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Nubeqa

Active substance: darolutamide

darolutamide

Centralised EU authorisationActive

Marketing holder: Bayer AG

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
  • NUBEQA
    TABLET, FILM COATED · DAROLUTAMIDE 300 mg/1
    50419-395
    Bayer HealthCare Pharmaceuticals Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12096-0412-7542-bd1c-c9ac919766f1;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004790
Registration status
Active
ATC code
L02BB
Sources
  • product · EMA · EMEA/H/C/004790 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004790 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004790 · Verified 2026-10-09