Levetiracetam Teva (levetiracetam)
- Region
- 🇪🇺 EU
- Active substance
- levetiracetam
- Company
- Teva B.V.
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Thu 19 May 2011
- EU approval
- Thu 25 Aug 2011
- Designations
- Generic
- Application
- EMEA/H/C/002316
- ATC
- N03AX14
- Official record
- www.ema.europa.eu
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-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 ratiopharm Authorised · ratiopharm GmbH
- 🇪🇺 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- 🇪🇺 Epixram Application withdrawn · Neuraxpharm Pharmaceuticals S.L.
Follow Levetiracetam Teva
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.