EPARs human use - Keppra//Levetiracetam

FICHA FARMACOLÓGICA de LevetiracetamContiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. SEPTIEMBRE 18, 2009.

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EPARs for authorised medicinal products for human use - Keppra

Active Substance
Levetiracetam
International Nonproprietary Name or Common Name
Levetiracetam
Pharmaco-therapeutic Group
Antiepileptics
ATC Code
N03 AX14

Therapeutic Indication:
Film-coated tablets, oral solution

Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients 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, children and infants from 1 month of age with epilepsy.
- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.


Concentrate for solution for infusion:

Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients 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 and children from 4 years of age with epilepsy.
- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible

Date of issue of Marketing Authorisation valid throughout the European Union
29 September 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use