EMEA-002577-PIP01-19 - paediatric investigation plan

Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11)

Key facts

• Active substance:
  Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11)
• Therapeutic area:
  • Diagnostic
  • Oncology
• Decision number:
  P/0290/2019
• PIP number:
  EMEA-002577-PIP01-19
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Visualisation of prostate specific membrane antigen in prostate cancer
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/08/2019
• Compliance check done:
  No

Decision

P/0290/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11) (EMEA-002577-PIP01-19)

Adopted Reference Number: EMA/436742/2019