Perjeta
pertuzumab
Table of contents
Overview
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.
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List item
Perjeta : EPAR - Medicine overview (PDF/84.02 KB)
First published: 02/04/2013
Last updated: 28/06/2018
EMA/824939/2012 -
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List item
Perjeta : EPAR - Risk-management-plan summary (PDF/244.49 KB)
First published: 29/07/2020
Authorisation details
Product details | |
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Name |
Perjeta
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Agency product number |
EMEA/H/C/002547
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Active substance |
pertuzumab
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International non-proprietary name (INN) or common name |
pertuzumab
|
Therapeutic area (MeSH) |
Breast Neoplasms
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Anatomical therapeutic chemical (ATC) code |
L01XC13
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Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
04/03/2013
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Contact address |
Product information
09/07/2020 Perjeta - EMEA/H/C/002547 - IB/0050
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
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Pharmacotherapeutic group
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Antineoplastic agents
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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.