Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Kadcyla   
Auth. number : EU/1/13/885
Active substance : Trastuzumab emtansine
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC14 - trastuzumab emtansine
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/11/2013 Centralised - Authorisation EMEA/H/C/2389 (2013)8149 of 15/11/2013
23/10/2014 Centralised - Variation EMEA/H/C/2389/II/6/G
Updated with Decision(2015)7212 of 15/10/2015
19/10/2015 Centralised - Yearly update (2015)7212 of 15/10/2015
23/10/2015 Centralised - Variation EMEA/H/C/2389/IB/17
Updated with Decision(2016)407 of 22/01/2016
26/01/2016 Centralised - 2-Monthly update EMEA/H/C/2389/II/20/G (2016)407 of 22/01/2016
25/02/2016 Centralised - Variation EMEA/H/C/2389/II/19/G
Updated with Decision(2017)1220 of 16/02/2017
04/05/2016 Centralised - Notification EMEA/H/C/2389/N/24
Updated with Decision(2017)1220 of 16/02/2017
10/10/2016 Corrigendum (2016)407 of 22/01/2016
15/12/2016 Centralised - Variation EMEA/H/C/2389/II/27/G
Updated with Decision(2017)1220 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017)1220 of 16/02/2017
11/05/2017 Centralised - Variation EMEA/H/C/2389/II/31
Updated with Decision(2018)1754 of 16/03/2018
13/07/2017 Centralised - Variation EMEA/H/C/2389/II/33
Updated with Decision(2018)1754 of 16/03/2018
20/03/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2389/T/38 (2018)1754 of 16/03/2018
05/04/2018 Corrigendum