| Product No | EMEA/H/C/002783 |
|---|---|
| Brand Name | Levetiracetam Hospira |
| Nonproprietary Name | levetiracetam |
| API | levetiracetam |
| ATC Code | N03AX14 |
| Indications | Levetiracetam Hospira 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 Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 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 Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Pfizer Europe MA EEIG |
| Status | Authorised(授权) |
| Authorization Date | 2014-01-07 |
| Version | 23 |
| 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