Thymanax

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Agomelatine

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketing authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets intended for the treatment of major depressive disorder. The company that applied is Les Laboratoires Servier. The applicant requested a reexamination of the opinion, but withdrew this request before the CHMP completed the re-examination.

This EPAR was last updated on 27/07/2006

Application details

Product details
Name
Thymanax
Active substance
Agomelatine
International non-proprietary name (INN) or common name
Agomelatine
Therapeutic area (MeSH)
Depressive Disorder, Major
Application details
Marketing-authorisation applicant
Les Laboratoires Servier
Date of opinion
27/07/2006
Date of refusal of marketing authorisation
16/01/2007

Assessment history

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