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Autorizzazione all’immissione in commercio senza designazione orfana - Europa
- denominazione commerciale: KEPPRA
- Codice ATC : N03AX14
- Numero EU: EU/1/00/146/...
- AIC data : 29/09/2000
- Titolare dell'AIC: UCB PHARMA SA BELGIUM
- Relazione di Valutazione Pubblica Europea (EPAR)
Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Keppra is indicated as adjunctive therapy :
- in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.