APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister

Main information

  • Trade name:
  • APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184888
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184888

APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

15/03/2012

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. APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister

Product Type

Single Medicine Product

Effective date

11/07/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of:,Hypertension,Patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction less than or

equal to 40 percent) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

18 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APOTEX-CANDESARTAN candesartan cilexetil 8 mg tablet blister

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Pink to light pink coloured, round shaped, biconvex tablets, engraved 'APO'

on,one side and 'CA' bisect '8' on the other side.

Active Ingredients

Candesartan cilexetil

8 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 04:02:22 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