APO-Entecavir

Main information

  • Trade name:
  • APO-Entecavir entecavir (as monohydrate) 0.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Entecavir entecavir (as monohydrate) 0.5mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217580
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217580

APO-Entecavir entecavir (as monohydrate) 0.5mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/03/2016

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. APO-Entecavir entecavir (as monohydrate) 0.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

6/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This

indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment naïve and lamivudine-resistant adult patients

with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-Entecavir entecavir (as monohydrate) 0.5mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White colored, triangular shaped film coated tablets, engraved 'APO' on

one side and '0.5' over 'ENT' on the other side

Active Ingredients

Entecavir

.5 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 06:14:38 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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