KELEVE (Medsurge Pharma Pty Ltd)
Product name
KELEVE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
159 (255 working days)
Active ingredients
Levetiracetam
Registration type
New generic medicine
Indication
[TRADE NAME] film-coated tablets and oral solution) is 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); and
- add-on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).