EMEA-001964-PIP01-16-M04 - paediatric investigation plan

cannabidiol

Key facts

• Invented name:
  Epidyolex
• Active substance:
  cannabidiol
• Therapeutic area:
  Neurology
• Decision number:
  P/0218/2022
• PIP number:
  EMEA-001964-PIP01-16-M04
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  • Treatment of seizures associated with Dravet Syndrome (DS)
  • Treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)
  • Treatment of seizures associated with Tuberous Sclerosis Complex (TSC)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/06/2022
• Compliance check done:
  No

Decision

P/0218/2022 : EMA decision of 8 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol (Epidyolex), (EMEA-001964-PIP01-16-M04)

Reference Number: EMA/562057/2022