EMEA-000455-PIP02-10-M09 - paediatric investigation plan

vortioxetine

Key facts

• Invented name:
  • Brintellix
  • Brintellix
• Active substance:
  vortioxetine
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0337/2022
• PIP number:
  EMEA-000455-PIP02-10-M09
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000455-PIP02-10-M09
• Compliance opinion date:
  20/01/2023
• Compliance outcome:
  Positive

Decision

P/0337/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vortioxetine (Brintellix), (EMEA-000455-PIP02-10-M09)

Adopted Reference Number: EMA/671868/2022