USANA Prenatal Vita Antioxidant

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

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Active ingredient:
alpha lipoic acid,betacarotene,Biotin,calcium ascorbate,calcium pantothenate,choline bitartrate,colecalciferol,curcumin,cyanocobalamin,Camellia sinensis,d-alpha-tocopheryl acid succinate,folic acid,hesperidin,inositol,lutein,lycopene,magnesium ascorbate monohydrate,menaquinone 7,mixed (low-alpha type) tocopherols concentrate,nicotinamide,Olea europaea,phytomenadione,potassium ascorbate,pyridoxine hydrochloride,quercetin dihydrate,riboflavine,rutoside,thiamine hydrochloride,ubidecarenone,zinc
Available from:
Usana Australia Pty Ltd
Authorization status:
Listed
Authorization number:
322797

Public Summary

Summary for ARTG Entry:

322797

USANA Prenatal Vita Antioxidant

ARTG entry for

Medicine Listed

Sponsor

Usana Australia Pty Ltd

Postal Address

PO Box 6744,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

6/09/2019

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. USANA Prenatal Vita Antioxidant

Product Type

Single Medicine Product

Effective date

6/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Helps enhance/promote collagen formation

Enhance/promote energy levels

Helps convert (state food) into energy

Helps maintain/support healthy eye development

Maintain/support healthy eye function

Maintain/support eye health

Helps enhance/promote healthy growth and development

Helps enhance/promote general health and wellbeing

Helps enhance/promote connective tissue health

Maintain/support body tissue repair/regeneration

Helps enhance/promote bone health

Aids/assists healthy bone development/growth/building

Helps enhance/promote bone mass/density

Maintain/support (state mineral) absorption in bones

Helps enhance/promote bone strength

Helps enhance/promote bone mineralisation

Helps enhance/promote/increase metabolism of (state mineral) in bones

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

Public Summary

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Produced at 29.09.2019 at 05:12:52 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

Aid/assist healthy red blood cell production

Helps enhance/promote red blood cell health

Helps in the maintenance of healthy blood lipids/blood fats

Helps maintain/support healthy cholesterol

Aid/assist/helps in the maintenance of blood levels of oxygen

Aid/assist/helps oxygen transport to body tissues

Helps maintain/support haemoglobin formation/synthesis

Maintain/support cardiovascular system health

Maintain/support heart health

Aid/assist digestion/breakdown of dietary fat

Aid/assist/helps digestion of fats/fatty acids/triglycerides/lipid

Helps enhance/promote healthy liver function

Maintain/support immune system health

Enhance/improve/promote immune defence/immunity

Helps enhance/improve/promote immune system function

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Helps enhance/promote/increase absorption of dietary (state vitamin/mineral/nutrient)

Enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Maintain/support cognitive function/mental function

Maintain/support healthy pregnancy

Helps enhance/promote maternal health

Help to prevent neural tube defects such as spina bifida and/or anencephaly

Helps enhance/promote preconception health

Helps enhance/promote skin health

Indication Requirements

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

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.

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

osteoporosis.

Product presentation must not imply or refer to infertility.

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

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

Indication can only be used for medicines that contain folic acid as an active ingredient and the recommended daily dose of the medicine provides a

minimum of 400 micrograms of folic acid. Product pre

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.

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

Product presentation must not imply or refer to serious immunological diseases.

Product presentation must not imply or refer to lowering blood lipids, blood fats and triglycerides.

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

Product presentation must not imply or refer to liver disease, such as cirrhosis, hepatitis.

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

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

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

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

Product presentation must not imply or refer to heart disease.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

Public Summary

Page 2 of

Produced at 29.09.2019 at 05:12:52 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

that effect].

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 medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words

to that effect].

Adults only (or words to that effect).

Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice (or

words to that effect).

Do not take while on warfarin therapy without medical advice.

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

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

alpha lipoic acid

25 mg

betacarotene

1.5 mg

Biotin

75 microgram

calcium ascorbate

62.5 mg

calcium pantothenate

25 mg

Camellia sinensis

17.5 mg

Equivalent: Camellia sinensis (Dry)

175 mg

choline bitartrate

62.5 mg

colecalciferol

.0062 mg

curcumin

3.25 mg

cyanocobalamin

50 microgram

d-alpha-tocopheryl acid succinate

41.3 mg

folic acid

125 microgram

hesperidin

10 mg

inositol

32 mg

lutein

.15 mg

lycopene

.25 mg

magnesium ascorbate monohydrate

18.75 mg

menaquinone 7

15 microgram

mixed (low-alpha type) tocopherols concentrate

20 mg

nicotinamide

10 mg

Olea europaea

3.75 mg

phytomenadione

120 microgram

potassium ascorbate

42.5 mg

pyridoxine hydrochloride

8 mg

quercetin dihydrate

15 mg

riboflavine

7.5 mg

rutoside

10 mg

thiamine hydrochloride

7.5 mg

ubidecarenone

3 mg

zinc ascorbate

1.25 mg

Public Summary

Page 3 of

Produced at 29.09.2019 at 05:12:52 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

© 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 4 of

Produced at 29.09.2019 at 05:12:52 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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