Blackmores Purely Kids Infant DHA

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

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Active ingredient:
docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.
Available from:
Blackmores Ltd
Authorization status:
Listed
Authorization number:
345894

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Public Summary

Summary for ARTG Entry:

345894

Blackmores Purely Kids Infant DHA

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725, WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

14/10/2020

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 . Blackmores Purely Kids Infant DHA

Product Type

Single Medicine Product

Effective Date

14/10/2020

Permitted Indications

Helps maintain/support healthy vision development

Maintain/support brain/central nervous system development

Indication Requirements

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

Product presentation must not imply or refer to neurological conditions or developmental delays.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

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

docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp.

293.5781 mg

Other Ingredients (Excipients)

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:55:39 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

ascorbyl palmitate

Gelatin

glycerol

lecithin

medium chain triglycerides

mixed (low-alpha type) tocopherols concentrate

Olive Oil

purified water

Rosmarinus officinalis

Soya 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 12.01.2021 at 12:55:39 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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