EMEA-001213-PIP03-23 - paediatric investigation plan

Ferric citrate coordination complex (FCCC)

Key facts

• Active substance:
  Ferric citrate coordination complex (FCCC)
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0036/2024
• PIP number:
  EMEA-001213-PIP03-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of anaemias due to chronic kidney disorders
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0036/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ferric citrate coordination complex (FCCC), (EMEA-001213-PIP03-23)

Adopted Reference Number: EMA/22039/2024