Herzuma

RSS

trastuzumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Herzuma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Herzuma.

For practical information about using Herzuma, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 18/09/2018

Authorisation details

Product details
Name
Herzuma
Agency product number
EMEA/H/C/002575
Active substance
trastuzumab
International non-proprietary name (INN) or common name
trastuzumab
Therapeutic area (MeSH)
  • Stomach Neoplasms
  • Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC03
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.

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
09/02/2018
Contact address
Vaci ut 1-3
WestEnd Office Building B torony
1062 Budapest
Hungary

Product information

23/08/2018 Herzuma - EMEA/H/C/002575 - IB/0011/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

Therapeutic indication

Breast cancer

Metastatic breast cancer

Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):

  • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
  • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
  • in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
  • in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

Early breast cancer

Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):

  • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
  • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
  • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
  • in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer

Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Herzuma should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

Assessment history

How useful was this page?

Add your rating