GENRX

Main information

  • Trade name:
  • GENRX BOSENTAN bosentan (as monohydrate) 125mg tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GENRX BOSENTAN bosentan (as monohydrate) 125mg tablets bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222210
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222210

GENRX BOSENTAN bosentan (as monohydrate) 125mg tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

25/02/2016

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. GENRX BOSENTAN bosentan (as monohydrate) 125mg tablets bottle

Product Type

Single Medicine Product

Effective date

4/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Bosentan is indicated for the treatment of:

·idiopathic pulmonary arterial hypertension;

·familial pulmonary arterial hypertension;

·pulmonary arterial hypertension associated with scleroderma; or

·pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology,in patients with WHO

Functional Class II, III or IV symptoms.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. GENRX BOSENTAN bosentan (as monohydrate) 125mg tablets bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Orange-white coloured, oval shaped, biconvex film coated tablet, engraved

"APO" on one side and "125" on the other side

Active Ingredients

bosentan monohydrate

129.083 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 26.11.2017 at 11:54:22 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

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