EMA/PE/0000240232 - paediatric investigation plan

Brivaracetam

Key facts

• Invented name:
  Briviact (in Italy: Nubriveo)
• Active substance:
  Brivaracetam
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000240232
• PIP number:
  EMA/PE/0000240232
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000240232 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact, Nubriveo)

Adopted Reference Number: EMADOC-1700519818-2107149