STN: 125738
Proper Name: omidubicel-onlv
Tradename: OMISIRGE
Manufacturer: Gamida Cell Ltd.
Indication:

• 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.

Product Information

• Package Insert - OMISIRGE 

Supporting Documents

• April 17, 2023 Approval Letter - OMISIRGE