EMA/PE/0000233864 - paediatric investigation plan

Daridorexant

Key facts

• Invented name:
  Quviviq
• Active substance:
  Daridorexant
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000233864
• PIP number:
  EMA/PE/0000233864
• 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:
  16/04/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000233864 : EMA decision of 16 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for daridorexant (Quviviq)

Adopted Reference Number: EMADOC-1700519818-2037057