HEMGENIX

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

Active ingredients

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

1	Etranacogene dezaparvovec UNII Z5XCD5Q9RL - 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.
	Read more about Etranacogene dezaparvovec

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
HEMGENIX Concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
B06	Other hematological agents	B Blood and blood forming organs
Discover more medicines within B06

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	1892628
IT	Agenzia del Farmaco	050548015
LT	Valstybinė vaistų kontrolės tarnyba	1096580
US	FDA, National Drug Code	0053-0099, 0053-0100, 0053-0110, 0053-0120, 0053-0130, 0053-0140, 0053-0150, 0053-0160, 0053-0170, 0053-0180, 0053-0190, 0053-0200, 0053-0210, 0053-0220, 0053-0230, 0053-0240, 0053-0250, 0053-0260, 0053-0270, 0053-0280, 0053-0290, 0053-0300, 0053-0310, 0053-0320, 0053-0330, 0053-0340, 0053-0350, 0053-0360, 0053-0370, 0053-0380, 0053-0390, 0053-0400, 0053-0410, 0053-0420, 0053-0430, 0053-0440, 0053-0450, 0053-0460, 0053-0470, 0053-0480