EMEA-001949-PIP01-16-M07 - paediatric investigation plan

Gadopiclenol

Key facts

• Invented name:
  Elucirem
• Active substance:
  Gadopiclenol
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0294/2024
• PIP number:
  EMEA-001949-PIP01-16-M07
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity 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:
  Non

Decision

P/0294/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (Elucirem), (EMEA-001949-PIP01-16-M07)

Adopted Reference Number: EMA/344055/2024