BLACKMORES WOMEN'S PREMIUM IRON

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

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Active ingredient:
iron (II) glycinate
Available from:
Blackmores Ltd
Authorization status:
Listed
Authorization number:
346422

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Public Summary

Summary for ARTG Entry:

346422

BLACKMORES WOMEN'S PREMIUM IRON

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725, WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

22/10/2020

Product Category

Medicine

Status

Active

Approval Area

Listed Medicines

Products

1 . BLACKMORES WOMEN'S PREMIUM IRON

Product Type

Single Medicine Product

Effective Date

22/10/2020

Permitted Indications

Maintain/support energy levels when dietary intake is inadequate

Maintain/support energy production when dietary intake is inadequate

Maintain/support vitality when dietary intake is inadequate

Relieve weariness/tiredness/fatigue/feeling of weakness when dietary intake is inadequate

Maintain/support general health and wellbeing when dietary intake is inadequate

Aid/assist healthy red blood cell production when dietary intake is inadequate

Maintain/support blood health when dietary intake is inadequate

Helps maintain/support transport of oxygen in the body when dietary intake is inadequate

Aid/assist/helps oxygen transport to body tissues when dietary intake is inadequate

Maintain/support (state vitamin/mineral/nutrient) levels in the body when dietary intake is inadequate

Maintain/support (state vitamin/mineral) within normal range when dietary intake is inadequate

Maintain/support healthy pregnancy when dietary intake is inadequate

Maintain/support maternal health when dietary intake is inadequate

Indication Requirements

Product presentation must not imply or refer to chronic fatigue syndrome.

Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

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

Product presentation must not imply or refer to heart disease.

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 balanced diet.

Label statement: If symptoms persist, talk to your health professional.

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.

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Not for the treatment of iron deficiency conditions (or words to that effect).

Additional Product information

Container information

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:21:28 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

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Child resistant closure

Not recorded

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

iron (II) glycinate

87.7 mg

Equivalent: iron

24 mg

Other Ingredients (Excipients)

calcium hydrogen phosphate

Carnauba Wax

citric acid

colloidal anhydrous silica

croscarmellose sodium

hypromellose

iron oxide red

macrogol 8000

magnesium stearate

maize starch

maltodextrin

medium chain triglycerides

microcrystalline cellulose

polydextrose

purified talc

sodium starch glycollate

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 12:21:28 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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