Valdoxan (agomelatine)
- Region
- 🇪🇺 EU
- Active substance
- agomelatine
- Company
- Les Laboratoires Servier
- Status
- Authorised
- Therapeutic area
- Depressive Disorder, Major
- CHMP opinion
- Thu 20 Nov 2008
- EU approval
- Thu 19 Feb 2009
- Application
- EMEA/H/C/000915
- ATC
- N06AX22
- Official record
- www.ema.europa.eu
Indication
Treatment of major depressive episodes in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Thymanax Withdrawn · Servier (Ireland) Industries Ltd
- 🇪🇺 Valdoxan Refused · Les Laboratoires Servier
- 🇪🇺 Thymanax Refused · Les Laboratoires Servier
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.