Quote this publication Share Print

VALDOXAN (agomelatine), antidepressant

Opinions on drugs - Posted on Apr 18 2016

Reason for request

Renewal of Inclusion

No clinical benefit demonstrated in the treatment of major depressive episodes in adults.


  • VALDOXAN has Marketing Authorisation in the treatment of major (i.e. clear) depressive episodes in adults.
  • Its efficacy is modest and has been demonstrated only in the short term (6-12 weeks) versus placebo. It has not been shown to have any impact on the remission rates for depressive episodes, the primary efficacy endpoint. Its use necessitates strict monitoring of liver function before the initiation of and throughout the treatment.

Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


Contact Us

Évaluation des médicaments