EMEA-002482-PIP01-24 - paediatric investigation plan

zirconium (89Zr) girentuximab senvedoxam

Key facts

• Active substance:
  zirconium (89Zr) girentuximab senvedoxam
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0362/2024
• PIP number:
  EMEA-002482-PIP01-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of indeterminate renal masses for diagnostic purposes
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0362/2024: EMA decision of 25 October 2024 on the granting of a product specific waiver for zirconium (89Zr) girentuximab senvedoxam (EMEA-002482-PIP01-24)

Adopted Reference Number: EMA/465872/2024