Centrum For Women

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

Buy It Now

Active ingredient:
ascorbic acid,betacarotene,Biotin,calcium carbonate,calcium hydrogen phosphate,calcium pantothenate,chromic chloride hexahydrate,colecalciferol,cupric sulfate,cyanocobalamin,dl-alpha-tocopheryl acetate,ferrous fumarate,folic acid,magnesium oxide,manganese sulfate monohydrate,nicotinamide,phytomenadione,potassium iodide,pyridoxine hydrochloride,retinol acetate,riboflavin,sodium selenate,thiamine nitrate,zinc oxide
Available from:
GlaxoSmithKline Consumer Healthcare Australia Pty Ltd
INN (International Name):
Ascorbic acid,Betacarotene,Biotin,calcium hydrogen phosphate,chromic chloride hexahydrate,colecalciferol,cupric sulfate,Calcium
Authorization status:
Listed
Authorization number:
293159

Read the complete document

Public Summary

Summary for ARTG Entry:

293159

Centrum For Women

ARTG entry for

Medicine Listed

Sponsor

Pfizer Australia Pty Ltd

Postal Address

PO Box 57,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

24/08/2017

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. Centrum For Women

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

Not for the treatment of iron deficiency conditions (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.

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

Standard Indications

Maintain/support healthy/normal eyesight/vision

Maintenance of healthy eyes.

Maintain/support healthy energy levels

For vitamin (may state the vitamin) supplementation.

For mineral (may state the mineral) supplementation.

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

Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.

Source of iron. Can assist in maintaining normal blood.

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

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

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

Provides a minimum daily dose of 290mg of elemental calcium which may assist in the prevention of osteoporosis when dietary intake is inadequate.

Provides a minimum daily dose of 290mg of elemental calcium. A diet deficient in calcium can lead to osteoporosis in later life

Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone.

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:37:09 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

Source of calcium. Women's calcium requirements are increased after menopause.

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

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

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

Specific Indications

Vitamin A, Vitamin C, Betacarotene & Biotin to help maintain healthy skin, hair and nails

Multivitamin and mineral supplement

A complete multivitamin and mineral supplement containing essential vitamins and minerals to help support multiple health benefits like energy,

immunity, healthy skin and your general good health.

A multivitamin and mineral supplement containing comprehensive range of vitamins and minerals.

Dietary multivitamin and multimineral supplement for adults whose dietary vitamin intake is inadequate.

B group vitamins including folic acid to support daily energy and vitality;

Key antioxidants such as Vitamin A, C & E, Betacarotene, Zinc and Selenium to help strengthen immunity or maintain / support healthy immune function

Magnesium and Vitamin D helps support muscle health;

Vitamin A to help support healthy eyes / eyesight

Calcium, Vitamin D, Magnesium, Copper, Zinc & Manganese to help maintain healthy bones

Vitamin B6 and folic acid to help maintain a healthy heart

A source of calcium. Adequate dietary calcium throughout life is required to maximise bone density

Vitamin A is essential for good eye sight

Vitamin C helps maintain healthy teeth and gums

Vitamin C is essential for synthesis of collagen. It is also acts as an antioxidant

Vitamin E is an antioxidant, it acts as free radical scavenger

B complex, vital for the regulation of the metabolism and the conversion of food to energy in the body

Vitamin D aids absorption of calcium and utilisation of calcium and phosphate required for bones and teeth

Calcium strengthens bone and tissue

Iron helps maintain normal blood

Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.

Chromium is required for the utilisation of carbohydrates;

Biotin is important in the metabolism of protein and fat

Centrum for Women tablet aids, assists or helps in the maintenance or improvement of the general well-being.

Centrum For Women helps maintain your long term health.

Centrum For Women helps support vitality.

A multivitamin and mineral supplement containing a comprehensive range of essential vitamins and minerals to help support nutritional needs or multiple

health benefits like, energy, immunity, healthy skin, healthy muscle, healthy heart, and your general good health.

Maintains/supports mental performance/cognitive function

Helps support cognitive health/ and/or brain and nerve functions

Additional Product information

Container 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

Ascorbic acid

149.9998 mg

Betacarotene

.6 mg

Biotin

.045 mg

Calcium carbonate

985.454 mg

calcium hydrogen phosphate

20 mg

Calcium pantothenate

11.9 mg

chromic chloride hexahydrate

128 microgram

Public Summary

Page 2 of

Produced at 24.11.2017 at 06:37:09 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

colecalciferol

.02 mg

cupric sulfate

2.261 mg

Cyanocobalamin

.0216 mg

dl-alpha-Tocopheryl acetate

28 mg

Ferrous fumarate

20.688 mg

Folic acid

400 microgram

Magnesium oxide

106.101 mg

Manganese sulfate monohydrate

15.389 mg

Nicotinamide

14 mg

Phytomenadione

20 microgram

potassium iodide

196 microgram

pyridoxine hydrochloride

6 mg

retinol acetate

.344 mg

Riboflavin

3.85 mg

sodium selenate

132 microgram

Thiamine nitrate

4.2 mg

zinc oxide

9.958 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 24.11.2017 at 06:37:09 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

Similar products

Search alerts related to this product

Share this information