Proper Name: omidubicel-onlv
Manufacturer: Gamida Cell Ltd.
- For use in 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.
- 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.
- April 17, 2023 Summary Basis for Regulatory Action - OMISIRGE
- April 17, 2023 Approval Letter - OMISIRGE
- Approval History, Letters, Reviews, and Related Documents - OMISIRGE