EMEA-000332-PIP01-08-M15 - paediatric investigation plan

Brivaracetam

Key facts

• Invented name:
  • QG01AA01
  • Briviact (in Italy: Nubriveo)
• Active substance:
  Brivaracetam
• Therapeutic area:
  Neurology
• Decision number:
  P/0324/2020
• PIP number:
  EMEA-000332-PIP01-08-M15
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
  • Solution for injection
• Condition(s) / indication(s):
  • Treatment of epilepsy with partial-onset seizures
  • Treatment of neonatal seizures
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2020
• Compliance check done:
  Όχι

Decision

P/0324/2020 : EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact and associated names) (EMEA-000332-PIP01-08-M15)

Adopted Reference Number: EMA/416812/2020