EMEA-003496-PIP01-23 - paediatric investigation plan

allogeneic cultured postnatal thymus-derived tissue

Key facts

• Active substance:
  allogeneic cultured postnatal thymus-derived tissue
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0518/2023
• PIP number:
  EMEA-003496-PIP01-23
• Pharmaceutical form(s):
  Living tissue equivalent
• Condition(s) / indication(s):
  Treatment of congenital athymia
• Route(s) of administration:
  Implant use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0518/2023 : EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for allogeneic cultured postnatal thymus-derived tissue (EMEA-003496-PIP01-23)

Reference Number: EMA/554964/2023