Slenyto

RSS

melatonin

Authorised
This medicine is authorised for use in the European Union.

Overview

Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:

  • autism spectrum disorder (ASD), a range of conditions that affects the patient’s social interactions;
  • Smith-Magenis syndrome, a condition that can lead to learning difficulties.

Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.

The medicine contains the active substance melatonin.

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Slenyto
Agency product number
EMEA/H/C/004425
Active substance
melatonin
International non-proprietary name (INN) or common name
melatonin
Therapeutic area (MeSH)
  • Sleep Initiation and Maintenance Disorders
  • Autistic Disorder
Anatomical therapeutic chemical (ATC) code
N05CH01
Publication details
Marketing-authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address

4 rue de Marivaux
75002 Paris
France

Product information

22/08/2019 Slenyto - EMEA/H/C/004425 - IB/0012

Contents

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Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

Assessment history

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