EMEA-003565-PIP01-23 - paediatric investigation plan

idroxioleic acid

Key facts

• Active substance:
  idroxioleic acid
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0369/2024
• PIP number:
  EMEA-003565-PIP01-23
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of glioma
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0369/2024: EMA decision of 25 October 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for idroxioleic acid (EMEA-003565-PIP01-23)

Adopted Reference Number: EMA/480700/2024