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Melatonine

Slenyto

Extended indication Extension of indication for the treatment of insomnia in children and adolescents aged 2 till 18 to
Therapeutic value Possibly no place in the treatment regimen
Registration phase Registration application pending

Product

Active substance Melatonine
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Sleep disorders
Extended indication Extension of indication for the treatment of insomnia in children and adolescents aged 2 till 18 to include neurogenetic disorders (e.g., Angelman syndrome, Rett syndrome, Tuberous sclerosis complex and Williams syndrome)
Proprietary name Slenyto
Manufacturer Neurim
Mechanism of action Hormonal therapy
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Slenyto is niet als product op de markt in Nederland op dit moment. Het moet uit het buitenland worden gehaald om gebruikt te worden. Voor zover bekend gebeurt dit niet.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration November 2025
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value Possibly no place in the treatment regimen
Frequency of administration 1 times a day

Expected patient volume per year

Additional remarks Slenyto wordt op dit moment niet gebruikt in Nederland. Een inschatting van het patiëntvolume en kosten is daarom niet van toepassing.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use Yes
Indications off label use Kinderen met andere slaapproblemen.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.