Is Defibrotide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Defibrotide, including Defitelio 200 mg per 2.5 (80 mg/ml, Concentrate for solution for infusion, SAR 22191.65).

Is Defibrotide approved by the US FDA?

Drugs@FDA lists 1 application product line for Defibrotide, including DEFITELIO (Prescription).

Is Defibrotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Defibrotide: Defitelio.

Active substance

Defibrotide

SFDA 1
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Defitelio 200 mg per 2.5	80 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Vial	SAR 22191.65	Biological · Prescription	Jazz Pharmaceutical Ireland Ltd	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DEFITELIO	200MG/2.5ML (80MG/ML)	solution · intravenous	JAZZ PHARMS INC	Prescription	30 Mar 2016

EMA European Union — centrally authorised medicines

Defitelio Gentium S.r.l. · Authorised · authorised 18 Oct 2013 · ATC B01AX01

Therapeutic indication (EMA)

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 Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DEFITELIO	02465981	80 MG / ML	SOLUTION · INTRAVENOUS	JAZZ PHARMACEUTICALS IRELAND LIMITED

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.