DEFITELIO

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

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.

Read about Defibrotide

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
DEFITELIO Solution for injection FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

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

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

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