Thymanax

Refused

This medicine has been refused authorisation

agomelatine

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.

Questions and answers on the recommendation for the refusal of the marketing authorization for Valdoxan/Thymanax

Product details

• Name of medicine:
  Thymanax
• Active substance:
  Agomelatine
• International non-proprietary name (INN) or common name:
  agomelatine
• Therapeutic area (MeSH):
  Depressive Disorder, Major

Application details

• EMA product number:
  EMEA/H/C/000657
• Marketing authorisation applicant:
  Les Laboratoires Servier
• Opinion adopted:
  27/07/2006
• Refusal of marketing authorisation:
  16/01/2007

Assessment history

Thymanax : EPAR - Refusal public assessment report

AdoptedReference Number: EMEA/37021/2007 - update