CHEMMART

Main information

  • Trade name:
  • CHEMMART TELMISARTAN telmisartan 80mg uncoated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHEMMART TELMISARTAN telmisartan 80mg uncoated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 189932
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189932

CHEMMART TELMISARTAN telmisartan 80mg uncoated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/09/2012

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. CHEMMART TELMISARTAN telmisartan 80mg uncoated tablet blister pack

Product Type

Single Medicine Product

Effective date

17/09/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of hypertension. Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral

artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

12 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CHEMMART TELMISARTAN telmisartan 80mg uncoated tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off white, modified capsule shaped, biconvex tablets with engraved

"APO" on one side and "TEL80" on the other side.

Active Ingredients

Telmisartan

80 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 12:00:21 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