FAB IRON

Main information

Documents

Localization

  • Available in:
  • FAB IRON + Vitamin B Complex
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219891
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219891

FAB IRON + Vitamin B Complex

ARTG entry for

Medicine Listed

Sponsor

Care Pharmaceuticals Pty Ltd

Postal Address

PO Box 1674,BONDI JUNCTION, NSW, 1355

Australia

ARTG Start Date

5/02/2014

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. FAB IRON + Vitamin B Complex

Product Type

Single Medicine Product

Effective date

5/02/2014

Warnings

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.

Standard Indications

For vitamin (may state the vitamin) supplementation.

Source of iron. Can assist in maintaining normal blood.

May assist in the management of dietary iron deficiency.

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. Blood tonic.

Specific Indications

Helps restore energy and vitality. A combination of easy to absorb iron, energy boosting B group vitamins and zinc to help restore and support your

immune system.

Iron out that tired feeling.

Easy to absorb. Contains Vitamin C to assist with maximum iron absorption.

Easy to digest. Contains an organic chelated form of iron that is easy to absorb and digest in the body.

Gentle on the stomach. Chelated iron is well tolerated and gentle on the stomach.

Iron is a mineral essential for everyday life. It is used by the body to transport oxygen, maintain healthy blood levels and release energy. Low iron levels

can result in tiredness and lack of energy.

Suitable for women, teenage girls and vegetarians.

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

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:34:34 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 Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

75 mg

Biotin

50 microgram

Calcium pantothenate

5 mg

Cyanocobalamin

10 microgram

Iron amino acid chelate

50 mg

Nicotinamide

15 mg

pyridoxine hydrochloride

4 mg

Riboflavin

10 mg

Thiamine nitrate

10 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 22.11.2017 at 11:34:34 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