EMEA-000488-PIP01-08 - paediatric investigation plan

Rubidium (82Rb)

Key facts

• Active Substance:
  Rubidium (82Rb)
• Therapeutic area:
  Diagnostic
• Decision number:
  P/91/2009
• PIP number:
  EMEA-000488-PIP01-08
• Pharmaceutical form(s):
  Radionuclide generator
• Condition(s) / indication(s):
  Visualisation of myocardial perfusion for diagnostic purposes
• Route(s) of administration:
  Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  18/05/2009

Decision

P/91/2009: European medicines agency decision of 18 May 2009 on the refusal of a product specific waiver for rubidium-82 (EMEA-000488-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliament a...

AdoptedReference Number: EMEA/294264/2009