EMEA-001644-PIP02-14-M03 - paediatric investigation plan

fluciclovine (18F)

Key facts

• Invented name:
  • Axumin
  • Axumin
• Active substance:
  fluciclovine (18F)
• Therapeutic area:
  • Diagnostic
  • Oncology
• Decision number:
  P/0335/2022
• PIP number:
  EMEA-001644-PIP02-14-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of amino acid metabolism in solid malignant tumours
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  No

Decision

P/0335/2022: EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for fluciclovine (18F) (Axumin), (EMEA-001644-PIP02-14-M03)

Reference Number: EMA/672312/2022