| Product No | EMEA/H/C/002305 |
|---|---|
| Brand Name | Levetiracetam Actavis Group |
| Nonproprietary Name | levetiracetam |
| API | levetiracetam |
| ATC Code | N03AX14 |
| Indications | 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. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Actavis Group PTC ehf |
| Status | Authorised(授权) |
| Authorization Date | 2011-12-04 |
| Version | 16 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information