Chloroprocaine Medicine 03 June 2025 Extended indication Chloroprocaine monotherapy for treatment of Local anaesthesia in newborns, infants and toddlers, children and adolescents. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Clinical trials Product Active substance Chloroprocaine Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Pain Extended indication Chloroprocaine monotherapy for treatment of Local anaesthesia in newborns, infants and toddlers, children and adolescents. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Sintetica Portfolio holder Mechanism of action Other Route of administration Ocular Therapeutical formulation Instillation fluid Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date July 2026 Expected Registration August 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. 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 De fase 3 trial heeft nog geen resultaten. Er wordt weinig inzet verwacht. Eventueel zou het gebruikt kunnen worden bij screening van premature baby's op retinopathie (ROP). Echter is er al een lidocaïne ooggel op de markt, welke oogheelkundig weinig gebruikt wordt en ook bij de screening/behandeling nog niet is ingezet. Duration of treatment Frequency of administration Dosage per administration References NCT05926258 (CHL.3-01-2021-M); Expertopinie Additional remarks Er worden twee druppels in beide ogen toegediend. Bij elke toediening worden de twee druppels één voor één toegediend, met een interval van 1 minuut. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Er wordt weinig inzet verwacht. Expected cost per patient per year Cost References drugs.com Additional remarks Er is geen Nederlandse lijstprijs bekend. In de Verenigde Staten kost een oplossing van 200ml $186,80 - $195,79. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks