Women’s

Main information

Documents

Localization

  • Available in:
  • Women’s Multi Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217440
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217440

Women's Multi Plus

ARTG entry for

Medicine Listed

Sponsor

Hazel Pharmaceuticals Pty Ltd

Postal Address

14 Junction Street,MARRICKVILLE, NSW, 2204

Australia

ARTG Start Date

18/11/2013

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. Women's Multi Plus

Product Type

Single Medicine Product

Effective date

18/11/2013

Warnings

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.

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

If symptoms persist consult your healthcare practitioner (or words to that effect).

Contains lactose (or words to that effect).

Standard Indications

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.

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

For mineral (may state the mineral) supplementation.

For vitamin (may state the vitamin) supplementation.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

Protects capillaries.

Maintain health of capillaries.

Source of folic acid. Can assist in maintaining normal blood.

Beneficial during times of stress. [Warning S required]

Source of vitamin B12. Can assist in maintaining normal blood.

Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

May help reduce the oxidation of LDL cholesterol.

Maintenance of healthy eyes.

Public Summary

Page 1 of

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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

Specific Indications

* Assists in the maintenance of a normal/healthy cardiovascular system.

* Supports the health of the cardiovascular system.

* Supports red blood cell health.

* Folic acid can assist in maintaining normal blood.

* Folic acid is one of the nutrients necessary for the production of normal red blood cells.

* Contains nutrients that can assist in maintaining normal blood. Blood tonic.

* Contains nutrients that are essential for the proper function of the immune system.

* Maintains a normal/healthy immune system.

* Supports the immune system by aiding the activity of the white blood cells and antibody response.

* Contains nutrients that play a vital role in many immune mechanisms.

* Contains nutrients that are involved in many immune mechanisms in the body and that support healthy immune function.

* Supports healthy functioning of the immune system.

* Zinc is an important nutrient for a healthy immune response.

* Contains important nutritional antioxidants / free radical scavengers.

* Contains antioxidant nutrients, which assist in protecting the body from the damaging effects of free radicals.

* Contains antioxidant nutrients, which assist in reducing the risk of cellular damage from free radicals.

* Contains important nutritional antioxidants and can therefore assist in protecting against potential free radical/oxidative damage.

* Protects the cells from free radical damage.

* Contains nutrients that are necessary for wound healing.

* Contains nutrients that are necessary for the maintenance of healthy skin.

* Supports skin repair and wound healing.

* Supports healthy skin.

* Supports healthy vision.

* Contains pantothenic acid, which is required for proper function of the adrenal gland.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

* The human body has increased requirements for the vitamins (especially the B group) and minerals during periods of stress.

* During stress, nutrients such as vitamin C, Vitamin B6, vitamin B5 and magnesium are important for supporting adrenal function.

* Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism.

* Some of the B group vitamins, such as folic acid and vitamin B6 are involved in the manufacture and action of mood enhancing hormones such as

serotonin.

* Provides support to the nervous system.

* Supports healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function and muscle action.

* Supports neuromuscular function.

* Contains nutrients that are involved in the production of energy in the body.

* Contains nutrients that play a vital role in the production of ATP, or cellular energy.

* Supports daily energy levels.

* Supports an active lifestyle.

* Supports/maintains healthy brain function.

* Supports healthy sleep patterns.

* Supports bone, joint, cartilage and tendon health.

* Supports normal calcification of the skeleton.

* Supports healthy bone mineral density.

* Vitamin D is important for bone health.

* Vitamin D helps to maintain serum calcium and phosphorus levels, which is critical for the normal development of bones and teeth.

* Supports the development and maintenance of strong, healthy bones, teeth and cartilage.

* Supports healthy pregnancy.

* Supports the health of the growing baby during pregnancy.

* Assists in the maintenance of a healthy urinary tract during pregnancy.

* Supports urinary tract health during pregnancy.

* Chromium aids in the transport of glucose into the cells.

* Chromium facilitates the uptake of glucose into the cells.

* Supports normal/healthy glycaemic control in healthy individuals.

* Helps to maintain normal/healthy glycaemic controls in healthy individuals.

* Assists in the maintenance of normal/healthy blood sugar levels in healthy individuals.

* Helps to maintain normal/healthy blood sugar control in healthy individuals.

* Contains chromium, which is a main component of glucose tolerance factor.

* Vitamin D plays a role in the maintenance of healthy blood sugar levels in healthy individuals.

* Chromium is an essential nutrient required for lipid and protein metabolism.

* Contains nutrients that play an essential role in carbohydrate metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* Thiamine, pantothenic acid, riboflavin, biotin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Biotin functions in the human body as an essential co-factor for enzyme that are involved in the metabolism of carbohydrates, fats and proteins.

* Pantothenic acid, biotin, riboflavin and cyanocobalamin are involved in the metabolism of protein, or amino acids in the body.

* Thiamine, pantothenic acid, riboflavin and cyanocobalamin are involved in the metabolism of carbohydrates in the body.

* Vitamin C aids in the metabolism of fats and proteins.

* Contains nutrients that are involved in hormone synthesis and modulation.

* Vitamin C improves iron absorption.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports connective tissue formation.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Zinc is required for protein synthesis and cell growth.

* Zinc is necessary for the proper action of many body hormones including sex hormones.

* Zinc supports the health and function of the female reproductive system.

* Zinc is an essential mineral for healthy ovulation in women.

* Contains nutrients that play an essential role in healthy ovulation in women.

* Supports/maintains healthy female function.

Additional Product information

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:56:53 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 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

10 mg

Ascorbic acid

300 mg

Betacarotene

2.5 mg

Biotin

3 microgram

Bromelains

12.5 mg

Calcium pantothenate

25 mg

Choline bitartrate

20 mg

Chromium picolinate

403 microgram

Citrus bioflavonoids extract

20 mg

colecalciferol

.005 mg

Cupric sulfate pentahydrate

1.96 mg

Cyanocobalamin

250 microgram

cysteine hydrochloride

15 mg

d-alpha-Tocopheryl acid succinate

41.32 mg

Folic acid

300 microgram

Inositol

20 mg

Iron amino acid chelate

25 mg

Magnesium amino acid chelate

50 mg

Manganese amino acid chelate

10 mg

molybdenum trioxide

105 microgram

Nicotinamide

20 mg

Phytomenadione

30 microgram

potassium iodide

157 microgram

pyridoxine hydrochloride

25 mg

Quercetin

6.88 mg

Riboflavin

15 mg

rutoside

15 mg

Selenomethionine

62.5 microgram

Thiamine hydrochloride

15 mg

Vaccinium macrocarpon

20 mg

Vitis vinifera

41.67 mg

zinc amino acid chelate

50 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 3 of

Produced at 23.11.2017 at 12:56:53 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