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LEVETIRACETAM DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)

Product name
LEVETIRACETAM DEMOGEN
Date registered
Evaluation commenced
Decision date
Approval time
124 (255 working days)
Active ingredients
levetiracetam
Registration type
New generic medicine
Indication

LEVETIRACETAM DEMOGEN Concentrated injection for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Levetiracetam is indicated for:

  • use in epileptic patients aged 4 years and older, initially as add-on therapy, in thetreatment of partial onset seizures with or without secondary generalisation,
  • monotherapy in the treatment of partial onset seizures, with or without secondarygeneralisation, in patients from 16 years of age with newly diagnosed epilepsy.
  • add-on therapy in the treatment of myoclonic seizures in adults and adolescents from12 years of age with Juvenile Myoclonic Epilepsy, and
  • add-on therapy in the treatment of primary generalised tonic-clonic seizures in adultsand children from 4 years of age with idiopathic generalised epilepsy.