Nerlynx

RSS

neratinib

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

Overview

An overview of Nerlynx and why it is authorised in the EU

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 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
Puma Biotechnology Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
30/08/2018
Contact address
11th Floor
Whitefriars Lewins Mead
Bristol BS1 2NT
United Kingdom

Product information

31/08/2018 Nerlynx - EMEA/H/C/004030 - -

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

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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