METAGENICS

Public Summary

Summary for ARTG Entry:

217948

METAGENICS VITAMIN D3 LIQUID

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

2/12/2013

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. METAGENICS VITAMIN D3 LIQUID

Product Type

Single Medicine Product

Effective date

7/10/2016

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

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

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

Specific Indications

Maintains normal healthy immune function/immunity.

Supplementation with vitamin D may increase vitamin D levels.

When taken in conjunction with the recommended daily intake of calcium, Vitamin D may help to reduce the risk of falls in the elderly by improving

muscle strength, which may reduce the risk of fractures.

Vitamin D is an essential nutrient for normal healthy bones.

Nutritional support for the maintenance of healthy skeletal, cardiovascular and immune systems.

Vitamin D3 aids in healthy calcium absorption and metabolism.

A significant number of Australians are at risk of vitamin D deficiency due to poor dietary intake and inadequate sun exposure.

Many elderly people, postmenopausal women and those with osteoporosis have low levels of vitamin D.

Concentrated and stabilised for strength and potency.

Glass is impervious to oxygen.

Metagenics in-use stability trials indicate the use of a glass bottle and rubber seal/dropper combination produces a barrier against oxygen to produce a

stable product.

Additional Product information

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:45:32 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

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

colecalciferol

.1 mg/mL

© 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 05:45:32 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