MHRA-100044-PIP01-21

Key Facts

Active Substance
Active Substance:
  • seltorexant
Invented Name
Not available at present
PIP Number MHRA-100044-PIP01-21
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate dosage 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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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 17/03/2022