Extended indication Extension of indication to include treatment of paediatric patients aged birth to less than 18 years
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ceftolozane / tazobactam
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Extension of indication to include treatment of paediatric patients aged birth to less than 18 years for Zerbaxa.
Proprietary name Zerbaxa
Manufacturer Merck
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Beta lactamase inhibitors; Cell wall inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

30

Market share is generally not included unless otherwise stated.

Additional comments Het is een geneesmiddel met een relatief smal antimicrobieel spectrum , wat pas bij het Nederlandse beleid om carbapenem-sparend voor te schrijven. Op dit moment wordt voornamelijk meropenem voorgeschreven wat mogelijk ook goedkoper zal zijn dan Zerbaxa. De meeste laboratoria zullen ook niet in de standaard testen en dat werkt ook beperkend. Rekening houdend met deze factoren wordt het gebruik ingeschat op 30 patiƫnten per jaar.

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.