MHRA-100632-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • FLUCICLOVINE (18F)
Invented Name
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
PIP Number MHRA-100632-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Diagnostic
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Diagnosis of amino acid metabolism in solid malignant tumours
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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):FLUCICLOVINE (18F).pdf
Published Date 25/05/2023