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Istodax

Active substance: romidepsin

romidepsin

Centralised EU authorisationActive

Marketing holder: Celgene Europe Ltd.

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 3
  • ISTODAX
    KIT · romidepsin
    59572-984
    Celgene Corporation
  • ROMIDEPSIN
    INJECTION, SOLUTION, CONCENTRATE · ROMIDEPSIN 5 mg/mL
    70121-2250
    Amneal Pharmaceuticals LLC
  • Romidepsin
    KIT · romidepsin
    63323-926
    Fresenius Kabi USA, LLC
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-a6a5-705a-baba-ba48aa34916c,01a12094-bb30-7503-aff8-b0cbd50cba78,01a1209b-582b-7aa2-aaf2-e2ecb25df4b2;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002122
Registration status
Active
ATC code
L01XX39
Sources
  • product · EMA · EMEA/H/C/002122 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002122 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002122 · Verified 2026-10-09