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Archived: agomelatine (Valdoxan)


Following a full submission

agomelatine (Valdoxan) is not recommended for use within NHS Scotland for the treatment of major depressive episodes in adults.

When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are limited comparative data against existing antidepressants and the results of such comparisons are variable.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.

Drug Details

Drug Name: agomelatine (Valdoxan)
SMC Drug ID: 564/09
Manufacturer: Servier Laboratories Ltd
Indication: Major depressive episodes
BNF Category:
Sub Category: 4.3 Antidepressant drugs
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 9 November 2009

Current Advice

Resubmission 13 September 2010