Main information

  • Trade name:
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug



  • Available in:
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216767
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:



ARTG entry for

Medicine Listed


Vitaco Health Australia Pty Ltd

Postal Address

PO Box 399,NORTH RYDE BC, NSW, 1670


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.



Product Type

Single Medicine Product

Effective date



Derived from seafood.

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

Standard Indications

Temporary relief of the pain of osteoarthritis (or) Temporary relief of osteoarthritic pain. [Warning S required]

May help reduce joint inflammation associated with arthritis.

May help reduce joint swelling associated with arthritis.

Symptomatic relief of osteoarthritis. [Warning S required]

May assist in the management of osteoarthritic pain. [Warning S required]

May assist in the management of osteoarthritis. [Warning S required]

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

May help increase joint mobility associated with arthritis.

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain. [Warning S required]

Specific Indications

* Krill oil is a valuable source of omega-3 fatty acids.

* Krill oil contains astaxanthin, a potent antioxidant.

* Glucosamine is produced naturally in the body and is an important/vital components of cartilage.

* Glucosamine assists in building and maintaining healthy cartilage, which is essential for healthy function of the joints.

* Glucosamine plays a role in the body in the formation of the articular cartilage, tendons, ligaments, synovial fluid & bone

* Glucosamine is necessary in the body for the structure and function of the articular cartilage.

* Helps maintain healthy joint function and provides structural support to the joints.

* Glucosamine is a naturally occurring compound that helps maintain healthy cartilage.

* Assists in maintaining joint flexibility and function.

* Helps to maintain healthy joint cartilage

* Helps to maintaining the health of the joints.

* Supports/maintains healthy joints

* Helps maintain the health of the digestive system.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:15:21 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.

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* Helps maintain a healthy digestive system

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration


Visual Identification

Active Ingredients

euphausia superba oil

150 mg

Glucosamine hydrochloride

750 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 07:15:21 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 for contact information