Levetiracetam ratiopharm (levetiracetam)
- Region
- 🇪🇺 EU
- Active substance
- levetiracetam
- Company
- ratiopharm GmbH
- Status
- Authorised
- Therapeutic area
- Epilepsy
- EU approval
- Fri 26 Aug 2011
- Designations
- Generic
- Application
- EMEA/H/C/002244
- ATC
- N03AX14
- Official record
- www.ema.europa.eu
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 adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Keppra Authorised · UCB Pharma SA
- 🇪🇺 Levetiracetam Actavis Authorised · Actavis Group PTC ehf
- 🇪🇺 Levetiracetam Teva Authorised · Teva B.V.
- 🇪🇺 Levetiracetam Actavis Group Authorised · Actavis Group PTC ehf
- 🇪🇺 Matever Authorised · Pharmathen S.A.
- 🇪🇺 Levetiracetam Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Levetiracetam Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Levetiracetam Hospira Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Epixram Application withdrawn · Neuraxpharm Pharmaceuticals S.L.
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