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ACTIVE SUBSTANCE / INN

SARGRAMOSTIM

Brand name(s): LEUKINE, Imreplys
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
BLA103362
Acute Radiation Syndrome
ACTIVE SUBSTANCE
Sargramostim
REGULATORS
FDA · EMA
SPONSORS / MAH
Partner Therapeutics Limited, BERLEX LABS
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LEUKINEBLA103362BERLEX LABSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ImreplysPartner Therapeutics LimitedAuthorised21/08/2025Acute Radiation Syndrome

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