Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Yervoy   
Auth. number : EU/1/11/698
Active substance : ipilimumab
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: L01XC11 - Ipilimumab
(See WHO ATC Index)
Indication: YERVOY is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, 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
14/07/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2213 (2011)5193 of 13/07/2011
15/07/2011 Centralised - Authorisation EMEA/H/C/2213 (2011)5192 of 13/07/2011
30/04/2012 Centralised - Variation EMEA/H/C/2213/II/1 (2012)2974 of 26/04/2012
25/06/2012 Centralised - Variation EMEA/H/C/2213/II/2 (2012)4353 of 21/06/2012
30/05/2013 Centralised - Variation EMEA/H/C/2213/II/14
Updated with Decision(2013)7501 of 31/10/2013
05/11/2013 Centralised - 2-Monthly update EMEA/H/C/2213/II/8 (2013)7501 of 31/10/2013
23/12/2013 PSUSA - Modification EMEA/H/C/2213/PSUV/20 (2013)9761 of 18/12/2013
25/09/2014 Centralised - Variation EMEA/H/C/2213/II/27/G
Updated with Decision(2015)4301 of 19/06/2015
25/09/2014 Centralised - Variation EMEA/H/C/2213/II/26/G
Updated with Decision(2015)4301 of 19/06/2015
26/03/2015 Centralised - Variation EMEA/H/C/2213/II/29
Updated with Decision(2015)4301 of 19/06/2015
23/06/2015 PSUSA - Modification EMEA/H/C/2213/PSUSA/9200/201409 (2015)4301 of 19/06/2015