remestemcel-l-rknd

FDA Drug Profile — RYONCIL

Drug Details

Generic Name
remestemcel-l-rknd
Brand Names
RYONCIL
Application Number
BLA125706
Sponsor
Mesoblast
NDC Codes
12
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE RYONCIL is indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. RYONCIL is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.