EMEA-000643-PIP02-20 - paediatric investigation plan

Dronabinol

Key facts

• Active Substance:
  Dronabinol
• Therapeutic area:
  Neurology
• Decision number:
  P/0344/2020
• PIP number:
  EMEA-000643-PIP02-20
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of spasticity
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bionorica Ethics GmbH

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2020

Decision

P/0344/2020 : EMA decision of 9 September 2020 on the granting of a product specific waiver for dronabinol (EMEA-000643-PIP02-20)

AdoptedReference Number: EMA/430119/2020