EMEA-000696-PIP02-10-M08 - paediatric investigation plan

eslicarbazepine acetate

Key facts

• Invented name:
  • Zebinix
  • Zebinix
• Active substance:
  eslicarbazepine acetate
• Therapeutic area:
  Neurology
• Decision number:
  P/0160/2022
• PIP number:
  EMEA-000696-PIP02-10-M08
• 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:
  13/05/2022
• Compliance check done:
  No

Decision

P/0160/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine acetate (Zebinix), (EMEA-000696-PIP02-10-M08)

Adopted Reference Number: EMA/169198/2022