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Carisbamate - paediatric investigation plan
Carisbamate
PIPHuman
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
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
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...