Hawaiian

Main information

  • Trade name:
  • Hawaiian Natural Astaxanthin
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hawaiian Natural Astaxanthin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218017
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218017

Hawaiian Natural Astaxanthin

ARTG entry for

Medicine Listed

Sponsor

Microrganics International Pty Ltd

Postal Address

Suite 2 13 Spa Avenue,HEPBURN SPRINGS, VIC, 3461

Australia

ARTG Start Date

3/12/2013

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. Hawaiian Natural Astaxanthin

Product Type

Single Medicine Product

Effective date

21/07/2017

Warnings

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

Standard Indications

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

Aids, assists or helps in the maintenance or improvement of general well-being.

May help reduce the oxidation of LDL cholesterol.

Specific Indications

*Aids, assists or helps in the maintenance or improvement of general well-being.

* Supports the health and function of the immune system.

* Astaxanthin is an important nutritional antioxidant/free radical scavenger.

* Has antioxidant, or free radical scavenging activity.

* Assists in protecting the body from the damaging effects of free radicals.

* Helps to reduce the risk of cellular damage from free radicals.

* Antioxidants are nutrients that assist in protecting the body from the damaging effects of free radicals.

* Contains ingredients with potent antioxidant activity and therefore assists in protecting the body from the damaging effects of free radicals.

* Vitamin E protects the cells in the body from oxidative damage by destroying or neutralising free radicals.

* Vitamin E is an important nutritional antioxidant, which averts the oxidization of fats/ lipids in the body/cell membranes.

* Vitamin E is an important lipid phase nutritional antioxidant, and therefore assists in protecting the body from free radicals that may be generated from

exposure to pollution, cigarettes, alcohol and stress.

* Helps protects cells from free radical damage.

* Vitamin E is a fat-soluble antioxidant vitamin that helps protect the cell membranes from damage.

* As an antioxidant vitamin E acts as a 'free-radical scavenger'

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:52:32 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

astaxanthin esters extracted from Haematococcus pluvialis

60 mg

d-alpha-Tocopherol

10 mg

Linseed Oil

400 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 12:52:32 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