Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide Medicine 03 June 2025 Extended indication Darunavir/cobicistat/emtricitabine/tenofovir alafenamide monotherapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25 kg. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Darunavir/cobicistat/emtricitabine/tenofovir alafenamide monotherapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25 kg. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date February 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 NCT02016924 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