REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle

Main information

  • Trade name:
  • REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 187257
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

187257

REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

3/05/2012

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. REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle

Product Type

Single Medicine Product

Effective date

20/08/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lamotrigine is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children.,There is extensive experience with

Lamotrigine used initially as Ôadd-onö therapy. The use of Lamotrigine has also been found to be effective as monotherapy following withdrawal of

concomitant antiepileptic drugs.,Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. REEDOS 5 lamotrigine 5 mg dispersible/chewable tablets bottle

Dosage Form

Tablet, dispersible

Route of Administration

Oral

Visual Identification

White to off-white capsule shaped uncoated tablets debossed with 'H' on

one side and '81' on other side

Active Ingredients

Lamotrigine

5 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 02:05:48 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