EMEA-003251-PIP01-22 - paediatric investigation plan

aticaprant

Key facts

• Active Substance:
  aticaprant
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0184/2023
• PIP number:
  EMEA-003251-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International NV

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/05/2023

Decision

P/0184/2023 : EMA decision of 19 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aticaprant (EMEA-003251-PIP01-22)

AdoptedReference Number: EMA/171173/2023