EMEA-000181-PIP01-08-M06 - paediatric investigation plan

cannabidiol

delta-9-tetrahydrocannabinol

Key facts

• Invented name:
  Sativex
• Active substance:
  • cannabidiol
  • delta-9-tetrahydrocannabinol
• Therapeutic area:
  Neurology
• Decision number:
  P/0110/2022
• PIP number:
  EMEA-000181-PIP01-08-M06
• Pharmaceutical form(s):
  Oromucosal spray
• Condition(s) / indication(s):
  Spasticity
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  Nej

Decision

P/0110/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol / delta-9- tetrahydrocannabinol (Sativex), (EMEA-000181-PIP01-08-M06)

Reference Number: EMA/145466/2022