Slenyto
melatonin
Table of contents
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.
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List item
Slenyto : EPAR - Medicine overview (PDF/73.1 KB)
First published: 10/10/2018
EMA/570422/2018 -
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List item
Slenyto : EPAR - Risk-management-plan summary (PDF/138.26 KB)
First published: 10/10/2018
Last updated: 18/11/2019
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) |
|
Anatomical therapeutic chemical (ATC) code |
N05CH01
|
Publication details | |
---|---|
Marketing-authorisation holder |
RAD Neurim Pharmaceuticals EEC SARL
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
20/09/2018
|
Contact address |
4 rue de Marivaux |
Product information
18/02/2021 Slenyto - EMEA/H/C/004425 - II/0017
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.