🇪🇺 Neratinib tablets in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Neratinib tablets on 31 August 2018

Marketing authorisation

EMA — authorised 31 August 2018

Application: EMEA/H/C/004030
Marketing authorisation holder: Pierre Fabre Medicament
Local brand name: Nerlynx
Indication: Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
Status: approved

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Frequently asked questions

Is Neratinib tablets approved in European Union?

Yes. EMA authorised it on 31 August 2018.

Who is the marketing authorisation holder for Neratinib tablets in European Union?

Pierre Fabre Medicament holds the EU marketing authorisation.