MHRA-100523-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • gadopiclenol
Invented Name
  • Elucirem
  • Elucirem
PIP Number MHRA-100523-PIP01-22-M02 (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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):gadopiclenol.pdf
Published Date 19/12/2023