MHRA-101496-PIP01-24

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • zirconium (89Zr) girentuximab senvedoxam
Invented Name
Not available at present
PIP Number MHRA-101496-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Uro-Nephrology
  • Diagnostic
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Diagnostic evaluation of indeterminate renal masses detected by conventional imaging
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):zirconium (89Zr) girentuximab senvedoxam.pdf
Published Date 28/10/2024