EMEA-002121-PIP03-19-M02 - paediatric investigation plan

Daridorexant

Key facts

• Invented name:
  Quviviq
• Active substance:
  Daridorexant
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0054/2024
• PIP number:
  EMEA-002121-PIP03-19-M02
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of insomnia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  Ei

Decision

P/0054/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for daridorexant (Quviviq) (EMEA-002121-PIP03-19-M02)

Adopted Reference Number: P/0054/2024