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agomelatine (Valdoxan) Resubmission


following a re-submission

agomelatine (Valdoxan®) is not recommended for use within NHS Scotland.

Indication under review: 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 no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome.

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) Resubmission
SMC Drug ID: 564/09
Manufacturer: Servier Laboratories Ltd
Indication: Major depressive epsiodes in adults.
BNF Category:
Sub Category: 4.3 Antidepressant drugs
Submission Type: Resubmission
Status: Not Recommended
Date Advice Published: 13 September 2010

Archived Advice

Full submission 9 November 2009