Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Valdoxan   
Auth. number : EU/1/08/499
INN : agomelatine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06A - Antidepressants
Chemical subgroup: N06AX - Other antidepressants
Chemical substance: N06AX22 - Agomelatine
(See WHO ATC Index)
Indication: Treatment of major depressive episodes in adults
Marketing Authorisation Holder: Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, 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
20/02/2009 Centralised - Authorisation EMEA/H/C/915 (2009)1247 of 19/02/2009
23/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/915 (2009)1248 of 19/02/2009
07/01/2010 Centralised - Variation EMEA/H/C/915/IA/3
07/01/2010 Centralised - Variation EMEA/H/C/915/IA/1
07/01/2010 Centralised - Variation EMEA/H/C/915/IA/2
31/08/2010 Centralised - Variation EMEA/H/C/915/II/4 (2010)6015 of 26/08/2010
26/01/2011 Centralised - Variation EMEA/H/C/915/II/5 (2011)406 of 21/01/2011
01/08/2011 Centralised - Variation EMEA/H/C/915/II/7 (2011)5591 of 27/07/2011
28/10/2011 Centralised - Variation EMEA/H/C/915/IA/8
Updated with Decision(2012)2170 of 26/03/2012
01/03/2012 Centralised - Variation EMEA/H/C/915/IAin/11/G
Updated with Decision(2012)2170 of 26/03/2012
28/03/2012 Centralised - Variation EMEA/H/C/915/II/9 (2012)2170 of 26/03/2012
24/04/2012 Centralised - Variation EMEA/H/C/915/II/9 (2012)2808 of 20/04/2012
26/10/2012 Centralised - Variation EMEA/H/C/915/II/12 (2012)7669 of 24/10/2012
21/02/2013 Centralised - Variation EMEA/H/C/915/II/15
Updated with Decision(2013)8086 of 13/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/915/II/16
Updated with Decision(2013)8086 of 13/11/2013
16/10/2013 Centralised - Variation EMEA/H/C/915/IB/18
Updated with Decision(2014)4275 of 19/06/2014
15/11/2013 Centralised - Renewal EMEA/H/C/915/R/17 (2013)8085 of 13/11/2013
15/11/2013 Centralised - Modification EMEA/H/C/915/PSUV/19 (2013)8086 of 13/11/2013
23/06/2014 Centralised - Variation EMEA/H/C/915/II/21 (2014)4275 of 19/06/2014