Is Sargramostim approved by the US FDA?

Drugs@FDA lists 1 application product line for Sargramostim, including LEUKINE (Prescription).

Is Sargramostim authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sargramostim: Imreplys.

Are there safety signals or safety updates for Sargramostim?

US FDA: 1 entry (latest 2017-02-10).

Active substance

Sargramostim

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LEUKINE	250UG/ML; 500UG/ML	vial	BERLEX LABS	Prescription	5 Mar 1991

EMA European Union — centrally authorised medicines

Imreplys Partner Therapeutics Limited · Authorised · authorised 21 Aug 2025 · ATC L03AA09

Therapeutic indication (EMA)

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). Imreplys should be used in accordance with official radiological/nuclear emergency recommendations.

Safety signals and safety-related labeling changes

US FDA 10 Feb 2017 LEUKINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for sargramostim →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.