MHRA-100099-PIP01-21-M02 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • BRIVARACETAM
Invented Name
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
PIP Number MHRA-100099-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
Route(s) of administration
  • Oral use
  • Intravenous bolus 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BRIVARACETAM.pdf
Published Date 17/05/2022