Valdoxan

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 marketi ng authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets in tended for the treatment of major depressive disorder. The company that applied is Les Labor atoires Servier. The applicant requested a re- examination 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:
  Valdoxan
• 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/000656
• Marketing authorisation applicant:
  Les Laboratoires Servier
• Opinion adopted:
  27/07/2006
• Refusal of marketing authorisation:
  16/01/2007

Assessment history

Valdoxan : EPAR - Refusal public assessment report

Adopted Reference Number: EMEA/CHMP/87018/2006