Fish Oil +

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
concentrated fish Omega-3 triglycerides
Available from:
JSHealth Vitamins Pty Ltd
Authorization status:
Listed
Authorization number:
322581

Public Summary

Summary for ARTG Entry:

322581

Mental Wellbeing + Skin + Joints

ARTG entry for

Medicine Listed

Sponsor

JSHealth Vitamins Pty Ltd

Postal Address

17 Kimberley Street,Vaucluse, NSW, 2030

Australia

ARTG Start Date

2/09/2019

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. Mental Wellbeing + Skin + Joints

Product Type

Single Medicine Product

Effective date

2/09/2019

Permitted Indications

Maintain/support eye health

Maintain/support general health and wellbeing

Anti-inflammatory/relieve inflammation

Decrease/reduce/relieve mild joint pain/soreness

Decrease/reduce/relieve mild joint stiffness

Helps maintain/support healthy cholesterol

Maintain/support healthy cardiovascular system function

Maintain/support heart health

Help maintain/support emotional wellbeing

Maintain/support cognitive function/mental function

Maintain/support general mental wellbeing

Maintain/support brain function

Decrease/reduce/relieve symptoms of mild eczema/dermatitis

Maintain/support skin health

Indication Requirements

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to serious cardiovascular conditions.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must only refer to mild eczema.

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:43:46 AEST

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

Product presentation must only refer to mild joint symptoms.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

Product presentation must not imply or refer to lowering or raising blood cholesterol levels from outside of the normal healthy range

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

No Warnings included on Record

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

concentrated fish Omega-3 triglycerides

1.5 g

© 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 29.09.2019 at 05:43:46 AEST

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

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