EMEA-003250-PIP01-22 - paediatric investigation plan

Fluorine (18F) PSMA-1007

Key facts

• Active Substance:
  Fluorine (18F) PSMA-1007
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0430/2022
• PIP number:
  EMEA-003250-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Visualisation of prostate specific membrane antigen in prostate cancer
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  BIOKOSMOS S.A.

  email: [e-mail]; tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022

Decision

P/0430/2022 : EMA decision of 28 October 2022 on the granting of a product-specific waiver for fluorine (18F) PSMA-1007 (EMEA-003250-PIP01-22)

AdoptedReference Number: EMA/808660/2022