Ceftobiprole medocaril Medicine 03 June 2025 Extended indication Ceftobiprole medocaril monotherapy for adjunctive treatment of late-onset neonatal sepsis in preterm neonates, neonates, infants and toddlers up to 3 months of age. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ceftobiprole medocaril Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Ceftobiprole medocaril monotherapy for adjunctive treatment of late-onset neonatal sepsis in preterm neonates, neonates, infants and toddlers up to 3 months of age. Current proprietary name Already available biosimilars / generics Proprietary name Zevtera Manufacturer Basilea Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Powder for injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials 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 De verwachting is dat het geen plaats in de behandeling krijgt in Nederland. Duration of treatment Frequency of administration Dosage per administration 7,5mg/kg om de 12 uur tot 15mg/kg om de 8 uur, intraveneus toegediend als een infuus van 2 uur. References NCT05856227 (BPR-PIP-003) Additional remarks Expected patient volume per year Patient volume < 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) CBS; (2) Neonatology of The Journal of Pediatrics. Additional remarks In Nederland worden jaarlijks ongeveer 170.000 baby's geboren (1). De incidentie van LOS bij te vroeg geboren baby's is ongeveer 20% (2). Dit betekent dat er jaarlijks ongeveer 340 te vroeg geboren baby's in Nederland de diagnose LOS zouden krijgen. De inschatting van de werkgroep is dat het middel geen plaats in de behandeling krijgt. 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