ADMED LEVETIRACETAM, LEVEFINTAIC, LEVENAKAI, LEVESINEAL, LEVECEUMID, LEVERIUOL (AdiraMedica Pty Ltd)
Product name
ADMED LEVETIRACETAM, LEVEFINTAIC, LEVENAKAI, LEVESINEAL, LEVECEUMID, LEVERIUOL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
168 working days (255)
Active ingredients
Levetiracetam
Registration type
New generic medicine
Indication
ADMED LEVETIRACETAM, LEVEFINTAIC, LEVENAKAI, LEVESINEAL, LEVECEUMID, LEVERIUOL (film-coated tablets) are indicated for:
- use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation
- monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy
- add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME)
- add-on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE)