Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo (krentenbaard) bij volwassenen, adolescenten en k
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Ozenoxacine
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo (krentenbaard) bij volwassenen, adolescenten en kinderen vanaf 2 jaar.
Proprietary name Ozenoxacin Ferrer
Manufacturer Ferrer Internat
Route of administration Cutaneous
Therapeutical formulation Cream
Budgetting framework Extramural (GVS)
Additional remarks Non-fluorinated quinolone antibacterial agent

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks 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.
Duration of treatment Average 5 day / days
Frequency of administration 2 times a day

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

Indication extension No

Other information

There is currently no futher information available.