Nerlynx

RSS

neratinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery. It is given following treatment with trastuzumab (another medicine used for the same purpose).

It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer), and that also have receptors (targets) for the female sex hormones (hormone-receptor positive breast cancer).

This EPAR was last updated on 05/12/2022

Authorisation details

Product details
Name
Nerlynx
Agency product number
EMEA/H/C/004030
Active substance
neratinib
International non-proprietary name (INN) or common name
neratinib
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01EH02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Pierre Fabre Medicament
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
31/08/2018
Contact address

Pierre Fabre Medicament
Les Cauquillous
81500 - Lavaur
France

Product information

10/11/2022 Nerlynx - EMEA/H/C/004030 - II/0029

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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.

Assessment history

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