EMEA-001549-PIP02-14 - paediatric investigation plan

baclofen

Key facts

• Active substance:
  baclofen
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0085/2017
• PIP number:
  EMEA-001549-PIP02-14
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of alcohol dependence
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2017
• Compliance check done:
  Nej

Decision

P/0085/2017: EMA decision of 17 March 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for baclofen (EMEA-001549-PIP02-14)

Adopted Reference Number: EMA/165668/2017