Organic

Main information

Documents

Localization

  • Available in:
  • Organic Iron MAX
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222575
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222575

Organic Iron MAX

ARTG entry for

Medicine Listed

Sponsor

Herbs of Gold Pty Ltd

Postal Address

PO Box 3143,KIRRAWEE, NSW, 2232

Australia

ARTG Start Date

16/04/2014

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. Organic Iron MAX

Product Type

Single Medicine Product

Effective date

21/04/2017

Warnings

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

Not for the treatment of iron deficiency conditions (or words to that effect).

Standard Indications

Source of iron. Can assist in maintaining normal blood. Blood tonic.

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.

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

May assist in the management of dietary iron deficiency.

Specific Indications

Helps maintain normal blood/blood tonic.

Contains B vitamin (vitamins B1, B6, B12) cofactors and folic acid to help maintain healthy blood.

Iron is necessary for the transport of oxygen around the body.

Iron is necessary for the formation of haemoglobin which transports oxygen in red blood cells to the tissues.

Iron is involved in oxygen storage by myoglobin, a protein found in muscle that stores and transports oxygen for muscle contraction.

Iron requirements are increased during pregnancy.

Vitamin C facilitates the absorption of iron from the digestive tract.

Vitamin B2 and B6 are important for the synthesis of haemoglobin, which carries oxygen in red blood cells.

Folic acid and vitamin B12 are necessary for the production of red blood cells for oxygen transport.

Vitamins B6, B12 and folic acid are necessary for oxygen transport in red blood cells.

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:05:04 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

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Arthrospira maxima

100 mg

calcium ascorbate dihydrate

304.1 mg

Cyanocobalamin

250 microgram

Folic acid

250 microgram

Iron amino acid chelate

120 mg

pyridoxine hydrochloride

12.15 mg

Riboflavin

10 mg

Spinacia oleracea

25 mg

Thiamine hydrochloride

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 26.11.2017 at 11:05:04 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