METAGENICS CALCITITE PROTECT

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

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Active ingredient:
borax,calcium hydrogen phosphate dihydrate,colecalciferol,hydroxyapatite,phytomenadione
Available from:
Metagenics (Aust) Pty Ltd
Authorization status:
Listed
Authorization number:
322269

Public Summary

Summary for ARTG Entry:

322269

METAGENICS CALCITITE PROTECT

ARTG entry for

Medicine Listed

Sponsor

Metagenics (Aust) Pty Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

26/08/2019

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Products

1. METAGENICS CALCITITE PROTECT

Product Type

Single Medicine Product

Effective date

26/08/2019

Permitted Indications

Aids/assists teeth development

Maintain/support bone health in elderly individuals

Maintain/support bone health

Aids/assists healthy bone development/growth/building

Helps enhance/promote bone mass/density in post-menopausal women

Maintain/support bone mass/density/integrity

Maintain/support bone mass/density/integrity in post-menopausal women

Maintain/support bone mass/density/integrity in elderly individuals

Helps enhance/promote bone strength in post-menopausal women

Maintain/support bone strength

Maintain/support bone strength in children

Maintain/support bone strength In older females

Maintain/support bone strength In older males

Maintain/support bone strength in elderly individuals

Help maintain/support bone mineralisation

Help maintain/support bone mineralisation

A diet deficient in calcium can lead to osteoporosis in later life. Calcium may help prevent osteoporosis when dietary intake is inadequate in

post-menopausal women

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

Helps enhance/improve/promote/increase muscle strength to improve balance/stability in elderly individuals

Maintain/support absorption of dietary (state vitamin/mineral/nutrient)

Maintain/support absorption of dietary (state vitamin/mineral/nutrient) in post-menopausal women

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Indication Requirements

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose

of 25 micrograms or less of vitamin D and as a min

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Indication can only be used for medicines that contain calcium as an active ingredient and the recommended daily dose of the medicine must provide at

least 290 milligrams of elemental calcium.

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin

and/or mineral supplements should not replace a

Standard Indications

No Standard Indications included on Record

Specific Indications

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.

Public Summary

Page 1 of

Produced at 29.08.2019 at 04:08:20 AEST

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

borax

8.85 mg

calcium hydrogen phosphate dihydrate

474.5 mg

colecalciferol

.0083 mg

hydroxyapatite

1 g

phytomenadione

27 microgram

© 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 29.08.2019 at 04:08:20 AEST

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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