Melatonine Medicine 03 December 2024 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) Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registration application pending Product Active substance Melatonine Domain Neurological disorders Reason of inclusion Indication extension IND 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) Current proprietary name Already available biosimilars / generics Proprietary name Slenyto Manufacturer Neurim Portfolio holder Mechanism of action Hormonal therapy Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise 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 Particularity Unknown ATMP No Submission date January 2024 Expected Registration November 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks