ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial

Main information

  • Trade name:
  • ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191988
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191988

ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

13/12/2012

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. ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial

Product Type

Single Medicine Product

Effective date

13/12/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

· Treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further

fractures.,· Treatment of Paget's disease of bone.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Plastic

24 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

1 Vial

(S4) Prescription Only Medicine

Components

1. ZOLEDRONATE-RDY 5 zoledronic acid 5mg/100mL injection solution vial

Dosage Form

Injection, solution

Route of Administration

Intravenous Infusion

Visual Identification

Clear colourless solution free from visible extraneous matter in vial

stoppered with grey colour butyl rubber stopper and sealed with flip off seal

Active Ingredients

zoledronic acid monohydrate

.0533 mg/mL

© 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 09:36:11 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