Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Iressa   
Auth. number : EU/1/09/526
Active substance : gefitinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE02 - Gefitinib
(See WHO ATC Index)
Indication: IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of EGFR TK
Marketing Authorisation Holder: AstraZeneca AB
151 85 Södertälje, Sverige
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
26/06/2009 Centralised - Authorisation EMEA/H/C/1016 (2009)5203 of 24/06/2009
17/09/2009 Centralised - Variation EMEA/H/C/1016/IA/1
Updated with Decision(2010)342 of 19/01/2010
21/01/2010 Centralised - Variation EMEA/H/C/1016/II/2 (2010)342 of 19/01/2010
01/12/2010 Centralised - Variation EMEA/H/C/1016/II/3/G (2010)8557 of 26/11/2010
07/01/2011 Centralised - Variation EMEA/H/C/1016/IG/35
Updated with Decision(2011)5689 of 01/08/2011
03/08/2011 Centralised - Variation EMEA/H/C/1016/II/4 (2011)5689 of 01/08/2011
26/04/2012 Centralised - Variation EMEA/H/C/1016/II/5 (2012)2858 of 20/04/2012
27/06/2013 Centralised - Variation EMEA/H/C/1016/II/11
Updated with Decision(2014)2820 of 23/04/2014
25/04/2014 Centralised - Renewal EMEA/H/C/1016/1016/R/12 (2014)2820 of 23/04/2014
25/09/2014 Centralised - Variation EMEA/H/C/1016/II/16
Updated with Decision(2015)7196 of 15/10/2015
19/10/2015 Centralised - Yearly update (2015)7196 of 15/10/2015
15/09/2016 Centralised - Variation EMEA/H/C/1016/II/24
Updated with Decision(2017)2214 of 29/03/2017
15/09/2016 Centralised - Variation EMEA/H/C/1016/II/25
Updated with Decision(2017)2214 of 29/03/2017
26/01/2017 Centralised - Variation EMEA/H/C/1016/II/27
Updated with Decision(2017)2214 of 29/03/2017
31/03/2017 Centralised - 2-Monthly update EMEA/H/C/1016/II/26 (2017)2214 of 29/03/2017