MHRA-100046-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • cenobamate
Invented Name
  • Ontozry
  • Ontozry
  • Xcopri
PIP Number MHRA-100046-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Tablet
  • Oral suspension
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of epilepsy
Route(s) of administration
  • Oral use
  • Parenteral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):CENOBAMATE.pdf
Published Date 29/07/2022