MHRA-101737-PIP01-24

Key Facts

Active Substance
Active Substance:
  • GOZETOTIDE
Invented Name
  • Isoprotrace
  • Isoprotrace 10 microgram, kit voor radiofarmaceutisch preparaat
  • Isoprotrace 10 Mikrogramm Kit für ein radioaktives Arzneimittel
PIP Number MHRA-101737-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
  • Diagnostic
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Visualisation of prostate specific membrane antigen in prostate cancer
Route(s) of administration
Route(s) of administration:
  • All routes of administration
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

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