EMEA-000332-PIP01-08-M16 - paediatric investigation plan

Brivaracetam

Key facts

• Invented name:
  Briviact (in Italy: Nubriveo)
• Active substance:
  Brivaracetam
• Therapeutic area:
  Neurology
• Decision number:
  P/0174/2021
• PIP number:
  EMEA-000332-PIP01-08-M16
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of epilepsy with partial-onset seizures
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/04/2021
• Compliance check done:
  Taip
• Compliance procedure number:
  EMEA-C-000332-PIP01-08-M16
• Compliance opinion date:
  14/10/2022
• Compliance outcome:
  Positive

Decision

P/0174/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact and associated names), (EMEA-000332-PIP01-08-M16)

Adopted Reference Number: EMA/198072/2021