Version 1

Ceftazidime / avibactam

Medicine

Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated i
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ceftazidime / avibactam
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) and in the treatment of infections due to aerobic Gram-negative organisms in patients with limited treatment options.
Proprietary name Zavicefta
Manufacturer Pfizer
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date January 2024
Expected Registration October 2024
Orphan drug Unknown
Registration phase Registration application pending
Additional remarks NCT04126031

Therapeutic value

Therapeutic value No estimate possible yet

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

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

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information