DEFITELIO (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)
Product name
DEFITELIO
Date registered
Evaluation commenced
Decision date
Approval time
223 working days (255)
Active ingredients
defibrotide
Registration type
NCE/NBE
Indication
DEFITELIO (concentrated solution for injection) 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.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.