EMEA-001949-PIP02-18-M02 - paediatric investigation plan

Gadopiclenol

Key facts

• Active Substance:
  Gadopiclenol
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0267/2022
• PIP number:
  EMEA-001949-PIP02-18-M02
• 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
• Contact for public enquiries:

  Guerbet

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/08/2022

Decision

P/0267/2022: EMA decision of 4 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (EMEA- 001949-PIP02-18-M02)

Reference Number: EMA/662817/2022