PERINDOPRIL

Main information

  • Trade name:
  • PERINDOPRIL AN perindopril erbumine 4mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PERINDOPRIL AN perindopril erbumine 4mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212716
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212716

PERINDOPRIL AN perindopril erbumine 4mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Servier Laboratories Australia Pty Ltd

Postal Address

PO Box 196,HAWTHORN, VIC, 3122

Australia

ARTG Start Date

25/09/2013

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. PERINDOPRIL AN perindopril erbumine 4mg tablet blister pack

Product Type

Single Medicine Product

Effective date

1/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

PERINDOPRIL AN is indicated for: the treatment of heart failure. In such patients it is recommended that PERINDOPRIL AN be given with a diuretic

and/or digoxin under close medical supervision. (The safety and efficacy of PERINDOPRIL AN has not been demonstrated for New York Heart

Association Category IV patients)

PERINDOPRIL AN is indicated for: Patients with established coronary artery disease (See Clinical Trials) who are stable on concomitant therapy and

have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

PERINDOPRIL AN is indicated for: The treatment of hypertension;

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PERINDOPRIL AN perindopril erbumine 4mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

A white elongated rod shaped biconvex uncoated tablet with rounded ends,

being 8mm long, 4mm in width and 2.75mm in depth with a breakline

scored on both faces.

Active Ingredients

Perindopril erbumine

4 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 12:04:12 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