Levetiracetam Sun (levetiracetam)
- Region
- 🇪🇺 EU
- Active substance
- levetiracetam
- Company
- Sun Pharmaceutical Industries Europe B.V.
- Status
- Authorised
- Therapeutic area
- Epilepsy
- CHMP opinion
- Thu 20 Oct 2011
- EU approval
- Wed 14 Dec 2011
- Designations
- Generic
- Application
- EMEA/H/C/002051
- ATC
- N03AX14
- Official record
- www.ema.europa.eu
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 adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
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
- 🇪🇺 Levetiracetam Actavis Group Authorised · Actavis Group PTC ehf
- 🇪🇺 Matever Authorised · Pharmathen S.A.
- 🇪🇺 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- 🇪🇺 Epixram Application withdrawn · Neuraxpharm Pharmaceuticals S.L.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.