MHRA-100523-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • gadopiclenol
Invented Name
Not available at present
PIP Number MHRA-100523-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Diagnostic
Conditions / Indications
Conditions / Indications:
  • Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity
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
29/07/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100523-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):gadopiclenol.pdf
Published Date 07/12/2022