Perjeta

RSS

pertuzumab

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

Overview

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

Perjeta is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called HER2 is found on the cancer cells). Perjeta is used in the following situations:

  • treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery. In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
  • treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
  • treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.

Perjeta contains the active substance pertuzumab.

This EPAR was last updated on 05/10/2018

Authorisation details

Product details
Name
Perjeta
Agency product number
EMEA/H/C/002547
Active substance
pertuzumab
International non-proprietary name (INN) or common name
pertuzumab
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC13
Publication details
Marketing-authorisation holder
Roche Registration GmbH 
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
03/03/2013
Contact address
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

04/07/2018 Perjeta - EMEA/H/C/002547 - II/0039

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

  • Monoclonal antibodies

Therapeutic indication

Metastatic Breast Cancer:

Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Neoadjuvant Treatment of Breast Cancer:

Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Assessment history

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