EMA/PE/0000223040 - paediatric investigation plan

iloperidone

Key facts

• Active substance:
  iloperidone
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  EMA/PE/0000223040
• PIP number:
  EMA/PE/0000223040
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of bipolar disorder
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/06/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000223040 : EMA decision of 12 June 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iloperidone

Adopted Reference Number: EMADOC-1700519818-2187648