AURO-LEVETIRACETAM 500 levetiracetam 500 mg tablets Blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

levetiracetam, Quantity: 500 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; purified talc; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 4000

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It 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).

Product summary:

Visual Identification: Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating 'E' and '11' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-12-23