Posaconazol Medicine 04 December 2025 Extended indication Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Posaconazol Domain Infectious diseases Reason of inclusion Biosimilar BS Main indication Fungal infections Extended indication Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104. Current proprietary name Already available biosimilars / generics Proprietary name Noxafil Manufacturer MSD Portfolio holder MSD Mechanism of action Antifungals Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dit betreft een verandering in de registratie om de posologie van de drie toedieningsvormen (IV, PFS en tablet) voor de leeftijdsgroep 2 tot 18 jaar te harmoniseren. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date April 2025 Expected Registration December 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04218851 (MK-5592-104) 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks