APO-LEFLUNOMIDE leflunomide 20mg tablets bottle

Main information

  • Trade name:
  • APO-LEFLUNOMIDE leflunomide 20mg tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-LEFLUNOMIDE leflunomide 20mg tablets bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 185717
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

185717

APO-LEFLUNOMIDE leflunomide 20mg tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

22/07/2011

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. APO-LEFLUNOMIDE leflunomide 20mg tablets bottle

Product Type

Single Medicine Product

Effective date

30/07/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Apo-Leflunomide is indicated for the treatment of active rheumatoid arthritis. The combined use of Apo-Leflunomide with other disease modifying

antirheumatic drugs (DMARDs) has not been adequately studied (see Precautions).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. APO-LEFLUNOMIDE leflunomide 20mg tablets

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, arc-triangular shaped tablet. Engraved "LE" over "20" on one side

and "APO" on the other side.

Active Ingredients

Leflunomide

20 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 03:46:04 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