Ozenoxacine

Active substance Ozenoxacine
Domain Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Bacterial infections
Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo (krentenbaard) bij volwassenen, adolescenten en kinderen vanaf 2 jaar.

Product

Proprietary name Ozenoxacin Ferrer
Manufacturer Ferrer Internat
Mechanism of action Antibiotic
Route of administration Cutaneous
Therapeutical formulation Cream
Budgetting framework Extramural (GVS)
Additional comments Non-fluorinated quinolone antibacterial agent

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments Vervolgonderzoek gewenst door CBG naar het risico op de ontwikkeling van antibioticaresistentie per juli 2017. Goedgekeurd door de FDA en in Canada.

Therapeutic value

Therapeutic value No judgement
Substantiation Geen meerwaarde verwacht. Genoeg behandelmethoden dus weinig plek. (Gelijke waarde niet aan te geven gezien de vergelijkende behandeling in de studies placebo-vehicle is).
Duration of treatment Average 5 day / days
Frequency of administration 2 times a day

Expected patient volume per year

Additional comments Aantal patiënten heel klein.

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

Indication extension No

Other information

There is currently no futher information available.