GOLD CROSS PRINCARD aspirin 100mg enteric coated tablet bottle

Main information

  • Trade name:
  • GOLD CROSS PRINCARD aspirin 100mg enteric coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GOLD CROSS PRINCARD aspirin 100mg enteric coated tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178832
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178832

GOLD CROSS PRINCARD aspirin 100mg enteric coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Biotech Pharmaceuticals Pty Ltd

Postal Address

83 Cherry Lane,LAVERTON NORTH, VIC, 3026

Australia

ARTG Start Date

6/01/2011

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. GOLD CROSS PRINCARD aspirin 100mg enteric coated tablet bottle

Product Type

Single Medicine Product

Effective date

5/10/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the treatment of patients with known cardiovascular disease or cerebrovascular disease, as an anti-platelet agent for prophylaxis against acute

myocardial infarction, unstable angina, transient ischemic attack and cerebrovascular accident (stroke).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 30

degrees Celsius

Child resistant closure

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

168 Tablets

(S2) Pharmacy Medicine

84 Tablets

Not Scheduled after consideration by Committee

120 tablets

(S2) Pharmacy Medicine

28 Tablets

Not Scheduled after consideration by Committee

60 tablets

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Reddish brown film coated, round, biconvex tablet.

Active Ingredients

Aspirin

100 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 10:04:59 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