EMEA-001652-PIP01-14-M05 - paediatric investigation plan

Cariprazine (hydrochloride)

Key facts

• Invented name:
  Reagila
• Active Substance:
  Cariprazine (hydrochloride)
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0162/2023
• PIP number:
  EMEA-001652-PIP01-14-M05
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  12/05/2023

Decision

P/0061/2023 : EMA decision of 24 February 2023 on the refusal of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila), (EMEA-001652-PIP01-14-M04)

Reference Number: EMA/74599/2023