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Unituxin

Active substance: dinutuximab

dinutuximab

Centralised EU authorisationWithdrawn

Marketing holder: United Therapeutics 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 1
  • Unituxin
    INJECTION · DINUTUXIMAB 3.5 mg/mL
    66302-014
    United Therapeutics Corporation
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12096-e9ff-70d4-8791-e3fa5a1cb41e;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002800
Registration status
Withdrawn
ATC code
L01FX06
Sources
  • product · EMA · EMEA/H/C/002800 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002800 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002800 · Verified 2026-10-09