COLAPTYN 50 atenolol 50 mg tablets blister pack

Main information

  • Trade name:
  • COLAPTYN 50 atenolol 50 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLAPTYN 50 atenolol 50 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186396
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186396

COLAPTYN 50 atenolol 50 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

19/06/2012

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. COLAPTYN 50 atenolol 50 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

24/07/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ATENOLOL is indicated in the management of:,· All grades of hypertension, including hypertension of renal origin.,· Frequent disabling angina without

evidence of cardiac failure.,· Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including,those associated with acute

myocardial infarction).,· Myocardial infarction - Late intervention (beta-blocker class effect greater than 12 hours after,onset of chest pain)

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. COLAPTYN 50 atenolol 50 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White colored, round, biconvex tablets with 8 mm diameter, with the

inscription ATENOLOL 50 on one side and scoring line on other side

Active Ingredients

Atenolol

50 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 02:50:21 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