Faulding

Main information

  • Trade name:
  • Faulding Remedies Zinc
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Faulding Remedies Zinc
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219957
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219957

Faulding Remedies Zinc

ARTG entry for

Medicine Listed

Sponsor

Symbion Pty Ltd

Postal Address

PO Box 7300,Melbourne, VIC, 3008

Australia

ARTG Start Date

7/02/2014

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. Faulding Remedies Zinc

Product Type

Single Medicine Product

Effective date

25/02/2014

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.

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

Maintenance of healthy eyes.

May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

May assist in the maintenance of normal healthy glycaemic controls in healthy individuals.

May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals.

Male support. Balances and supports normal male physiology and function.

Male support. May be beneficial to men in satisfying physiological requirements of the male body.

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

For mineral (may state the mineral) supplementation.

For vitamin (may state the vitamin) supplementation.

Specific Indications

* Zinc is an essential trace mineral that is a component in over 200 enzymes in the body.

* Zinc is necessary for the proper action of many body hormones including sex hormones.

* Zinc is involved in protein, carbohydrate and lipid metabolism.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* Contains nutrients that support and maintain healthy immune function.

* Zinc is important for the health and function of the immune system.

* Zinc is an important nutrient for a healthy immune response. * Contains nutrients that play important roles in the proper functioning of the immune

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:07:11 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

system.

* Pyridoxine is involved in immune system processes in the body.

* Zinc supports the health of the male reproductive system.

* Zinc is an important nutrient in supporting male reproductive health and function.

* Zinc is an important mineral for the formation and maturation of spermatozoa.

* Selenium is required for testosterone synthesis.

* Selenium is required for the health of the reproductive system.

* Selenium supports normal sperm motility in healthy men.

* Selenium supports the health and function of the male reproductive system.

* Selenium supports and maintains prostate health.

* Selenium supports the health of the cells of the prostate.

* Zinc supports the health and function of the female reproductive system.

* Zinc is an essential mineral for healthy ovulation in women.

* Selenium supports healthy pregnancy.

* Selenium supports healthy growth and development of baby.

* Zinc supports healthy testosterone levels in men.

* Zinc supports healthy hormonal balance.

* Thyroid hormones increase basal metabolic rate, cellular metabolism and growth and development.

* Selenium plays a role in thyroid hormone production.

* Zinc and selenium are important nutritional antioxidants that assist in protecting the body from the damaging effects of free radicals.

* Selenium has a role in the antioxidant systems.

* Selenium is an important part of the enzyme glutathione peroxidise, and therefore is involved in the body's antioxidant systems.

* Zinc is required for protein synthesis and cell growth.

* Supports healthy vision and eye function.

* Zinc is important for healthy eye function.

* Zinc plays an important role in the visual system.

* Supports healthy skin renewal processes.

* Supports the health and maintenance of the skin.

* Zinc helps to maintain healthy skin function and repair.

* Zinc assists in the maintenance of healthy skin.

* Pyridoxine has an essential role in healthy nervous system function.

* Supports the health and function of the nervous system.

* Supports healthy brain function.

Additional Product information

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

pyridoxine hydrochloride

20 mg

Selenomethionine

65 microgram

zinc amino acid chelate

100 mg

Zinc sulfate monohydrate

68.7 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 03:07:11 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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety