OMISIRGE

STN: 125738 Proper Name: omidubicel-onlv Tradename: OMISIRGE Manufacturer: Gamida Cell Ltd. Indication: For the treatment of: Adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. Product Information Package Insert - OMISIRGE Demographic Subgroup Information – omidubicel-onlv [OMISIRGE] Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable. Supporting Documents December 5, 2025 Approval Letter - OMISIRGE April 17, 2023 Approval Letter - OMISIRGE April 17, 2023 Summary Basis for Regulatory Action - OMISIRGE Approval History, Letters, Reviews, and Related Documents - OMISIRGE