EMA/PE/0000183866 - paediatric investigation plan

brexpiprazole

Key facts

• Invented name:
  Rxulti
• Active substance:
  brexpiprazole
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  EMA/PE/0000183866
• PIP number:
  EMA/PE/0000183866
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/12/2024
• Compliance check done:
  Nie

Decision

EMA/PE/0000183866 : EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for brexpiprazole (Rxulti)

Adopted Reference Number: EMADOC-1700519818-1791709