EMEA-001557-PIP01-13-M06 - paediatric investigation plan

roxadustat

Key facts

• Active substance:
  roxadustat
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0400/2022
• PIP number:
  EMEA-001557-PIP01-13-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of anaemia due to chronic disorders
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022
• Compliance check done:
  No

Decision

P/0400/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for roxadustat (Evrenzo), (EMEA-001557-PIP01-13-M06)

Reference Number: EMA/709114/2022