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LEVETIRACETAM MEDICIANZ; LEVETIRACETAM MEDSURGE (Medicianz Healthcare Pty Ltd)
Product name
LEVETIRACETAM MEDICIANZ; LEVETIRACETAM MEDSURGE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 (255 working days)
Active ingredients
levetiracetam
Registration type
New generic medicine
Indication
LEVETIRACETAM MEDICIANZ; LEVETIRACETAM MEDSURGE concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.
Levetiracetam concentrate solution for IV infusion 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).
- Add on therapy in the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).