NUTRA-LIFE

Main information

  • Trade name:
  • NUTRA-LIFE OCEANCLEAN TRIPLE STRENGTH OMEGA 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NUTRA-LIFE OCEANCLEAN TRIPLE STRENGTH OMEGA 3
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212877
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212877

NUTRA-LIFE OCEANCLEAN TRIPLE STRENGTH OMEGA 3

ARTG entry for

Medicine Listed

Sponsor

Vitaco Health Australia Pty Ltd

Postal Address

PO Box 399,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

2/08/2013

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. NUTRA-LIFE OCEANCLEAN TRIPLE STRENGTH OMEGA 3

Product Type

Single Medicine Product

Effective date

2/08/2013

Warnings

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

Standard Indications

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

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

For the symptomatic relief of dry skin.

May assist in the management of dry skin.

For the symptomatic relief of eczema. [Warning S required]

May help increase joint mobility associated with arthritis.

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May help reduce joint inflammation associated with arthritis.

May help reduce joint swelling associated with arthritis.

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

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

Specific Indications

* Supports the health of the joints

* Supports healthy joint function

* Assists in maintaining joint mobility

* Maintains healthy skin

* Supports/maintains the health of the cardiovascular system.

* Omega 3 fatty acids are important for cardiovascular health

* Maintains the health of the heart

* Maintains healthy brain function

* Supports brain health

* Helps to maintain healthy cognitive function

* A natural source of marine omega 3 fatty acids

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:56:41 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

* Omega 3 fatty acids are very important as the body cannot produce them and they can therefore only obtain them from the diet

* Polyunsaturated fatty acids, such as those found in fish oil, are used in the body in the manufacture of prostaglandins

* May assist blood circulation

* Marine triglycerides are an important nutrient for brain development in the newborn.

* Supports healthy eye function

* Supports the health of the eyes

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 26.11.2017 at 11:56:41 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

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls

H&C Food Inc. Issues Allergy Alert on Undeclared Wheat, Pork, Egg, and Crustacean in Frozen Fish Balls

H&C Food Inc of Brooklyn, NY is recalling the Frozen Fuzhou Fish Balls and the Fish Balls, because they may contain undeclared wheat, pork, egg, and crustacean. People who have an allergy or severe sensitivity to wheat, pork, egg and crustacean run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

12-4-2018

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”

Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat and fish. People who have an allergy or severe sensitivity to these allergens may run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

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