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:
  EMA/PE/0000224597
• 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:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  06/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000224597 : EMA decision of 6 January 2025 on the refusal of a modification of an agreed paediatric investigation plan for cariprazine hydrochloride (Reagila)

Adopted Reference Number: EMADOC-1700519818-1809723