Eye Max

Main information

Documents

Localization

  • Available in:
  • Eye Max
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218797
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218797

Eye Max

ARTG entry for

Medicine Listed

Sponsor

Sunpab Health Products Pty Ltd

Postal Address

PO Box 993,CASTLE HILL, NSW, 1765

Australia

ARTG Start Date

24/12/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Eye Max

Product Type

Single Medicine Product

Effective date

18/03/2014

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

If symptoms persist consult your healthcare practitioner (or words to that effect).

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

Standard Indications

Specific Indications

Eye Max has been formulated to preserve eye function and provide nutrients important to the macular region of the eye.

Antioxidants have been added to promote healthy eyes and to help fight the effects of free radical damage.

Bilberry supports healthy eye function

Lutein is a strong antioxidant that may help reduce the risk of macular degneration.

Vitamin A helps form and maintain healthy skin, teeth, skeletal and soft tissue, mucus membranes, and skin. It is also known as retinol because it

produces the pigments in the retina of the eye.

Vitamin A promotes good vision, especially in low light.

Eye Max may preserve macular eye health and offers support for eye function and healthy vision, dry eyes and relief of eye strain.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:48:37 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

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

250 mg

concentrated fish Omega-3 triglycerides

372.975 mg

Cupric oxide

1.25 mg

d-alpha-Tocopherol

153 mg

retinol palmitate

2.8 mg

Selenomethionine

62.5 microgram

Tagetes erecta

10 mg

Equivalent: Tagetes erecta (Dry)

Vaccinium myrtillus

10 mg

Equivalent: Vaccinium myrtillus (Dry)

Zeaxanthin

1 mg

zinc oxide

49.79 mg

© 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 2 of

Produced at 23.11.2017 at 12:48:37 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

31-10-2018

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