EMEA-003315-PIP01-22 - paediatric investigation plan

mRNA encoding modified human ornithine transcarbamylase (ARCT-810)

Key facts

• Active substance:
  mRNA encoding modified human ornithine transcarbamylase (ARCT-810)
• Therapeutic area:
  Other
• Decision number:
  P/0314/2023
• PIP number:
  EMEA-003315-PIP01-22
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of ornithine transcarbamylase deficiency
• 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:
  09/08/2023
• Compliance check done:
  No

Decision

P/0314/2023 : EMA decision of 9 August 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for mRNA encoding modified human ornithine transcarbamylase (ARCT-810), (EMEA-003315-PIP01-22)

Adopted Reference Number: EMA/336054/2023