Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Thymanax   
Auth. number : EU/1/08/498
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: Servier (Ireland) Industries Limited
Gorey Road, Arklow, Co. Wicklow, Ireland

  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/916 (2009)1245 of 19/02/2009
23/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/916 (2009)1246 of 19/02/2009
06/01/2010 Centralised - Variation EMEA/H/C/916/IA/3
06/01/2010 Centralised - Variation EMEA/H/C/916/N/1
Updated with Decision(2010)6031 of 26/08/2010
07/01/2010 Centralised - Variation EMEA/H/C/916/IA/2
31/08/2010 Centralised - Variation EMEA/H/C/916/II/4 (2010)6031 of 26/08/2010
25/01/2011 Centralised - Variation EMEA/H/C/916/II/5 (2011)396 of 21/01/2011
29/07/2011 Centralised - Variation EMEA/H/C/916/II/7 (2011)5583 of 27/07/2011
26/03/2012 Centralised - Variation EMEA/H/C/916/II/8 (2012)2040 of 21/03/2012
25/04/2012 Centralised - Variation EMEA/H/C/916/II/8 (2012)2807 of 20/04/2012
26/10/2012 Centralised - Variation EMEA/H/C/916/II/10 (2012)7643 of 24/10/2012
21/02/2013 Centralised - Variation EMEA/H/C/916/II/13
Updated with Decision(2013)8060 of 13/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/916/II/14
Updated with Decision(2013)8060 of 13/11/2013
16/10/2013 Centralised - Variation EMEA/H/C/916/IB/16
Updated with Decision(2014)4365 of 23/06/2014
15/11/2013 Centralised - Modification EMEA/H/C/916/PSUV/17 (2013)8060 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/916/R/15 (2013)8058 of 13/11/2013
25/06/2014 Centralised - Variation EMEA/H/C/916/II/19 (2014)4365 of 23/06/2014