OmegaTrienols

Main information

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

Documents

Localization

  • Available in:
  • OmegaTrienols
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221424
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221424

OmegaTrienols

ARTG entry for

Medicine Listed

Sponsor

FIT-BioCeuticals Limited

Postal Address

PO Box 6454,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

18/03/2014

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. OmegaTrienols

Product Type

Single Medicine Product

Effective date

21/01/2016

Warnings

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

Standard Indications

May assist in the maintenance of triglycerides within the normal range in healthy individuals.

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

May help reduce joint inflammation associated with arthritis.

May help reduce joint swelling associated with arthritis.

Maintenance of healthy eyes.

May assist in the maintenance of normal blood pressure in healthy individuals.

May help to support normal blood pressure in healthy individuals.

Specific Indications

[P72] Assists in the maintenance of general wellbeing.

[P16] Helps normal growth and development.

[P22] Helps maintain general health / wellbeing.

[P23] Promotes general health.

[P24] For the maintenance of good health.

[P26] Helps in the maintenance of good health.

[1] Source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for the maintenance of good health. / Omega-3 triglycerides are essential

for normal health and development / Helps to maintain good health.

[P530] Helps reduce joint inflammation associated with arthritis.

[P531] Helps to reduce joint swelling associated with arthritis.

[P147] Assists in the maintenance of triglycerides within the normal range in healthy individuals.

[P125] Assists in the maintenance of normal blood fat levels in healthy individuals.

[P126] Assists in the maintenance of normal blood lipid levels in healthy individuals.

[P202] Helps maintain healthy eyes.

[P203] Supports eye health.

[P224] Assists in the maintenance of normal blood pressure in healthy individuals.

[P225] Helps to support normal blood pressure in healthy individuals.

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:57:32 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

[2] Omega-3 triglycerides and tocotrienol rich vitamin E helps to maintain a healthy heart/cardiovascular system/function.

[P236] Helps to support the cardiovascular system.

[P239] Helps maintain cardiovascular health.

[P241] Helps support cardiovascular health.

[3] Omega-3 triglyceride supplement for people who do not eat enough fish / have enough fish in their diet.

[4] Omega-3 triglycerides help to maintain the flexibility of blood vessels/helps to maintain the flexibility of blood vessels to promote healthy blood flow.

[P106] Assists blood circulation.

[5] Vitamin E supports vascular health.

[6] Maternal intake of omega-3 fatty acids during pregnancy and breastfeeding is important for normal growth and development in children.

[7] The DHA in fish oil is essential for the normal development and functioning of the retina and brain.

[P12] Supports foetal growth and development.

[P13] Contributes to normal growth of the foetus.

[8] Pregnant and lactating women have an increased requirement for omega-3 essential fatty acids.

[9] Omega-3 fatty acids in fish oil may assist in maintaining normal healthy mood in adults.

[10] A higher intake of dietary omega-3 fatty acids is associated with less age-related mental and cognitive decline / may help maintain mental and

cognitive function as you age.

[11] May help maintain normal brain/cognitive function in adults.

[P165] Helps to support cognitive function in healthy people.

[P166] Helps to support cognitive health.

[12] Omega-3 triglycerides provide nutritional support for healthy skin.

[P467] Helps to maintain healthy skin.

[P468] Support skin health.

[13] Dietary intake of long chain omega-3 fatty acids from fish / EPA and DHA support the health of ageing eyes.

[P25] Provides antioxidants for the maintenance of good health.

[P1] Antioxidant.

[14] Vitamin E is a potent lipid soluble antioxidant that protects cell membranes from free radicals.

[15] Vitamin E contributes to mitochondrial membrane integrity and is an important mitochondrial antioxidant.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, enteric

Route of Administration

Oral

Visual Identification

Active Ingredients

concentrated fish Omega-3 triglycerides

1.3466 g

palm tocotrienols complex

100 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 12:57:32 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