MHRA-100044-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • seltorexant
Invented Name
Not available at present
PIP Number MHRA-100044-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate form
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of major depressive disorder (MDD)
Route(s) of administration
Route(s) of administration:
  • Oral 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):Seltorexant.pdf
Published Date 15/08/2024