MHRA-101711-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
Invented Name
  • Fabhalta
  • Fabhalta
  • Fabhalta
PIP Number MHRA-101711-PIP01-24-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Other: Complement-driven renal disease
Conditions / Indications
Conditions / Indications:
  • Treatment of C3 glomerulopathy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
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
07/01/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101711-PIP01-24-M01 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IPTACOPAN HYDROCHLORIDE MONOHYDRATE.pdf
Published Date 11/02/2025