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

jazz pharmaceuticals, inc. - defibrotide sodium (unii: l7chh2b2j0) (defibrotide free acid - unii:568fy5i1yi) - defibrotide sodium 80 mg in 1 ml - defitelio is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (vod), also known as sinusoidal obstruction syndrome (sos), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (hsct). the use of defitelio is contraindicated in the following conditions: risk summary there are no available data on defitelio use in pregnant women. when administered to pregnant rabbits during the period of organogenesis at doses that were comparable to the recommended human dose based on body surface area, defibrotide sodium decreased the number of implantations and viable fetuses. advise pregnant women of the potential risk of miscarriage. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. data animal data embryo-fetal tox

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

jazz pharmaceuticals anz pty ltd - defibrotide, quantity: 200 mg - injection, concentrated - excipient ingredients: hydrochloric acid; sodium citrate dihydrate; sodium hydroxide; water for injections - defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (vod) also known as sinusoidal obstruction syndrome (sos) in haematopoietic stem-cell transplantation (hsct) therapy.,it is indicated in adults and in adolescents, children and infants of 1 month of age and above.

Israel - English - Ministry of Health

medison pharma ltd - defibrotide - concentrate for solution for infusion - defibrotide 80 mg / 1 ml - defibrotide - defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (vod) also known as sinusoidal obstructive syndrome (sos) in haematopoietic stem-cell transplantation (hsct) therapy.it is indicated in adults and in adolescents, children and infants over 1 month of age .

European Union - English - EMA (European Medicines Agency)

gentium s.r.l. - defibrotide - hepatic veno-occlusive disease - antithrombotic agents - defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (vod) also known as sinusoidal obstructive syndrome (sos) in haematopoietic stem-cell transplantation (hsct) therapy.it is indicated in adults and in adolescents, children and infants over 1 month of age.

Canada - English - Health Canada

jazz pharmaceuticals ireland limited - defibrotide - solution - 80mg - defibrotide 80mg - thrombolytic agents

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

jazz pharmaceuticals uk - defibrotide - solution for infusion - 80mg/1ml

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

imported (italy) - defibrotide - solution for injection - 80mg/1ml

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

imported (italy) - defibrotide - oral capsule - 400mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazz pharmaceutical ireland ltd, ireland - defibrotide - concentrate for solution for infusion - 80 mg/ml

European Union - English - EMA (European Medicines Agency)

bayer ag - iloprost - hypertension, pulmonary - antithrombotic agents - treatment of patients with primary pulmonary hypertension, classified as new york heart association functional class iii, to improve exercise capacity and symptoms.