MHRA-100523-PIP01-22-M04 (update)

Key Facts

Active Substance
Active Substance:
  • gadopiclenol
Invented Name
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
PIP Number MHRA-100523-PIP01-22-M04 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Diagnostic
Conditions / Indications
Conditions / Indications:
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
Route(s) of administration
Route(s) of administration:
  • Intravenous 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
22/04/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100523-PIP01-22-M04-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):GADOPICLENOL.pdf
Published Date 01/05/2026