EMEA-001666-PIP01-14-M01 - paediatric investigation plan

atrasentan (hydrochloride)

Key facts

• Active substance:
  atrasentan (hydrochloride)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0171/2016
• PIP number:
  EMEA-001666-PIP01-14-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of nephropathy
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/06/2016
• Compliance check done:
  No

Decision

P/0171/2016: EMA decision of 17 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for atrasentan (hydrochloride) (EMEA-001666-PIP01-14-M01)

Adopted Reference Number: EMA/385694/2016