EMEA-002563-PIP02-19-M02 - paediatric investigation plan

cenobamate

Key facts

• Invented name:
  Ontozry
• Active Substance:
  cenobamate
• Therapeutic area:
  Neurology
• Decision number:
  P/0214/2023
• PIP number:
  EMEA-002563-PIP02-19-M02
• Pharmaceutical form(s):
  • Tablet
  • Film-coated tablet
  • Age-appropriate oral liquid dosage form
  • Age-appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of epilepsy
• Route(s) of administration:
  • Oral use
  • Parenteral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0214/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M02)

Reference Number: EMA/256562/2023