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  1. Cellular & Gene Therapy Products

STN: 125706 
Proper Name: remestemcel-L-rknd
Tradename: RYONCIL  
Manufacturer: Mesoblast, Inc. 
Indication:

  • Indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.

Product Information

  • Package Insert - RYONCIL
  • Demographic Subgroup Information – remestemcel-L-rknd (RYONCIL) 
    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

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