MHRA-101342-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ESKETAMINE HYDROCHLORIDE
Invented Name
  • Spravato
  • Spravato
PIP Number MHRA-101342-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nasal spray, solution
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of major depressive disorder (MDD)
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ESKETAMINE HYDROCHLORIDE.pdf
Published Date 15/08/2024