MHRA-100099-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • BRIVARACETAM
Invented Name
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Briviact
PIP Number MHRA-100099-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Oral solution
  • Solution for injection/infusion
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
Route(s) of administration
  • Oral use
  • INTRAVENOUS 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
20/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100099-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BRIVARACETAM.pdf
Published Date 19/12/2023