EMA/PE/0000245997 - paediatric investigation plan

ketamine

sufentanil

Key facts

• Active substance:
  • ketamine
  • sufentanil
• Therapeutic area:
  General disorders and administration site conditions
• Decision number:
  EMA/PE/0000245997
• PIP number:
  EMA/PE/0000245997
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  Nasal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  Не

Decision

EMA/PE/0000245997 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ketamine / sufentanil

Adopted Reference Number: EMADOC-1700519818-2191809