Dronabinol - paediatric investigation plan

Dronabinol

Key facts

• Active Substance:
  Dronabinol
• Therapeutic area:
  Pain
• Decision number:
  P/214/2010
• PIP number:
  Dronabinol
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of central and peripheral neuropathic pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bionorica AG

  [e-mail]; Germany; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2010

Decision

P/214/2010: European Medicines Agency decision of 29 October 2010 on the granting of a product specific waiver for dronabinol (EMEA-000643-PIP01-09)

AdoptedReference Number: EMA/655072/2010