MHRA-100108-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BRIVARACETAM
Invented Name
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • BRIVLERA
  • BRIVLERA
  • Briviact
  • Briviact
PIP Number MHRA-100108-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of epilepsy with partial onset seizures.
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
Yes
Compliance Check Decision Date
Compliance opinion date
04/02/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100108-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BRIVARACETAM.pdf
Published Date 14/04/2026