APOTEX-Adefovir

Main information

  • Trade name:
  • APOTEX-Adefovir adefovir 10mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APOTEX-Adefovir adefovir 10mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212044
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212044

APOTEX-Adefovir adefovir 10mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/05/2014

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. APOTEX-Adefovir adefovir 10mg tablet bottle

Product Type

Single Medicine Product

Effective date

5/11/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

òAdefovir dipivoxil is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and

either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

òFor adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and

HBeAg-/HBVDNA+ chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B

virus with either compensated or decompensated liver function.

òFor adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with HBeAg+ chronic

hepatitis B virus with compensated liver function.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Protect from Moisture

Protect from Heat

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APOTEX-Adefovir adefovir 10mg tablet bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, round, flat-faced bevelled edge tablet. Engraved "APO"

on one side, "A10" on the other side.

Active Ingredients

Adefovir dipivoxil

10 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 27.11.2017 at 12:46:14 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

31-5-2018

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

1-8-2018

Grastofil (Apotex Europe B.V.)

Grastofil (Apotex Europe B.V.)

Grastofil (Active substance: filgrastim) - Centralised - Yearly update - Commission Decision (2018)5228 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2034 (Apotex Europe B.V.)

EU/3/18/2034 (Apotex Europe B.V.)

EU/3/18/2034 (Active substance: Deferiprone) - Orphan designation - Commission Decision (2018)4179 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/006/18

Europe -DG Health and Food Safety

30-5-2018

Hepsera (Gilead Sciences Ireland UC)

Hepsera (Gilead Sciences Ireland UC)

Hepsera (Active substance: adefovir dipivoxil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3450 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/485/T/78

Europe -DG Health and Food Safety