BRINZOLAMIDE

Main information

  • Trade name:
  • BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10 mg/mL eye drops bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10 mg/mL eye drops bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218986
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218986

BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10 mg/mL eye drops bottle

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

28/04/2015

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. BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10 mg/mL eye drops bottle

Product Type

Single Medicine Product

Effective date

11/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

BRINZOLAMIDE SANDOZ 1.0% Eye Drops are indicated to decrease intraocular pressure in : Ocular hypertension; Open-angle glaucoma.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10mL

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. BRINZOLAMIDE SANDOZ 1.0% brinzolamide 10mg/mL eye drops bottle

Dosage Form

Eye Drops

Route of Administration

Ophthalmic

Visual Identification

White to off-white, uniform suspension.

Active Ingredients

Brinzolamide

10 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 19.10.2017 at 04:31:15 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