)Ireland (IE)Italy (IT)Lithuania (LT)Poland (PL)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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