EMEA-001949-PIP02-18-M05 - paediatric investigation plan

Gadopiclenol

Key facts

• Active substance:
  Gadopiclenol
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0293/2024
• PIP number:
  EMEA-001949-PIP02-18-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Detection and visualization of disorders or lesions with suspected abnormal vascularity in various body regions for diagnostic purposes
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0293/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (Elucirem), (EMEA-001949-PIP02-18-M05)

Adopted Reference Number: EMA/344196/2024