Thymanax

Withdrawn

This medicine's authorisation has been withdrawn

agomelatine

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The European Public Assessment Report (EPAR) for Thymanax is updated to indicate that the marketing authorisation is no longer valid.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

Thymanax : EPAR - Risk-management-plan summary

Product information

Thymanax : EPAR - Product Information

Thymanax : EPAR - All Authorised presentations

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

Psychoanaleptics

Therapeutic 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

Changes since initial authorisation of medicine

Thymanax : EPAR - Procedural steps taken and scientific information after authorisation

Thymanax : EPAR-H-C-000916-P46-032 - Assessment Report

Adopted Reference Number: EMA/CHMP/613378/2022

Thymanax-H-C-PSUSA-00000071-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Thymanax-PSUSA-0000071-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/19569/2016

Thymanax-H-C-916-P46-0027: EPAR - Assessment Report

Adopted Reference Number: EMA/6251/2016

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

Thymanax-H-C-916-PSUV-0019 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/702809/2013

Thymanax-H-C-916-PSUV-0017 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/740413/2013

CHMP post-authorisation summary of positive opinion for Thymanax

Adopted Reference Number: EMA/CHMP/578213/2013

Initial marketing authorisation documents

Thymanax : EPAR - Public assessment report