Vegan Omega 500 mg

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

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Active ingredient:
DHA/EPA rich Schizochytrium algal oil
Available from:
Digital Services Australia II Pty Ltd
Authorization status:
Listed
Authorization number:
348823

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Public Summary

Summary for ARTG Entry:

348823

Vegan Omega 500 mg

ARTG entry for

Medicine Listed

Sponsor

Digital Services Australia II Pty Ltd

Postal Address

1-9 Buckingham St Level 3, Surry Hills, NSW, 2020

Australia

ARTG Start Date

18/11/2020

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.

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 . Vegan Omega 500 mg

Product Type

Single Medicine Product

Effective Date

20/11/2020

Permitted Indications

Maintain/support eye health

Maintain/support general health and wellbeing

Maintain/support cardiovascular system health

Maintain/support healthy cardiovascular system function

Maintain/support heart health

Maintain/support brain function

Maintain/support brain health

Indication Requirements

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

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

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

No Specific Indications included on Record

Warnings

If symptoms persist, seek the advice of a healthcare professional.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:46:09 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

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

DHA/EPA rich Schizochytrium algal oil

481.35 mg

Other Ingredients (Excipients)

ascorbyl palmitate

caramel

glycerol

mixed (low-alpha type) tocopherols concentrate

modified food starch

purified water

Rosemary Oil

Sunflower Oil

© 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 11.01.2021 at 10:46:09 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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