Women's Multivitamin & Minerals

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

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Active ingredient:
alpha lipoic acid,ascorbic acid,Biotin,calcium carbonate,calcium pantothenate,choline bitartrate,colecalciferol,cyanocobalamin,Citrus bioflavonoids extract,d-alpha-tocopheryl acid succinate,ferrous fumarate,folic acid,fructooligosaccharides,hydrolysed collagen,inositol,levocarnitine hydrochloride,magnesium oxide,manganese sulfate monohydrate,nicotinamide,potassium iodide,pyridoxine hydrochloride,retinol palmitate,riboflavin,selenomethionine,taurine,thiamine hydrochloride,ubidecarenone,Vaccinium
Available from:
Health Spring Australia
Authorization status:
Listed
Authorization number:
322089

Public Summary

Summary for ARTG Entry:

322089

Women's Multivitamin & Minerals

ARTG entry for

Medicine Listed

Sponsor

Health Spring Australia

Postal Address

40-60 Bellona Avenue,Regents Park, NSW, 2143

Australia

ARTG Start Date

21/08/2019

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. Women's Multivitamin & Minerals

Product Type

Single Medicine Product

Effective date

21/08/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Maintain/support energy levels

Maintain/support body metabolism/metabolic rate

Helps enhance/promote/increase vitality

Maintain/support vitality

Helps enhance/promote general health and wellbeing

Maintain/support general health and wellbeing

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

Decrease/reduce/relieve symptoms of stress

Indication Requirements

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

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.

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

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

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 04:31:29 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

Warnings

Do not take while on warfarin therapy without medical advice.

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.

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

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

ascorbic acid

75 mg

Biotin

90 microgram

calcium carbonate

225 mg

calcium pantothenate

11.7 mg

choline bitartrate

4.5 mg

Citrus bioflavonoids extract

25 mg

colecalciferol

.009 mg

cyanocobalamin

10 microgram

d-alpha-tocopheryl acid succinate

5.4 mg

ferrous fumarate

26.1 mg

folic acid

250 microgram

fructooligosaccharides

25 mg

hydrolysed collagen

50 mg

inositol

5.4 mg

levocarnitine hydrochloride

15.75 mg

magnesium oxide

112.5 mg

manganese sulfate monohydrate

1.4 mg

nicotinamide

14.4 mg

potassium iodide

90 microgram

pyridoxine hydrochloride

4.5 mg

retinol palmitate

641.2 microgram

riboflavin

3.6 mg

selenomethionine

187.5 microgram

taurine

15 mg

thiamine hydrochloride

5.4 mg

ubidecarenone

25 mg

Vaccinium macrocarpon

5 mg

Equivalent: Vaccinium macrocarpon (Dry)

2.5 g

Vitis vinifera

12.5 mg

Equivalent: Vitis vinifera (Dry)

1.5 g

zinc oxide

9 mg

© 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 04:31:29 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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