Seviprotimut-L Medicine 13 December 2018 Extended indication Malignant melanoma; post-resection, stages IIb-III. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Seviprotimut-L Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Malignant melanoma; post-resection, stages IIb-III. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Polynoma Portfolio holder Mechanism of action Immunostimulation Route of administration Intrader meal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Vaccin Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indien de MAVIS trial succesvol is zal er mogelijk snel een indiening volgen. Primary completion date is januari 2019. 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 0,2 ml References Additional remarks NCT01546571: "POL-103A is administered intradermally, divided into 4 injections (0,2mL each injection) into the volar surface of forearms and into the anterior upper thighs". Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Stadium II melanoom 950 patiënten en stadium III melanoom 419 patiënten. 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 No Indication extensions References Additional remarks Other information Additional remarks