Ozenoxacine Medicine 09 January 2018 Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo (krentenbaard) bij volwassenen, adolescenten en kinderen vanaf 2 jaar. Therapeutic value No judgement Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Ozenoxacin Ferrer Manufacturer Ferrer Internat Portfolio holder Mechanism of action Antibiotic Route of administration Cutaneous Therapeutical formulation Cream Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Non-fluorinated quinolone antibacterial agent Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice 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 Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. 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 Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Aantal patiënten heel klein. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks