EMEA-001090-PIP02-21 - paediatric investigation plan

florbetaben (18F)

Key facts

• Invented name:
  Neuraceq
• Active substance:
  florbetaben (18F)
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0352/2021
• PIP number:
  EMEA-001090-PIP02-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis of cardiac amyloidosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021
• Compliance check done:
  Ne

Decision

P/0352/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for florbetaben (18F) (Neuraceq), (EMEA-001090-PIP02- 21)

Adopted Reference Number: EMA/470748/2021