MHRA-100594-PIP01-22

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

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