EMEA-002706-PIP01-19-M03 - paediatric investigation plan

allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)

Key facts

• Active substance:
  allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0276/2024
• PIP number:
  EMEA-002706-PIP01-19-M03
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of acute graft-versus-host disease (aGvHD)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2024
• Compliance check done:
  No

Decision

P/0276/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518), (EMEA-002706-PIP01-19- M03)

Adopted Reference Number: EMA/307425/2024