Pritelivir Medicine 03 June 2025 Extended indication Pritelivir monotherapie voor de behandeling van aciclovir-resistente mucocutane HSV-infectie bij immuun gecompromitteerde adolescenten ouder dan 16 jaar, volwassenen en ouderen. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pritelivir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Pritelivir monotherapie voor de behandeling van aciclovir-resistente mucocutane HSV-infectie bij immuun gecompromitteerde adolescenten ouder dan 16 jaar, volwassenen en ouderen. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aicuris Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: DNA helicase-primase inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. 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 NCT03073967 (PRIOH-1) 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 Er is nog niets bekend over de mogelijke prijs in Nederland. 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