TENELOL Atenolol 50 mg film coated tablets blister pack

Main information

  • Trade name:
  • TENELOL Atenolol 50 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TENELOL Atenolol 50 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 197726
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197726

TENELOL Atenolol 50 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

13/09/2013

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. TENELOL Atenolol 50 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

30/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Atenolol is indicated in the management of:,(i) All grades of hypertension, including hypertension of renal origin.

(ii) Frequent disabling angina without evidence of cardiac failure.

(iii) Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction),

(iv) 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/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

10 tablets

(S4) Prescription Only Medicine

60 tablets

(S4) Prescription Only Medicine

112 tablets

(S4) Prescription Only Medicine

120 tablets

(S4) Prescription Only Medicine

50 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

28 tablets

(S4) Prescription Only Medicine

84 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

56 tablets

(S4) Prescription Only Medicine

98 tablets

(S4) Prescription Only Medicine

Components

1. Atenolol 50 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Atenolol tablets 50 mg are white to off-white, circular biconvex film coated

tablets with "50" embossed on one side and break line on other side.

Active Ingredients

Atenolol

50 mg

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:02:25 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

© 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 2 of

Produced at 28.11.2017 at 12:02:26 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