Ozenoxacine Medicine 09 January 2018 Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo bij volwassenen, adolescenten en kinderen vanaf 2 jaar. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Ozenoxacine Domain Infectious diseases Reason of inclusion Main indication Bacterial infections Extended indication Kortetermijnbehandeling van niet-bulleuze impetigo bij volwassenen, adolescenten en kinderen vanaf 2 jaar. Current proprietary name Already available biosimilars / generics Proprietary name Ozanex Manufacturer Cipher Portfolio holder Mechanism of action Unknown Route of administration Cutaneous Therapeutical formulation Cream Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Ozenoxacine is een antibioticumhoudende crème voor behandeling van impetigo (krentenbaard). Registration Registration route National (CBG) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Vervolgonderzoek gewenst door CBG naar het risico op de ontwikkeling van antibioticaresistentie per juli 2017. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Geen meerwaarde verwacht. 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 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 Unknown Indication extensions References Additional remarks Other information Additional remarks