EMEA-001912-PIP01-15 - paediatric investigation plan

angiotensin II (LJPC-501)

Key facts

• Active substance:
  angiotensin II (LJPC-501)
• Therapeutic area:
  Other
• Decision number:
  P/0253/2016
• PIP number:
  EMEA-001912-PIP01-15
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of catecholamine-resistant hypotension associated with distributive shock
• Route(s) of administration:
  Intravenous use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  26/09/2016
• Compliance check done:
  Nej

Decision

P/0253/2016: EMA decision of 9 September 2016 on the refusal of a paediatric investigation plan and on the refusal of a deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15)

Adopted Reference Number: EMA/557943/2016