European Union - English - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

United States - English - NLM (National Library of Medicine)

csl behring - etranacogene dezaparvovec (unii: z5xcd5q9rl) (etranacogene dezaparvovec - unii:z5xcd5q9rl) - hemgenix is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with hemophilia b (congenital factor ix deficiency) who: - currently use factor ix prophylaxis therapy, or - have current or historical life-threatening hemorrhage, or - have repeated, serious spontaneous bleeding episodes. none. risk summary hemgenix is not intended for administration in women. no adverse effects on mating rate and fertility indices or fetal weights were observed in healthy naïve female mice mated with healthy male mice that were intravenously administered a predecessor of hemgenix product 6 days prior to mating. vector dna was not detected in the uterus, placenta, or fetus. in the united states general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary hemgenix is not intended for administration in women. risk summary no clinical studies have been performed to evaluate the eff

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - etranacogene dezaparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: monobasic potassium phosphate; water for injections; potassium chloride; dibasic sodium phosphate; sodium chloride; polysorbate 20; hydrochloric acid; sucrose - this medicine has provisional approval in australia.,hemgenix? is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with haemophilia b (congenital factor ix deficiency), without a history of factor ix inhibitors, who:,- currently use factor ix prophylaxis therapy, or,- have current or historical life-threatening haemorrhage, or repeated, serious spontaneous bleeding episodes.,the decision to approve this indication has been made on the basis of short-term efficacy and safety data from the clinical trial program. continued approval of this indication depends on confirmation of longer-term benefit from ongoing clinical trials.

Australia - English - Department of Health (Therapeutic Goods Administration)

agilent technologies australia pty ltd -