Centrum

Main information

Documents

Localization

  • Available in:
  • Centrum 50+ Travel Pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216811
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216811

Centrum 50+ Travel Pack

ARTG entry for

Medicine Listed

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

1/11/2013

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. Centrum 50+ Travel Pack

Product Type

Single Medicine Product

Effective date

6/03/2014

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.

Standard Indications

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

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

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

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

Specific Indications

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

Vitamin C helps maintain healthy teeth and gums; Vitamin C is essential for synthesis of collagen. It is also acts as an antioxidant

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

Calcium strengthens bone and tissue

Chromium is required for the utilisation of carbohydrates

Key antioxidants such as Vitamins C and E, Betacarotene, Copper, Selenium and Zinc may help maintain or support a healthy immune function

Biotin is important in the metabolism of protein and fat

Iron helps maintain normal blood; Iron is necessary for

the formation of haemoglobin which trancports oxygen to the tissues

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

B group vitamins including Folic acid to support daily energy and vitality.

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

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:10:26 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

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

60 mg

Betacarotene

1.796 mg

Biotin

.03 mg

Calcium carbonate

295 mg

calcium hydrogen phosphate

207.64 mg

Calcium pantothenate

10.87 mg

chromic chloride hexahydrate

.256 mg

colecalciferol

.01 mg

cupric sulfate

1.25 mg

Cyanocobalamin

.025 mg

dl-alpha-Tocopheryl acetate

45 mg

Ferrous fumarate

27.38 mg

Folic acid

.2 mg

Magnesium oxide

165.81 mg

Manganese sulfate monohydrate

7.69 mg

Nicotinamide

20 mg

Phytomenadione

.055 mg

potassium iodide

.196 mg

Potassium sulfate

111.43 mg

pyridoxine hydrochloride

3 mg

Riboflavin

1.7 mg

Sodium molybdate dihydrate

.063 mg

sodium selenate

.06 mg

Thiamine nitrate

1.5 mg

zinc oxide

9.33 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 26.11.2017 at 07:10:26 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