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).
-
List item
Nerlynx : EPAR - Medicine overview (PDF/76.75 KB)
First published: 12/09/2018
Last updated: 12/09/2018
EMA/455200/2018 -
-
List item
Nerlynx : EPAR - Risk-management-plan summary (PDF/77.71 KB)
First published: 12/09/2018
Last updated: 12/09/2018
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 |
L01X
|
Additional 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 Médicament
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
31/08/2018
|
Contact address |
Product information
02/10/2019 Nerlynx - EMEA/H/C/004030 - IAIN/0006/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents