Imreplys (sargramostim)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sargramostim
- Company
- Partner Therapeutics Limited
- Status
- Authorised
- Therapeutic area
- Acute Radiation Syndrome
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Thu 21 Aug 2025
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/006411
- ATC
- L03AA09
- Official record
- www.ema.europa.eu
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). Imreplys should be used in accordance with official radiological/nuclear emergency recommendations.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.