MHRA-100594-PIP01-22

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide
Invented Name
Not yet available
PIP Number MHRA-100594-PIP01-22
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral liquid dosage form Age-appropriate intravenous dosage form
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of focal onset seizures
Route(s) of administration
Route(s) of administration:
  • ORAL USE INTRAVENOUS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide.pdf
Published Date 30/04/2024