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

cenobamate
PIP Human

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
Contact for public enquiries

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. 
E-mail: patrizia.ciavatta@angelinipharma.com  
Tel.  +39 3429277049

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance check done
No

Decision

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