MHRA-102374-PIP01-26

Key Facts

Active Substance
  • KETAMINE HYDROCHLORIDE
  • SUFENTANIL CITRATE
Invented Name
Kemsu
PIP Number MHRA-102374-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nasal spray, solution
Therapeutic area
Therapeutic area:
  • Pain
Conditions / Indications
Conditions / Indications:
  • Treatment of acute pain
Route(s) of administration
Route(s) of administration:
  • NASAL USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
14/10/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102374-PIP01-26-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):KETAMINE HYDROCHLORIDESUFENTANIL CITRATE.pdf
Published Date 11/11/2026