PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle

Main information

  • Trade name:
  • PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 194892
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

194892

PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Servier Laboratories Australia Pty Ltd

Postal Address

PO Box 196,HAWTHORN, VIC, 3122

Australia

ARTG Start Date

12/02/2013

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. PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle

Product Type

Single Medicine Product

Effective date

30/07/2018

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

PERINDO ARG is indicated for: the treatment of hypertension; and the treatment of heart failure. In such patients it is recommended that PERINDO ARG

be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of PERINDO ARG has not been demonstrated for New

York Heart Association Category IV patients); and 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.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 30

degrees Celsius

Child resistant closure

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PERINDO ARG 5 perindopril arginine 5 mg film-coated tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light-green, rod-shaped film-coated tablet engraved with Servier logo one

one face and scored on both edges

Active Ingredients

perindopril arginine

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 22.05.2019 at 12:45:15 AEST

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

Public Summary

Page 2 of

Produced at 22.05.2019 at 12:45:15 AEST

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