EMEA-002746-PIP01-20-M03 - paediatric investigation plan

Seltorexant

Key facts

• Active Substance:
  Seltorexant
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  P/0104/2024
• PIP number:
  EMEA-002746-PIP01-20-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate dosage form
• 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:
  12/04/2024

Decision

P/0104/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for seltorexant (EMEA-002746-PIP01-20-M03)