EMEA-000882-PIP03-11-M05 - paediatric investigation plan

rubidium (82Rb) chloride

Key facts

• Invented name:
  Ruby-Fill (82Sr/82Rb Generator)
• Active substance:
  rubidium (82Rb) chloride
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0356/2021
• PIP number:
  EMEA-000882-PIP03-11-M05
• Pharmaceutical form(s):
  Radionuclide generator
• Condition(s) / indication(s):
  Visualisation of myocardial perfusion for diagnostic purposes
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021
• Compliance check done:
  No

Decision

P/0356/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rubidium (82Rb) chloride (Ruby-Fill (82Sr/82Rb Generator)), (EMEA-000882-PIP03-11-M05)

Adopted Reference Number: EMA/471940/2021