EMEA-001964-PIP03-21 - paediatric investigation plan

cannabidiol

Key facts

• Active substance:
  cannabidiol
• Therapeutic area:
  Neurology
• Decision number:
  P/0234/2022
• PIP number:
  EMEA-001964-PIP03-21
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Epilepsy with myoclonic atonic seizures
• 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:
  08/07/2022
• Compliance check done:
  No

Decision

P/0234/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP03-21)

Reference Number: EMA/575947/2022