EMEA-003037-PIP01-21 - paediatric investigation plan

perflubutane

Key facts

• Active substance:
  perflubutane
• Therapeutic area:
  • Diagnostic
  • Oncology
• Decision number:
  P/0435/2021
• PIP number:
  EMEA-003037-PIP01-21
• Pharmaceutical form(s):
  Powder and solvent for dispersion for injection
• Condition(s) / indication(s):
  Diagnostic evaluation of focal hepatic lesions
• 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:
  22/11/2021
• Compliance check done:
  No

Decision

P/0435/2021: EMA decision of 22 November 2021 on the refusal of a product-specific waiver for perflubutane (EMEA-003037-PIP01-21)

Adopted Reference Number: EMA/648358/2021