Extended indication Imipenem/cilastatin/funobactam monotherapy for treatment of complicated Urinary tract infection in adults and eldery.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Imipenem / cilastatin / funobactam
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Imipenem/cilastatin/funobactam monotherapy for treatment of complicated Urinary tract infection in adults and eldery.
Manufacturer Evopoint
Portfolio holder Evopoint
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2026
Expected Registration October 2027
Orphan drug No
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet

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

References NCT05204368; NCT05204563 (REITAB-2)
Additional remarks Imipenem/cilastatine 500mg/500mg in combinatie met funobactam 250mg intraveneus elke zes uur toegediend over 30 minuten.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information