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VALDOXAN (agomelatine), antidepressant

PSYCHIATRY - Focus
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.

Actual benefit

Faible

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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