Kadcyla

RSS

trastuzumab emtansine

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

Overview

This is a summary of the European public assessment report (EPAR) for Kadcyla. 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 Kadcyla.

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

This EPAR was last updated on 19/09/2018

Authorisation details

Product details
Name
Kadcyla
Agency product number
EMEA/H/C/002389
Active substance
trastuzumab emtansine
International non-proprietary name (INN) or common name
trastuzumab emtansine
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC14
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
14/11/2013
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

16/09/2018 Kadcyla - EMEA/H/C/002389 - R/0039

Contents

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

Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • received prior therapy for locally advanced or metastatic disease; or
  • developed disease recurrence during or within six months of completing adjuvant therapy.

Assessment history

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