Wellgrove Extra Virgin Olive Oil 1000mg Super Antioxidant Capsules

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

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Active ingredient:
Olive Oil
Available from:
Boundary Bend Wellness Pty Ltd
Authorization status:
Listed
Authorization number:
346240

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Public Summary

Summary for ARTG Entry:

346240

Wellgrove Extra Virgin Olive Oil 1000mg Super Antioxidant Capsules

ARTG entry for

Medicine Listed

Sponsor

Boundary Bend Wellness Pty Ltd

Postal Address

PO Box 92, Lara, VIC, 3212

Australia

ARTG Start Date

20/10/2020

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 . Wellgrove Extra Virgin Olive Oil 1000mg Super Antioxidant Capsules

Product Type

Single Medicine Product

Effective Date

4/01/2021

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps maintain/support healthy cholesterol

Maintain/support heart health

Indication Requirements

Product presentation must not imply or refer to lowering or raising blood cholesterol levels from outside of the normal healthy range

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

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

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:30:09 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

Olive Oil

1000 mg

Other Ingredients (Excipients)

glycerol

modified food starch

purified water

sorbitol

vanillin

© 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 12.01.2021 at 12:30:09 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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