EMEA-001964-PIP02-19 - paediatric investigation plan

Cannabidiol

Key facts

• Invented name:
  Epidyolex
• Active Substance:
  Cannabidiol
• Therapeutic area:
  Neurology
• Decision number:
  P/0095/2020
• PIP number:
  EMEA-001964-PIP02-19
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Rett syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/03/2020

Decision

P/0095/2020 : EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for cannabidiol (Epidyolex) (EMEA-001964-PIP02-19)

AdoptedReference Number: EMA/115522/2020