Sargramostim Medicine 04 December 2025 Extended indication Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome [H-ARS]. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Sargramostim Domain Hematology Reason of inclusion New medicine (specialité) Main indication Other hematology Extended indication Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome [H-ARS]. Current proprietary name Already available biosimilars / generics Proprietary name Imreplys Manufacturer Partner Therapeutics Portfolio holder Partner Therapeutics Mechanism of action Other, see general comments Route of administration Unknown Therapeutical formulation Powder for injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Partner Therapeutics. Granulocyte-macrophage colony-stimulating factor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2024 Expected Registration August 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in juni 2025. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks