| Product No | EMEA/H/C/002316 |
|---|---|
| Brand Name | Levetiracetam Teva |
| Nonproprietary Name | levetiracetam |
| API | levetiracetam |
| ATC Code | N03AX14 |
| Indications | 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. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Teva B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2011-08-25 |
| Version | 19 |
| 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