LEFLUNOMIDE

Main information

  • Trade name:
  • LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210905
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210905

LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

2/04/2014

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. LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle

Product Type

Single Medicine Product

Effective date

6/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of active rheumatoid arthritis.,Treatment of active psoriatic arthritis.

Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

The combined use of 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

3 Years

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Keep Container

Tightly Closed/Airtight

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablet

(S4) Prescription Only Medicine

Components

1. LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round biconvex tablet

Active Ingredients

Leflunomide

10 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 27.11.2017 at 01:47:57 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

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