European Union - English - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

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

csl behring lengnau ag - albutrepenonacog alfa (unii: a57kx1vl5p) (albutrepenonacog alfa - unii:a57kx1vl5p) - albutrepenonacog alfa 250 [iu] in 2.5 ml - idelvion® , coagulation factor ix (recombinant), albumin fusion protein (rix-fp), a recombinant dna-derived coagulation factor ix concentrate, is indicated in children and adults with hemophilia b (congenital factor ix deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes limitations of use: idelvion is not indicated for immune tolerance induction in patients with hemophilia b. idelvion is contraindicated in patients who have had life-threatening hypersensitivity reactions to idelvion, or its components, including hamster proteins [see warnings and precautions (5.1)] . risk summary there are no data with idelvion use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using idelvion. it is not known whether idelvion can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. in the u.s. general populati

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

csl behring uk ltd - albutrepenonacog alfa - powder and solvent for solution for injection - 250unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

csl behring uk ltd - albutrepenonacog alfa - powder and solvent for solution for injection - 2000unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

csl behring uk ltd - albutrepenonacog alfa - powder and solvent for solution for injection - 500unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

csl behring uk ltd - albutrepenonacog alfa - powder and solvent for solution for injection - 1000unit

Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 1000 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 2000 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Israel - English - Ministry of Health

csl behring ltd., israel - albutrepenonacog alfa - powder and solvent for solution for injection - albutrepenonacog alfa 500 iu - coagulation factor ix - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dksh malaysia sdn. bhd. - albutrepenonacog alfa -