EMEA-001666-PIP02-21-M01 - paediatric investigation plan

atrasentan

Key facts

• Active substance:
  atrasentan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0171/2024
• PIP number:
  EMEA-001666-PIP02-21-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/05/2024
• Compliance check done:
  No

Decision

P/0171/2024: EMA decision of 3 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for atrasentan (hydrochloride), (EMEA-001666-PIP02-21-M01)

Adopted Reference Number: EMA/182112/2024