EMEA-001452-PIP01-13-M04 - paediatric investigation plan

daprodustat

Key facts

• Active substance:
  daprodustat
• Therapeutic area:
  • Haematology-Hemostaseology
  • Uro-nephrology
• Decision number:
  P/0242/2022
• PIP number:
  EMEA-001452-PIP01-13-M04
• Pharmaceutical form(s):
  • Dispersible tablet
  • Tablet
• Condition(s) / indication(s):
  Treatment of anaemia due to chronic disorders
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2022
• Compliance check done:
  No

Decision

P/0242/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for daprodustat (EMEA-001452-PIP01-13-M04)

Reference Number: EMA/602322/2022