EMEA-001739-PIP02-16-M01 - paediatric investigation plan

ketamine (hydrochloride)

sufentanil citrate

Key facts

• Active Substance:
  • ketamine (hydrochloride)
  • sufentanil citrate
• Therapeutic area:
  Pain
• Decision number:
  P/0177/2022
• PIP number:
  EMEA-001739-PIP02-16-M01
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  Intranasal use
• Contact for public enquiries:

  Cessatech A/S

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01)

AdoptedReference Number: EMA/205591/2022