EMEA-003236-PIP01-22 - 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:
  Oncology
• Decision number:
  P/0361/2022
• PIP number:
  EMEA-003236-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Visualisation of prostate specific membrane antigen in prostate cancer
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  ROTOP Pharmaka GmbH

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2022

Decision

P/0361/2022 : EMA decision of 9 September 2022 on the granting of a product specific waiver for Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11) (EMEA-003236-PIP01-22)

AdoptedReference Number: EMA/703426/2022