PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0215/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tisagenlecleucel (Kymriah), (EMEA-001654-PIP01-14-M04)
Public summary of the evaluation of a proposed product-specific waiver: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (CTL019)