GANFORT

Main information

  • Trade name:
  • GANFORT PF 0.3/5 bimatoprost 300 microgram/mL and timolol 5.0 mg/mL (as maleate) eye drops
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GANFORT PF 0.3/5 bimatoprost 300 microgram/mL and timolol 5.0 mg/mL (as maleate) eye drops
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211161
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211161

GANFORT PF 0.3/5 bimatoprost 300 microgram/mL and timolol 5.0 mg/mL eye drops

ARTG entry for

Medicine Registered

Sponsor

Allergan Australia Pty Ltd

Postal Address

Locked Bag 1514,PYMBLE, NSW, 2073

Australia

ARTG Start Date

13/11/2013

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. GANFORT PF 0.3/5 bimatoprost 300 microgram/mL and timolol 5.0 mg/mL (as maleate) eye drops

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

GANFORT PF 0.3/5 eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular

hypertension who are insufficiently responsive to monotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

LDPE

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Store in Original

Container

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

5 x 0.4 mL unit dose ampoule

(S4) Prescription Only Medicine

30 x 0.4 mL unit dose ampoule

(S4) Prescription Only Medicine

Components

1. GANFORT PF 0.3/5 bimatoprost 300 microgram/mL and timolol 5.0 mg/mL eye drops

Dosage Form

Eye Drops, solution

Route of Administration

Topical

Visual Identification

Clear, colourless sterile ophthalmic solution.

Active Ingredients

Bimatoprost

300 microgram/mL

Timolol maleate

6.8 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 01:35:45 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

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