EMA/PE/0000248063 - paediatric investigation plan

eslicarbazepine acetate

Key facts

• Invented name:
  Zebinix
• Active substance:
  eslicarbazepine acetate
• Therapeutic area:
  • Nervous system disorders
  • Neurology
• Decision number:
  EMA/PE/0000248063
• PIP number:
  EMA/PE/0000248063
• Pharmaceutical form(s):
  • Oral suspension
  • Tablet
• Condition(s) / indication(s):
  Treatment of epilepsy with partial-onset seizures
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000248063 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine acetate (Zebinix)

Adopted Reference Number: EMADOC-1700519818-2252154