Cefiderocol Medicine 04 June 2026 Extended indication Extension of indication to include treatment of infections due to aerobic Gram-negative organisms in paediatric (birth to less than 18 years old) patients with limited treatment options. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Cefiderocol Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include treatment of infections due to aerobic Gram-negative organisms in paediatric (birth to less than 18 years old) patients with limited treatment options. Current proprietary name Already available biosimilars / generics Proprietary name Fetcroja Manufacturer Shionogi Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date April 2026 Expected Registration March 2027 Orphan drug Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value 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 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