ZMA

Main information

Documents

Localization

  • Available in:
  • ZMA
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208082
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208082

ARTG entry for

Medicine Listed

Sponsor

Global Link Nutrition Pty Ltd

Postal Address

PO BOX 176,Upper Coomera, QLD, 4209

Australia

ARTG Start Date

11/04/2013

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. ZMA

Product Type

Single Medicine Product

Effective date

29/04/2016

Warnings

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 mineral (may state the mineral) supplementation.

For vitamin (may state the vitamin) supplementation.

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

Specific Indications

* Magnesium is a vital catalyst in many enzymatic reactions in the body.

* Magnesium is involved in more than 300 essential metabolic reactions in the body.

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

* Magnesium plays a critical role in energy production in the body.

* Magnesium is involved in the production of ATP, or cellular energy.

* Magnesium plays an important role in cellular activity.

* Magnesium plays a vital role in the metabolism of carbohydrates and fats in the body.

* Zinc is involved in carbohydrate metabolism.

*Contains nutrients that are essential for carbohydrate and fat metabolism.

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

* Magnesium and zinc are involved in protein synthesis in the body.

* Contains nutrients that support healthy metabolism of proteins.

* Magnesium plays a vital role in the body in neuromuscular transmission.

* Magnesium plays a role in nerve conduction on the body.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function and muscle action.

* Magnesium is in vital for muscle activity and contraction and vascular tone in the body.

* Magnesium is required for the synthesis of nucleic acids.

* Magnesium plays a necessary role in the synthesis of RNA and replication of DNA.

* Magnesium is an essential constituent of the bones and it supports the health and strength of the bones.

* Magnesium assists in maintaining healthy bone mineral density.

* Supports/helps to maintain healthy bone mineral density.

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:30:52 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 the maintenance of strong, healthy bones.

* Supports the development and maintenance of strong, healthy bones.

* Supports healthy bone mineral density.

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

* Pyridoxine and zinc are involved in immune system processed in the body.

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

*Contains nutrients that are involved in hormone synthesis and modulation.

* Zinc and vitamin B6 support healthy hormonal balance.

* Zinc supports the health and function of male and female reproductive systems.

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

* Zinc supports healthy testosterone levels in men.

* Zinc is an important nutritional antioxidant and assists in protecting the body from the damaging effects of free radicals.

* Zinc is important for healthy eye function.

* Zinc plays an important role in the visual system.

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function.

* 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.

* Vitamin B6 (Pyridoxine) interacts with magnesium and helps to increase the body's accumulation of magnesium.

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 amino acid chelate

575 mg

magnesium aspartate

59.52 mg

pyridoxine hydrochloride

10 mg

zinc amino acid chelate

50 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 27.11.2017 at 11:30:52 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

1-2-2019

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Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

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Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

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Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

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Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

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EU/3/16/1731 (Alnylam Netherlands B.V.)

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Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

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

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1-6-2018

Valproate

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