Nerlynx
neratinib
Table of contents
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).
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Nerlynx : EPAR - Medicine overview (PDF/76.75 KB)
First published: 12/09/2018
Last updated: 12/09/2018
EMA/455200/2018 -
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Nerlynx : EPAR - Risk-management-plan summary (PDF/148.81 KB)
First published: 12/09/2018
Last updated: 15/06/2023
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pierre Fabre Medicament
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
31/08/2018
|
Contact address |
Pierre Fabre Medicament |
Product information
26/05/2023 Nerlynx - EMEA/H/C/004030 - R/0031
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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