EMEA-001799-PIP03-19 - paediatric investigation plan

the whole range of unmanipulated autologous mononuclear cells derived from human umbilical cord blood (Hau-UCB-mnc)

Key facts

• Active substance:
  the whole range of unmanipulated autologous mononuclear cells derived from human umbilical cord blood (Hau-UCB-mnc)
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0385/2020
• PIP number:
  EMEA-001799-PIP03-19
• Pharmaceutical form(s):
  Suspension for infusion
• Condition(s) / indication(s):
  Treatment of periventricular leukomalacia
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/09/2020
• Compliance check done:
  No

Decision

P/0385/2020 : EMA decision of 25 September 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for the whole range of unmanipulated autologous mononuclear cells... (EMEA-001799-PIP03-19)

Adopted Reference Number: EMA/488671/2020