DEFITELIO

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, UK.

Active ingredients

The drug DEFITELIO contains one active pharmaceutical ingredient (API):

1	Defibrotide UNII L7CHH2B2J0 - DEFIBROTIDE SODIUM
	Defibrotide is an oligonucleotide mixture with demonstrated antithrombotic, fibrinolytic, anti-adhesive and anti-inflammatory actions. The mechanism of action is multifactorial. It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance. However, the exact mechanism of action of defibrotide is not fully elucidated.
	Read more about Defibrotide

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DEFITELIO Concentrate for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)
DEFITELIO Solution for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

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

ATC Group		Classification
B01AX01	Defibrotide	B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AX Other antithrombotic agents
Discover more medicines within B01AX01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	534220030020807
CA	Health Products and Food Branch	02465981
EE	Ravimiamet	1630617
FI	Lääkealan turvallisuus- ja kehittämiskeskus	035203
FR	Base de données publique des médicaments	69439245
GB	Medicines & Healthcare Products Regulatory Agency	245517
IL	מִשְׂרַד הַבְּרִיאוּת	7580
JP	医薬品医療機器総合機構	3919401A1020
LT	Valstybinė vaistų kontrolės tarnyba	1071758
NL	Z-Index G-Standaard, PRK	118087
PL	Rejestru Produktów Leczniczych	100309415
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68907001
US	FDA, National Drug Code	68727-800