TRANDOLAPRIL

Main information

  • Trade name:
  • TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 187205
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

187205

TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

3/10/2012

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. TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

19/12/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Trandolapril is indicated for the treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not

available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35%

or WMI (Wall Motion Index) less than or equal to 1.2].

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

28 Capsules

(S4) Prescription Only Medicine

Components

1. TRANDOLAPRIL AN trandolapril 1 mg capsule

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

"Size 4" Orange coloured cap imprinted with 'TR' in black ink and light

orange coloured body imprinted with '1' in black ink

Active Ingredients

Trandolapril

1 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 29.11.2017 at 02:12:15 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