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.