Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: XALKORI   
Auth. number : EU/1/12/793
Active substance : crizotinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE16 - Crizotinib
(See WHO ATC Index)
Indication: XALKORI is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
26/10/2012 Centralised - Authorisation EMEA/H/C/2489 (2012)7617 of 23/10/2012
28/01/2013 Centralised - Variation EMEA/H/C/2489/IB/3
Updated with Decision(2013)5608 of 26/08/2013
25/04/2013 Centralised - Variation EMEA/H/C/2489/II/2
Updated with Decision(2013)5608 of 26/08/2013
19/07/2013 Centralised - Notification EMEA/H/C/2489/N/8
Updated with Decision(2014)565 of 29/01/2014
29/08/2013 Centralised - Annual renewal EMEA/H/C/2489/R/6 (2013)5608 of 26/08/2013
24/10/2013 Centralised - Variation EMEA/H/C/2489/II/5
Updated with Decision(2014)565 of 29/01/2014
31/01/2014 Centralised - 2-Monthly update EMEA/H/C/2489/II/7 (2014)565 of 29/01/2014
20/02/2014 Centralised - Variation EMEA/H/C/2489/II/13
Updated with Decision(2014)2063 of 21/03/2014
25/03/2014 Centralised - 2-Monthly update EMEA/H/C/2489/II/4 (2014)2063 of 21/03/2014
16/05/2014 PSUSA - Modification EMEA/H/C/2489/PSUV/12 (2014)3365 of 14/05/2014
24/07/2014 Centralised - Variation EMEA/H/C/2489/II/16
26/08/2014 Centralised - Annual renewal EMEA/H/C/2489/R/15 (2014)6103 of 22/08/2014
22/01/2015 Centralised - Variation EMEA/H/C/2489/II/22
08/04/2015 Centralised - Notification EMEA/H/C/2489/N/27
23/04/2015 Centralised - Variation EMEA/H/C/2489/II/21