Version 2

Imipenem / Cilastatin / Relebactam

Medicine

Extended indication Imipenem/cilastatin/relebactam monotherapy for treatment of gram-negative Bacterial infection in newborns, infants, toddlers, children and adolescents
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Imipenem / Cilastatin / Relebactam
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Imipenem/cilastatin/relebactam monotherapy for treatment of gram-negative Bacterial infection in newborns, infants, toddlers, children and adolescents with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infection, or complicated urinary tract infection.
Proprietary name Recarbrio
Manufacturer MSD
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date April 2025
Expected Registration February 2026
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
References NCT03969901

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks De inzet van Recarbio is beperkt in Nederland. Deze indicatieuitbreiding naar niet-volwassenen zal daarom een zeer gering effect hebben op het patiëntvolume.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information