| Product No | EMEA/H/C/000277 |
|---|---|
| Brand Name | Keppra |
| Nonproprietary Name | levetiracetam |
| API | levetiracetam |
| ATC Code | N03AX14 |
| Indications | Keppra 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.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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 | no |
| Marketing Authorization Holder | UCB Pharma SA |
| Status | Authorised(授权) |
| Authorization Date | 2000-09-29 |
| Version | 53 |
| 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