BicoZn

Main information

Documents

Localization

  • Available in:
  • BicoZn
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217902
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217902

BicoZn

ARTG entry for

Medicine Listed

Sponsor

Biomedica Nutraceuticals Pty Ltd

Postal Address

PO Box 7052,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

29/11/2013

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. BicoZn

Product Type

Single Medicine Product

Effective date

20/04/2016

Warnings

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

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (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

May reduce the severity of colds. [Warning COLD required]

May reduce the duration of colds. [Warning COLD required]

May reduce the severity and duration of colds. [Warning COLD required]

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

For vitamin (may state the vitamin) supplementation.

Maintenance of healthy eyes.

For mineral (may state the mineral) supplementation.

Specific Indications

Maintains and supports a normal/healthy immune system.

Provides nutritional support during pregnancy and lactation, when nutritional requirements are increased.

Contains nutrients that are involved in protein, carbohydrate and fat metabolism in the body

Supports the body's detoxification mechanisms.

Supports/maintains the health of the liver.

Vitamin B6 is involved in the manufacture and action of hormones such as serotonin.

Supports healthy nervous system function.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:47:00 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

Supports healthy skin

Contains Zinc which assists in the healing and repair of the skin.

Zinc is necessary for wound healing.

Contains essential nutrients to support the health of mother and baby

Zinc is involved in the maintenance of normal healthy blood sugar levels in healthy individuals.

Zinc is required for the metabolism of many body hormones including sex hormones.

Taken orally, Zinc bis-glycinate/Chelazome has superior bioavailability when compared to zinc gluconate.

Contains nutrients necessary for the function of healthy neurotransmitters.

Zinc supports the health of the female and male reproductive system

Pyridoxine and zinc play a role in immune mechanisms

Contains zinc an important nutritional antioxidant that can reduce the risk of cellular damage and can therefore assist in protecting against potential free

radical/oxidative damage.

Zinc is required for the health of the reproductive system.

Zinc helps support sperm formation, sperm maturation and normal sperm motility in healthy men

Assists in protecting the cells of the body from free radical damage.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Magnesium citrate

129.45 mg

pyridoxal 5-phosphate monohydrate

11.76 mg

pyridoxine hydrochloride

9.12 mg

zinc citrate dihydrate

38.94 mg

Zinc glycinate

40.97 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 05:47:00 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