Thymanax

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Withdrawn

This medicine's authorisation has been withdrawn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The European Public Assessment Report (EPAR) for Thymanax is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: N/0048
31/07/2022
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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).

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slovenčina (SK) (72.01 KB - PDF)

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slovenščina (SL) (91.59 KB - PDF)

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Suomi (FI) (41.43 KB - PDF)

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svenska (SV) (40.64 KB - PDF)

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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

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