PERINDOPRIL-VIS

Main information

  • Trade name:
  • PERINDOPRIL-VIS perindopril arginine 5mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PERINDOPRIL-VIS perindopril arginine 5mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221161
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221161

PERINDOPRIL-VIS perindopril arginine 5mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

7/08/2015

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-VIS perindopril arginine 5mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

7/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The treatment of hypertension; The treatment of heart failure. In such patients it is recommended that perindopril be given with a diuretic and/or digoxin

under close medical supervision. (The safety and efficacy of perindopril arginine 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

6 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. PERINDOPRIL-VIS perindopril arginine 5mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval, biconvex, film-coated tablets engraved with two dots on one

side and scored on both sides

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 26.11.2017 at 01:09:39 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

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