EMEA-003482-PIP01-23 - paediatric investigation plan

actinium chloride (non-carrier added)

Key facts

• Active substance:
  actinium chloride (non-carrier added)
• Therapeutic area:
  Oncology
• Decision number:
  P/0409/2023
• PIP number:
  EMEA-003482-PIP01-23
• Pharmaceutical form(s):
  • Radiopharmaceutical precursor
  • Solution
• Condition(s) / indication(s):
  Radiolabelling agent
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0409/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for actinium chloride (non-carrier added) (EMEA-003482- PIP01-23)

Adopted Reference Number: EMA/424785/2023