This brand name is authorized in Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States
The drug ROCTAVIAN contains one active pharmaceutical ingredient (API):
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1
Valoctocogene roxaparvovec
UNII 681K1JDI8M - VALOCTOCOGENE ROXAPARVOVEC
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ROCTAVIAN Solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1892392 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 61342997 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 050297011 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1095411 |
| Country: US | FDA, National Drug Code | Identifier(s): 68135-927 |
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