EMEA-002946-PIP01-20 - paediatric investigation plan

MIJ821

Key facts

• Active substance:
  MIJ821
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0082/2022
• PIP number:
  EMEA-002946-PIP01-20
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• 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:
  11/03/2022
• Compliance check done:
  No

Decision

P/0082/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for MIJ821 (EMEA-002946-PIP01-20)

Adopted Reference Number: EMA/99133/2022