TRITORVIS

Main information

  • Trade name:
  • TRITORVIS
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRITORVIS
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 182975
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

182975

TRITORVIS atorvastatin 10mg (as calcium) tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

14/07/2011

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. TRITORVIS

Product Type

Single Medicine Product

Effective date

9/07/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TRITORVIS is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin,

secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive

liver disease, other drug therapy, and alcoholism) should be identified and treated. TRITORVIS is indicated in hypertensive patients with multiple risk

factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or

existing asymptomatic CHD (see Clinical Trials, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal

stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension,

diabetes and smoking.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round film coated tablets debossed with10 on one side and ATV on

the other side

Active Ingredients

Atorvastatin calcium

10.85 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 06:36:04 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