MHRA-100036-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • FERRIC MALTOL
Invented Name
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • Accrufer
  • FERACCRU
  • FERACCRU
PIP Number MHRA-100036-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Oral suspension
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Iron deficiency anaemia (IDA)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Norgine Pharmaceuticals Limited
  • Country United Kingdom
  • Tel +441895453571
  • Email takubuko@norgine.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
11/08/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100036-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):FERRIC MALTOL.pdf
Published Date 14/04/2026