EMEA-001869-PIP01-15-M02 - paediatric investigation plan

rivogenlecleucel

Key facts

• Active substance:
  rivogenlecleucel
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0378/2019
• PIP number:
  EMEA-001869-PIP01-15-M02
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Adjunctive treatment in haematopoietic stem cell transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/12/2019
• Compliance check done:
  No

Decision

P/0378/2019: EMA decision of December 2019 on the acceptance of a modification of an agreed paediatric investigation plan for rivogenlecleucel (EMEA-001869-PIP01-15-M02)

Adopted Reference Number: EMA/630189/2019