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

  • Content current as of:

    12/08/2025

Source

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

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Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.