APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial

Main information

  • Trade name:
  • APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190334
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190334

APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

9/11/2012

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. APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

6/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

- Prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced

malignancies involving bone. ,- Treatment of tumour-induced hypercalcaemia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Plastic

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APOTEX-Zoledronic Acid 4mg/5mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear colourless sterile solution, practically free from visible particles in a

clear plastic vial made of cycloolefine copolymer, 20mm bromobutyl rubber

closure, alumunium flip off cap

Active Ingredients

zoledronic acid monohydrate

4.264 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 28.11.2017 at 11:22:26 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