Perflubutane - paediatric investigation plan

perflubutane

Key facts

• Active substance:
  perflubutane
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/106/2008
• PIP number:
  Perflubutane
• Pharmaceutical form(s):
  Lyophilisate for suspension for injection
• 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:
  28/11/2008
• Compliance check done:
  No

Decision

P/106/2008: European Medicines Agency decision of 28 November 2008 on the application for product specific waiver for perflubutane EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 of the European Parl...

Adopted Reference Number: EMEA/625241/2008