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Ceftazidime / avibactam

Zavicefta

Extended indication

Extension of indication to include treatment of paediatric patients from birth to less than 3-months

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Ceftazidime / avibactam
Domain

Infectious diseases
Reason of inclusion

Indication extension
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
ATMP

No
Submission date

January 2024
Expected Registration

October 2024
Registration phase

Registration application pending
Additional remarks 
NCT04126031

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.