🇪🇺 Oral levetiracetam in European Union

EMA authorised Oral levetiracetam on 25 August 2011

Marketing authorisations

Application: EMEA/H/C/002316
Marketing authorisation holder: Teva B.V.
Local brand name: Levetiracetam Teva
Indication: Levetiracetam Teva 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. Levetiracetam Teva 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 myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-cloni
Status: approved

Application: EMEA/H/C/002244
Marketing authorisation holder: ratiopharm GmbH
Local brand name: Levetiracetam ratiopharm
Indication: Levetiracetam ratiopharm 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. Levetiracetam ratiopharm 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 a
Status: approved

Application: EMEA/H/C/002355
Marketing authorisation holder: Actavis Group PTC ehf
Local brand name: Levetiracetam Actavis
Indication: Levetiracetam Actavis 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. Levetiracetam Actavis is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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 adult
Status: approved

Application: EMEA/H/C/002290
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Levetiracetam Accord
Indication: Levetiracetam 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. Levetiracetam is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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 adolescent
Status: approved

Application: EMEA/H/C/002024
Marketing authorisation holder: Pharmathen S.A.
Local brand name: Matever
Indication: Matever 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. Matever is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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 ye
Status: approved

Application: EMEA/H/C/002305
Marketing authorisation holder: Actavis Group PTC ehf
Local brand name: Levetiracetam Actavis Group
Indication: Levetiracetam Actavis Group 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. Levetiracetam Actavis Group 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 seizure
Status: approved

Application: EMEA/H/C/002051
Marketing authorisation holder: Sun Pharmaceutical Industries Europe B.V.
Local brand name: Levetiracetam Sun
Indication: Levetiracetam Sun 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. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 adolescent
Status: approved

Application: EMEA/H/C/002783
Marketing authorisation holder: Pfizer Europe MA EEIG
Local brand name: Levetiracetam Hospira
Indication: Levetiracetam Hospira 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. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents 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 se
Status: approved

Is Oral levetiracetam approved in European Union?

Yes. EMA authorised it on 25 August 2011; EMA authorised it on 26 August 2011; EMA authorised it on 3 October 2011.

Who is the marketing authorisation holder for Oral levetiracetam in European Union?

Teva B.V. holds the EU marketing authorisation.