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Pharmaceuticals - Community Register
Community register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Thymanax
![]() |
Auth. number : | EU/1/08/498 |
Active substance : | 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 procedures |
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 - Notification | EMEA/H/C/916/N/1 | ||||
Updated with Decision(2010)6031 of 26/08/2010 | ||||||
06/01/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/916/IA/3 | ||||
07/01/2010 | Centralised - Variation (no change in Commission Decision) | 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 - Decision addressed to Member States | 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 | PSUSA - 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 - 2-Monthly update | EMEA/H/C/916/II/19 | (2014)4365 of 23/06/2014 | |||
21/11/2014 | PSUSA - Modification | EMEA/H/C/916/PSUV/21 | (2014)8885 of 19/11/2014 | |||
06/05/2015 | Centralised - Variation | EMEA/H/C/916/IB/23/G | ||||
Updated with Decision(2015)8263 of 19/11/2015 | ||||||
18/06/2015 | Centralised - Notification | EMEA/H/C/916/N/27 | ||||
Updated with Decision(2015)8263 of 19/11/2015 | ||||||
23/11/2015 | PSUSA - Modification | EMEA/H/C/916/PSUSA/71/201502 | (2015)8263 of 19/11/2015 | |||
22/11/2016 | PSUSA - Modification | EMEA/H/C/PSUSA/71/201602 | (2016)7602 of 18/11/2016 | |||
28/11/2016 | Centralised - Variation | EMEA/H/C/916/IAin/32 | ||||
Updated with Decision(2017)8312 of 01/12/2017 | ||||||
09/06/2017 | Centralised - Notification | EMEA/H/C/916/N/35 | ||||
Updated with Decision(2017)8312 of 01/12/2017 | ||||||
11/09/2017 | Centralised - Variation | EMEA/H/C/916/IA/36 | ||||
Updated with Decision(2017)8312 of 01/12/2017 | ||||||
05/12/2017 | Centralised - Yearly update | (2017)8312 of 01/12/2017 |