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Melatonin

Slenyto

Extended indication Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Melatonin
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Sleep disorders
Extended 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.
Proprietary name Slenyto
Manufacturer Neurim
Mechanism of action Hormonal therapy
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date June 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registered
Additional remarks Betreft een nieuwe formulering. Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018.

Therapeutic value

Therapeutic value No judgement
Substantiation Het is nog onduidelijk wat er nieuw is aan de formulering van dit middel en wat de directe vergelijkende behandeling is. Om die reden lastig in te schatten wat de therapeutische waarde is van dit geneesmiddel bij de desbetreffende indicatie.
Frequency of administration 1 times a day
Dosage per administration 0,5 mg tot 3 mg
References Farmacotherapuetisch Kompas; Sánchez-Barceló et al. Int J Pediatr. 2011;2011:892624

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 100.00 - 200.00
References Medicijnkosten.nl.
Additional remarks Verwachting is dat het meerkosten gaat opleveren. Schatting kosten per patiënt per jaar: huidige kosten melatonin.

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 slaap problemen.

Indication extension

Indication extension Yes
Indication extensions Kinderen met andere slaapproblemen
References Clinicaltrials.gov.

Other information

There is currently no futher information available.