MHRA-100824-PIP01-22

Key Facts

Active Substance
Active Substance:
  • perflubutane
Invented Name
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
PIP Number MHRA-100824-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for dispersion for injection
Therapeutic area
  • Diagnostic
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Diagnostic evaluation of focal hepatic lesions
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
24/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100824-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):perflubutane.pdf
Published Date 16/07/2026