EMEA-002563-PIP02-19-M03 - paediatric investigation plan

cenobamate

Key facts

• Invented name:
  Ontozry
• Active substance:
  cenobamate
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0279/2024
• PIP number:
  EMEA-002563-PIP02-19-M03
• Pharmaceutical form(s):
  • Tablet
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
  • 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:
  16/08/2024
• Compliance check done:
  Non

Decision

P/0279/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M03)

Adopted Reference Number: EMA/362694/2024