PIP-ENALAPRIL enalapril maleate 5mg tablet blister pack

Main information

  • Trade name:
  • PIP-ENALAPRIL enalapril maleate 5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIP-ENALAPRIL enalapril maleate 5mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196507
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196507

PIP-ENALAPRIL enalapril maleate 5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

28/05/2013

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. PIP-ENALAPRIL enalapril maleate 5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

23/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

HYPERTENSION ,Enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,CONGESTIVE HEART

FAILURE ,Enalapril is indicated for the treatment of all degrees of symptomatic heart failure. In such patients, it is recommended that Enalapril be

administered together with a diuretic. ,LEFT VENTRICULAR DYSFUNCTION ,All degrees of left ventricular dysfunction where the left ventricular ejection

fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Carton

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PIP-Enalapril enalapril maleate 5mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off white, round, flat faced, beveled edge tablets with breakline on

one side and "5" debossed on the other side.

Active Ingredients

enalapril maleate

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 01:48:41 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