MHRA-100336-PIP01-21-M02 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Soticlestat
Invented Name
Not yet available
PIP Number MHRA-100336-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
  • Treatment of Dravet Syndrome
  • Treatment of Lennox-Gastaut Syndrome
Route(s) of administration
  • Oral use
  • Gastric use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP): Soticlestat.pdf
Published Date 30/01/2024