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Defitelio

Active substance: defibrotide

defibrotide

Centralised EU authorisationActive

Marketing holder: Gentium S.r.l.

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 1
  • DEFITELIO
    INJECTION, SOLUTION · DEFIBROTIDE SODIUM 80 mg/mL
    68727-800
    Jazz Pharmaceuticals, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12094-794c-702f-8737-db3610561d67;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002393
Registration status
Active
ATC code
B01AX01
Sources
  • product · EMA · EMEA/H/C/002393 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002393 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002393 · Verified 2026-10-09