EMEA-002785-PIP01-20 - paediatric investigation plan

edaravone

Key facts

• Active substance:
  edaravone
• Therapeutic area:
  Neurology
• Decision number:
  P/0203/2021
• PIP number:
  EMEA-002785-PIP01-20
• Pharmaceutical form(s):
  Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/05/2021
• Compliance check done:
  No

Decision

P/0203/2021 : EMA decision of 10 May 2021 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for edaravone (EMEA-002785-PIP01-20)

Adopted Reference Number: EMA/252904/2021