AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack

Main information

  • Trade name:
  • AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 182832
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

182832

AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

23/12/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack

Product Type

Single Medicine Product

Effective date

21/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

It is indicated for:,ò 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,,ò monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of

age with newly diagnosed epilepsy.,ò add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile

Myoclonic Epilepsy (JME),and,ò 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).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, modified oval shaped, biconvex film-coated tablets debossed with a

deep break line separating 'E' & '13' on one side & plain on the other side

Active Ingredients

Levetiracetam

1000 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 06:47:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information