LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack

Main information

  • Trade name:
  • LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 187276
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

187276

LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

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. LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack

Product Type

Single Medicine Product

Effective date

10/01/2014

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 ¶add-on÷ 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

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. LAMOTRIGINE CH lamotrigine 50 mg dispersible/chewable tablets blister pack

Dosage Form

Tablet, dispersible

Route of Administration

Oral

Visual Identification

White to off-white rounded square shaped uncoated tablets debossed with

'H' on multifaceted side and '79' on flat side

Active Ingredients

Lamotrigine

50 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 01:58:42 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