Hetlioz (tasimelteon)
- Region
- 🇪🇺 EU
- Active substance
- tasimelteon
- Company
- Vanda Pharmaceuticals Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Sleep Disorders, Circadian Rhythm
- CHMP opinion
- Thu 23 Apr 2015
- EU approval
- Fri 03 Jul 2015
- Application
- EMEA/H/C/003870
- ATC
- N05CH
- Official record
- www.ema.europa.eu
Indication
Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Regulatory milestones
No milestones recorded in the last year.
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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.