EMEA-001176-PIP01-11-M06 - paediatric investigation plan

pitolisant

Key facts

• Invented name:
  Wakix
• Active substance:
  pitolisant
• Therapeutic area:
  Neurology
• Decision number:
  P/0057/2021
• PIP number:
  EMEA-001176-PIP01-11-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of narcolepsy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/01/2021
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-001176-PIP01-11-M06
• Compliance opinion date:
  20/05/2022
• Compliance outcome:
  Positive

Decision

P/0057/2021 : EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pitolisant (Wakix) (EMEA-001176-PIP01-11-M06)

Adopted Reference Number: EMA/18865/2021