- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 31 July 2022, the European Commission withdrew the marketing authorisation for Thymanax (agomelatine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Servier (Ireland) Industries Ltd., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Thymanax was granted marketing authorisation in the EU on 19 February 2009 for treatment of major depressive disorder. The product had not been marketed in the EU since 2021.
Thymanax was a duplicate application to Valdoxan, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Valdoxan.
The European Public Assessment Report (EPAR) for Thymanax is updated to indicate that the marketing authorisation is no longer valid.
Thymanax : EPAR - Summary for the public
English (EN) (185.4 KB - PDF)
български (BG) (265.32 KB - PDF)
español (ES) (189.36 KB - PDF)
čeština (CS) (240.21 KB - PDF)
dansk (DA) (187.1 KB - PDF)
Deutsch (DE) (196.52 KB - PDF)
eesti keel (ET) (175.2 KB - PDF)
ελληνικά (EL) (282.5 KB - PDF)
français (FR) (193.28 KB - PDF)
hrvatski (HR) (226.52 KB - PDF)
italiano (IT) (186.03 KB - PDF)
latviešu valoda (LV) (234.67 KB - PDF)
lietuvių kalba (LT) (237.82 KB - PDF)
magyar (HU) (221.45 KB - PDF)
Malti (MT) (244.64 KB - PDF)
Nederlands (NL) (191.44 KB - PDF)
polski (PL) (240.61 KB - PDF)
português (PT) (190.48 KB - PDF)
română (RO) (242.93 KB - PDF)
slovenčina (SK) (228.66 KB - PDF)
slovenščina (SL) (222.81 KB - PDF)
Suomi (FI) (178.88 KB - PDF)
svenska (SV) (185.36 KB - PDF)
Thymanax : EPAR - Risk-management-plan summary
English (EN) (301.31 KB - PDF)
Product information
Thymanax : EPAR - Product Information
English (EN) (1.2 MB - PDF)
български (BG) (1.67 MB - PDF)
español (ES) (632.66 KB - PDF)
čeština (CS) (1.5 MB - PDF)
dansk (DA) (1005.48 KB - PDF)
Deutsch (DE) (1.24 MB - PDF)
eesti keel (ET) (1.22 MB - PDF)
ελληνικά (EL) (1.97 MB - PDF)
français (FR) (1.31 MB - PDF)
hrvatski (HR) (1.48 MB - PDF)
íslenska (IS) (1.02 MB - PDF)
italiano (IT) (1.17 MB - PDF)
latviešu valoda (LV) (1.46 MB - PDF)
lietuvių kalba (LT) (1.41 MB - PDF)
magyar (HU) (1.36 MB - PDF)
Malti (MT) (1.3 MB - PDF)
Nederlands (NL) (1.04 MB - PDF)
norsk (NO) (997.47 KB - PDF)
polski (PL) (1.44 MB - PDF)
português (PT) (1.15 MB - PDF)
română (RO) (1.47 MB - PDF)
slovenčina (SK) (1.17 MB - PDF)
slovenščina (SL) (1.36 MB - PDF)
Suomi (FI) (1.06 MB - PDF)
svenska (SV) (1.06 MB - PDF)
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Thymanax : EPAR - All Authorised presentations
English (EN) (76.89 KB - PDF)
български (BG) (95.19 KB - PDF)
español (ES) (38.56 KB - PDF)
čeština (CS) (83.91 KB - PDF)
dansk (DA) (78.01 KB - PDF)
Deutsch (DE) (42.43 KB - PDF)
eesti keel (ET) (37.7 KB - PDF)
ελληνικά (EL) (115.34 KB - PDF)
français (FR) (41.7 KB - PDF)
hrvatski (HR) (138.35 KB - PDF)
íslenska (IS) (73.54 KB - PDF)
italiano (IT) (37.71 KB - PDF)
latviešu valoda (LV) (109.09 KB - PDF)
lietuvių kalba (LT) (107.35 KB - PDF)
magyar (HU) (108.52 KB - PDF)
Malti (MT) (102.34 KB - PDF)
Nederlands (NL) (37.97 KB - PDF)
norsk (NO) (74.61 KB - PDF)
polski (PL) (68.86 KB - PDF)
português (PT) (40.26 KB - PDF)
română (RO) (102.32 KB - PDF)
slovenčina (SK) (72.01 KB - PDF)
slovenščina (SL) (91.59 KB - PDF)
Suomi (FI) (41.43 KB - PDF)
svenska (SV) (40.64 KB - PDF)
Product details
- Name of medicine
- Thymanax
- Active substance
- Agomelatine
- International non-proprietary name (INN) or common name
- agomelatine
- Therapeutic area (MeSH)
- Depressive Disorder, Major
- Anatomical therapeutic chemical (ATC) code
- N06AX22
Pharmacotherapeutic group
PsychoanalepticsTherapeutic indication
Treatment of major depressive episodes in adults.
Authorisation details
- EMA product number
- EMEA/H/C/000916
- Marketing authorisation holder
- Servier (Ireland) Industries Ltd
Gorey Road
Arklow, Co. Wicklow
Ireland - Opinion adopted
- 27/07/2006
- Marketing authorisation issued
- 19/02/2009
- Withdrawal of marketing authorisation
- 31/07/2022
- Revision
- 24
Assessment history
Thymanax : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (833.23 KB - PDF)
Thymanax : EPAR-H-C-000916-P46-032 - Assessment Report
English (EN) (1.39 MB - PDF)
Thymanax-H-C-PSUSA-00000071-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
English (EN) (116.99 KB - PDF)
Thymanax-PSUSA-0000071-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (105.02 KB - PDF)
Thymanax-H-C-916-P46-0027: EPAR - Assessment Report
English (EN) (1.47 MB - PDF)
Thymanax-H-C-916-PSUV-0021 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (124.68 KB - PDF)
Thymanax-H-C-916-PSUV-0019 : EPAR - Assessment Report - Variation
English (EN) (4.31 MB - PDF)
Thymanax-H-C-916-PSUV-0017 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (84.64 KB - PDF)
CHMP post-authorisation summary of positive opinion for Thymanax
English (EN) (81.04 KB - PDF)
Thymanax : EPAR - Public assessment report
English (EN) (2.46 MB - PDF)