MHRA-101342-PIP01-24-M02 (update)

Key Facts

Active Substance
Active Substance:
  • ESKETAMINE HYDROCHLORIDE
Invented Name
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
PIP Number MHRA-101342-PIP01-24-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nasal spray, solution
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of Major Depressive Disorder
Route(s) of administration
Route(s) of administration:
  • INTRANASAL 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
23/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101342-PIP01-24-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ESKETAMINE HYDROCHLORIDE.pdf
Published Date 16/07/2026