EMA/PE/0000232780 - paediatric investigation plan

probenecid

Key facts

• Active substance:
  probenecid
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000232780
• PIP number:
  EMA/PE/0000232780
• Pharmaceutical form(s):
  Prolonged-release granules
• Condition(s) / indication(s):
  Treatment of seizures associated with focal cortical dysplasia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000240469 : EMA decision of 15 May 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for probenecid

Adopted Reference Number: EMADOC-1700519818-2117339