Slenyto (melatonin)
- Region
- 🇪🇺 EU
- Active substance
- melatonin
- Company
- RAD Neurim Pharmaceuticals EEC SARL
- Status
- Authorised
- Therapeutic area
- Sleep Initiation and Maintenance Disorders; Autistic Disorder
- CHMP opinion
- Thu 26 Jul 2018
- EU approval
- Thu 20 Sep 2018
- Application
- EMEA/H/C/004425
- ATC
- N05CH01
- Official record
- www.ema.europa.eu
Indication
Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Circadin Authorised · RAD Neurim Pharmaceuticals EEC SARL
- 🇪🇺 Melatonin Neurim Authorised · RAD Neurim Pharmaceuticals EEC SARL
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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.