EMA Authorised: Slenyto (melatonin) — RAD Neurim Pharmaceuticals EEC SARL

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Summary

The EMA authorised Slenyto (melatonin) for sleep initiation and maintenance disorders and sleep disturbances associated with autism spectrum disorder.

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Diseases / indications

• Autism Spectrum Disorder
• Insomnia

Drugs mentioned

• Slenyto (melatonin)

Snippet

Status: Authorised. Therapeutic area: Sleep Initiation and Maintenance Disorders;Autistic Disorder. MAH: RAD Neurim Pharmaceuticals EEC SARL. Decision date: 07/11/2025