Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: JEVTANA   
Auth. number : EU/1/11/676
Active substance : cabazitaxel
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CD - Taxanes
Chemical substance: L01CD04 - Cabazitaxel
(See WHO ATC Index)
Indication: JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, F-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
22/03/2011 Centralised - Authorisation EMEA/H/C/2018 (2011)1888 of 17/03/2011
26/10/2011 Centralised - Variation EMEA/H/C/2018/IA/2/G
Updated with Decision(2012)3296 of 14/05/2012
11/11/2011 Centralised - Variation EMEA/H/C/2018/IB/1
Updated with Decision(2012)3296 of 14/05/2012
08/03/2012 Centralised - Variation EMEA/H/C/2018/IAin/5
Updated with Decision(2012)3296 of 14/05/2012
16/05/2012 Centralised - Variation (2012)3296 of 14/05/2012
24/07/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2018/T/11 (2012)4215 of 15/06/2012
12/09/2012 Centralised - Variation EMEA/H/C/2018/II/4/G (2012)6383 of 10/09/2012
11/10/2012 Centralised - Variation EMEA/H/C/2018/IA/12
Updated with Decision(2012)7862 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7862 of 29/10/2012
13/12/2012 Centralised - Variation EMEA/H/C/2018/II/15
Updated with Decision(2013)9487 of 13/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/2018/II/17
Updated with Decision(2013)9487 of 13/12/2013
17/12/2013 Centralised - Yearly update (2013)9487 of 13/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/2018/II/20
Updated with Decision(2014)6803 of 18/09/2014
20/02/2014 Centralised - Variation EMEA/H/C/2018/II/22
Updated with Decision(2014)6803 of 18/09/2014
22/09/2014 PSUSA - Modification EMEA/H/C/2018/PSUV/23 (2014)6803 of 18/09/2014
23/04/2015 Centralised - Variation EMEA/H/C/2018/II/29
Updated with Decision(2015)4367 of 22/06/2015
24/06/2015 Centralised - 2-Monthly update EMEA/H/C/2018/II/28 (2015)4367 of 22/06/2015