ROCTAVIAN

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, France, Ireland, Italy, Lithuania, Poland.

Active ingredients

The drug ROCTAVIAN contains one active pharmaceutical ingredient (API):

1	Valoctocogene roxaparvovec UNII 681K1JDI8M - 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.
	Read more about Valoctocogene roxaparvovec

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ROCTAVIAN Solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1892392
FR	Base de données publique des médicaments	61342997
IT	Agenzia del Farmaco	050297011
LT	Valstybinė vaistų kontrolės tarnyba	1095411
US	FDA, National Drug Code	68135-927