Seviprotimut-L Active substance Seviprotimut-LDomain Oncology and HematologyReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Skin cancerExtended indication Malignant melanoma; post-resection, stages IIb-III 1. Product Manufacturer PolynomaMechanism of action ImmunostimulationRoute of administration Intrader mealTherapeutical formulation InjectionBudgetting framework Intermural (MSZ)Additional comments Vaccin 2. Registration Registration route Centralised (EMA)Submission date 2019Expected Registration 2020Registration phase Clinical trialsAdditional comments Indien de MAVIS trial succesvol is zal er mogelijk snel een indiening volgen. Primary completion date is januari 2019. 3. Therapeutic value Therapeutic value No judgementDuration of treatment Not foundDosage per administration 0,2 mlAdditional comments NCT01546571: "POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs." 4. Expected patient volume per year References NKRAdditional comments Stadium II melanoom 950 patiënten en stadium III melanoom 419 patiënten. 5. Expected cost per patient per year There is currently nothing known about the expected cost. 6. Potential total cost per year There is currently nothing known about the possible total cost. 7. Off label use There is currently nothing known about off label use. 8. Indication extension Indication extension No 9. Other information There is currently no futher information available.