Thymanax
Withdrawn
This medicine's authorisation has been withdrawn
agomelatine
MedicineHumanWithdrawn
- 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The European Public Assessment Report (EPAR) for Thymanax is updated to indicate that the marketing authorisation is no longer valid.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)
First published: Last updated:
български (BG) (265.32 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
español (ES) (189.36 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
čeština (CS) (240.21 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
dansk (DA) (187.1 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Deutsch (DE) (196.52 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
eesti keel (ET) (175.2 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
ελληνικά (EL) (282.5 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
français (FR) (193.28 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
hrvatski (HR) (226.52 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
italiano (IT) (186.03 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
latviešu valoda (LV) (234.67 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
lietuvių kalba (LT) (237.82 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
magyar (HU) (221.45 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Malti (MT) (244.64 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Nederlands (NL) (191.44 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
polski (PL) (240.61 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
português (PT) (190.48 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
română (RO) (242.93 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenčina (SK) (228.66 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenščina (SL) (222.81 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Suomi (FI) (178.88 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
svenska (SV) (185.36 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Thymanax : EPAR - Risk-management-plan summary
English (EN) (301.31 KB - PDF)
First published: Last updated:
Product information
Thymanax : EPAR - Product Information
English (EN) (1.2 MB - PDF)
First published: Last updated:
български (BG) (1.67 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
español (ES) (632.66 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
čeština (CS) (1.5 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
dansk (DA) (1005.48 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Deutsch (DE) (1.24 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
eesti keel (ET) (1.22 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
ελληνικά (EL) (1.97 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
français (FR) (1.31 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
hrvatski (HR) (1.48 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
íslenska (IS) (1.02 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
italiano (IT) (1.17 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
latviešu valoda (LV) (1.46 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
lietuvių kalba (LT) (1.41 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
magyar (HU) (1.36 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Malti (MT) (1.3 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Nederlands (NL) (1.04 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
norsk (NO) (997.47 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
polski (PL) (1.44 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
português (PT) (1.15 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
română (RO) (1.47 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenčina (SK) (1.17 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenščina (SL) (1.36 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Suomi (FI) (1.06 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
svenska (SV) (1.06 MB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Latest procedure affecting product information:
N/0048
31/07/2022
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)
First published: Last updated:
български (BG) (95.19 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
español (ES) (38.56 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
čeština (CS) (83.91 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
dansk (DA) (78.01 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Deutsch (DE) (42.43 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
eesti keel (ET) (37.7 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
ελληνικά (EL) (115.34 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
français (FR) (41.7 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
hrvatski (HR) (138.35 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
íslenska (IS) (73.54 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
italiano (IT) (37.71 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
latviešu valoda (LV) (109.09 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
lietuvių kalba (LT) (107.35 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
magyar (HU) (108.52 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Malti (MT) (102.34 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Nederlands (NL) (37.97 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
norsk (NO) (74.61 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
polski (PL) (68.86 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
português (PT) (40.26 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
română (RO) (102.32 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenčina (SK) (72.01 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
slovenščina (SL) (91.59 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
Suomi (FI) (41.43 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
svenska (SV) (40.64 KB - PDF)
First published: 16/03/2009Last updated: 08/08/2023
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)
First published: Last updated:
Thymanax : EPAR-H-C-000916-P46-032 - Assessment Report
AdoptedReference Number: EMA/CHMP/613378/2022
English (EN) (1.39 MB - PDF)
First published:
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)
First published: Last updated:
Thymanax-PSUSA-0000071-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/19569/2016
English (EN) (105.02 KB - PDF)
First published: Last updated:
Thymanax-H-C-916-P46-0027: EPAR - Assessment Report
AdoptedReference Number: EMA/6251/2016
English (EN) (1.47 MB - PDF)
First published: Last updated:
Thymanax-H-C-916-PSUV-0021 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/717807/2014
English (EN) (124.68 KB - PDF)
First published: Last updated:
Thymanax-H-C-916-PSUV-0019 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/702809/2013
English (EN) (4.31 MB - PDF)
First published: Last updated:
Thymanax-H-C-916-PSUV-0017 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/740413/2013
English (EN) (84.64 KB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Thymanax
AdoptedReference Number: EMA/CHMP/578213/2013
English (EN) (81.04 KB - PDF)
First published: Last updated:
Thymanax : EPAR - Public assessment report
English (EN) (2.46 MB - PDF)
First published: Last updated:
News on Thymanax
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