EMEA-001912-PIP02-16-M03 - paediatric investigation plan

angiotensin II (LJPC-501)

Key facts

• Invented name:
  Giapreza
• Active substance:
  angiotensin II (LJPC-501)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0415/2023
• PIP number:
  EMEA-001912-PIP02-16-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of hypotension associated with distributive or vasodilatory shock
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2023
• Compliance check done:
  No

Decision

P/0415/2023 : EMA decision of 25 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for angiotensin II (LJPC-501), (Giapreza), (EMEA-001912-PIP02-16-M03)

Adopted Reference Number: EMA/469423/2023