MHRA-101906-PIP01-25

Key Facts

Active Substance
Active Substance:
  • florbetaben (18F)
Invented Name
  • Neuraceq
  • Neuraceq
  • Neuraceq
PIP Number MHRA-101906-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
  • Neurology
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Diagnosis of cardiac amyloidosis
Route(s) of administration
Route(s) of administration:
  • All routes of administration
PIP applicant
  • Life Molecular Imaging Ltd.
  • Country United Kingdom
  • Tel +4930461124670
  • Email gra@life-mi.com
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):florbetaben (18F).pdf
Published Date 24/10/2025