Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Inlyta   
Auth. number : EU/1/12/777
Active substance : Axitinib
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: L01XE17 - Axitinib
(See WHO ATC Index)
Indication: Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
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
05/09/2012 Centralised - Authorisation EMEA/H/C/2406 (2012)6191 of 03/09/2012
04/07/2013 Centralised - Notification EMEA/H/C/2406/N/04
29/08/2013 Centralised - Variation EMEA/H/C/2406/X/1 (2013)5621 of 26/08/2013
24/10/2013 Centralised - Variation EMEA/H/C/2406/II/3/G
Updated with Decision(2014)8413 of 07/11/2014
22/05/2014 Centralised - Variation EMEA/H/C/2406/II/7
Updated with Decision(2014)8413 of 07/11/2014
22/05/2014 Centralised - Variation EMEA/H/C/2406/II/8
Updated with Decision(2014)8413 of 07/11/2014
11/11/2014 Centralised - Yearly update (2014)8413 of 07/11/2014
21/05/2015 Centralised - Variation EMEA/H/C/2406/II/13
Updated with Decision(2016)2944 of 11/05/2016
24/06/2015 Centralised - Notification EMEA/H/C/2406/N/14
Updated with Decision(2016)2944 of 11/05/2016
13/05/2016 Centralised - Yearly update (2016)2944 of 11/05/2016
09/06/2016 Centralised - Variation EMEA/H/C/2406/IA/20