Bupivacaine extended release Medicine 07 December 2021 Extended indication Extension of indication to include children over 6 years old Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Bupivacaine extended release Domain Neurological disorders Reason of inclusion Indication extension IND Main indication Pain Extended indication Extension of indication to include children over 6 years old Current proprietary name Already available biosimilars / generics Proprietary name Exparel Manufacturer Pacira Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2021 Expected Registration July 2022 Orphan drug No 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 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 Website fabrikant Additional remarks Fabrikant geeft aan dat een dosering van 133 mg (10 ml) voor $189,37 beschikbaar is en 266 mg (20 ml) voor $344,20 in Amerika 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 Unknown Indication extensions References Additional remarks Other information Additional remarks