EMEA-001185-PIP01-11-M08 - paediatric investigation plan

brexpiprazole

Key facts

• Invented name:
  Rxulti
• Active Substance:
  brexpiprazole
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0294/2022
• PIP number:
  EMEA-001185-PIP01-11-M08
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of schizophrenia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Otsuka Pharmaceutical Development and Commercialisation Europe GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022

Decision

P/0294/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brexpiprazole (Rxulti), (EMEA-001185-PIP01-11-M08)

AdoptedReference Number: EMA/638299/2022