HEMGENIX

This brand name is authorized in Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States

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 about Etranacogene dezaparvovec

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC code	Group title	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)
Country: EE	Ravimiamet	Identifier(s): 1892628
Country: IT	Agenzia del Farmaco	Identifier(s): 050548015
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1096580
Country: US	FDA, National Drug Code	Identifier(s): 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