EMEA-001531-PIP01-13-M04 - paediatric investigation plan

tasimelteon

Key facts

• Invented name:
  • Hetlioz
  • Hetlioz
• Active Substance:
  tasimelteon
• Therapeutic area:
  Neurology
• Decision number:
  P/0215/2018
• PIP number:
  EMEA-001531-PIP01-13-M04
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of non-24-hour sleep-wake disorder in the totally blind
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2018

Decision

P/0215/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tasimelteon (Hetlioz), (EMEA-001531-PIP01-13-M04)

AdoptedReference Number: EMA/465547/2018