EMEA-000332-PIP02-17-M05 - paediatric investigation plan

Brivaracetam

Key facts

• Invented name:
  Briviact (in Italy: Nubriveo)
• Active Substance:
  Brivaracetam
• Therapeutic area:
  Neurology
• Decision number:
  P/0398/2023
• PIP number:
  EMEA-000332-PIP02-17-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
  • Solution for injection/infusion
• Condition(s) / indication(s):
  • Treatment of neonatal seizures
  • Treatment of paediatric epilepsy syndromes
• Route(s) of administration:
  • Oral use
  • Intravenous use
  • Intravenous bolus use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023

Decision

P/0398/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact), (EMEA-000332-PIP02-17-M05)

AdoptedReference Number: EMA/400670/2023