EMEA-001531-PIP01-13-M06 - paediatric investigation plan

tasimelteon

Key facts

• Invented name:
  • Hetlioz
  • Hetlioz
• Active substance:
  tasimelteon
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0329/2024
• PIP number:
  EMEA-001531-PIP01-13-M06
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate liquid form
• Condition(s) / indication(s):
  Treatment of disorders of the sleep-wake schedule
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0329/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tasimelteon (Hetlioz), (EMEA-001531-PIP01-13-M06)

Adopted Reference Number: EMA/413795/2024