EMEA-003176-PIP02-22 - paediatric investigation plan

cannabidiol

Key facts

• Active substance:
  cannabidiol
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0081/2024
• PIP number:
  EMEA-003176-PIP02-22
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of fragile-X syndrome
• Route(s) of administration:
  Transdermal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/03/2024
• Compliance check done:
  No

Decision

P/0081/2024 : EMA decision of 15 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cannabidiol (EMEA-003176-PIP02-22)

Adopted Reference Number: EMA/101137/2024