Sufentanil / ketamine Medicine 04 December 2025 Extended indication Treatment of acute pain in children aged 1 to less than 18 years. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sufentanil / ketamine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Treatment of acute pain in children aged 1 to less than 18 years. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Proveca Portfolio holder Proveca Mechanism of action Route of administration Nasal Therapeutical formulation Spray Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Proveca Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date August 2025 Expected Registration September 2026 Orphan drug Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 NCT06364072 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