MHRA-101509-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Ferric Citrate Coordination Complex
Invented Name
  • Xoanacyl
  • Auryxia
  • Riona
  • Nephoxil
  • Nephoxil
PIP Number MHRA-101509-PIP01-24
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form.
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of anaemias due to chronic kidney disorders
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
16/04/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101509-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ferric Citrate Coordination Complex.pdf
Published Date 16/07/2026