CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle

Main information

  • Trade name:
  • CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196433
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196433

CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

5/12/2012

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. CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle

Product Type

Single Medicine Product

Effective date

16/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

6 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. CANDESAN COMBI 32/12.5 candesartan cilexetil 32 mg & hydrochlorothiazide 12.5 mg tablet bottle

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light yellow oval biconvex uncoated mottled tablets debossed with 'L3' &

'04' on either side of break line on one side & break line on one other side

Active Ingredients

Candesartan cilexetil

32 mg

Hydrochlorothiazide

12.5 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 28.11.2017 at 02:08:28 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