Roluperidon Medicine 07 December 2022 Extended indication Adult Patients With Negative Symptoms of Schizophrenia Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Roluperidon Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Schizophrenia, psychosis, bipolar disorder Extended indication Adult Patients With Negative Symptoms of Schizophrenia Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Minerva Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indiening bij de FDA heeft al plaatsgevonden. Therapeutic value Current treatment options Risperidon Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog te vroeg om iets over de mogelijke meerwaarde te zeggen. Ook is het de vraag of dit geneesmiddel echt iets nieuws brengt ten opzichte van risperidon. Duration of treatment Frequency of administration 1 times a day Dosage per administration 32-64 mg References NCT03397134 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie(1); Additional remarks Er wordt indien dit geneesmiddel registratie zal halen een klein patiëntvolume verwacht. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Adis insight Additional remarks Nieuwe indicaties bevinden zich nog in de preklinische fases. Other information Additional remarks