EMEA-001739-PIP02-16-M02 - paediatric investigation plan

sufentanil citrate

ketamine (hydrochloride)

Key facts

• Active substance:
  • sufentanil citrate
  • ketamine (hydrochloride)
• Therapeutic area:
  General disorders and administration site conditions
• Decision number:
  P/0282/2024
• PIP number:
  EMEA-001739-PIP02-16-M02
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  Intranasal 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/0320/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M02)

Reference Number: EMA/330868/2023