Nourex Professional Ultra Omega 3 Daily

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

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Active ingredient:
concentrated fish Omega-3 triglycerides
Available from:
PBA Wholesale Pty Ltd
INN (International Name):
concentrated fish Omega-3 triglycerides
Authorization status:
Listed
Authorization number:
290037

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Public Summary

Summary for ARTG Entry:

290037

Nourex Professional Ultra Omega 3 Daily

ARTG entry for

Medicine Listed

Sponsor

PBA Wholesale Pty Ltd

Postal Address

PO Box 1001,TOOWONG, QLD, 4066

Australia

ARTG Start Date

10/06/2017

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. Nourex Professional Ultra Omega 3 Daily

Product Type

Single Medicine Product

Effective date

10/06/2017

Warnings

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

Standard Indications

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

Specific Indications

Contains Fish oil, which, supports the health and function of the brain. Contains Fish oil, which supports cognitive he

alth. Contains

Fish oil, which supports normal/healthy cognitive/brain function. Contains DHA, which is one of the most abundant fatty

acids in

the brain. Contains DHA, which is required for normal/healthy brain function. Omega¯3 fatty acids help to maintain heal

thy cognitive

function. Maintains healthy brain function. Contains Fish oil, which helps support the development of the brain, eyes an

d nerves in

children up to 12 years of age. Contains DHA, which is essential for the proper growth and development of the br

ain, nervous

system, and for the retina of the eyes. omega

3 Contains DHA, which plays an important role in the growth and development of the brain

during the third trimester. Contains DHA, which is essential for neural and visual development during the first 6 mont

hs of life.

Contains omega 3 fatty acids, which are essential for normal growth and development. Helps support the development

of the eyes

in children up to 12 years of age. Contains Fish oil, which supports the health and function of the cardiovascular

system. Maintains

the health of the heart. Helps/supports cardiovascular health. Contains Fish oil, a natural source of marine omega 3 f

atty acids.

Source of omega¯3 fatty acids for the maintenance of good health. Source of eicosapentaenoic acid (EPA) and docosa

hexaenoic

acid (DHA) for the maintenance of good health. Contains Omega 3 fatty acids, which are important as the body ca

nnot produce

them and they can therefore only be obtained from the diet Contains Fish oil, a source of eicosapentaenoic acid (E

PA) and

Public Summary

Page 1 of

Produced at 24.11.2017 at 09:03:40 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

docosahexaenoic acid (DHA) for the maintenance of good health. Contains Fish oil, a natural source of marine omega

3 fatty acids.

## Contains Fish oil, which supports the health and function of the nervous system. Contains Fish oil which supports

normal/healthy nervous system function. Contains Omega 3 fatty acids, which support the normal/healthy function of the

nervous

system. Contains Omega 3 fatty acids, which support the health and function of the myelin sheath. Contains Fish oil,

which

supports the health and function of the eyes. Contains DHA, which supports the health and function of the retina. S

upports healthy

eye function/vision. Supports the health of the eyes. EPA is the precursor of the 3 series of prostaglandins in the

body.

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

Supplementation with Omega 3 fatty acids may assist in dry eye syndrome.

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 24.11.2017 at 09:03:40 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

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