This is a summary of the European public assessment report (EPAR) for Levetiracetam ratiopharm. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam ratiopharm.
Therapeutic Indication
### Therapeutic indication Levetiracetam ratiopharm 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 ratiopharm 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.
Therapeutic Area (MeSH)
ATC Code
N03AX14
ATC Item
levetiracetam
Pharmacotherapeutic Group
Antiepileptics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| levetiracetam | N/A | 左乙拉西坦 |
EMA Name
Levetiracetam ratiopharm
Medicine Name
Levetiracetam ratiopharm
Aliases
N/ANo risk management plan link.
