Melatonin Neurim (melatonin)
- Region
- 🇪🇺 EU
- Active substance
- melatonin
- Company
- RAD Neurim Pharmaceuticals EEC SARL
- Status
- Authorised
- Therapeutic area
- Sleep Initiation and Maintenance Disorders
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Mon 07 Nov 2022
- Application
- EMEA/H/C/005603
- ATC
- N05CH01
- Official record
- www.ema.europa.eu
Indication
Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Slenyto Authorised · RAD Neurim Pharmaceuticals EEC SARL
- 🇪🇺 Circadin 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.