EMA — authorised 18 October 2013
- Marketing authorisation holder: Gentium S.r.l.
- Status: approved
🇪🇺 Defitelio in European Union
EMA authorised Defitelio on 18 October 2013
Marketing authorisations
EMA — authorised 18 October 2013
- Application: EMEA/H/C/002393
- Marketing authorisation holder: Gentium S.r.l.
- Local brand name: Defitelio
- Indication: 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.
- Pathway: exceptional circumstances
- Status: approved
Defitelio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Defitelio approved in European Union?
Yes. EMA authorised it on 18 October 2013; EMA authorised it on 18 October 2013.
Who is the marketing authorisation holder for Defitelio in European Union?
Gentium S.r.l. holds the EU marketing authorisation.