Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: ZALTRAP   
Auth. number : EU/1/12/814
Active substance : aflibercept
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX44 - aflibercept
(See WHO ATC Index)
Indication: ZALTRAP in combination with irinotecan/5 fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin containing regimen.
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France
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
05/02/2013 Centralised - Authorisation EMEA/H/C/2532 (2013)646 of 01/02/2013
21/06/2013 Centralised - Variation EMEA/H/C/2532/IA/1
Updated with Decision(2014)4513 of 27/06/2014
25/09/2013 Centralised - Notification EMEA/H/C/2532/N/3
Updated with Decision(2014)4513 of 27/06/2014
18/12/2013 Centralised - Variation EMEA/H/C/2532/II/7
Updated with Decision(2014)4513 of 27/06/2014
01/07/2014 Centralised - Yearly update (2014)4513 of 27/06/2014
21/11/2014 PSUSA - Modification EMEA/H/C/2532/PSUV/9 (2014)8894 of 19/11/2014
06/08/2015 Centralised - Notification EMEA/H/C/2532/N/19
Updated with Decision(2016)2760 of 28/04/2016
02/05/2016 PSUSA - Modification EMEA/H/C/2532/PSUSA/10019/201508 (2016)2760 of 28/04/2016
26/10/2016 Centralised - 2-Monthly update EMEA/H/C/2532/II/26 (2016)6963 of 24/10/2016
23/02/2017 Centralised - Variation EMEA/H/C/2532/II/35
Updated with Decision(2017)6519 of 21/09/2017
13/03/2017 Corrigendum (2013)646 of 01/02/2013
25/09/2017 Centralised - Renewal EMEA/H/C/2532/R/37 (2017)6519 of 21/09/2017