Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

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 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
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 Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
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
04/05/2016 Centralised - Notification EMEA/H/C/2389/N/24