EMEA-001652-PIP01-14-M06 - paediatric investigation plan

cariprazine hydrochloride

Key facts

• Invented name:
  Reagila
• Active substance:
  cariprazine hydrochloride
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  P/0235/2024
• PIP number:
  EMEA-001652-PIP01-14-M06
• Pharmaceutical form(s):
  • Capsule, hard
  • Orodispersible 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:
  18/07/2024
• Compliance check done:
  No

Decision

P/0235/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila), (EMEA-001652-PIP01-14-M06)

Adopted Reference Number: EMA/320584/2024