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Nerlynx

Active substance: neratinib

neratinib

Centralised EU authorisationActive

Marketing holder: Pierre Fabre Medicament

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 2
  • Nerlynx
    TABLET · NERATINIB MALEATE ANHYDROUS 40 mg/1
    70437-240
    Puma Biotechnology, Inc.
  • neratinib
    TABLET · NERATINIB MALEATE ANHYDROUS 40 mg/1
    46014-2400
    Excella GmbH & Co. KG
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-d813-7d03-be6b-09718331d733,01a12097-da0f-7130-af12-d3508e02fb04;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004030
Registration status
Active
ATC code
L01EH02
Sources
  • product · EMA · EMEA/H/C/004030 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004030 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004030 · Verified 2026-10-09