Raltegravir Medicine 07 June 2022 Extended indication patients with human immunodeficiency virus 1 (HIV-1) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Raltegravir Domain Infectious diseases Reason of inclusion Biosimilar BS Main indication HIV Extended indication patients with human immunodeficiency virus 1 (HIV-1) Current proprietary name Isentress (MSD) Already available biosimilars / generics Proprietary name onbekend Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2022 Expected Registration April 2023 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Biosimilar opgenomen in de "medicine under evaluation" by the CHMP van de EMA in Maart 2022. SPC voor volwassenen verloopt 1 januari 2023, voor pediatrische indicatie op 1 juli 2023. 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 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