APO-Latanoprost Timolol

Main information

  • Trade name:
  • APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210787
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210787

APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

8/04/2014

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. APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle

Product Type

Single Medicine Product

Effective date

18/12/2014

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 and ocular hypertension who are insufficiently responsive to

beta-blockers, prostaglandins or other intraocular pressure lowering medications. Latanoprost/Timolol eye drops should not be used to initiate therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

18 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

2.5 mL (in 5 mL bottle)

(S4) Prescription Only Medicine

Components

1. APO-Latanoprost/Timolol 0.05/5 Eye drops latanoprost 50 ug/mL and timolol (as maleate) 5 mg/mL bottle

Dosage Form

Eye Drops, solution

Route of Administration

Ophthalmic

Visual Identification

Clear colourless solution, white translucent LDPE bottle, with white

translucent LDPE dropper, light yellow opaque HDPE cap with sealing tape

Active Ingredients

Latanoprost

50 microgram/mL

Timolol maleate

5 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 27.11.2017 at 02:05:48 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

5-6-2018

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