XANOPT latanoprost 50 microgram/mL eye drop solution bottle

Main information

  • Trade name:
  • XANOPT latanoprost 50 microgram/mL eye drop solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XANOPT latanoprost 50 microgram/mL eye drop solution bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184920
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184920

XANOPT latanoprost 50 microgram/mL eye drop solution bottle

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

6/02/2013

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. XANOPT latanoprost 50 microgram/mL eye drop solution bottle

Product Type

Single Medicine Product

Effective date

1/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

18 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Discard 4 weeks after

opening

Protect from Light

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 2.5 mL

(S4) Prescription Only Medicine

Components

1. XANOPT latanoprost 50 microgram/mL eye drop solution bottle

Dosage Form

Eye Drops, solution

Route of Administration

Topical

Ophthalmic

Visual Identification

A clear, colourless, aqueous solution free from visible extraneous matter.

Active Ingredients

Latanoprost

.0525 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 29.11.2017 at 04:00:24 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