BLACKMORES

Main information

  • Trade name:
  • BLACKMORES LUTEIN DEFENCE
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLACKMORES LUTEIN DEFENCE
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213213
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213213

BLACKMORES LUTEIN DEFENCE

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

15/08/2013

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. BLACKMORES LUTEIN DEFENCE

Product Type

Single Medicine Product

Effective date

15/08/2013

Warnings

No Warnings included on Record

Standard Indications

Maintenance of healthy eyes.

Eyes formula. Support of healthy eye function.

Specific Indications

May assist with the support of healthy eye function.

May assist with the maintenance of healthy eyes.

(Contains antioxidant nutrients that) may help [defend

against/protect against] free radical damage in the

[retina/macula.

May help [defend against/protect against] changes to the macula.

Provides nutrients that form the protective macular pigment of the

[retina/eye].

May increase the density of the protective macular pigment of the

retina May [support/help to maintain] [eye health/ a healthy

macula/a healthy retina].

Provides nutrients which may increase the density of macular

pigment which may help reduce [oxidative/photo-oxidative]

damage to the macula.

May help [defend against/protect against] changes to the macula.

by [reducing oxidative damage/reducing photo-oxidative

damage] .

In the macula, lutein and zeaxanthin filter high-energy blue light

and may help to reduce light-induced damage to the

[retina/macula].

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:23:14 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

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

lutein

10 mg

Zeaxanthin

2 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 26.11.2017 at 11:23:14 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