BANSEP

Main information

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

Documents

Localization

  • Available in:
  • BANSEP
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173504
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173504

BANSEP atorvastatin (as calcium) 10 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

22/08/2011

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. BANSEP

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

Atorvastatin 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. Atorvastatin 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

2 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets per pack

(S4) Prescription Only Medicine

30 tablets per pack

(S4) Prescription Only Medicine

100 tablets per pack

(S4) Prescription Only Medicine

Components

1. BANSEP atorvastatin (as calcium) 10 mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, film-coated, oval tablets debossed with "AT1" on one

side and plain on the other side.

Active Ingredients

Atorvastatin calcium

10.36 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 03:55:37 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