Caruso's

Main information

  • Trade name:
  • Caruso's Hawaiian Astaxanthin
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Caruso's Hawaiian Astaxanthin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219257
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219257

Caruso's Hawaiian Astaxanthin

ARTG entry for

Medicine Listed

Sponsor

Caruso's Natural Health Pty Ltd

Postal Address

PO Box 310,HORSLEY PARK, NSW, 2175

Australia

ARTG Start Date

15/01/2014

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. Caruso's Hawaiian Astaxanthin

Product Type

Single Medicine Product

Effective date

17/03/2016

Warnings

If symptoms persist, seek the advice of a healthcare professional.

Standard Indications

Maintenance of healthy eyes.

May help reduce the oxidation of LDL cholesterol.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

Eyes formula. Support of healthy eye function.

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

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

Specific Indications

Antioxidant:

-Astaxanthin is known as the king of carotenoids

-Astaxanthin is a special type of carotenoid which has the ability to neutralize free radicals on the cell membrane

-It inserts itself within the cell membrane and can intercept damaging reactive species whereby providing protection to the cell membrane surface

-The structure of astaxanthin is both polar and non-polar, which allows the molecule to fit precisely into the span of the cell membrane making it a cell

membrane antioxidant

-Has higher antioxidant capacity than other antioxidants

-Acts as an antioxidant protectant for biological membranes

-Astaxanthin has the strongest free radical scavenging activity of all the carotenoids as it is more active as an antioxidant than other carotenoids

-May improve total antioxidant status

Eye Health

-May help support vision and eye health

-May help maintain health of the eyes

-May help support microcirculation

-May help support the health of the macula by improving blood flow to the eye

-Astaxanthin has specific antioxidant capacity for the eye

-Decreases oxidative stress on the eye

-May help support visual fatigue with people using visual display terminals such as Computers and devices

Cardiovascular health:

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:49:02 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

-Protects and supports the cardiovascular system

-May help support heart health

-Helps support cardiovascular health by reducing oxidative stress and inflammation on the cardiovascular system

-May help support healthy blood flow

-May support cardiovascular health in post-menopausal women

-Minimizing lipid oxidation plays a central role in supporting the health of the cardiovascular system

Skin Health:

-May help support skin health

-May help improve the condition of the skin in both men and women

-May assist with wrinkles and skin elasticity

Sports performance:

-May assist with recovery after exercise

-Has anti fatigue actions and fatigue resistance effects

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

astaxanthin esters extracted from Haematococcus pluvialis

60 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 03:49:02 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