EMA/PE/0000232449 - paediatric investigation plan

sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate

Key facts

• Active substance:
  sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000232449
• PIP number:
  EMA/PE/0000232449
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hepatocellular carcinoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2025
• Compliance check done:
  Не

Decision

EMA/PE/0000232449 : EMA decision of 15 May 2025 on the granting of a product specific waiver for sodium 2-(3'(-3-(1-(4-(tert-butyl)benzyl)-4-ethyl-5- oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)propyl)-4-ethoxy-[1,1'-biphenyl]-3-yl)acetate

Adopted Reference Number: EMADOC-1700519818-2115876