Levetiracetam Actavis Group (levetiracetam)
- Region
- 🇪🇺 EU
- Active substance
- levetiracetam
- Company
- Actavis Group PTC ehf
- Status
- Authorised
- Therapeutic area
- Epilepsy
- EU approval
- Sun 04 Dec 2011
- Designations
- Generic
- Application
- EMEA/H/C/002305
- ATC
- N03AX14
- Official record
- www.ema.europa.eu
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 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 ratiopharm Authorised · ratiopharm GmbH
- 🇪🇺 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- 🇪🇺 Epixram Application withdrawn · Neuraxpharm Pharmaceuticals S.L.
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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.