Eagle

Main information

  • Trade name:
  • Eagle Omega Vital EFA
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Eagle Omega Vital EFA
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221696
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221696

Eagle Omega Vital EFA

ARTG entry for

Medicine Listed

Sponsor

Integria Healthcare Australia Pty Ltd

Postal Address

PO Box 4854,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

26/03/2014

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. Eagle Omega Vital EFA

Product Type

Single Medicine Product

Effective date

15/05/2014

Warnings

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

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Standard Indications

For the symptomatic relief of dry skin.

Specific Indications

DHA is an important nutrient for infant development.

For use as a dietary source of essential fatty acids including gamma-Linolenic acid (GLA) from Evening Primrose Oil and long chain omega-3 fatty acids

- eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil / An essential fatty acid supplement (for essential fatty acid deficiency).

Increasing the ratio of n-3 to n-6 fatty acids in the diet may shift the balance of eicosanoids produced to those with anti-inflammatory activity.

Essential fatty acids helps support the structure and function of cellular membranes.

Helps maintain the stability and fluidity of cell membranes throughout the body.

Essential fatty acids are important for the structure and function of cell.

Fatty acids from fish oil are important structural components of the phospholipid membranes of cells throughout the body.

Essential fatty acids and their metabolites EPA, DHA and GLA help to modulate inflammatory processes in the body.

Fish Oil and Evening Primrose Oil may assist in symptomatic relief of inflammatory and dry skin conditions.

Insufficient omega-3 fatty acids in the diet leads to dry, rough skin and dermatitis.

EPO has anti-inflammatory effects and correcting deficiency may particularly improve regulation of skin inflammation.

Helps support / maintain cardiovascular health / Helps to support the cardiovascular system.

Helps maintain healthy eyes / supports eye health / supports healthy eye function.

Helps support cognitive health / brain function.

Increased fish oil consumption may aid/assist in the maintenance of cognitive function as we age.

Adequate omega-3 fatty acid levels may be of benefit during pregnancy and lactation.

Research suggests that eczema patients have a reduced ability to convert linoleic acid to GLA.

Mothers supplementing DHA pass higher amounts to the foetus and through lactation.

Pregnant and lactating women have an extra requirement for omega-3 essential fatty acids.

Fish oil contains omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docasahexaenoic acid (DHA).

Polyunsaturated fatty acid are precursors to eicosanoids (prostaglandins and leukotrienes), which have important roles in the regulation of inflammation.

This product contains antioxidant vitamin E (as d-alpha tocopherol).

Additional Product information

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:24:33 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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

d-alpha-Tocopherol

33.6 mg

Evening Primrose Oil

750 mg

natural fish oil

500 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 23.11.2017 at 12:24:33 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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