MHRA-101278-PIP01-23

Key Facts

Active Substance
Active Substance:
  • oveporexton
Invented Name
Not yet available
PIP Number MHRA-101278-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film coated tablet
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
  • Treatment of narcolepsy.
  • Treatment of idiopathic hypersomnia.
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
Yes
Compliance Check Decision Date
Compliance opinion date
17/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101278-PIP01-23-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):oveporexton.pdf
Published Date 24/07/2026