Midazolam/ketamine Medicine 03 June 2025 Extended indication Midazolam/ketamine monotherapy for treatment of procedural Sedation in adults and elderly undergoing cataract extraction with lens replacement. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Midazolam/ketamine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Midazolam/ketamine monotherapy for treatment of procedural Sedation in adults and elderly undergoing cataract extraction with lens replacement. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Melt Portfolio holder Mechanism of action Route of administration Sublingual Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2027 Expected Registration April 2028 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 No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT06383273 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 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks