Carisbamate - paediatric investigation plan

carisbamate

Key facts

• Active substance:
  carisbamate
• Therapeutic area:
  Neurology
• Decision number:
  P/108/2009
• PIP number:
  Carisbamate
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral suspension
  • Intravenous formulation
• Condition(s) / indication(s):
  • Infantile spasms (West Syndrome)
  • Lennox-Gastaut Syndrome
  • Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
  • Neonatal seizures
  • Other paediatric epilepsy syndromes such as Dravet Syndrome, myoclonic astatic syndrome, epilepsy with continuous sharp-waves in sleep, idiopathic partial epilepsy, absence epilepsy
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/06/2009
• Compliance check done:
  No

Decision

P/108/2009: European Medicines Agency decision of 9 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for carisbamate (EMEA-000360-PIP01-08) i...

Adopted Reference Number: EMEA/348643/2009